Pulsed field ablation pulse train with varying characteristics

Abstract

Waveform characteristics of pulses in a pulse train configured to cause pulsed field tissue ablation may be varied in a manner that improves electromagnetic compatibility while retaining treatment efficacy. Such waveform characteristics may include pulse-to-pulse initiation intervals, inter-pulse delays, pulse on-times, pulse widths, inter-phase delays in the case of biphasic pulses, or a combination thereof. Such waveform characteristics may be varied in a random manner. Variations of waveform characteristics may be bounded by minimum, maximum, or both minimum and maximum differences between various pulses or pulse groups, or between various pulse trains or pulse train groups, for example, to help ensure sufficient stability of treatment signal waveforms while allowing sufficient variability, for example, to improve electromagnetic compatibility.

Description

[0001] PULSED FIELD ABLATION PULSE TRAIN WITH VARYING CHARACTERISTICS

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of each of U.S. Provisional Application No. 63 / 672,841, filed July 18, 2024; U.S. Provisional Application No. 63 / 827,324, filed June 20, 2025; and U.S. Provisional Application No. 63 / 829,978, filed June 25, 2025, the entire disclosure of each of these applications is hereby incorporated herein by reference.

[0004] TECHNICAL FIELD

[0005] Aspects of this disclosure generally are related to medical systems and methods for generating signal waveforms for pulsed field ablation.

[0006] BACKGROUND

[0007] Cardiac surgery was initially undertaken using highly invasive open procedures. A sternotomy, which is a type of incision in the center of the chest that separates the sternum was typically employed to allow access to the heart. In the past several decades, more and more cardiac operations are performed using intravascular or percutaneous techniques, where access to inner organs or other tissue is gained via a catheter. Intravascular or percutaneous surgeries benefit patients by reducing surgery risk, complications, and recovery time.

[0008] One example of where intravascular or percutaneous medical techniques have been employed is in the treatment of a heart disorder called atrial fibrillation. Atrial fibrillation is a disorder in which spurious electrical signals cause an irregular heartbeat. Atrial fibrillation has been treated with various methods including a technique known as pulmonary vein (“PV”) isolation. Research has shown that atrial fibrillation typically begins in the pulmonary veins or at the point where they attach to the left atrium. There are typically four major pulmonary veins, and some or all may be a focal point for activity that may cause atrial fibrillation. During this PV isolation procedure, physicians create specific patterns of lesions in the heart to block various paths taken by the spurious electrical signals. The patterns of lesions may include a pattern of one or more lesions that encircle at least one of the pulmonary veins. Lesions have typically been formed by ablating the tissue with various techniques including radiofrequency (“RF”) ablation, microwave ablation, laser ablation, and cryogenic ablation.

[0009] Recently, a new ablation modality known as pulsed field ablation (“PFA”) has gained significant popularity in the ablation of various tissue structures, for example, in cardiac ablation. PFA is an ablation method that employs high voltage pulsed energy delivery in proximity to target tissue. The electric field applied by the high voltage pulses in PFA physiologically changes the cells of the target tissue to which the energy is applied. In particular, the electric field applied by the high voltage pulses in PFA punctures or perforates the cell membranes to form various pores therein. If a relatively low electric field strength is established, the formed pores may close in time and cause the cells to maintain viability (e.g., a process sometimes referred to as reversible electroporation). If a relatively greater electric field strength is established, then permanent and sometimes larger, pores form in the tissue cells, which cause the cells to lose control of ion concentration gradients (both inward and outward), thereby resulting in cell death (e.g., in a process sometimes referred to as irreversible electroporation). In contrast to thermal ablation techniques such as RF ablation and cryogenic ablation, PFA is considered to be “non-thermal” in nature since the resulting tissue cellular death or destruction is not primarily or substantially dependent on thermal processes.

[0010] Conventionally, the delivered pulsed energy for PFA may have various forms, such as being formed of conventional monophasic pulses or being formed of conventional biphasic pulses. The phases of a biphasic pulse may be temporally separated by a relatively short time interval, which may be referred to as a between-phase delay or an intra-biphasic-pulse delay. Successive biphasic pulses may be separated by a period of time, which may be referred to as a between-biphasic pulse delay or an inter-biphasic-pulse delay.

[0011] The present inventors recognize that PFA pulse trains may have potentially problematic electromagnetic interference with other electronic devices that are concurrently operating. Electromagnetic compatibility (“EMC”) refers to the ability of an electrical or electronic device to operate in a particular electromagnetic environment without causing undue electromagnetic disturbances that could adversely affect other devices and without being unacceptably affected by electromagnetic disturbances present in such environment. In many jurisdictions, EMC- related requirements (e.g., limits on the magnitude of a device’s electromagnetic emissions) are imposed by law or regulation, which in turn may reference EMC standards for technical details.

[0012] Electromagnetic emission requirements typically place limits on the amplitudes of a device’s radiated and conducted emissions. Radiated emissions are electromagnetic fields emitted into free space by the device (e.g., due to the device unintentionally acting as an antenna), while conducted emissions are typically disturbances to the mains voltage injected onto the power line conductors by the device.

[0013] Depending on the law, regulation, standard, or other factors, the frequency ranges of interest for radiated and conducted emissions may vary; however, 30 MHz to 6 GHz is typical for radiated emissions (e.g., per Comite International Special des Perturbations Radioelectriques or International Special Committee on Radio Interference (“CISPR”) 11:2024) and 150 kHz to 30 MHz is typical for conducted emissions (e.g., per CISPR 11:2024). Power line voltage disturbances below 150 kHz may also be of concern and the related frequency ranges, or requirements associated with related frequency ranges, have particular names such as harmonics (e.g., per International Electrotechnical Commission (“IEC”) 61000-3-2), flicker (e.g., IEC 61000-3-3), or supraharmonics (e.g., IEC 61000-2-2). The term “conducted emissions” is intended to encompass any power line related emissions, regardless of the particular frequency range or name used in other documentation (e.g., standards).

[0014] Electromagnetic emission requirements may be more difficult to meet for certain types of devices, based on the characteristics of their circuits. For example, all else being equal, it is generally more difficult to meet emission requirements as the voltage and / or current used within a circuit increase. Since pulsed field ablation circuits typically operate with significant voltage (e.g., multi kilovolt) and current (e.g., tens of amperes), and deliver pulse waveforms with energy content in the 0 Hz to 6 GHz range, meeting conducted and radiated emission requirements can be challenging for devices containing such circuits.

[0015] Pulsed field waveforms are generally delivered to patient tissue via long cables, which may act as unintentional radiators (i.e., they may act as better antennas than shorter cables), thus potentially causing a radiated emissions problem, depending on the spectrum of the pulsed field waveform. Even in cases where the spectrum of the pulsed field waveform does not contain significant energy content in a frequency range of concern for radiated emissions (e.g., 30 MHz to 6 GHz), delivery of the pulsed field waveform may present a conducted emissions concern if the device’s power supply does not adequately decouple the pulsed field output from the mains supply (e.g., a power supply may couple some voltage from the pulsed field waveform back to the mains supply conductors).

[0016] In this regard, the present inventors recognize that a need in the art exists at least for techniques for improving electromagnetic compatibility for power generation systems, such as those for PFA.

[0017] SUMMARY

[0018] At least the above-discussed need is addressed and technical solutions are achieved in the art by various embodiments of the present invention. In some embodiments, an ablation system includes an input-output device system; a pulse generator communicatively connected to the input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system. In some embodiments, the data processing device system is configured at least by the program at least to: cause, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of pairs of consecutive biphasic pulses including a respective inter-pulse delay extending from a completion of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses. The data processing device system is configured at least by the program at least to randomly determine a respective duration of each respective inter-pulse delay of at least some of the respective inter-pulse delays.

[0019] In some embodiments, durations of the respective inter-pulse delays of at least three consecutive respective inter-pulse delays in the sequence of pairs of consecutive biphasic pulses are all different from each other, the at least three consecutive respective inter-pulse delays including the at least some of the respective inter-pulse delays.

[0020] In some embodiments, the at least some of the respective inter-pulse delays include at least three consecutive respective inter-pulse delays, such that the data processing device system is configured at least by the program at least to randomly determine a respective duration of each respective inter-pulse delay of the at least three consecutive respective inter-pulse delays.

[0021] In some embodiments, the data processing device system is configured at least by the program at least to cause, via the input-output device system, the sequence of pairs of consecutive biphasic pulses to be delivered to at least one transducer of a transducer-based device communicatively connected to the input-output device system.

[0022] In some embodiments, the biphasic pulses in the sequence of pairs of consecutive biphasic pulses are arranged in a sequence of consecutive biphasic pulses, and the data processing device system is configured at least by the program at least to cause, via the inputoutput device system, each biphasic pulse in the sequence of consecutive biphasic pulses to be delivered to a respective set of transducers in a plurality of sets of transducers of a transducerbased device communicatively connected to the input-output device system, each respective set of transducers in the plurality of sets of transducers including at least one transducer not included in any other set of transducers in the plurality of sets of transducers.

[0023] In some embodiments, the pulse train is a second pulse train that consecutively follows a first pulse train generated by the pulse generator, and the data processing device system is configured at least by the program at least to randomly determine the respective durations of the respective inter-pulse delays of the at least some of the respective inter-pulse delays in the second pulse train so as not to exceed a maximum difference in duration of the second pulse train from a duration of the first pulse train.

[0024] In some embodiments, the pulse train is a second pulse train that consecutively follows a first pulse train generated by the pulse generator, and the data processing device system is configured at least by the program at least to randomly determine the respective durations of the respective inter-pulse delays in the second pulse train so as not to exceed a minimum difference in duration of the second pulse train from a duration of the first pulse train.

[0025] In some embodiments, the data processing device system is configured at least by the program at least to randomly determine the respective durations of the respective inter-pulse delays of the at least some of the respective inter-pulse delays to be within 1.2% of each other.

[0026] In some embodiments, an ablation system includes an input-output device system; a pulse generator communicatively connected to the input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system. In some embodiments, the data processing device system configured at least by the program at least to cause, via the inputoutput device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of at least three pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of three pairs of consecutive biphasic pulses including a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses. Each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse-to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse-to-pulse initiation interval, if present.

[0027] In some embodiments, the durations of the respective pulse-to-pulse initiation intervals in the sequence of three pairs of consecutive biphasic pulses are different from each other.

[0028] In some embodiments, the sequence of at least three pairs of consecutive biphasic pulses is a sequence of at least four pairs of consecutive biphasic pulses, and each respective pulse-to- pulse initiation interval in the sequence of four pairs of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse-to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse-to-pulse initiation interval, if present.

