Control of pacing pulses provided to patient

Abstract

Methods and systems for controlling pacing pulses delivered to a patient are disclosed. An example method includes monitoring an electrical signal causing the heart of the patient to beat after performing ablation of the heart of the patient. The method may also include determining, with an electronic processor and based on the electrical signal, that an amount of time between consecutive cardiac cycles is greater than a desired value. The method may also include, in response to determining that the amount of time between consecutive cardiac cycles is greater than the desired value, automatically and with the electronic processor, controlling electrodes to deliver pacing pulses to the heart.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 484,569, filed February 13, 2023, which is incorporated herein by reference in its entirety. Technical Field

[0002] The present technology generally relates to methods and systems for controlling pacing pulses provided to a patient's heart. Background Art

[0003] There are many examples of medical treatments that involve cutting, ablating, coagulating, destroying, or otherwise changing the physiological properties of tissue. These techniques can be beneficially used to change the electrophysiological properties of tissue, such as those associated with cardiac arrhythmias or other electrophysiological abnormalities. Arrhythmias can occur in the atria, for example, as in atrial tachycardia, atrial fibrillation ("AF"), or atrial flutter. Arrhythmias can also occur in the ventricles, for example, as in ventricular tachycardia. In addition, there may be ectopic sites within the heart that produce premature activation from such tissue sites, thereby producing arrhythmogenic conduction patterns.

[0004] A method for treating cardiac arrhythmias comprises creating one or more lesions that separate abnormal pathways and direct electrical conduction along selected pathways to promote organized signal conduction while also isolating AF triggers from contra-atrial connections. Typically, the application of energy is used to destroy cells at the ablation site while leaving the surrounding structures of the organ substantially intact. Radiofrequency ("RF") energy and cryogenic cooling have been found to be highly feasible in this regard and are commonly employed. Other ablation techniques include the application of ultrasound, microwaves, lasers, cytotoxic agents, and the like. Yet another ablation technique comprises applying energy in the form of a pulsed electric field (PEF).

[0005] Before, during, and / or after ablation, it may be desirable to attempt to ensure that the heart is beating within a desired heart rate range. Summary of the Invention

[0006] Pulsed field ablation (PFA) is a term used to explain the application of energy in the form of PEF via an electroporation mechanism to ablate cardiac tissue (e.g., create lesions). The electric field and the lesions created by the electric field can depend on many factors, including but not limited to the applied voltage, electrode configuration, pulse waveform, number and length of pulse trains, mode of energy application (i.e., bipolar vs. monopolar), and proximity of the electrodes to the target tissue.

[0007] In some cases, after delivering (e.g., providing, administering, etc.) PFA energy to the patient's heart, the patient's heart may experience a pause (or multiple pauses) in which the patient's heart rate slows. For example, a pause (e.g., a vagal pause) can be an extended pause (e.g., longer than desired or expected) between consecutive heartbeats / cardiac cycles of the heart. It is hypothesized that in some cases, a vagal pause may be caused by electric fields from the PFA energy, which may briefly stimulate the vagus nerve, which in turn temporarily slows the conduction velocity of the vagus nerve and causes a vagal pause and / or a decrease in heart rate (also known as bradycardia, which may include or result from an extended pause between consecutive heartbeats / cardiac cycles of the heart). Although a vagal pause and / or bradycardia may occur after delivering PFA energy to the heart, a vagal pause and / or bradycardia may occur at any time and may be caused by one or more of a variety of other factors.

[0008] For the health and safety of the patient, it is desirable for the patient to maintain a stable heart rate (e.g., above a predetermined heart rate) without vagal pauses. Because cardiac output depends on the amount of blood ejected by the heart (i.e., stroke volume), but also on the rate at which blood is ejected (i.e., heart rate), heart rate is a key factor in determining cardiac output. Clinically significant vagal pauses and / or bradycardia can result in a significant reduction in cardiac output, thereby leading to lowered blood pressure and reduced perfusion to vital organs. Therefore, when vagal pauses and / or bradycardia are detected, a rapid response is desired in order to reduce the length of time of the vagal pause, the amount of vagal pauses experienced by the patient, and / or the length of time the heart is beating at a reduced heart rate.

[0009] The technology of the present disclosure generally relates to automatically controlling pacing pulses provided to a patient's heart in response to determining that the amount of time between consecutive cardiac cycles (e.g., heartbeats) is greater than a desired value. In some cases, determining that the amount of time between consecutive cardiac cycles is greater than a desired value includes determining that a next cardiac cycle expected to follow the previous cardiac cycle has not been detected for a period of time longer than a predetermined amount of time since the previous cardiac cycle was detected (e.g., a vagal pause is detected). Such automatic control of pacing pulses may be particularly useful after or during cardiac ablation. However, such control may also be performed in other situations that do not necessarily involve cardiac ablation.

[0010] In one example, the present disclosure provides a method for controlling pacing pulses provided to a patient. The method may include monitoring an electrical signal that causes the patient's heart to beat after ablation of the patient's heart is performed. The method may also include determining, using an electronic processor and based on the electrical signal, that an amount of time between consecutive cardiac cycles is greater than an expected value. The method may also include automatically controlling, using the electronic processor, an electrode to deliver a pacing pulse to the heart in response to determining that the amount of time between consecutive cardiac cycles is greater than an expected value.

[0011] In some aspects, the method further includes controlling, with the electronic processor, the electrodes to deliver pulsed field ablation (PFA) energy to the heart before determining that the amount of time between consecutive cardiac cycles is greater than a desired value.

[0012] In some aspects, the electrode comprises a first electrode or a pair of first electrodes, and the method further comprises, before determining that the amount of time between consecutive cardiac cycles is greater than a desired value, controlling, using an electronic processor, a second electrode or a pair of second electrodes to deliver pulsed field ablation (PFA) energy to the heart. The second (paired) electrode may be located at a different location in the patient's body than the first electrode. In some aspects, the first (paired) electrode is included on a diagnostic catheter (e.g., a coronary sinus catheter) and the second (paired) electrode is included on an ablation catheter (e.g., a pulmonary vein ablation catheter (PVAC)).

[0013] In some aspects, the electrode includes a first electrode or a pair of first electrodes, and the method further includes continuing to monitor the electrical signal while the pacing pulse is being delivered to the heart. The method may also include determining, using the electronic processor and based on the electrical signal, that a second amount of time between subsequent consecutive cardiac cycles remains greater than a desired value. The method may also include automatically and using the electronic processor to control, in response to determining that the second amount of time between subsequent consecutive cardiac cycles remains greater than the desired value, a second electrode or pair of second electrodes located in the patient's body at a different location than the first electrode to deliver a second pacing pulse to the heart.

[0014] In some aspects, determining that the amount of time between consecutive cardiac cycles is greater than an expected value includes determining the amount of time between consecutive cardiac cycles by determining a RR interval between a first R-wave in a first cardiac cycle and a second R-wave in a second cardiac cycle.

[0015] In some aspects, determining that the amount of time between consecutive cardiac cycles is greater than an expected value includes determining that a next cardiac cycle expected to follow the previous cardiac cycle has not been detected for longer than a predetermined amount of time since the previous cardiac cycle was detected.

[0016] In some aspects, the expected value comprises a predetermined value established independently of previous cardiac cycles of the patient's heart.

[0017] In some aspects, the expected value comprises a predetermined value established based on a predetermined increase in time compared to an average amount of time between consecutive cardiac cycles of a predetermined number of previously monitored cardiac cycles.

[0018] In another example, the present disclosure provides a cardiac pacing device that may include an electrode or a pair of electrodes configured to deliver pacing pulses to a patient's heart. The cardiac pacing device may also include an electronic processor coupled to the electrodes to provide control signals to the electrodes. The electronic processor may be configured to monitor electrical signals that cause the patient's heart to beat after performing ablation on the patient's heart. The electronic processor may also be configured to determine, based on the electrical signals, that an amount of time between consecutive cardiac cycles is greater than a desired value. The electronic processor may also be configured to automatically control the electrodes to deliver pacing pulses to the heart in response to determining that the amount of time between consecutive cardiac cycles is greater than a desired value.

[0019] In some aspects, the electronic processor may be further configured to control the electrode or pair of electrodes to deliver pulsed field ablation (PFA) energy to the heart prior to determining that the amount of time between consecutive cardiac cycles is greater than a desired value.

[0020] In some aspects, the electrodes include a first electrode or a pair of first electrodes, and the electronic processor may be further configured to control a second electrode or a pair of second electrodes to deliver pulsed field ablation (PFA) energy to the heart before determining that the amount of time between consecutive cardiac cycles is greater than a desired value. The second (paired) electrode may be located at a different location within the patient's body than the first (paired) electrode.

[0021] In some aspects, the electrode includes a first electrode or a pair of first electrodes, and the electronic processor can be further configured to continue monitoring the electrical signal while the pacing pulse is being delivered to the heart. The electronic processor can be further configured to determine, based on the electrical signal, that a second amount of time between subsequent consecutive cardiac cycles remains greater than a desired value. The electronic processor can be further configured to automatically control a second electrode or pair of second electrodes located at a different location within the patient's body than the first (paired) electrode to deliver a second pacing pulse to the heart in response to determining that the second amount of time between subsequent consecutive cardiac cycles remains greater than the desired value.

[0022] In some aspects, the electronic processor can be configured to determine that the amount of time between consecutive cardiac cycles is greater than an expected value by determining that a next cardiac cycle expected to follow the previous cardiac cycle has not been detected for longer than a predetermined amount of time since the previous cardiac cycle was detected.

[0023] In another example, the present disclosure provides a method of controlling pacing pulses provided to a patient. The method may include delivering pulsed field ablation (PFA) energy to the patient's heart. The method may also include monitoring an electrical signal that causes the patient's heart to beat after delivering the PFA energy to the patient's heart. The method may also include detecting, with an electronic processor and based on the electrical signal, bradycardia of the heart between consecutive cardiac cycles of the heart by determining that an amount of time between consecutive cardiac cycles is greater than an expected value. The method may also include automatically and with the electronic processor controlling an electrode or pair of electrodes to deliver pacing pulses to the heart in response to detecting bradycardia by determining that the amount of time between consecutive cardiac cycles is greater than an expected value.

[0024] In some aspects, delivering PFA energy to the patient's heart includes delivering PFA energy to the patient's heart via the electrode (pair of electrodes) before determining that the amount of time between consecutive cardiac cycles is greater than a desired value.

[0025] In some aspects, the electrode includes a first electrode or a pair of first electrodes, and the method may further include controlling, using an electronic processor, a second electrode or a pair of second electrodes to deliver PFA energy to the heart. The second (paired) electrode may be located at a different location within the patient's body than the first (paired) electrode.

[0026] In some aspects, the first (pair of) electrodes are included on a diagnostic catheter (eg, a coronary sinus catheter) and the second (pair of) electrodes are included on an ablation catheter.

[0027] In some aspects, the electrode includes a first electrode or a pair of first electrodes, and the method may further include continuing to monitor the electrical signal while the pacing pulse is being delivered to the heart. The method may further include determining, using the electronic processor and based on the electrical signal, that a second amount of time between subsequent consecutive cardiac cycles remains greater than a desired value. The method may further include automatically and using the electronic processor to control, in response to determining that the second amount of time between subsequent consecutive cardiac cycles remains greater than the desired value, a second electrode or pair of second electrodes located in the patient's body at a different location than the first electrode to deliver a second pacing pulse to the heart.

[0028] In some aspects, determining that the amount of time between consecutive cardiac cycles is greater than an expected value includes determining that a next cardiac cycle expected to follow the previous cardiac cycle has not been detected for longer than a predetermined amount of time since the previous cardiac cycle was detected.

[0029] The details of one or more aspects of the present disclosure are set forth in the following drawings and the description. Other features, objects, and advantages of the technology described in this disclosure will be apparent from the description and drawings, and from the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] Figure 1A An example ablation system including a pulsed field ablation catheter having a distal circular electrode array portion is shown according to one example.

[0031] Figure 1B According to an example, a Figure 1A A more detailed view of an additional medical device having a linear electrode array portion in the system.

[0032] Figure 2 Based on an example Figure 1A Block diagram of the generator of the ablation system.

[0033] Figure 3 Shown by Figure 2 Flowchart of a method that an electronic processor of a generator executes to control the delivery of pacing pulses to a patient's heart. DETAILED DESCRIPTION

[0034] The present application provides, among other things, methods and systems for use during diagnosis and / or treatment of undesirable physiological or anatomical tissue regions, such as those contributing to abnormal electrical pathways in the heart. Referring now to the drawings, in which like reference numerals refer to like elements, examples of medical systems constructed in accordance with the principles of the present disclosure are shown in FIG. Figure 1A and Figure 1B , and generally designated as “10”. The system 10 generally includes a medical device 12 that can be directly coupled to an energy supply (e.g., a pulsed field ablation (PFA) generator 14) that includes an energy control, delivery system, and monitoring system. In some aspects, the medical device 12 is indirectly coupled to the energy supply via a catheter electrode distribution system 13. A remote controller 15 can also be included that communicates with the generator 14 for operating and controlling various functions of the generator 14. The medical device 12 can generally include one or more diagnostic or treatment regions for energy, therapeutic, and / or investigative interactions between the medical device 12 and a treatment site. The treatment region can deliver, for example, pulsed electroporation energy to a tissue region proximate the treatment region.

[0035] The medical device 12 may include an elongated body 16, such as a catheter, sheath, or intravascular introducer, which can be passed through the vasculature of a patient and / or can be positioned proximate to a tissue area to be diagnosed or treated. The elongated body 16 may define a proximal portion 18 and a distal portion 20, and may also include one or more lumens disposed within the elongated body 16, thereby providing mechanical, electrical, and / or fluid communication between the proximal portion 18 of the elongated body 16 and the distal portion 20 of the elongated body 16. The distal portion 20 may generally define one or more treatment regions of the medical device 12, which are operable to monitor, diagnose, and / or treat a portion of a patient. The treatment region may have a variety of configurations to facilitate such operations. In the case of pure bipolar pulsed field delivery, the distal portion 20 includes electrodes forming a bipolar configuration for energy delivery. In an alternative configuration, a plurality of electrodes 24 are used as one pole, and a second device comprising one or more electrodes (not shown) will be positioned to serve as the opposite pole of the bipolar configuration. For example, as Figure 1A As shown, the distal portion 20 may include an electrode carrier arm 22 that is transitionable between a linear configuration and an expanded configuration, wherein the carrier arm 22 has an arcuate or substantially circular configuration. The carrier arm 22 may include a plurality of electrodes 24 (e.g., nine electrodes 24, such as Figure 1A , the plurality of electrodes 24 are configured to deliver pulsed field energy. Furthermore, when in the expanded configuration, the carrier arm 22 can lie in a plane that is substantially orthogonal to the longitudinal axis of the elongated body 16. The planar orientation of the expanded carrier arm 22 facilitates easy placement of the plurality of electrodes 24 into contact with the target tissue. Alternatively, the medical device 12 can have a linear configuration with the plurality of electrodes 24. In one example, the distal portion 20 includes six electrodes 24 linearly arranged along a common longitudinal axis. In some cases, the distal portion / catheter 20 is referred to as / used as a pulmonary vein isolation catheter or an ablation catheter.