[0029] In some embodiments, the respective durations of the respective pulse-to-pulse initiation intervals in the sequence of three pairs of consecutive biphasic pulses are within 1.2% of each other.

[0030] In some embodiments, the pulse train includes a respective inter-pulse delay between each respective pair of consecutive biphasic pulses in the sequence of three pairs of consecutive biphasic pulses, and at least some of the respective inter-pulse delays are different in duration from each other.

[0031] In some embodiments, the pulse train includes a respective inter-pulse delay between each respective pair of consecutive biphasic pulses in the sequence of three pairs of consecutive biphasic pulses, and each respective inter-pulse delay in the sequence of three pairs of consecutive biphasic pulses is either: (c) longer in duration than each of (v) an immediately preceding inter-pulse delay, if present, and (vi) an immediately following inter-pulse delay, if present, or (d) shorter in duration than each of (vii) an immediately preceding inter-pulse delay, if present, and (viii) an immediately following inter-pulse delay, if present.

[0032] In some embodiments, each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses includes a respective inter-phase delay, and at least some of the respective interphase delays are different in duration from each other.

[0033] In some embodiments, each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses includes a respective inter-phase delay, and each respective inter-phase delay in the sequence of three pairs of consecutive biphasic pulses is either: (c) longer in duration than each of (v) an immediately preceding inter-phase delay, if present, and (vi) an immediately following inter-phase delay, if present, or (d) shorter in duration than each of (vii) an immediately preceding inter-phase delay, if present, and (viii) an immediately following interphase delay, if present.

[0034] In some embodiments, each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses includes a respective inter-phase delay, and the inter-phase delays are within 10% of each other.

[0035] In some embodiments, each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses includes a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combining to form a respective on-time of the biphasic pulse. In some embodiments, several of the respective on-times are different in duration from each other. In some embodiments, each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses includes a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combining to form a respective on-time of the biphasic pulse. In some embodiments, each respective on-time in the sequence of three pairs of consecutive biphasic pulses is either: (c) longer in duration than each of (v) an immediately preceding on- time, if present, and (vi) an immediately following on-time, if present, or (d) shorter in duration than each of (vii) an immediately preceding on-time, if present, and (viii) an immediately following on-time, if present. In some embodiments, the respective on-times for the biphasic pulses in the sequence of three pairs of consecutive biphasic pulses are within 10% of each other.

[0036] In some embodiments, the data processing device system is configured at least by the program at least to cause, via the input-output device system, the sequence of at least three pairs of consecutive biphasic pulses to be delivered to at least one transducer of a transducer-based device communicatively connected to the input-output device system.

[0037] In some embodiments, the sequence of at least three pairs of consecutive biphasic pulses are arranged in a sequence of consecutive biphasic pulses, and the data processing device system is configured at least by the program at least to cause, via the input-output device system, each biphasic pulse in the sequence of consecutive biphasic pulses to be delivered to a respective set of transducers in a plurality of sets of transducers of a transducer-based device communicatively connected to the input-output device system, each respective set of transducers in the plurality of sets of transducers including at least one transducer not included in any other set of transducers in the sequence of sets of transducers.

[0038] In some embodiments, the data processing device system is configured at least by the program at least to cause, via the input-output device system, the sequence of at least three pairs of consecutive biphasic pulses to be delivered to a particular transducer of a transducer-based device communicatively connected to the input-output device system.

[0039] In some embodiments, an ablation system includes an input-output device system; a pulse generator communicatively connected to the input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system. In some embodiments, the data processing device system is configured at least by the program at least to cause, via the inputoutput device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of biphasic pulses. In some embodiments, each biphasic pulse in the sequence of biphasic pulses includes a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combining to form a respective on-time of the biphasic pulse. In some embodiments, each biphasic pulse in the sequence of biphasic pulses includes a respective inter-phase delay. In some embodiments, each respective pair of consecutive biphasic pulses in the sequence of biphasic pulses includes: (i) a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, the respective pulse-to-pulse initiation intervals being equal in duration, and (ii) a respective interpulse delay extending from a completion of the first biphasic pulse in the respective pair of consecutive biphasic pulses to the initiation of the second biphasic pulse in the respective pair of consecutive biphasic pulses. In some embodiments, at least (a) a duration of the respective on- time of a first biphasic pulse in a first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective on-time of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, (b) the respective interphase delay of the first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-phase delay of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, or (c) the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-pulse delay of a second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses.

[0040] In some embodiments, both (a) and (b) occur, both (a) and (c) occur, both (b) and (c) occur, or all of (a), (b) and (c) occur.

[0041] In some embodiments, at least the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-pulse delay of the second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses, and the second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses includes the second biphasic pulse in the first respective pair of consecutive biphasic pulses and a third biphasic pulse that consecutively follows the second biphasic pulse in the sequence of biphasic pulses. In some embodiments, the respective interpulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is longer in duration as compared to the respective inter-pulse delay of the second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses, and the respective on-time and the respective inter-phase delay of the first biphasic pulse have a combined duration that is shorter as compared to a combined duration of the respective on-time and the respective inter-phase delay of the second biphasic pulse. In some embodiments, the respective on-time of the first biphasic pulse is shorter in duration as compared to the respective on-time of the second biphasic pulse. In some embodiments, the respective inter-phase delay of the first biphasic pulse is shorter in duration as compared to the respective inter-phase delay of the second biphasic pulse.

[0042] In some embodiments, the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is equal in duration as compared to the respective inter-pulse delay of the second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses, and the respective on-time of the first biphasic pulse is longer in duration than the respective on-time of the second biphasic pulse, or the respective on-time of the second biphasic pulse is longer in duration than the respective on-time of the first biphasic pulse.

[0043] In some embodiments, the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is equal in duration as compared to the respective inter-pulse delay of the second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses, and the respective inter-phase delay of the first biphasic pulse is longer in duration than the respective inter-phase delay of the second biphasic pulse, or the respective inter-phase delay of the second biphasic pulse is longer in duration than the respective inter-phase delay of the first biphasic pulse.

[0044] In some embodiments, an ablation system includes an input-output device system; a pulse generator communicatively connected to the input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system. In some embodiments, the data processing device system configured at least by the program at least to cause, via the inputoutput device system, the pulse generator to output at least a first pulse train and a second pulse train, each of the first pulse train and the second pulse train configured to cause pulsed field tissue ablation. In some embodiments, each of the first pulse train and the second pulse train includes a respective sequence of at least three pairs of consecutive biphasic pulses, each biphasic pulse in each respective sequence of three pairs of consecutive biphasic pulses including a respective positive pulse and a respective negative pulse. In some embodiments, (a) durations of the respective positive pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, (b) durations of the respective negative pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, or (a) and (b). In some embodiments, each respective pair of consecutive biphasic pulses in each respective sequence of three pairs of consecutive biphasic pulses includes a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses. In some embodiments, the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train form a first pattern of pulse- to-pulse initiation intervals, and the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train form a second pattern of pulse-to-pulse initiation intervals, the second pattern of pulse-to-pulse initiation intervals different than the first pattern of pulse-to-pulse initiation intervals.

[0045] In some embodiments, the first pulse train includes a respective inter-pulse delay between each respective pair of consecutive biphasic pulses in the respective sequence of three pairs of consecutive biphasic pulses. In some embodiments, the second pulse train includes a respective inter-pulse delay between each respective pair of consecutive biphasic pulses in the respective sequence of three pairs of consecutive biphasic pulses. In some embodiments, the second pattern of pulse-to-pulse initiation intervals differs from the first pattern of pulse-to-pulse initiation intervals at least because each of at least one of the respective inter-pulse delays in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train is different than every respective inter-pulse delay in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train.

[0046] In some embodiments, (a) or (b) occurs, but not both (a) and (b). In some embodiments, each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the first pulse train includes a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the first pulse train combining to form a respective on-time of the biphasic pulse. In some embodiments, each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the second pulse train includes a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the second pulse train combining to form a respective on-time of the biphasic pulse. In some embodiments, the second pattern of pulse-to-pulse initiation intervals differs from the first pattern of pulse-to-pulse initiation intervals at least because each of at least one of the respective on-times in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train is different than every respective on-time in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train.

[0047] In some embodiments, each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the first pulse train includes a respective inter-phase delay. In some embodiments, each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the second pulse train includes a respective inter-phase delay. In some embodiments, the second pattern of pulse-to-pulse initiation intervals differs from the first pattern of pulse-to-pulse initiation intervals at least because each of at least one of the respective inter-phase delays in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train is different than every respective inter-phase delay in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train.

[0048] In some embodiments, a duration of the first pulse train is different than a duration of the second pulse train. In some embodiments, a duration of the first pulse train is within 10% of a duration of the second pulse train.

[0049] In some embodiments, the first pattern of pulse-to-pulse initiation intervals includes a first pulse-to-pulse initiation interval consecutively followed by a second pulse-to-pulse initiation interval, consecutively followed by a third pulse-to-pulse initiation interval. In some embodiments, the second pattern of pulse-to-pulse initiation intervals includes a first pulse-to- pulse initiation interval consecutively followed by a second pulse-to-pulse initiation interval, consecutively followed by a third pulse-to-pulse initiation interval. In some embodiments, the first pulse-to-pulse initiation interval, the second pulse-to-pulse initiation interval, and the third pulse-to-pulse initiation interval in the first pattern of pulse-to-pulse initiation intervals occupy same corresponding positions in the first pulse train as the first pulse-to-pulse initiation interval, the second pulse-to-pulse initiation interval, and the third pulse-to-pulse initiation interval in the second pattern of pulse-to-pulse initiation intervals occupy in the second pulse train. In some embodiments, the first pulse-to-pulse initiation interval in the first pattern of pulse-to-pulse initiation intervals is different than the first pulse-to-pulse initiation interval in the second pattern of pulse-to-pulse initiation intervals.

[0050] In some embodiments: (c) the sequence of at least three pairs of consecutive biphasic pulses in the first pulse train is a sequence of at least four pairs of consecutive biphasic pulses, (d) wherein the sequence of at least three pairs of consecutive biphasic pulses in the second pulse train is a sequence of at least four pairs of consecutive biphasic pulses, or (c) and (d). In some embodiments, an ablation system includes an input-output device system; a pulse generator communicatively connected to the input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system. In some embodiments, the data processing device system configured at least by the program at least to cause the pulse generator, via the input-output device system, to output a pulse train configured to cause pulsed field tissue ablation, the pulse train including a sequence of at least three pairs of consecutive pulses. In some embodiments, each respective pair of consecutive pulses in the sequence of three pairs of consecutive pulses includes a respective pulse-to-pulse initiation interval extending from an initiation of a first pulse in the respective pair of consecutive pulses to an initiation of a second pulse in the respective pair of consecutive pulses. In some embodiments, each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse-to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse-to-pulse initiation interval, if present.

[0051] In some embodiments, a medical system includes a data processing device system; an input-output device system communicatively connected to the data processing device system, the input-output device system communicatively connectable to an energy source device system circuit configured to provide pulsed field ablation energy to at least some electrodes of a plurality of electrodes supported by a structure of a catheter. In some embodiments, the medical system includes a memory device system communicatively connected to the data processing device system and storing a program executable by the data processing device system. In some embodiments, the data processing device system is configured by the program at least to cause, via the input-output device system and via operation of at least the energy source device system circuit, provision of at least one pulse train. In some embodiments, each pulse train of the at least one pulse train includes a plurality of biphasic voltage pulses. In some embodiments, each biphasic voltage pulse in the plurality of biphasic voltage pulses includes a first monophasic voltage pulse having a first polarity and a second monophasic voltage pulse having a second polarity opposite the first polarity, the first monophasic voltage pulses of the biphasic voltage pulses having a same duration and the second monophasic voltage pulses of the biphasic voltage pulses having a same duration. In some embodiments, the biphasic voltage pulses are successively arranged in the pulse train with the biphasic voltage pulses of each pair of successive biphasic voltage pulses in the pulse train spaced from one another by a respective inter-biphasic -pulse delay. In some embodiments, the respective inter-biphasic-pulse delay between the biphasic voltage pulses of each pair of successive ones of the biphasic voltage pulses in the pulse train is different than the respective inter-biphasic-pulse delay between the biphasic voltage pulses of (a) an immediately preceding pair of successive ones of the biphasic voltage pulses in the pulse train, if present, and (b) an immediately succeeding pair of successive ones of the biphasic voltage pulses in the pulse train, if present.

[0052] In some embodiments, the pulse train includes a sequence of the respective inter- biphasic-pulse delays. In some embodiments, the successive respective inter-biphasic-pulse delays in the sequence of the respective inter-biphasic-pulse delays cycle between a first duration and a second duration. In some embodiments, each of the first duration and the second duration is between 300 microseconds and 1000 microseconds. In some embodiments, each of the first duration and the second duration is between 0.5 milliseconds and 15 milliseconds. In some embodiments, each of the first duration and the second duration is between 15 milliseconds and 30 milliseconds. In some embodiments, each of the first duration and the second duration is between 100 milliseconds and 1.5 seconds.

[0053] In some embodiments, respective biphasic pulse widths of the plurality of biphasic voltage pulses have a same duration.

[0054] In some embodiments, (i) the first monophasic voltage pulse of each biphasic voltage pulse of the plurality of biphasic voltage pulses has a duration between 1 microsecond and 8 microseconds, (ii) the second monophasic voltage pulse of each biphasic voltage pulse of the plurality of biphasic voltage pulses has a duration between 1 microsecond and 8 microseconds, or both (i) and (ii).

[0055] In some embodiments, (i) the first monophasic voltage pulse of each of at least some of the biphasic voltage pulses of the plurality of biphasic voltage pulses has a pulse amplitude between 200 V and 3000 V, (ii) the second monophasic voltage pulse of each of the at least some of the biphasic voltage pulses of the plurality of biphasic voltage pulses has a pulse amplitude between 200 V and 3000 V, or both (i) and (ii).

[0056] In some embodiments, each of the biphasic voltage pulses of the plurality of biphasic voltage pulses includes an intra-biphasic-pulse delay between the first monophasic voltage pulse and the second monophasic voltage pulse. In some embodiments, the intra-biphasic-pulse delay of each particular biphasic voltage pulse of at least some of the biphasic voltage pulses in the plurality of biphasic voltage pulses has a duration that is less than a duration of the respective inter-biphasic -delay between any pair of successive biphasic voltage pulses in the pulse train. In some embodiments, the intra-biphasic-pulse delay of each of at least some of the biphasic voltage pulses of the plurality of biphasic voltage pulses has a duration between 0 and 8 microseconds. In some embodiments, each respective inter-biphasic-pulse delay has a duration between 300 microseconds and 1000 microseconds. In some embodiments, each respective inter-biphasic -pulse delay has a duration between 0.5 milliseconds and 15 milliseconds. In some embodiments, each respective inter-biphasic-pulse delay has a duration between 15 milliseconds and 30 milliseconds. In some embodiments, each respective inter-biphasic-pulse delay has a duration between 100 milliseconds and 1.5 seconds.

[0057] In some embodiments, the energy source device system circuit is configured to generate each pulse train of the at least one pulse train.

[0058] In some embodiments, the data processing device system is configured by the program at least to cause delivery of the at least one pulse train from an electrode set of the plurality of electrodes.

[0059] In some embodiments, the at least one pulse train includes a plurality of pulse trains arranged in a regularly repeating sequence of pulse trains.

[0060] In some embodiments, the at least one pulse train includes a plurality of pulse trains arranged in a sequence of pulse trains, each pulse train in the sequence of pulse trains spaced (i) by a respective inter-pulse-train delay from an immediately preceding pulse train, if present in the sequence of pulse trains, (ii) by a respective inter-pulse-train delay from an immediately succeeding pulse train, if present in the sequence of pulse trains, or each of (i) and (ii), wherein each respective inter-pulse -train delay is greater in duration than each respective inter-biphasic- pulse delay.

[0061] In some embodiments, the plurality of biphasic voltage pulses includes (a) a first plurality of biphasic voltage pulses, each biphasic voltage pulse in the first plurality of biphasic voltage pulses having the same biphasic pulse waveform characteristics, and (b) a second plurality of biphasic voltage pulses, each biphasic voltage pulse in the second plurality of biphasic voltage pulses having the same biphasic pulse waveform characteristics. In some embodiments, the pulses of the first plurality of biphasic voltage pulses alternate with the pulses of the second plurality of biphasic voltage pulses.

[0062] In some embodiments, the plurality of biphasic voltage pulses include an interleaving of a first plurality of biphasic voltage pulses and a second plurality of biphasic voltage pulses, each biphasic voltage pulse in the first plurality of biphasic voltage pulses having a sequence of a first particular monophasic voltage pulse of the first polarity followed by a second particular monophasic voltage pulse of the second polarity, and each biphasic voltage pulse in the second plurality of biphasic voltage pulses having a sequence of a third particular monophasic voltage pulse of the second polarity followed by a fourth particular monophasic voltage pulse of the first polarity.

[0063] Various embodiments of the present invention may include systems, devices, or machines that are or include combinations or subsets of any one or more of the systems, devices, or machines and associated features thereof summarized above or otherwise described herein (which should be deemed to include the figures).

[0064] Further, all or part of any one or more of the systems, devices, or machines summarized above or otherwise described herein or combinations or sub-combinations thereof may implement or execute all or part of any one or more of the processes or methods described herein or combinations or sub-combinations thereof.

[0065] For example, in some embodiments, a method is executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the method including: causing, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of pairs of consecutive biphasic pulses including a respective inter-pulse delay extending from a completion of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses; and randomly determining a respective duration of each respective inter-pulse delay of at least some of the respective inter-pulse delays.

[0066] In some embodiments, a method is executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the method including causing, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of at least three pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of three pairs of consecutive biphasic pulses including a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses. In some embodiments, each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse-to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse-to-pulse initiation interval, if present.

[0067] In some embodiments, a method is executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the method including causing, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of biphasic pulses, each biphasic pulse in the sequence of biphasic pulses including a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combining to form a respective on-time of the biphasic pulse. In some embodiments, each biphasic pulse in the sequence of biphasic pulses includes a respective inter-phase delay, each respective pair of consecutive biphasic pulses in the sequence of biphasic pulses including: (i) a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, the respective pulse-to-pulse initiation intervals being equal in duration, and (ii) a respective inter-pulse delay extending from a completion of the first biphasic pulse in the respective pair of consecutive biphasic pulses to the initiation of the second biphasic pulse in the respective pair of consecutive biphasic pulses. In some embodiments, at least (a) a duration of the respective on-time of a first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective on-time of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, (b) the respective inter-phase delay of the first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-phase delay of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, or (c) the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-pulse delay of a second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses. In some embodiments, a method is executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the method including causing, via the input-output device system, the pulse generator to output at least a first pulse train and a second pulse train. In some embodiments, each of the first pulse train and the second pulse train is configured to cause pulsed field tissue ablation. In some embodiments, each of the first pulse train and the second pulse train includes a respective sequence of at least three pairs of consecutive biphasic pulses, each biphasic pulse in each respective sequence of three pairs of consecutive biphasic pulses including a respective positive pulse and a respective negative pulse. In some embodiments, (a) durations of the respective positive pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, (b) durations of the respective negative pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, or (a) and (b). In some embodiments, each respective pair of consecutive biphasic pulses in each respective sequence of three pairs of consecutive biphasic pulses includes a respective pulse-to- pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses. In some embodiments, the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train form a first pattern of pulse-to-pulse initiation intervals. In some embodiments, the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train form a second pattern of pulse-to-pulse initiation intervals, the second pattern of pulse-to-pulse initiation intervals different than the first pattern of pulse-to-pulse initiation intervals.

[0068] In some embodiments, a method is executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the method including causing the pulse generator, via the input-output device system, to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of at least three pairs of consecutive pulses, each respective pair of consecutive pulses in the sequence of three pairs of consecutive pulses including a respective pulse-to-pulse initiation interval extending from an initiation of a first pulse in the respective pair of consecutive pulses to an initiation of a second pulse in the respective pair of consecutive pulses. In some embodiments, each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse- to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse- to-pulse initiation interval, if present.

[0069] In some embodiments, a method is executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to an energy source device system circuit configured to provide pulsed field ablation energy to at least some electrodes of a plurality of electrodes supported by a structure of a catheter, and the method including causing, via the input-output device system and via operation of at least the energy source device system circuit, provision of at least one pulse train, each pulse train of the at least one pulse train including a plurality of biphasic voltage pulses. In some embodiments, each biphasic voltage pulse in the plurality of biphasic voltage pulses includes a first monophasic voltage pulse having a first polarity and a second monophasic voltage pulse having a second polarity opposite the first polarity, the first monophasic voltage pulses of the biphasic voltage pulses having a same duration and the second monophasic voltage pulses of the biphasic voltage pulses having a same duration. In some embodiments, the biphasic voltage pulses are successively arranged in the pulse train with the biphasic voltage pulses of each pair of successive biphasic voltage pulses in the pulse train spaced from one another by a respective inter-biphasic-pulse delay. In some embodiments, the respective inter-biphasic-pulse delay between the biphasic voltage pulses of each pair of successive ones of the biphasic voltage pulses in the pulse train is different than the respective inter-biphasic -pulse delay between the biphasic voltage pulses of (a) an immediately preceding pair of successive ones of the biphasic voltage pulses in the pulse train, if present, and (b) an immediately succeeding pair of successive ones of the biphasic voltage pulses in the pulse train, if present.