[0036] The system 10 may also include three or more electrocardiogram (ECG) electrodes 26 that are configured to be placed in or on the patient and are configured to communicate with the generator 14 via the catheter electrode distribution box 13. The electrodes 26 can be used to monitor the patient's cardiac activity to determine how to control pacing pulses delivered to the patient's heart (e.g., when / whether to deliver pacing pulses to the heart, the location / catheter to be used to deliver pacing pulses to the heart, etc.), as explained in more detail below. For example, the electrodes 26 and / or other electrodes 24, 110 described herein can collect data that can be used by the generator 14 to determine the QRS complex of the patient's heartbeat / cardiac cycle. In some cases, based on continuous QRS complexes, the generator 14 determines, for example, the patient's heart RR interval, which indicates the patient's instantaneous heart rate. In addition to monitoring, recording, or otherwise transmitting measurements or conditions within the medical device 12 or the surrounding environment at the distal portion 20 of the medical device 12, additional measurements can be made through connection to the multi-electrode catheter, including, for example, temperature in the generator 14 and / or the medical device 12, electrode-tissue interface impedance, delivered charge, current, power, voltage, work, etc. The surface ECG electrodes 26 can communicate with the generator 14 to initiate or trigger one or more alerts, therapeutic delivery, and / or pacing pulse delivery during operation of the medical device 12. In some cases, additional or alternative information is used to monitor patient information, such as cardiac cycle and timing. For example, the system 10 can receive intracardiac electrogram (EGM) information and / or other information from one or more other electrodes and / or devices / sensors. An additional neutral electrode patient ground patch (not shown) may be employed to assess the desired bipolar electrical path impedance, as well as to monitor and alert the operator when inappropriate and / or unsafe conditions are detected, including, for example: inappropriate (excessive or insufficient) delivery of charge, current, power, voltage, and work performed by the plurality of electrodes 24; inappropriate and / or excessive temperature of the plurality of electrodes 24; inappropriate electrode-tissue interface impedance; and assessing the integrity of the tissue electrical path by delivering one or more low voltage test pulses, and improper and / or unintentional electrical connection to the patient prior to delivering high voltage energy.

[0037] The generator 14 may include a current or pulse generator having multiple output channels, each channel coupled to a single electrode of the plurality of electrodes 24 or multiple electrodes of the plurality of electrodes 24 of the medical device 12. In some cases, the generator 14 can operate in one or more modes of operation, including, for example: (i) bipolar energy delivery between at least two electrodes 24 or conductive portions of the medical device 12 within the patient's body; (ii) monopolar energy delivery to one or more of the electrodes 24 or conductive portions on the medical device 12 within the patient's body and through a second device (not shown) within the body or a patient return or ground electrode (not shown) spaced apart from the plurality of electrodes 24 of the medical device 12, such as on the patient's skin or on an auxiliary device positioned within the patient's body remote from the medical device 12; and (iii) a combination of monopolar and bipolar modes.

[0038] Generator 14 can provide electric pulse to medical device 12 to perform electroporation process to other tissues in heart tissue or body (for example, organs or tissues in kidney tissue, airway tissue and cardiothoracic space). "Electroporation" utilizes high amplitude pulse to complete the physiological modification (for example, permeabilization) of the cell to which energy is applied. Such pulses can preferably be short-lived (for example, nanosecond, microsecond or millisecond pulse width) to allow application of high voltage, high current (for example, 20 amperes or more amperes) and long-duration current flow without causing significant tissue heating and muscle stimulation. Preferably, pulse energy induces formation of microscopic pores or openings in cell membranes. Depending on the characteristics of the electric pulse, the electroporated cells can survive (for example, "reversible electroporation") or die (for example, irreversible electroporation, "IEP") after electroporation. Reversible electroporation can be used for reagents (including macromolecules) to be delivered to target cells for various purposes, including changing the action potential of cardiomyocytes.

[0039] In some cases, the generator 14 can be configured (e.g., programmed) to deliver a pulsed high voltage electric field suitable for achieving the desired pulsed high voltage ablation (or pulsed field ablation). As a point of reference, the pulsed, high voltage, non-RF ablation effect of the present disclosure can be distinguished from DC current ablation and thermally induced ablation that accompanies conventional RF techniques. For example, the pulse trains delivered by the generator 14 are delivered at a frequency of less than 3 kHz, and in an example configuration are delivered at a frequency of 1 kHz (which is a lower frequency than RF treatment). The pulsed field energy according to the present disclosure is sufficient to induce cell death so as to completely block abnormal conduction pathways along or through cardiac tissue, thereby destroying the ability of the cardiac tissue so ablated to propagate or conduct cardiac depolarization waveforms and associated electrical signals.

[0040] In some cases, the plurality of electrodes 24 perform diagnostic functions, such as collecting intracardiac electrograms (EGMs) and selectively pacing intracardiac sites for diagnostic purposes. In one configuration, the measured ECG signals are transmitted from the catheter electrode energy distribution system 13 to an electrophysiology (EP) recording system input box (not shown) included with the generator 14. The plurality of electrodes 24 may also monitor proximity to target tissue and the quality of contact with such tissue using impedance-based measurements of the connection to the catheter electrode energy distribution system 13. The catheter electrode energy distribution system 13 may include a high-speed relay to disconnect / reconnect specific electrodes 24 from the generator 14 during treatment. Immediately after the pulse energy is delivered, the relay reconnects the electrodes 24 so that they can be used for diagnostic purposes.

[0041] While in some cases one or more of the electrodes 24 can perform both pacing (e.g., providing pacing pulses) and ablation, in some cases the system 10 can include one or more optional additional medical devices and associated elongated structures / catheters that can be configured to perform pacing. In one example, the system 10 includes another instance of the medical device 12 having another instance of the distal portion 20. In another example, the system 10 includes one or more additional medical devices 28 having an elongated body 30 that includes a proximal portion 32 and a distal portion 34 that is different from the distal portion 34. Figure 1A and Figure 1B Distal portion 20 is shown. Except for the differences described below, these components 28, 30, 32 and 34, which share names with previously described components 12, 16, 18 and 20, respectively, can be similar to and function similarly to their respective similarly named components.

[0042] In some cases, the distal portion 34 (which is Figure 1B 10 (shown in an enlarged scale in FIG1 ) includes a catheter / elongated structure 112 carrying a plurality of electrodes 110A to 110H (collectively referred to as "electrodes 110"). The catheter 112 may include a distal portion 106 and a proximal portion 108. The electrodes 110 may generally be positioned at the distal portion 106, while the proximal portion 108 may ultimately be connected to the catheter electrode distribution system 13. Similar to the electrodes 24 previously described herein, the electrodes 110 may be configured to deliver pacing pulses and / or perform diagnostic functions, such as collecting intracardiac electrograms (EGMs). In some cases, unlike the electrodes 24 previously described herein, the electrodes 110 are not used to deliver PFA energy to the heart. In some cases, the electrodes 110 are dedicated pacing and / or diagnostic electrodes 110, and the catheter 112 is a dedicated pacing and / or diagnostic catheter 112. In some cases, the catheter 112 is referred to as / used as a diagnostic catheter, such as a coronary sinus catheter.