[0070] It should be noted that various embodiments of the present invention include variations of the methods or processes summarized above or otherwise described herein (which should be deemed to include the figures) and, accordingly, are not limited to the actions described or shown in the figures or their ordering, and not all actions shown or described are required according to various embodiments. According to various embodiments, such methods may include more or fewer actions and different orderings of actions. Any of the features of all or part of any one or more of the methods or processes summarized above or otherwise described herein may be combined with any of the other features of all or part of any one or more of the methods or processes summarized above or otherwise described herein.

[0071] In addition, a computer program product may be provided that includes program code portions for performing some or all of any one or more of the methods or processes and associated features thereof described herein, when the computer program product is executed by a computer or other computing device or device system. Such a computer program product may be stored on one or more computer-readable storage mediums, also referred to as one or more computer-readable data storage mediums or a computer-readable storage medium system.

[0072] For example, in some embodiments one or more computer-readable storage mediums store a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator. In some embodiments, the program includes pulse generation instructions configured to cause, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of pairs of consecutive biphasic pulses including a respective inter-pulse delay extending from a completion of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses. In some embodiments, the program includes random determination instructions configured to cause random determination of a respective duration of each respective inter-pulse delay of at least some of the respective inter-pulse delays.

[0073] In some embodiments, one or more computer-readable storage mediums store a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator. In some embodiments, the program includes pulse generation instructions configured to cause, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of at least three pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of three pairs of consecutive biphasic pulses including a respective pulse- to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses. In some embodiments, each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse-to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse-to-pulse initiation interval, if present.

[0074] In some embodiments, one or more computer-readable storage mediums store a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator. In some embodiments, the program includes pulse generation instructions configured to cause, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of biphasic pulses, each biphasic pulse in the sequence of biphasic pulses including a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combining to form a respective on-time of the biphasic pulse, and each biphasic pulse in the sequence of biphasic pulses includes a respective inter-phase delay. In some embodiments, each respective pair of consecutive biphasic pulses in the sequence of biphasic pulses includes: (i) a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, the respective pulse-to-pulse initiation intervals being equal in duration, and (ii) a respective inter-pulse delay extending from a completion of the first biphasic pulse in the respective pair of consecutive biphasic pulses to the initiation of the second biphasic pulse in the respective pair of consecutive biphasic pulses. In some embodiments, at least (a) a duration of the respective on-time of a first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective on-time of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, (b) the respective inter-phase delay of the first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-phase delay of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, or (c) the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-pulse delay of a second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses.

[0075] In some embodiments, one or more computer-readable storage mediums store a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator. In some embodiments, the program includes pulse generation instructions configured to cause, via the input-output device system, the pulse generator to output at least a first pulse train and a second pulse train. In some embodiments, each of the first pulse train and the second pulse train is configured to cause pulsed field tissue ablation. In some embodiments, each of the first pulse train and the second pulse train includes a respective sequence of at least three pairs of consecutive biphasic pulses, each biphasic pulse in each respective sequence of three pairs of consecutive biphasic pulses including a respective positive pulse and a respective negative pulse. In some embodiments, (a) durations of the respective positive pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, (b) durations of the respective negative pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, or (a) and (b). In some embodiments, each respective pair of consecutive biphasic pulses in each respective sequence of three pairs of consecutive biphasic pulses includes a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses. In some embodiments, the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train form a first pattern of pulse-to-pulse initiation intervals. In some embodiments, the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train form a second pattern of pulse-to-pulse initiation intervals, the second pattern of pulse-to-pulse initiation intervals different than the first pattern of pulse-to-pulse initiation intervals.

[0076] In some embodiments, one or more computer-readable storage mediums store a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator. In some embodiments, the program includes pulse generation instructions configured to cause the pulse generator, via the input-output device system, to output a pulse train configured to cause pulsed field tissue ablation. In some embodiments, the pulse train includes a sequence of at least three pairs of consecutive pulses, each respective pair of consecutive pulses in the sequence of three pairs of consecutive pulses including a respective pulse-to-pulse initiation interval extending from an initiation of a first pulse in the respective pair of consecutive pulses to an initiation of a second pulse in the respective pair of consecutive pulses. In some embodiments, each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse-to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse- to-pulse initiation interval, if present.

[0077] In some embodiments, one or more computer-readable storage mediums store a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to an energy source device system circuit configured to provide pulsed field ablation energy to at least some electrodes of a plurality of electrodes supported by a structure of a catheter. In some embodiments, the program includes provision instructions configured to cause, via the inputoutput device system and via operation of at least the energy source device system circuit, provision of at least one pulse train. In some embodiments, each pulse train of the at least one pulse train includes a plurality of biphasic voltage pulses. In some embodiments, each biphasic voltage pulse in the plurality of biphasic voltage pulses includes a first monophasic voltage pulse having a first polarity and a second monophasic voltage pulse having a second polarity opposite the first polarity. In some embodiments, the first monophasic voltage pulses of the biphasic voltage pulses have a same duration and the second monophasic voltage pulses of the biphasic voltage pulses have a same duration. In some embodiments, the biphasic voltage pulses are successively arranged in the pulse train with the biphasic voltage pulses of each pair of successive biphasic voltage pulses in the pulse train spaced from one another by a respective inter-biphasic -pulse delay. In some embodiments, the respective inter-biphasic-pulse delay between the biphasic voltage pulses of each pair of successive ones of the biphasic voltage pulses in the pulse train is different than the respective inter-biphasic-pulse delay between the biphasic voltage pulses of (a) an immediately preceding pair of successive ones of the biphasic voltage pulses in the pulse train, if present, and (b) an immediately succeeding pair of successive ones of the biphasic voltage pulses in the pulse train, if present.

[0078] In some embodiments, each of any of one or more or all of the computer-readable data storage mediums or medium systems (also referred to as processor-accessible memory device systems) described herein is a non-transitory computer-readable (or processor-accessible) data storage medium or medium system (or memory device system) including or consisting of one or more non-transitory computer-readable (or processor-accessible) storage mediums (or memory devices) storing the respective program(s) which may configure a data processing device system to execute some or all of any of one or more of the methods or processes described herein.

[0079] Further, any of all or part of one or more of the methods or processes and associated features thereof discussed herein may be implemented or executed on or by all or part of a device system, apparatus, or machine, such as all or a part of any of one or more of the systems, apparatuses, or machines described herein or a combination or sub-combination thereof.

[0080] BRIEF DESCRIPTION OF THE DRAWINGS

[0081] It is to be understood that the attached drawings are for the purposes of illustrating aspects of various embodiments and may include elements that are not to scale. It is noted that like reference characters in different figures refer to the same objects.

[0082] FIG. 1 includes a schematic representation of a medical system according to various example embodiments, the medical system including a data processing device system, an inputoutput device system, and a memory device system.

[0083] FIG. 2 includes a cutaway diagram of a heart showing a transducer-based device percutaneously placed in a left atrium of the heart, according to various example embodiments.

[0084] FIG. 3A includes a partially schematic representation of a medical system according to various example embodiments, the medical system including a data processing device system, an input-output device system, a memory device system, and a transducer-based device including a plurality of transducers and an expandable structure shown in a delivery or unexpanded configuration.

[0085] FIG. 3B includes the representation of the medical system of FIG. 3A with the expandable structure shown in a deployed or expanded configuration, according to some embodiments.

[0086] FIG. 4 includes a schematic representation of a transducer-based device that includes a flexible circuit structure, according to various example embodiments.

[0087] FIG. 5 includes a block diagram of various methods for generating signal waveforms for pulsed field ablation, according to various example embodiments.

[0088] Each of FIGS. 6, 7, and 8 illustrates at least a portion of a pulse train including a plurality of biphasic voltage pulses sequentially or consecutively arranged in the pulse train, according to various example embodiments.

[0089] FIG. 9 illustrates at least a portion of each of two pulse trains sequentially or consecutively arranged, each pulse train including a plurality of biphasic voltage pulses sequentially or consecutively arranged in the pulse train, according to various example embodiments.

[0090] FIG. 10 illustrates at least a portion of a pulse train including a plurality of biphasic voltage pulses sequentially or consecutively arranged in the pulse train, the biphasic voltage pulses having different polarity sequences where inter-biphasic-pulse delays between biphasic voltage pulses are different, according to various example embodiments.

[0091] FIG. 11 illustrates at least a portion of a pulse train including a plurality of biphasic voltage pulses sequentially or consecutively arranged in the pulse train, each biphasic voltage pulse including a first monophasic voltage pulse having a first particular polarity followed by a second monophasic voltage pulse having a second particular polarity opposite the first particular polarity, where inter -biphasic-pulse delays between biphasic voltage pulses are different, according to various example embodiments.

[0092] FIG. 12 illustrates at least a portion of a pulse train including a plurality of biphasic voltage pulses sequentially or consecutively arranged in the pulse train, the biphasic voltage pulses having different polarity sequences, and the monophasic voltage pulses of the biphasic voltage pulses shown having different pulse widths, according to various example embodiments.

[0093] FIG. 13 shows a portion of the frequency spectrum for a waveform having biphasic pulses at 50 ps intervals, where each biphasic pulse has phase durations of 2 ps and an interphase duration of 3 ps, with all the energy concentrated at 20 kHz and its harmonics.

[0094] FIG. 14 shows a portion of the frequency spectrum when the original waveform that produced the frequency spectrum of FIG. 13 has dithering applied to its pulse delivery times, according to some embodiments, where the dithering significantly reduces the amplitude of the major spurs from the original waveform by moving energy into other parts of the spectrum.

[0095] DETAILED DESCRIPTION

[0096] At least the above-discussed need in the art is addressed, and technical solutions are achieved by various embodiments of the present invention. In this regard, the present inventors recognize that, in many existing PFA devices, voltage pulses are delivered with a fixed duration between successive pulses. This fixed duration between successive pulses results in a spectrum with energy concentrated into discrete peaks at particular frequencies (e.g., those associated with the pulse repetition rate). These discrete peaks are suboptimal with respect to compliance with electromagnetic emission requirements, as electromagnetic emissions limits are generally given as limits on an amplitude (e.g., peak, quasi-peak, or average) at each frequency within the range of interest, as opposed to, e.g., a limit on the total energy of the emissions across the entire range of interest. Consequently, the present inventors recognize that modified pulsed field waveforms that result in reduced emissions peaks without adversely affecting clinical safety or effectiveness may provide advantages at least in meeting electromagnetic emission requirements. For example, such waveforms may ease other aspects of the design of the electrical system, such as allowing for fewer emissions suppression components or for longer cables.