[0043] In some cases, the use of multiple electrodes 24, 110 and / or catheters 20, 112 allows for the delivery of pacing pulses to the heart at a location different from where PFA energy is delivered to the heart, as explained in more detail below. In some cases, the use of multiple electrodes 24, 110 and / or catheters 20, 112 allows for the delivery of pacing pulses to the heart at multiple different locations, either simultaneously or sequentially, as explained in more detail below.

[0044] Electrodes 24 and / or 110 can have any suitable geometry. Example electrode geometries include, but are not necessarily limited to, a circular (e.g., ring) electrode surrounding the body of the lead, a conformable electrode, a hoop-shaped electrode, a segmented electrode (e.g., an electrode disposed at different circumferential locations around the lead, rather than a continuous ring electrode), or any combination thereof (e.g., a ring electrode and a segmented electrode). Electrodes 110 can be distributed axially along the longitudinal axis LA of catheter 112. Figure 1A and Figure 1B The catheter 112 and electrodes 24, 110 shown are merely examples. In some cases, the catheter 112 includes more or fewer electrodes 110, and / or the distal portion 20 may include more or fewer electrodes 24. Additionally or alternatively, the electrodes 24 and / or 110 may be arranged in different configurations, including the use of coils or other return electrodes. In some cases, the catheter 112 and / or distal portion 20 have different shapes at the point where the catheter 112 and / or distal portion 20 contacts the patient's tissue.

[0045] In some aspects, the plurality of electrodes 24 deliver therapeutic biphasic pulses having a pre-programmed pattern and duty cycle, as explained in U.S. Patent No. 10,531,914 (U.S. Patent Application No. 15 / 228,406), which is incorporated herein by reference and attached hereto. In some aspects, when delivered from a bipolar electrode array (such as the array shown in FIG1 ), the pulse train produces lesions in the myocardium in the range of approximately 2 mm to 3 mm deep, 4 mm to 7 mm deep, etc. Increasing the voltage can correspondingly increase the depth of the lesion.

[0046] As previously explained herein, the system 10 may include ECG electrodes 26 that may be electrically coupled to the generator 14 and configured to measure electrical signals from the heart. The ECG measurements, or Einthoven signals, performed by the ECG electrodes 26 may be performed sequentially or simultaneously with the delivery of pulse trains from the plurality of electrodes 24. In an example configuration, three ECG electrodes 26 are adhered to the surface of the patient and further coupled to the generator 14. The generator 14 may be configured to process and correlate the measured Einthoven signals to determine when to deliver a pulse of PFA energy and / or whether and when to deliver a pacing pulse. In some cases, the generator 14 is configured to process and correlate the measured Einthoven signals to determine whether and when to deliver a pacing pulse to the heart, as explained in more detail below. For example, the generator 14 may be programmed with predetermined measured patient parameters (e.g., timing parameters associated with a desired heart rate value or related value) to control the timing of delivery of pacing pulses to the patient's heart, as explained in more detail below. Generator 14 may initiate delivery of pacing pulses when at least one of the predetermined measured patient parameters is met.

[0047] In some cases, the generator 14 automatically controls the timing of delivering pacing pulses to the patient's heart in response to determining that the amount of time between consecutive cardiac cycles (e.g., heartbeats) is greater than a desired value. For example, in some cases, the generator 14 may perform Figure 3 Method 300 is shown for controlling the delivery of pacing pulses to a patient's heart. In some cases, determining that the amount of time between consecutive cardiac cycles is greater than an expected value includes determining that a next cardiac cycle expected to follow the previous cardiac cycle has not been detected for more than a predetermined amount of time since the previous cardiac cycle was detected (e.g., a vagal pause is detected). Such automatic control of pacing pulses may be particularly useful after or during cardiac ablation. However, such control may also be performed in other situations not necessarily involving cardiac ablation.

[0048] Figure 2 is a block diagram of a generator 14 of an ablation system 10 according to one example. In the example shown, the generator 14 includes an electronic processor 205 (e.g., a microprocessor or another electronic device). The electronic processor 205 can be electrically connected to a memory 210 and can include input and output interfaces to communicate with other devices of the system 10 (e.g., a microprocessor or another electronic device). Figure 2 A remote controller 15 is shown coupled to a catheter electrode distribution system 13).

[0049] The memory 210 may include read-only memory (ROM), random access memory (RAM), other non-transitory computer-readable media, or a combination thereof. The electronic processor 205 is configured to receive instructions and data from the memory 210 and, in particular, execute these instructions. In particular, the electronic processor 205 executes the instructions or algorithms stored in the memory 210 to provide for automated operation and execution of the features, sequences, calculations, or procedures described herein.

[0050] In some aspects, the generator 14 includes a Figure 2 The configuration shown may include fewer or additional components in a different configuration. For example, the generator 14 may include a display and / or an integrated user input device in addition to or in lieu of the remote controller 15. As another example, in some aspects, the generator 14 includes one or more additional electronic processors that can perform specific functions and are communicatively coupled (electrically or electromagnetically) to each other and / or to the electronic processor 205. When reference is made herein to the electronic processor 205, it should be understood that the functions performed by the electronic processor 205 may be performed by one or more electronic processors 205 within the generator 14 and / or distributed within other devices of the system 10.

[0051] Other devices of the system 10 may include similar components as the generator 14. For example, the catheter electrode distribution system 13, the remote controller 15, and / or the medical devices 12, 28 may each include an electronic processor and memory similar to those previously described herein with respect to the generator 14. In some aspects, these other devices 12, 13, 15, 28 may additionally or alternatively have other components that allow each device 12, 13, 15, 28 to perform its respective functions as described herein.

[0052] exist Figure 2 , the medical device 28 is shown in dashed lines to indicate that in some cases the medical device 28 may not be included in the system 100. Figure 2 Other devices are shown in solid lines in FIG. 1 , but in some cases, some of such devices may not be included in system 100 .

[0053] In some cases, the medical device 12 includes a catheter 20 that provides both PFA energy for ablation (e.g., a first signal / pulse train) and pacing pulses for pacing the patient's heart (e.g., a second signal / pulse train that is different from the first signal / pulse train). For example, the catheter 20 provides the PFA energy and the pacing pulses at different times and using the same or different electrodes 24, as explained herein. In some cases, one or more of the electrodes 24 can also perform diagnostics (e.g., EGM monitoring / recording). In some cases, an optional medical device 28 includes a catheter 112 that is configured to provide only pacing pulses, configured to provide only diagnostic capabilities, or configured to provide both pacing pulses and diagnostic capabilities.

[0054] In some cases, the electronic processor 205 of the generator 14 is configured to function as a PFA generator / controller, a pacing controller, and / or a diagnostic controller. In some cases, the electronic processor 205 automatically controls the timing of the delivery of pacing pulses to the patient's heart in response to determining that the amount of time between consecutive cardiac cycles (e.g., heartbeats) is greater than a desired value. For example, in some cases, the generator 14 may perform Figure 3 Method 300 is shown for controlling the delivery of pacing pulses to a patient's heart. As previously explained herein, this automatic control of the delivery of pacing pulses to the heart addresses technical challenges (e.g., a patient experiencing a vagal pause or a decrease in heart rate / bradycardia, such as caused by the delivery of PFA energy) by rapidly responding when a vagal pause and / or bradycardia is detected. The rapid and automatic response provided by method 300 reduces the length of time of a vagal pause, the amount of vagal pause experienced by the patient, and / or the length of time the heart beats at a reduced heart rate. Thus, by attempting to maintain a stable heart rate (e.g., above a predetermined heart rate) without a vagal pause, the rapid and automatic response of system 100 results in increased patient health and safety.

[0055] Figure 3 A flow chart of a method 300 is shown that is executed by the electronic processor 205 of the generator 14 (in some cases in conjunction with other devices in the system 100) to control the delivery of pacing pulses to the patient's heart. Figure 3 A particular order of processing steps is indicated in the as an example, but the timing and sequencing of such steps may be varied where appropriate without negating the purposes and advantages of the examples set forth throughout this document. Figure 3 In the embodiment of the present invention, some boxes / steps are shown in dashed lines to indicate that these boxes / steps are optional and may not be performed in some instances of the method 300. Although other boxes / steps are shown in dashed lines, they may not be performed in some instances of the method 300. Figure 3 300 , but in some cases, some of such boxes / steps may not be included in the method 300 .

[0056] At block 305, pulsed field ablation (PFA) energy is optionally delivered to the patient's heart. Where block 305 is performed, method 300 may be performed in conjunction with the application of PFA energy to control the delivery of pacing pulses to the heart during and / or after the PFA energy delivery. However, as previously indicated herein, method 300 may also be performed without PFA energy being delivered to the heart. In some cases, a pacing pulse may be used. Figure 1A One or more electrodes of the catheter / distal portion 20 or using Figure 1B One or more electrodes of the catheter / distal portion 112 deliver PFA energy to the heart.

[0057] At block 310, the electrical signals that cause the patient's heart to beat are monitored. For example, an electrocardiogram (ECG) of the patient's heart is determined by the electronic processor 205 of the generator 14. In some aspects, the ECG may be determined by another electronic processor of another device. The ECG is determined based on electrical signals received from one or more electrodes. The electrodes that provide the electrical signals that allow the ECG to be determined may include one or more of the electrodes 24, one or more of the electrodes 110, one or more of the ECG electrodes 26, or a combination thereof. In some aspects, the first electrode 24 or 110 that delivers PFA energy to the treatment site of the heart can also be used to monitor the heart's electrical signals for generating the ECG. Although a single electrode is discussed herein for the purposes of discussing electrodes 24 and 110, it should be understood that paired electrodes are contemplated with respect to electrodes 24 and 100 and are within the scope of this disclosure (unless otherwise discussed). In one example, a unipolar signal is measured from an indwelling PFA catheter having electrodes 24 or 110, and PFA energy is delivered from the same electrodes 24 and 110. As another example, bipolar signals from an indwelling PFA catheter can be measured from both electrodes 24 or 110, and PFA energy can be delivered in a bipolar manner from both electrodes 24 or 110. In some cases, the two examples above can be mixed and matched. In one example, a unipolar signal is measured by the indwelling catheter while bipolar PFA energy is delivered to the treatment site, or vice versa. In some aspects, a second electrode (e.g., ECG electrode 26) that is separate from electrodes 24, 110 and not used to deliver PFA energy to the treatment site is used to monitor the heart's electrical signals for generating an ECG. In some cases, one or more of electrodes 24 can be used to deliver PFA energy to the heart, and one or more of electrodes 110 can be used to monitor cardiac signals, or vice versa. In some cases, the electronic processor 205 receives additional or alternative information to monitor the cardiac cycle. For example, the electronic processor 205 can receive intracardiac electrogram (EGM) information and / or other information from one or more other electrodes and / or devices / sensors. In examples of method 300 performing block 305 to deliver PFA energy to a patient's heart, monitoring of the electrical signals that beat the patient's heart may occur after performing ablation on the patient's heart.

[0058] At block 315, the electronic processor 205 of the generator 14 determines whether the amount of time between consecutive cardiac cycles is greater than a desired value (e.g., whether bradycardia is detected) based on the electrical signal monitored at block 310. In some cases, the electronic processor 205 is configured to determine the amount of time between consecutive cardiac cycles by determining a first time interval between the occurrence of a first wave in the current cardiac cycle and the occurrence of a second wave in the electrical signal (e.g., ECG) of one or more previous cardiac cycles. In some aspects, the first wave and the second wave are consecutive occurrences of the same first type of wave included in the electrical signal. In other words, in some aspects, the electronic processor 205 is configured to determine a first time interval between consecutive occurrences of a first type of wave (e.g., R wave, P wave, Q wave, etc.) included in the electrical signal. For example, the electronic processor 205 is configured to determine the RR interval between a first R wave in a first cardiac cycle and a second R wave in a second cardiac cycle (e.g., the RR interval between consecutive heartbeats / cardiac cycles). Other types of waves and intervals may also be used in some aspects.

[0059] In some cases, the electronic processor 205 is configured to determine that the amount of time between consecutive cardiac cycles is greater than an expected value by determining that a next cardiac cycle expected to follow the previous cardiac cycle has not been detected for a period of time longer than a predetermined amount of time since the previous cardiac cycle was detected. For example, if the next cardiac cycle has not occurred within a certain period of time, the electronic processor 205 determines that the amount of time between cardiac cycles is greater than an expected amount of time, even if the next cardiac cycle has not occurred / been detected. Thus, the electronic processor 205 can determine that the amount of time between consecutive cardiac cycles is greater than an expected value even if the second / next cardiac cycle has not occurred / been detected. This configuration allows the electronic processor 205 to detect pauses (e.g., vagal pauses) in which the patient's heart does not beat / participate in a cardiac cycle for a period of time longer than expected / expected. In some cases, detection of a vagal pause occurs when the next heartbeat / cardiac cycle is not detected within a predetermined amount of time, or when the next heartbeat / cardiac cycle is detected but occurs more than a predetermined amount of time after the previous heartbeat / cardiac cycle. In other words, in some cases, at block 315, the electronic processor 205 is configured to detect a cardiac vagal pause between consecutive cardiac cycles of the heart based on the electrical signal by determining that an amount of time between consecutive cardiac cycles is greater than an expected value.

[0060] In some cases, the desired value at block 315 comprises a predetermined value (e.g., a predetermined amount of time). In some cases, the desired value comprises a predetermined value established independently of previous cardiac cycles of the patient's heart. For example, a predetermined value may be established to initiate / trigger a pacing pulse to be delivered in response to the amount of time between consecutive cardiac cycles being greater than a critical threshold that is undesirable for most or all patients, regardless of their historical heartbeat / cardiac cycle timing / pattern. For example, the predetermined value may be set to 40 beats per minute (BPM), 45 BPM, etc.