[0097] In some embodiments, such a modified pulsed field waveform can be produced, in one example, at least by configuring a data processing device system to dither the durations between successive pulses. In this context, in some embodiments, dithering may be interpreted, for example, to mean modifying each duration between successive pulses by adding a relatively small offset (which can be negative or positive according to various embodiments). In some embodiments, the offset may be randomly determined from a distribution that has a mean value of zero. For example, consider a system that generates, by way of non-limiting example, biphasic pulses at 50 ps intervals, where each biphasic pulse has phase durations of 2 ps and an inter-phase duration of 3 ps. FIG. 13 shows a portion of the frequency spectrum for this waveform, with the energy clearly concentrated at 20 kHz and its harmonics.

[0098] When the pulse delivery times are dithered by up to + / - 5 ps (i.e., inter-pulse duration dither of up to + / - 10 ps), according to some embodiments of the present invention, the spectrum is changed as shown in FIG. 14. Notably, the amplitude of the major spurs from the original waveform are significantly reduced due to the dithering moving energy into other parts of the spectrum (e.g., those that had zero amplitude in the figure above). Consequently, the present inventors recognize that a system employing dithering according to various embodiments of the present invention may be less likely to produce emissions violating a legal or recommended (e.g., from a standard) limit, all else being equal.

[0099] It should be noted that both spectra (from FIGS. 13 and 14) were generated using square waves with a magnitude of one for illustration purposes only. Even if the waveforms had been set to have a magnitude more typical of pulsed field ablation (e.g., 2 kV), it is not possible to directly compare the spectra to emissions limits, since the spectra do not describe how efficiently a particular device converts a particular frequency to undesired emissions (e.g., due to unintentionally acting as an antenna).

[0100] While the above example associated with FIGS. 13 and 14 use biphasic pulses and interpulse durations, phase durations, and inter-phase durations on the order of microseconds to tens of microseconds, the present inventors recognize that the same principles apply equally to monophasic pulses and to durations of any length (e.g., spanning at least from nanoseconds to tens of milliseconds), according to various embodiments. Similarly, while the above example associated with FIG. 14 dithered the inter-pulse duration, according to some embodiments, peaks in the frequency spectrum can also be reduced in amplitude by dithering the inter-phase duration or phase durations, or any combination thereof, according to various embodiments. Further, when considering inter-pulse duration for systems employing a driver that can be switched between different electrodes or groups of electrodes, the relevant inter-pulse duration may be the inter-pulse duration of one or more electrode sets, or the inter-pulse duration as seen by the driver, according to various embodiments.

[0101] Also, while the above example associated with FIGS. 13 and 14 use idealized square waveforms (e.g., with very short rise and fall times), the present inventors recognize that the demonstrated principle still holds true for waveforms with more realistic rise and fall times (e.g., those associated with delivery of pulsed field energy to human tissue, according to some embodiments).

[0102] In view of the above discussion and the discussions otherwise herein, some embodiments of the present invention vary waveform characteristics or parameters of one or more pulse trains, e.g., either by causing such waveform characteristics or parameters to be different or by randomly determining them in some embodiments, which may improve the electromagnetic compatibility of the system generating or delivering the waveforms (e.g., as compared to a device that is configured to provide constant waveform characteristics or parameters). According to various embodiments, the varied waveform characteristics or parameters may be pulse-to-pulse initiation intervals, inter-pulse delays, inter-phase delays, pulse on-times, pulse widths, pulse polarity sequencing, or combinations thereof. In some embodiments, inter-pulsetrain delays between pulse trains are varied, e.g., either by causing such delays to be different or by randomly determining them to potentially assist in improving electromagnetic compatibility.

[0103] It should be noted that various embodiments of the invention are not limited to the above features and benefits, which are referred to for purposes of illustration only, and additional and alternative features and benefits will become apparent from the following description in conjunction with reference to the figures.

[0104] In this regard, in the descriptions herein, certain specific details are set forth in order to provide a thorough understanding of various embodiments of the invention. However, one skilled in the art will understand that the invention may be practiced at a more general level without one or more of these details. In other instances, well-known structures have not been shown or described in detail to avoid unnecessarily obscuring descriptions of various embodiments of the invention. Any reference throughout this specification to “one embodiment”, “an embodiment”, “an example embodiment”, “an illustrated embodiment”, “a particular embodiment”, and the like means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, any appearance of the phrase “in one embodiment”, “in an embodiment”, “in an example embodiment”, “in this illustrated embodiment”, “in this particular embodiment”, or the like in this specification is not necessarily all referring to one embodiment or a same embodiment. Furthermore, the particular features, structures or characteristics of different embodiments may be combined in any suitable manner to form one or more other embodiments. In one embodiment, all references to “some embodiments” may refer to the same single embodiment.

[0105] Unless otherwise explicitly noted or required by context, the word “or” is used in this disclosure in a non-exclusive sense. In addition, unless otherwise explicitly noted or required by context, the word “set” is intended to mean one or more. For example, the phrase “a set of objects” means one or more of the objects. In some embodiments, the word “subset” is intended to mean a set having the same or fewer elements of those present in the subset’s parent or superset. In other embodiments, the word “subset” is intended to mean a set having fewer elements of those present in the subset’s parent or superset. In this regard, when the word “subset” is used, some embodiments of the present invention utilize the meaning that “subset” has the same or fewer elements of those present in the subset’s parent or superset, and other embodiments of the present invention utilize the meaning that “subset” has fewer elements of those present in the subset’s parent or superset.

[0106] Further, the phrase “at least” is or may be used herein at times merely to emphasize the possibility that other elements may exist besides those explicitly listed. However, unless otherwise explicitly noted (such as by the use of the term “only”) or required by context, nonusage herein of the phrase “at least” nonetheless includes the possibility that other elements may exist besides those explicitly listed. For example, the phrase ‘based at least on A’ includes A as well as the possibility of one or more other additional elements besides A. In the same manner, the phrase ‘based on A’ includes A, as well as the possibility of one or more other additional elements besides A. However, the phrase ‘based only on A’ includes only A. Similarly, the phrase ‘configured at least to A’ includes a configuration to perform A, as well as the possibility of one or more other additional actions besides A. In the same manner, the phrase ‘configured to A’ includes a configuration to perform A, as well as the possibility of one or more other additional actions besides A. However, the phrase ‘configured only to A’ means a configuration to perform only A. The word “device”, the word “machine”, the word “system”, and the phrase “device system” all are intended to include one or more physical devices or sub-devices (e.g., pieces of equipment) that interact to perform one or more actions, regardless of whether such devices or sub-devices are located within a same housing or different housings. However, it may be explicitly specified according to various embodiments that a device or machine or device system resides entirely within a same housing to exclude embodiments where the respective device, machine, system, or device system resides across different housings. The word “device” may equivalently be referred to as a “device system” in some embodiments, and the word “system” may equivalently be referred to as a “device system” in some embodiments.

[0107] Further, the phrase “in response to” may be used in this disclosure. For example, this phrase may be used in the following context, where an event A occurs in response to the occurrence of an event B. In this regard, such phrase includes, for example, that at least the occurrence of the event B causes or triggers or is a necessary precondition for the event A, according to various embodiments.

[0108] In some embodiments, the word “adjacent”, the word “proximate”, and the like refer at least to a sufficient closeness between the objects or events defined as adjacent, proximate, or the like, to allow the objects or events to interact in a designated way. For example, in the case of physical objects, if object A performs an action on an adjacent or proximate object B, objects A and B would have at least a sufficient closeness to allow object A to perform the action on object B. In this regard, some actions may require contact between the associated objects, such that if object A performs such an action on an adjacent or proximate object B, objects A and B would be in contact, for example, in some instances or embodiments where object A needs to be in contact with object B to successfully perform the action. In some embodiments, the word “adjacent”, the word “proximate”, and the like additionally or alternatively refer to objects or events that do not have another substantially similar object or event between them. For example, object or event A and object or event B could be considered adjacent or proximate (e.g., physically or temporally) if they are immediately next to each other (with no other object or event between them) or are not immediately next to each other but no other object or event that is substantially similar to object or event A, object or event B, or both objects or events A and B, depending on the embodiment, is between them. In some embodiments, the word “adjacent”, the word “proximate”, and the like additionally or alternatively refer to at least a sufficient closeness between the objects or events defined as adjacent, proximate, and the like, the sufficient closeness being within a range that does not place any one or more of the objects or events into a different or dissimilar region or time period, or does not change an intended function of any one or more of the objects or events or of an encompassing object or event that includes a set of the objects or events. Different embodiments of the present invention adopt different ones or combinations of the above definitions. Of course, however, the word “adjacent”, the word “proximate”, and the like are not limited to any of the above example definitions, according to some embodiments. In addition, the word “adjacent” and the word “proximate” do not have the same definition, according to some embodiments.

[0109] The phrase “pulsed field ablation” (“PF A”) as used in this disclosure refers, in some embodiments, to an ablation method that employs high voltage pulsed energy delivery in a monopolar ablation mode (e.g., pulse delivery between at least one intra-body transducer and an external body return patch) or bipolar ablation mode (e.g., pulse delivery between at least two intra-body transducers) in proximity to target tissue. Each high voltage pulse may be a monophasic pulse including a single voltage polarity, or a biphasic pulse including a first component having a first particular voltage polarity and a second component having a second particular voltage polarity opposite the first particular voltage polarity. Each of the first component and the second component of a biphasic pulse may be referred to as a monophasic pulse, such that a biphasic pulse may be considered to be made of two adjacent or successive monophasic pulses of opposite polarity, in some embodiments. In some embodiments, the second component of the biphasic pulse follows immediately after the first component of the biphasic pulse. In some embodiments, the first and second components of the biphasic pulse are temporally separated by a relatively short time interval (e.g., an intra-biphasic-pulse delay) during which a zero or nominally zero voltage occurs. In some embodiments, successive monophasic pulses having a same polarity are separated by a period of time referred to as an inter-monophasic-pulse delay (also referred to simply as an inter-pulse delay). In some embodiments, successive biphasic pulses are separated by a period of time referred to as an inter-biphasic -pulse delay or simply as an inter-pulse delay in the context of biphasic pulses according to various embodiments. In the case where a biphasic pulse is considered to be made of two monophasic pulses of opposite polarity, a delay between such two monophasic pulses may be considered an intra-biphasic-pulse delay, whereas a delay between the last of such two monophasic pulses and the first monophasic pulse of the next biphasic pulse may be considered an inter-biphasic-pulse delay. In some embodiments, the duration of the inter-biphasic-pulse delay may be greater than the duration of each of the monophasic components of the corresponding biphasic pulses or may be greater than the duration of each of the corresponding biphasic pulses. The word "proximal", in the context of a proximal portion, proximal location, and the like of a medical device, includes, for example, the portion, location, and the like, being or being configured to be further away from a patient or portion of or region within a patient (e.g., a bodily cavity) intended to be treated or assessed by the medical device, as compared to a distal portion, location, and the like of the medical device, according to some embodiments. In some embodiments, the word "proximal", in the context of a proximal portion, proximal location, and the like of a medical device, includes, for example, the portion, location, and the like, being or being configured to be delivered (e.g., percutaneously or intravascularly) toward a patient or portion of or region within a patient (e.g., a bodily cavity) intended to be treated or assessed by the medical device, after or behind a distal portion, location, and the like of the medical device. On the other hand, the word "distal", in the context of a distal portion, distal location, and the like of a medical device, includes, for example, the portion, location, and the like, being or being configured to be closer to a patient or portion of or region within a patient (e.g., a bodily cavity) intended to be treated or assessed by the medical device, as compared to a proximal portion, location, and the like of the medical device, according to some embodiments. In some embodiments, the word "distal", in the context of a distal portion, distal location, and the like of a medical device, includes, for example, the portion, location, and the like, being or being configured to be delivered (e.g., percutaneously or intravascularly) toward a patient or portion of or region within a patient (e.g., a bodily cavity) intended to be treated or assessed by the medical device, before or ahead of a proximal portion, location, and the like of the medical device.

[0110] According to some embodiments, the word “fluid” as used in this disclosure should be understood to include any fluid that can be contained within a bodily cavity or can flow into or out of, or both into and out of a bodily cavity via one or more bodily openings positioned in fluid communication with the bodily cavity. In the case of cardiac applications, fluid such as blood will flow into and out of various intra-cardiac cavities (e.g., a left atrium or right atrium).

[0111] According to some embodiments, the phrase “bodily opening” as used in this disclosure should be understood to include, for example, a naturally occurring bodily opening or channel or lumen; a bodily opening or channel or lumen or perforation formed by an instrument or tool using techniques that can include, but are not limited to, mechanical, thermal, electrical, chemical, and exposure or illumination techniques; a bodily opening or channel or lumen or perforation formed by trauma to a body; or various combinations of one or more of the above. Various elements having respective openings, lumens, or channels and positioned within the bodily opening (e.g., a catheter sheath or catheter introducer) may be present in various embodiments. These elements may provide a passageway through a bodily opening for various devices employed in various embodiments.

[0112] The phrase “bodily cavity” as used in this disclosure should be understood to mean a cavity in a body. The bodily cavity may be a cavity or chamber provided in a bodily organ (e.g., an intra-cardiac cavity or chamber of a heart). The bodily cavity may be provided by a bodily vessel.

[0113] The word “tissue” as used in this disclosure should be understood to include, for example, any surface-forming tissue that is used to form a surface of a body or a surface within a bodily cavity, a surface of an anatomical feature or a surface of a feature associated with a bodily opening positioned in fluid communication with the bodily cavity. The tissue may include, for example, part or all of a tissue wall or membrane that defines a surface of the bodily cavity. In this regard, the tissue may form an interior surface of the cavity that surrounds a fluid within the cavity. In the case of cardiac applications, tissue may include, for example, tissue used to form an interior surface of an intra-cardiac cavity such as a left atrium or right atrium. In some embodiments, tissue is non-excised tissue. In some embodiments, the word “tissue” may refer to a tissue having fluidic properties (e.g., blood) and may be referred to as fluidic tissue.

[0114] According to some embodiments, the word “transducer” as used in this disclosure should be interpreted broadly as any device configured to transmit or deliver energy; distinguish between fluid and tissue; sense temperature; generate heat; ablate tissue; sense, sample, or measure electrical activity of a tissue surface (e.g., sense, sample, or measure intra-cardiac electrograms, or sense, sample, or measure intra-cardiac voltage data); stimulate tissue; provide location information (e.g., in conjunction with a navigation system); or any combination thereof. A transducer may convert input energy of one form into output energy of another form. Without limitation, a transducer may include, for example, an electrode that functions as, or as part of, a sensing device included in the transducer, an energy delivery device included in the transducer, or both a sensing device and an energy delivery device included in the transducer. A transducer may be constructed from several parts, which may be discrete components or may be integrally formed. In this regard, although transducers, electrodes, or both transducers and electrodes are referenced with respect to various embodiments, it is understood that other transducers or transducer elements may be employed in other embodiments. It is understood that a reference to a particular transducer in various embodiments may also imply a reference to an electrode, as an electrode may be part of the transducer as shown, e.g., at least with FIG. 4 discussed below. The term “activation” as used in this disclosure, according to some embodiments, should be interpreted broadly as making active a particular function as related to various transducers such as those disclosed herein, for example. Particular functions can include, but are not limited to, tissue ablation; sensing, sampling, or measuring electrophysiological activity (e.g., sensing, sampling, or measuring intra-cardiac electrogram information, or sensing, sampling, or measuring intra-cardiac voltage data); sensing, sampling, or measuring temperature; and sensing, sampling, or measuring electrical characteristics (e.g., tissue impedance or tissue conductivity). For example, in some embodiments, activation of a tissue ablation function of a particular transducer or electrode is initiated by causing energy sufficient to cause tissue ablation to be delivered to the particular transducer or electrode from an energy source device system (also known as a power supply system in some embodiments). In some embodiments, activation of a tissue ablation function of a particular transducer or electrode is initiated by causing energy sufficient for tissue ablation to be delivered by the particular transducer or electrode. Alternatively, in some embodiments, the activation can be deemed to be initiated when the particular transducer or particular electrode causes tissue that is to be ablated to exhibit tissueablative damage. In some embodiments, the activation can last for a duration concluding when the ablation function is no longer active, such as when energy sufficient for the tissue ablation is no longer delivered or provided to, or transmitted by, the particular transducer or particular electrode. Alternatively, in some embodiments, the activation period can be deemed to be concluded when the tissue that is being ablated no longer accrues tissue-ablative damage, which may be due to a reduction or cessation of the energy provided or transmitted by the energy source device system or delivered by the particular transducer or electrode. In some contexts and embodiments, however, the word “activation” may merely refer to the initiation of the activating of a particular function, as opposed to referring to both the initiation of the activating of the particular function and the subsequent duration in which the particular function is active. In these contexts, the phrase or a phrase similar to “activation initiation” may be used. For example, in some embodiments, activation initiation may cause initiation of a delivery of energy (e.g., energy sufficient for tissue ablation) to or from a particular transducer or electrode.

[0115] Various ranges of values are disclosed herein. In some embodiments, one or more or all of the disclosed ranges are inclusive of both endpoints of the respective range. In some embodiments, one or more or all of the disclosed ranges are inclusive of one of the endpoints of the respective range. In some embodiments, one or more or all of the disclosed ranges are exclusive of one of the endpoints of the respective range. In some embodiments, one or more or all of the disclosed ranges are exclusive of both endpoints of the respective range. Various embodiments include various sub-ranges of each of the disclosed ranges.

[0116] Some embodiments of the present invention may be implemented at least in part by a data processing device system, or a controller system configured by a software program. Such a program may equivalently be implemented as multiple programs, and some, or all, of such software program(s) may be equivalently constructed in hardware. Reference to “a program” should be interpreted to include one or more programs.

[0117] According to some embodiments, the term “program” in this disclosure should be interpreted to include one or more programs including a set of instructions or modules that may be executed by one or more components in a system, such as a controller system or data processing device system, in order to cause or configure the system to perform one or more operations. The set of instructions or modules may be stored by any kind of memory device, such as those described subsequently with respect to the memory device system 130, 330, or both, shown in FIGS. 1 and 3, respectively. In addition, this disclosure may describe or similarly describe that the instructions or modules of a program are configured to cause the performance of an action. The phrase “configured to” in this context is intended to include, for example, at least (a) instructions or modules that are presently in a form executable by one or more data processing devices to cause performance of the action (e.g., in the case where the instructions or modules are in a compiled and unencrypted form ready for execution), and (b) instructions or modules that are presently in a form not executable by the one or more data processing devices, but could be translated into the form executable by the one or more data processing devices to cause performance of the action (e.g., in the case where the instructions or modules are encrypted in a non-executable manner, but through performance of a decryption process, would be translated into a form ready for execution). In some instances, this disclosure may describe that the instructions or modules of a program perform an action. Such descriptions should be deemed to be equivalent to describing that the instructions or modules are configured to cause the performance of the action. The term “module” may be defined as a set of instructions. The term “program” and the term “module” may each be interpreted to include multiple sub-programs or multiple sub-modules, respectively. In this regard, reference to a program or a module may be considered to refer to multiple programs or multiple modules.

[0118] Further, it is understood that information or data may be operated upon, manipulated, or converted into different forms as it moves through various devices or workflows. In this regard, unless otherwise explicitly noted or required by context, it is intended that any reference herein to information, signals, or data or the like includes modifications to that information, signals, or data. For example, “data X” may be encrypted for transmission, and a reference to “data X” is intended to include both its encrypted and unencrypted forms, unless otherwise required or indicated by context. For another example, “image information Y” may undergo a noise filtering process, and a reference to “image information Y” is intended to include both the pre- processed form and the noise-filtered form, unless otherwise required or indicated by context. In other words, both the pre-processed form and the noise-filtered form are considered to be “image information Y”, unless otherwise required or indicated by context. In order to stress this point, the phrase “or a derivative thereof’ or the like may be used herein. Continuing the preceding example, the phrase “image information Y or a derivative thereof’ refers to both the pre-processed form and the noise-filtered form of “image information Y”, unless otherwise required or indicated by context, with the noise-filtered form potentially being considered a derivative of “image information Y”. However, non-usage of the phrase “or a derivative thereof’ or the like nonetheless includes derivatives or modifications of information or data unless otherwise explicitly noted or required by context.

[0119] Various embodiments are described herein in the context of varying one or more waveform characteristics. In this regard, various embodiments are described herein in the context of determining one or more waveform characteristics to implement such varying. According to some embodiments, such determining of one or more waveform characteristics may be performed based at least on an analysis of data. An example of such data may be data describing one or more waveform characteristics of one or more previous portions of the waveform (e.g., to enforce minimum or maximum variations across the waveform, in some embodiments). Another example of such data may be sensor data, such as data from one or more electrodes or transducers indicating treatment (e.g., PFA treatment) conditions. In some embodiments, such determining of one or more waveform characteristics may include a randomized determination (e.g., such as by utilization of a random number generator, in some embodiments).