[0061] In some cases, the desired value at block 315 includes a predetermined value established based on a predetermined increase in time compared to an average amount of time between consecutive cardiac cycles of a predetermined number of previously monitored patient cardiac cycles. Using such a predetermined value can allow the electronic processor 205 to initiate / trigger a pacing pulse to be delivered in response to determining an increase (e.g., a percentage increase in the time between heartbeats / cardiac cycles) compared to a previously monitored patient cardiac cycle that caused pacing to be triggered. For example, the predetermined value can be a 30% increase in time between heartbeats / cardiac cycles (or a corresponding 30% decrease in heart rate), a 50% increase in time between heartbeats / cardiac cycles (or a corresponding 50% decrease in heart rate), etc. In such cases, the patient's heart rate may be above the critical threshold explained in the previous example, but the electronic processor 205 can still initiate / trigger a pacing pulse to be delivered to the heart based on the decrease in heart rate being greater than the predetermined value. Thus, in some cases, the electronic processor 205 may use any of the predetermined values ​​explained in the two examples above to determine whether the amount of time between consecutive cardiac cycles is greater than a desired value (at block 315). In other words, the electronic processor 205 may initiate / trigger a pacing pulse (at block 320) in response to any of the monitored characteristics explained in the two examples above falling outside of the range of its corresponding predetermined value.

[0062] In some cases, the electronic processor 205 is configured to determine that the amount of time between consecutive cardiac cycles is greater than a desired value by determining that bradycardia has persisted for a predetermined period of time. For example, if bradycardia and / or pauses are detected for two seconds, but then the heart's activity returns to normal function, pacing may not be initiated. However, if the bradycardia and / or pauses persist for a predetermined period of time, pacing may be initiated. In some cases, the predetermined period of time may be set to correspond to a period of time expected to induce syncope (e.g., loss of consciousness in an unsedated / anesthetized patient). Thus, in such cases, pacing may be initiated if the bradycardia and / or pauses persist for longer than a predetermined period of time (e.g., approximately 6 to 10 seconds, etc.). In some cases, the electronic processor 205 is configured to determine that the amount of time between consecutive cardiac cycles is greater than a desired value by determining that the patient's average heart rate over the predetermined period of time is below a threshold (even if some of the specific amounts of time between two specific consecutive cardiac cycles within the predetermined period of time may not be greater than the desired value). For example, pacing may be initiated in response to determining that the patient's average heart rate has been below a threshold value (e.g., 30 BPM, 40 BPM, etc.) for a predetermined period of time (e.g., five seconds, six to ten seconds, etc.). Similarly, in some cases, the electronic processor 205 is configured to determine that the amount of time between consecutive cardiac cycles is greater than a desired value by determining that the amount of cardiac cycles within a predetermined period of time is less than a desired amount (even though some of the specific amounts of time between two specific consecutive cardiac cycles within the predetermined period of time may not be greater than the desired value). In some cases, pacing may be initiated / triggered in response to detecting a pause and / or bradycardia in other ways. For example, a pause and / or bradycardia may be detected in other ways as disclosed in U.S. Patent No. 11,260,234 (U.S. Patent Application No. 16 / 702,928) and / or U.S. Patent No. 9,937,352 (U.S. Patent Application No. 14 / 920,228), the entire contents of each of which are incorporated herein by reference and attached herein.

[0063] At block 315, when the electronic processor 205 determines that the amount of time between consecutive cardiac cycles is not greater than the expected value, the method 300 returns to block 310 to continue monitoring the electrical signals that beat the patient's heart. On the other hand, at block 315, when the electronic processor 205 determines that the amount of time between consecutive cardiac cycles is greater than the expected value, the method 300 proceeds to block 320.

[0064] At block 320, the electronic processor 205 automatically controls the electrodes 24, 110 to deliver pacing pulses to the heart in response to determining that the amount of time between consecutive cardiac cycles is greater than a desired value. As indicated in the previous explanation of block 315, in some cases, the electronic processor 205 automatically controls the electrodes 24, 110 to deliver pacing pulses to the heart in response to detecting a vagal pause by determining that the amount of time between consecutive cardiac cycles is greater than a desired value. The pacing pulses may be delivered at a predetermined rate (e.g., 70 BPM, etc.).

[0065] In some cases, the electrode 24, 110 used to deliver the pacing pulse to the heart (at block 320) is the same electrode 24, 110 that was used to deliver PFA energy to the heart (at block 305) before determining that the amount of time between consecutive cardiac cycles is greater than a desired value. In such cases, the PFA energy and the pacing pulse can be delivered to the same location of the heart. In some cases, the same catheter 20, 112 can be used to deliver the pacing pulse to the heart (at block 320) and to deliver the PFA energy to the heart (at block 305), but different electrodes 24, 110 of the catheter 20, 112 can be used to deliver the pacing pulse and the PFA energy, respectively. In such cases, the PFA energy and the pacing pulse can be delivered to the same area of ​​the heart, but at slightly different locations corresponding to the locations of the separate electrodes 24, 110.

[0066] In some cases, a first catheter 112 including a first electrode 110 is used to deliver pacing pulses (at block 320), and a second catheter 20 including a second electrode 24 is used to deliver PFA energy (at block 305). Thus, catheters 112 and 20 (and their electrodes 110 and 24) can be located at different locations within a patient's body to deliver pacing pulses to a different region of the heart than where PFA energy is delivered. For example, first catheter 112 can be a diagnostic catheter (e.g., a coronary sinus catheter) located at or near a diagnostic location (e.g., near the coronary sinus of the heart), and second catheter 20 can be an ablation catheter located at or near the pulmonary veins of the heart. As another example, first catheter 112 (or another catheter) configured to deliver pacing pulses (at block 320) can be located at the left ventricle (e.g., the epicardial left ventricle) and / or the right ventricle (e.g., the epicardial right ventricle).

[0067] In some cases, when different electrodes 24, 110 and / or different catheters 20, 112 are used to deliver pacing pulses and PFA energy, the pacing pulses and PFA energy may be delivered during overlapping time periods (e.g., simultaneously) and / or during different time periods.

[0068] After executing block 320 and while pacing pulses are being delivered to the patient's heart, the electronic processor 205 can continue to monitor the electrical signals that beat the patient's heart in a manner similar to that previously described herein with respect to block 310. At block 325, the electronic processor 205 determines whether a second amount of time between subsequent consecutive cardiac cycles remains greater than a desired value based on the patient's electrical signals being monitored. In some cases, the determination made at block 325 is similar to the determination made at block 315.

[0069] At block 325, when the second amount of time between subsequent consecutive cardiac cycles does not remain greater than the desired value (e.g., the patient's heart rate has increased to the desired rate), method 300 proceeds to block 330. In such situations, the control of the pacing pulses (at block 320) performed in a rapid and automatic manner can increase the patient's health and safety because their heart rate returns to the desired rate very quickly. At block 330, the electronic processor 205 can control the electrodes 24, 110 that are providing the pacing pulses to stop providing the pacing pulses. In some cases, at block 330, the electronic processor 205 can control the electrodes 24, 110 that are providing the pacing pulses to continue providing the pacing pulses for a limited period of time (e.g., five seconds, ten seconds, etc.) before controlling the electrodes 24, 110 that are providing the pacing pulses to stop providing the pacing pulses. In some cases, after executing block 330, method 300 returns to block 310 (or block 305) to continue monitoring the electrical signals that cause the patient's heart to beat.

[0070] On the other hand, at block 325, when the second amount of time between subsequent consecutive cardiac cycles remains greater than the desired value (or when the second amount of time at least does not begin to shorten / decrease), the method 300 proceeds to block 335. At block 335, the electronic processor 205 may automatically control a second electrode 24, 110 located at a different location within the patient's body than the first electrode 24, 110 that is already delivering the first pacing pulse to the heart to deliver an additional or alternative pacing pulse (e.g., a second pacing pulse) to the heart in response to determining that the second amount of time between subsequent consecutive cardiac cycles remains greater than the desired value. In other words, because the first pacing pulse already being delivered by the first electrode 24, 110 has not increased the patient's heart rate slightly or to the desired heart rate, the system 100 may implement additional or alternative pacing at a different location within the heart (e.g., using a different second electrode 24, 110 and / or catheter 20, 112).

[0071] For example, if the pacing pulses being delivered by the ablation catheter 20 to the pulmonary veins of the heart do not increase the patient's heart rate slightly or to a desired rate, the electronic processor 205 may automatically control the diagnostic catheter 112 (e.g., a coronary sinus catheter) to deliver additional or alternative pacing pulses to an area such as the coronary sinus. For another example, if the pacing pulses being delivered by the diagnostic catheter 112 to an area such as the coronary sinus of the heart do not increase the patient's heart rate slightly or to a desired rate, the electronic processor 205 may automatically control the ablation catheter 20 to deliver additional or alternative pacing pulses to the pulmonary veins of the heart. For another example, if the pacing pulses being delivered by the diagnostic catheter 112 to the coronary sinus of the heart do not increase the patient's heart rate to a desired rate, the electronic processor 205 may automatically control an additional electrode and / or catheter (e.g., a third catheter) located at a different location (e.g., a third location) of the heart to deliver additional or alternative pacing pulses to that different location of the heart. For example, the third location may include a ventricular chamber, such as the left ventricle (e.g., epicardial left ventricle) and / or the right ventricle (e.g., epicardial right ventricle). As indicated by the "additional or alternative" language in the previous example, at block 335, the electronic processor 205 may control the initial / first pacing pulse to continue delivering the initial / first pacing pulse when the second pacing pulse (and / or third pacing pulse) is also being delivered to a different region of the heart, or may control the initial / first pacing pulse to cease delivering the initial / first pacing pulse when the second pacing pulse (and / or third pacing pulse) is being delivered to a different region of the heart.

[0072] like Figure 3As indicated in FIG, at block 335, the electronic processor 205 may additionally or alternatively output a notification to the user of the system 100 (e.g., an audible or visual notification on the remote controller 15). The notification may indicate that the second amount of time between subsequent consecutive cardiac cycles remains greater than the desired value, so that the user can take additional action if necessary. In some cases, after executing block 335, the method 300 returns to block 325 to continue monitoring the electrical signals of the patient's heart to determine whether the amount of time between subsequent consecutive cardiac cycles remains greater than the desired value. In some cases, the electronic processor 205 may execute blocks 325 and 335 multiple times to provide pacing pulses from different electrodes 24, 110 and / or catheters 20, 112 until the patient's heart rate begins to improve (e.g., increase) toward the desired rate and / or improves (e.g., increases) to the desired rate. In other words, the electronic processor 205 may automatically control a different electrode 24, 110 and / or catheter 20, 112 to provide pacing pulses in response to determining that the pacing pulses being provided from the first electrode 24, 110 and / or catheter 20, 112 are not improving the patient's condition (e.g., not reducing the amount of time between consecutive heartbeats / cardiac cycles). This control, performed in a rapid and automatic manner, may increase the patient's health and safety because their heart rate returns to a desired rate very quickly.

[0073] The ranges included herein (e.g., percentage ranges of the first time interval) are examples. One or both ends of each of these example ranges may vary, for example, by 1%, 5%, 10%, etc. These example ranges are intended to depict approximate time ranges during which the myocardium / heart wall thickness at the treatment site is estimated / expected to be low or at a minimum thickness compared to the myocardium / heart wall thickness at other times in the cardiac cycle.

[0074] It should be understood that the various aspects disclosed herein may be combined in combinations different from those specifically presented in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, may be added, combined, or omitted entirely (e.g., not all described actions or events may be required to perform these techniques). In addition, although for clarity, certain aspects of the present disclosure are described as being performed by a single module or unit, it should be understood that the techniques of the present disclosure may be performed by a combination of units or modules associated with, for example, a medical device.

[0075] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may include a non-transitory computer-readable medium that corresponds to a tangible medium such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0076] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Thus, the term "processor," as used herein, may refer to any of the aforementioned structures or any other physical structure suitable for implementing the described techniques. Additionally, these techniques may be fully implemented in one or more circuits or logic elements.

[0077] Example 1. A method for controlling pacing pulses provided to a patient, the method comprising: after ablation of the patient's heart is performed, monitoring the electrical signals that cause the patient's heart to beat; determining, using an electronic processor and based on the electrical signals, that the amount of time between consecutive cardiac cycles is greater than an expected value; and in response to determining that the amount of time between consecutive cardiac cycles is greater than the expected value, automatically and using the electronic processor to control an electrode or pairs of electrodes to deliver the pacing pulses to the heart.

[0078] Example 2. The method according to Example 1 further includes: before determining that the amount of time between consecutive cardiac cycles is greater than the expected value, using the electronic processor to control the electrode or pair of electrodes to deliver pulsed field ablation (PFA) energy to the heart.

[0079] Example 3. A method according to Example 1 or Example 2, wherein the electrode includes a first electrode or a pair of first electrodes, and the method further includes: before determining that the amount of time between consecutive cardiac cycles is greater than the expected value, using the electronic processor to control a second electrode or a pair of second electrodes to deliver pulsed field ablation (PFA) energy to the heart, wherein the second (paired) electrode is located at a different position in the patient's body than the first (paired) electrode.

[0080] Example 4. The method of Example 3, wherein the first (pair of) electrodes are included on a diagnostic catheter, such as a coronary sinus catheter, and wherein the second (pair of) electrodes are included on an ablation catheter.

[0081] Example 5. A method according to any one of Examples 1 to 4, wherein the electrode includes a first electrode or a pair of first electrodes, and the method further includes: continuing to monitor the electrical signal while the pacing pulse is being delivered to the heart; determining, using the electronic processor and based on the electrical signal, that a second amount of time between subsequent consecutive cardiac cycles remains greater than the expected value; and in response to determining that the second amount of time between subsequent consecutive cardiac cycles remains greater than the expected value, automatically and using the electronic processor to control a second electrode or a pair of second electrodes located at a different location in the patient's body than the first (paired) electrode to deliver a second pacing pulse to the heart.

[0082] Example 6. A method according to any one of Examples 1 to 5, wherein determining that the amount of time between consecutive cardiac cycles is greater than the expected value includes: determining the amount of time between consecutive cardiac cycles by determining the RR interval between a first R wave in a first cardiac cycle and a second R wave in a second cardiac cycle.

[0083] Example 7. A method according to any one of Examples 1 to 5, wherein determining that the amount of time between consecutive cardiac cycles is greater than the expected value includes: determining that the next cardiac cycle expected to follow the previous cardiac cycle has not been detected for a time period longer than a predetermined amount of time since the previous cardiac cycle was detected.

[0084] Example 8. The method of any one of Examples 1 to 7, wherein the expected value comprises a predetermined value established independently of previous cardiac cycles of the heart of the patient.

[0085] Example 9. A method according to any one of Examples 1 to 7, wherein the expected value comprises a predetermined value established based on a predetermined increase in time compared to an average amount of time between consecutive cardiac cycles of a predetermined amount of previously monitored cardiac cycles.