[0120] Example methods are described herein with respect to FIG. 5. Such figures are described to include blocks associated with actions, instructions of one or more programs, or both actions and instructions, according to various embodiments. It should be noted that the respective instructions associated with any such blocks therein need not be separate instructions and may be combined with other instructions to form a combined instruction set. The same set of instructions may be associated with more than one block. In this regard, the block arrangements shown in FIG. 5 are not limited to an actual structure of any program or set of instructions or required ordering of method tasks, and such method figures, according to some embodiments, merely illustrate the tasks that instructions are configured to perform, for example, upon execution by a data processing device system in conjunction with interactions with one or more other devices or device systems.

[0121] FIG. 1 schematically illustrates a portion of a transducer-activation system or controller system thereof 100 that may be employed to at least select, control, activate, or monitor a function or activation of a number of electrodes or transducers (e.g., ablation transducers configured to cause PF A), according to some embodiments. The system 100 includes a data processing device system 110, an input-output device system 120, and a processor- accessible memory device system 130. The processor-accessible memory device system 130 and the inputoutput device system 120 are communicatively connected to the data processing device system 110. According to some embodiments, various components such as data processing device system 110, input-output device system 120, and processor-accessible memory device system 130 form at least part of a controller system (e.g., controller system 324 shown in FIGS. 3).

[0122] The data processing device system 110 includes one or more data processing devices that implement or execute, in conjunction with other devices, such as one or more of those in the system 100, various methods and actions described herein, including those described with respect to methods exemplified in FIG. 5. Each of the phrases “data processing device”, “data processor”, “processor”, “controller”, “computing device”, “computer” and the like is intended to include any data or information processing device, such as a central processing unit (CPU), a control circuit, a desktop computer, a laptop computer, a mainframe computer, a tablet computer, a cellular or smart phone, and any other device configured to process information or data, manage information or data, or handle information or data, whether implemented with electrical, magnetic, optical, quantum components, or otherwise. The data processing device system 110 may be a distributed data processing device system including multiple communicatively connected data processing devices. On the other hand, the data processing device system 110 need not be a distributed data processing device system and, consequently, may include one or more data processing devices located within a single housing.

[0123] The memory device system 130 includes one or more processor- accessible memory devices configured to store one or more programs and information, including the program(s) and information needed to execute the methods or actions described herein, including those described with respect to FIG. 5. In some embodiments, each of the actions illustrated in the example methods of FIG. 5 may represent or be associated with program instructions stored in the memory device system 130 and configured to cause execution of the respective action(s). The memory device system 130 may be a distributed processor-accessible memory device system including multiple processor-accessible memory devices communicatively connected to the data processing device system 110 via a plurality of computers and / or devices. However, the memory device system 130 need not be a distributed processor-accessible memory system and, consequently, may include one or more processor-accessible memory devices located within a single data processing device or housing.

[0124] Each of the phrases “processor-accessible memory” and “processor-accessible memory device” and the like is intended to include any processor-accessible data storage device or medium, whether volatile or nonvolatile, electronic, magnetic, optical, quantum, or otherwise, including but not limited to, registers, hard disk drives, Compact Discs, DVDs, SSDs, flash memories, ROMs, and RAMs. In some embodiments, each of the phrases “processor-accessible memory” and “processor-accessible memory device” is intended to include or be a processor- accessible (or computer-readable) data storage medium. In some embodiments, each of the phrases “processor-accessible memory” and “processor-accessible memory device” may include or may be a non-transitory processor-accessible (or computer-readable) data storage medium. In some embodiments, the processor-accessible memory device system 130 may include or may be a non-transitory processor-accessible (or computer-readable) data storage medium system. In some embodiments, the processor-accessible memory device system 130 may include or may be a non-transitory processor-accessible (or computer-readable) storage medium system or data storage medium system including or consisting of one or more non-transitory processor- accessible (or computer-readable) data storage mediums.

[0125] The phrase “communicatively connected” is intended to include any type of connection, whether wired or wireless, between devices, data processors, or programs between which data may be communicated. Further, the phrase “communicatively connected” is intended to include a connection between devices or programs within a single data processor or computer, a connection between devices or programs located in different data processors or computers, and a connection between devices not located in data processors or computers at all. In this regard, although the memory device system 130 is shown separately from the data processing device system 110 and the input-output device system 120, one skilled in the art will appreciate that the memory device system 130 may be located completely or partially within the data processing device system 110 or the input-output device system 120. Further in this regard, although the input-output device system 120 is shown separately from the data processing device system 110 and the memory device system 130, one skilled in the art will appreciate that such system may be located completely or partially within the data processing device system 110 or the memory device system 130, for example, depending upon the contents of the input-output device system 120. Further still, the data processing device system 110, the input-output device system 120, and the memory device system 130 may be located entirely within the same device or housing or may be separately located, but communicatively connected, among different devices or housings. In at least the case where the data processing device system 110, the input-output device system 120, and the memory device system 130 are located within the same device, the system 100 of FIG. 1 may be implemented by a single application-specific integrated circuit (ASIC), field programmable gate array (FPGA), system on chip (SOC), or other type of integrated circuit, in some embodiments. In this regard, in some embodiments, the processor- accessible memory device system 130 may be considered to be integrated with the data processing device system 110, such that circuitry or hardware may itself be encoded with the equivalent of program instructions to produce a configuration to execute the methods and actions described herein, including those described with respect to the methods 500 of FIG. 5. Such integration may be considered a type of communicative connection between the data processing device system 110 and the processor-accessible memory device system 130. Such integration may also be considered control circuitry or a controller that combines at least some functionality of the processor-accessible memory device system 130 and the data processing device system 110, such that the control circuitry or controller is communicatively connected to the input-output device system 120 and is configured (e.g., via circuitry or hardware encoded with the equivalent of program instructions) at least to perform the methods and actions described herein, including those described with respect to the methods 500 of FIG. 5.

[0126] The input-output device system 120 may include a display device (e.g., display device 332 in FIGS. 3A and 3B), a mouse (e.g., a mouse 335 in FIGS. 3A and 3B), a keyboard, a touch screen, another computer, a processor-accessible memory device system, a network-interface card or network-interface circuitry, or any device or combination of devices from which a selection, information, instructions, or any other data is input to the data processing device system 110. The input-output device system 120 may include any suitable interface for receiving information, instructions, or any data from other devices and systems described in various ones of the embodiments. In this regard, the input-output device system 120 may include various ones of other systems described in various embodiments. For example, the input-output device system 120 may include at least a portion of a transducer-based device (e.g., a catheter, or portion thereof) that includes a spatial distribution of electrodes. Each of the phrases “transducer-based device” and “transducer-based device system” is intended to include one or more physical systems that include various transducers (e.g., electrodes). The input-output device system 120 also may include an image generating device system, a display device system, a speaker or audio output device system (e.g., speaker or audio output device system 334 shown in FIGS. 3A and 3B, discussed below), a computer, a processor-accessible memory device system, a network-interface card or network-interface circuitry, or any device or combination of devices to which information, instructions, or any other data is output by the data processing device system 110. In this regard, the input-output device system 120 may include various other devices or systems described in various embodiments. The input-output device system 120 may include any suitable interface for outputting information, instructions, or data to other devices and systems described in various ones of the embodiments. If the input-output device system 120 includes a processor-accessible memory device, such memory device may, or may not, form part, or all, of the memory device system 130. In some embodiments, the input-output device system 120 may include a transducer-based device, as discussed above, and in some embodiments, the transducer-based device may act as a device or device system that provides information to, receives instructions or energy from, or both provides information to and receives instructions or energy from the data processing device system 110. In this regard, the input-output device system 120 may include various devices or systems described in various embodiments. In some embodiments, the input-output device system 120 may include one or more display devices that display one or more of the graphical interfaces.

[0127] According to some embodiments of the present invention, the system 100 includes some or all of the system 200 shown in FIG. 2 (discussed below), or vice versa. According to some embodiments, the system 100 includes some or all of the system 300 shown in FIGS. 3 (discussed below), or vice versa. Various embodiments of transducer-based devices (e.g., forming part of catheters) are described herein in this disclosure. Some of the described devices are tissue ablation (e.g., PF A) devices that are percutaneously or intravascularly deployed. Some of the described devices are movable between a delivery or unexpanded configuration (e.g., FIG. 3 A discussed below) in which a portion of the device is sized for passage through a bodily opening leading to a bodily cavity, and an expanded or deployed configuration (e.g., FIGS. 2 and 3B discussed below) in which the portion of the device has a size too large for passage through the bodily opening leading to the bodily cavity. An example of an expanded or deployed configuration, in some embodiments, is when the portion of the transducer-based device (e.g., catheter, or part thereof) is in its intended-deployed-operational state, which may be inside the bodily cavity when, e.g., performing an intended therapeutic or diagnostic procedure for a patient, or which may be outside the bodily cavity when, e.g., performing testing, quality control, or other evaluation of the device. Another example of the expanded or deployed configuration, in some embodiments, is when the portion of the transducer-based device (e.g., catheter, or part thereof) is being changed from the delivery configuration to the intended- deployed-operational state to a point where the portion of the device now has a size too large for passage through the bodily opening leading to the bodily cavity.

[0128] In some example embodiments, the described devices are part of a transducer-activation system capable of ablating tissue in a desired pattern within the bodily cavity using various techniques (e.g., via PFA, etc., according to various embodiments).

[0129] In some example embodiments, the devices are capable of sensing various cardiac functions (e.g., electrophysiological activity including intra-cardiac voltages which form the basis of recorded electrograms, according to some embodiments). In some example embodiments, the devices are capable of providing stimulation (e.g., electrical stimulation) to tissue within the bodily cavity. Electrical stimulation may include pacing.

[0130] FIG. 2 is a representation of a transducer-based device 200 useful in investigating or treating a bodily organ, for example, a heart 202, according to at least one example embodiment.

[0131] Transducer-based device 200 can be percutaneously or intravascularly inserted into a portion of the heart 202, such as an intra-cardiac cavity like left atrium 204. In this example, the transducer-based device 200 is part of a catheter 206 inserted via the inferior vena cava 208 and penetrating through a bodily opening in transatrial septum 210 from right atrium 212. (In this regard, transducer-based devices or device systems described herein that include a catheter may also be referred to as catheters, catheter devices or catheter-based devices, in some embodiments). In other embodiments, other paths may be taken.