[0086] Example 10. A cardiac pacing device comprising: an electrode or a pair of electrodes, wherein the electrode or the pair of electrodes are configured to deliver pacing pulses to a patient's heart; and an electronic processor connected to the electrode to provide a control signal to the electrode, wherein the electronic processor is configured to: monitor the electrical signal that causes the patient's heart to beat after performing ablation on the patient's heart; determine based on the electrical signal that the amount of time between consecutive cardiac cycles is greater than an expected value; and in response to determining that the amount of time between consecutive cardiac cycles is greater than the expected value, automatically control the electrode to deliver the pacing pulse to the heart.

[0087] Example 11. A cardiac pacing device according to Example 10, wherein the electronic processor is further configured to: control the electrodes to deliver pulsed field ablation (PFA) energy to the heart before determining that the amount of time between consecutive cardiac cycles is greater than the expected value.

[0088] Example 12. A cardiac pacemaker device according to Example 10 or Example 11, wherein the electrode includes a first electrode or a pair of first electrodes, and wherein the electronic processor is further configured to: control a second electrode or a pair of second electrodes to deliver pulsed field ablation (PFA) energy to the heart before determining that the amount of time between consecutive cardiac cycles is greater than the expected value, wherein the second (paired) electrode is located at a different location in the patient's body than the first electrode.

[0089] Example 13. A cardiac pacing device according to Example 10 or Example 11, wherein the electrode includes a first electrode or a pair of first electrodes, and wherein the electronic processor is further configured to: continue to monitor the electrical signal while the pacing pulse is being delivered to the heart; determine based on the electrical signal that a second amount of time between subsequent consecutive cardiac cycles remains greater than the expected value; and in response to determining that the second amount of time between subsequent consecutive cardiac cycles remains greater than the expected value, automatically control a second electrode or a pair of second electrodes located at a different location in the patient's body than the first (paired) electrode to deliver a second pacing pulse to the heart.

[0090] Example 14. A cardiac pacing device according to any one of Examples 10 to 14, wherein the electronic processor is configured to determine that the amount of time between consecutive cardiac cycles is greater than the expected value by determining that a next cardiac cycle expected to follow the previous cardiac cycle has not been detected for a time period longer than a predetermined amount of time since the previous cardiac cycle was detected.

[0091] Example 15. A method of controlling pacing pulses provided to a patient, the method comprising: delivering pulsed field ablation (PFA) energy to the patient's heart; after delivering the PFA energy to the patient's heart, monitoring the electrical signals that cause the patient's heart to beat; detecting bradycardia of the heart between consecutive cardiac cycles of the heart using an electronic processor and based on the electrical signals by determining that the amount of time between consecutive cardiac cycles is greater than an expected value; and in response to detecting bradycardia by determining that the amount of time between consecutive cardiac cycles is greater than the expected value, automatically and using the electronic processor, controlling an electrode or pairs of electrodes to deliver the pacing pulses to the heart.

[0092] Example 16. The method of Example 15, wherein delivering the PFA energy to the heart of the patient comprises delivering the PFA energy to the heart of the patient via the electrodes before determining that the amount of time between consecutive cardiac cycles is greater than the expected value.

[0093] Example 17. A method according to Example 15 or Example 16, wherein the electrode includes a first electrode or a pair of first electrodes, and the method further includes: using the electronic processor to control a second electrode or a pair of second electrodes to deliver the PFA energy to the heart, wherein the second (paired) electrode is located at a different position in the patient's body than the first (paired) electrode.

[0094] Example 18. The method of Example 17, wherein the first (pair of) electrodes are included on a diagnostic catheter, such as a coronary sinus catheter, and wherein the second (pair of) electrodes are included on an ablation catheter.

[0095] Example 19. A method according to any one of Examples 15 to 18, wherein the electrode includes a first electrode or a pair of first electrodes, and the method further includes: continuing to monitor the electrical signal while the pacing pulse is being delivered to the heart; determining, using the electronic processor and based on the electrical signal, that a second amount of time between subsequent consecutive cardiac cycles remains greater than the expected value; and in response to determining that the second amount of time between subsequent consecutive cardiac cycles remains greater than the expected value, automatically and using the electronic processor to control a second electrode or a pair of second electrodes located at a different location in the patient's body than the first (paired) electrode to deliver a second pacing pulse to the heart.

[0096] Example 20. A method according to any one of Examples 15 to 19, wherein determining that the amount of time between consecutive cardiac cycles is greater than the expected value includes: determining that the next cardiac cycle expected to follow the previous cardiac cycle has not been detected for a time period longer than a predetermined amount of time since the previous cardiac cycle was detected.

Claims

1. A cardiac pacemaker device comprising: an electrode configured to deliver pacing pulses to the patient's heart; and an electronic processor coupled to the electrodes to provide control signals to the electrodes, the electronic processor being configured to monitor electrical signals that cause the patient's heart to beat after performing ablation on the patient's heart, determining, based on the electrical signal, that an amount of time between consecutive cardiac cycles is greater than an expected value, and In response to determining that the amount of time between consecutive cardiac cycles is greater than the expected value, the electrodes are automatically controlled to deliver the pacing pulses to the heart.

2. The cardiac pacing device of claim 1 , wherein the electronic processor is further configured to, before determining that the amount of time between consecutive cardiac cycles is greater than the expected value, control the electrodes to deliver pulsed field ablation (PFA) energy to the heart.

3. A cardiac pacemaker device according to any one of claims 1 or 2, wherein the electrode includes a first electrode, and wherein the electronic processor is further configured to: before determining that the amount of time between consecutive cardiac cycles is greater than the expected value, control a second electrode to deliver pulsed field ablation (PFA) energy to the heart, wherein the second electrode is located at a different position in the patient's body than the first electrode.

4. The cardiac pacing device according to claim 3, further comprising a diagnostic catheter and an ablation catheter, wherein the first electrode is included on the diagnostic catheter, and wherein the second electrode is included on the ablation catheter.

5. The cardiac pacing device according to any one of claims 1 to 4, wherein the electronic processor is further configured to: continuing to monitor the electrical signals while the pacing pulses are being delivered to the heart; determining, based on the electrical signal, that a second amount of time between subsequent consecutive cardiac cycles remains greater than the expected value; as well as In response to determining that the second amount of time between subsequent consecutive cardiac cycles remains greater than the desired value, automatically controlling the second electrode located at a different location within the patient than the first electrode to deliver a second pacing pulse to the heart.

6. A cardiac pacing device according to any one of claims 1 to 5, wherein the electronic processor is configured to determine that the amount of time between consecutive cardiac cycles is greater than the expected value by determining that a next cardiac cycle expected to follow the previous cardiac cycle has not been detected for a time period longer than a predetermined amount of time since the previous cardiac cycle was detected.

7. The cardiac pacing device of any one of claims 1 to 5, wherein the electronic processor is configured to determine that the amount of time between consecutive cardiac cycles is greater than the expected value comprises: The amount of time between consecutive cardiac cycles is determined by determining the RR interval between a first R-wave in a first cardiac cycle and a second R-wave in a second cardiac cycle.

8. The cardiac pacing device of any one of claims 1 to 5, wherein the expected value comprises a predetermined value established independently of previous cardiac cycles of the heart of the patient.

9. A cardiac pacing device according to any one of claims 1 to 5, wherein the expected value comprises a predetermined value established based on a predetermined time increase compared to an average amount of time between consecutive cardiac cycles of a predetermined amount of previously monitored cardiac cycles.

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