[0132] Catheter 206 includes an elongated flexible rod or shaft member appropriately sized to be delivered percutaneously or intravascularly. Various portions of catheter 206 may be steerable. Catheter 206 may include one or more lumens. The lumen(s) may carry one or more communications or power paths, or both. For example, the lumens(s) may carry one or more electrical conductors 216 (two shown). Electrical conductors 216 provide electrical connections to transducer-based device 200 that are accessible externally from a patient in which the transducer-based device 200 is inserted.

[0133] According to some embodiments, transducer-based device 200 includes a frame or structure 218 which assumes an unexpanded configuration for delivery to left atrium 204. Structure 218 is expanded (e.g., shown in a deployed or expanded configuration in FIG. 2) upon delivery to left atrium 204 to position a plurality of transducers 220 (three called out in FIG. 2) proximate the interior surface formed by tissue 222 of left atrium 204. In some embodiments, at least some of the transducers 220 are used to sense a physical characteristic of a fluid (e.g., blood) or tissue 222, or both, that may be used to determine a position or orientation (e.g., pose), or both, of a portion of a device 200 within, or with respect to left atrium 204. For example, transducers 220 may be used to determine a location of pulmonary vein ostia or a mitral valve 226, or both. In some embodiments, at least some of the transducers 220 may be used to selectively ablate portions of the tissue 222. In some embodiments, at least some of the transducers 220 are used to sense a physical characteristic of a fluid (e.g., blood) or tissue 222, or both, that may be used to determine contact or a degree of contact between a portion of a device 200 and a tissue surface (e.g., an internal tissue surface). In some embodiments, some of the transducers 220 may be used to ablate a pattern around the bodily openings, ports or pulmonary vein ostia, for instance to reduce or eliminate the occurrence of atrial fibrillation. In some embodiments, at least some of the transducers 220 are used to ablate cardiac tissue. In some embodiments, at least some of the transducers 220 are used to sense or sample intracardiac voltage data or sense or sample intra-cardiac electrogram data.

[0134] FIGS. 3A and 3B (collectively, FIGS. 3) include a transducer-based device system (e.g., a portion thereof shown schematically) that includes a catheter including a transducer-based device 300 according to some embodiments. Transducer-based device 300 includes a plurality of elongate members 304 (not all of the elongate members called out in each of FIG. 3A and 3B) and a plurality of transducers 306 (not all of the transducers called out in FIGS. 3). It is noted that, for clarity of illustration, all the elongate members shown in FIG. 3B are not represented in FIG. 3A. The plurality of transducers 306 are positionable within a bodily cavity. For example, in some embodiments, the transducers 306 are able to be positioned in a bodily cavity by movement into, within, or into and within the bodily cavity, with or without a change in a configuration of the plurality of transducers 306. In some embodiments, the plurality of transducers 306 are arrangeable into various spatial distributions including two- or three- dimensional distributions, grids or arrays of the transducers capable of mapping, ablating or stimulating an inside surface of a bodily cavity or lumen. As shown, for example, in FIG. 3A, the plurality of transducers 306 are arranged in a configuration that is receivable in a bodily cavity. In various ones of FIGS. 3, each of at least some of transducers 306 includes a respective electrode 315 (not all of the transducers 306 or electrodes 315 are called out in each of the FIGS. 3). According to various embodiments, the input-output device system 120 is communicatively connected to each electrode in the spatial distribution of electrodes 315 provided by the catheter. In some embodiments, the data processing device system (e.g., 110, 310) is communicatively connected to the plurality of electrodes 315 via the input-output device system (e.g., 120, 320).

[0135] According to some embodiments, the elongate members 304 may be arranged in a frame or structure 308 that is selectively movable between an unexpanded or delivery configuration (e.g., as shown in FIG. 3A) and an expanded or deployed configuration (e.g., as shown in FIG. 3B) that may be used during a positioning of the elongate members 304 against a tissue surface within the bodily cavity or during a positioning of the elongate members 304 in the vicinity of the tissue surface. At least the expanded or deployed configuration shown in FIG. 3B is an example of a spatial distribution of the transducers 306 (e.g., a three-dimensional spatial distribution). In some embodiments, structure 308 has a size in the unexpanded or delivery configuration suitable for delivery through a bodily opening (e.g., via catheter sheath 312 to the bodily cavity. At least in a state in which the structure 308 is in the expanded or deployed configuration, the structure 308 may be considered to have two opposing poles 341a and 341b, marked by the intersection with axis 342 extending through the structure 308 as shown in FIG. 3B according to some embodiments. In some embodiments, at least some of the plurality of transducers 306 are circumferentially arranged, e.g., in successive ring-like arrangements, about each of the poles 341a and 341b according to some embodiments. Such a ring-like arrangement is illustrated, for example, as broken-line ring 343b in FIG. 3B. According to some embodiments, at least some of the plurality of transducers 306 are arranged in a plurality of groups of the transducers 306, the groups of transducers 306 arranged like lines of longitude (e.g., along respective elongate members 304) about the structure 308 between each of the poles 341a and 341b, according to some embodiments.

[0136] In some embodiments, structure 308 has a size in the expanded or deployed configuration too large for delivery through a bodily opening (e.g., via catheter sheath 312) to the bodily cavity. The elongate members 304 may form part of a flexible circuit structure (e.g., also known as a flexible printed circuit board (PCB)). The elongate members 304 may include a plurality of different material layers. Each of the elongate members 304 may include a plurality of different material layers. The structure 308 may include a shape memory material, for instance, Nitinol. The structure 308 can include a metallic material, for instance stainless steel, or non-metallic material, for instance polyimide, or both a metallic and non-metallic material by way of non- limiting example. The incorporation of a specific material into structure 308 may be motivated by various factors including the specific requirements of each of the unexpanded or delivery configuration and expanded or deployed configuration, the required position or orientation (e.g., pose), or both of structure 308 in the bodily cavity or the requirements for successful ablation of a desired pattern.

[0137] FIG. 4 is a schematic side elevation view of at least a portion of a transducer-based device 400 that includes a flexible circuit structure 401 that is employed to provide a plurality of transducers 406 (two called out), according to an example embodiment. In some embodiments, the flexible circuit structure 401 may form part of a structure (e.g., structure 308) that is selectively movable between a delivery configuration sized for percutaneous delivery and an expanded or deployed configuration sized too large for percutaneous delivery. In some embodiments, the flexible circuit structure 401 may be located on, or form at least part of, a structural component (e.g., elongate member 304) of a transducer-based device system.

[0138] The flexible circuit structure 401 can be formed by various techniques including flexible printed circuit techniques. In some embodiments, the flexible circuit structure 401 includes various layers including flexible layers 403a, 403b and 403c (e.g., collectively flexible layers 403). In some embodiments, each of flexible layers 403 includes an electrical insulator material (e.g., polyimide). One or more of the flexible layers 403 can include a different material than another of the flexible layers 403. In some embodiments, the flexible circuit structure 401 includes various electrically conductive layers 404a, 404b, and 404c (collectively electrically conductive layers 404) that are interleaved with the flexible layers 403. In some embodiments, each of the electrically conductive layers 404 is patterned to form various electrically conductive elements. For example, electrically conductive layer 404a is patterned to form a respective electrode 415 of each of the transducers 406. Electrodes 415 have respective electrode edges 415-1 that form a periphery of an electrically conductive surface associated with the respective electrode 415. It is noted that other electrodes employed in other embodiments may have electrode edges arranged to form different electrode shapes (e.g., as shown by electrode edges 315-1 in FIG. 3B).

[0139] Electrically conductive layer 404b is patterned, in some embodiments, to form respective temperature sensors 408 for each of the transducers 406 as well as various leads 410a arranged to provide electrical energy to the temperature sensors 408. In some embodiments, each temperature sensor 408 includes a patterned resistive member 409 (two called out) having a predetermined electrical resistance. In some embodiments, each resistive member 409 includes a metal having relatively high electrical conductivity characteristics (e.g., copper). In some embodiments, electrically conductive layer 404c is patterned to provide portions of various leads 410b arranged to provide an electrical communication path to electrodes 415. In some embodiments, leads 410b are arranged to pass through vias in flexible layers 403a and 403b to connect with electrodes 415. Although FIG. 4 shows flexible layer 403c as being a bottom-most layer, some embodiments may include one or more additional layers underneath flexible layer 403c, such as one or more structural layers such as a steel or composite layer. These one or more structural layers, in some embodiments, are part of the flexible circuit structure 401 and can be part of, e.g., elongate member 304. In some embodiments, the one or more structural layers may include at least one electrically conductive surface (e.g., a metallic surface) exposed to blood flow. In addition, although FIG. 4 shows only three flexible layers 403a-403c and only three electrically conductive layers 404a-404c, it should be noted that other numbers of flexible layers, other numbers of electrically conductive layers, or both, can be included.

[0140] In some embodiments, electrodes 415 are employed to selectively deliver ablative energy (e.g., PFA energy) to various tissue structures within a bodily cavity (e.g., an intra-cardiac cavity or chamber). The energy delivered to the tissue structures may be sufficient for ablating portions of the tissue structures. Energy that is sufficient for tissue ablation may be dependent upon factors including transducer location, size, shape, relationship with respect to another transducer or a bodily cavity, material or lack thereof between transducers, et cetera.

[0141] In some embodiments, each electrode 415 is employed to sense or sample an electrical potential in the tissue proximate the electrode 415 typically at a different time than delivering PFA energy sufficient for tissue ablation. In some embodiments, each electrode 415 is employed to sense or sample intra-cardiac voltage data in the tissue proximate the electrode 415. In some embodiments, each electrode 415 is employed to sense or sample data in the tissue proximate the electrode 415 from which an electrogram may be derived. In some embodiments, each resistive member 409 is positioned adjacently to a respective one of the electrodes 415. In some embodiments, each of the resistive members 409 is positioned in a stacked or layered array with a respective one of the electrodes 415 to form a respective one of the transducers 406. In some embodiments, leads 410a are arranged to allow for a sampling of electrical voltage between resistive members 409. This arrangement allows for the electrical resistance of each resistive member 409 to be accurately measured. The ability to accurately measure the electrical resistance of each resistive member 409 may be motivated by various reasons including determining temperature values at locations at least proximate the resistive member 409 based at least on changes in the resistance caused by convective cooling effects (e.g., as provided by blood flow).

[0142] Referring to FIGS. 3A and 3B transducer-based device 300 can communicate with, receive power from, or be controlled by a transducer-activation system 322 (e.g., via leads 317). In some embodiments, the transducer-activation system 322 represents one or more particular implementations of the system 100 illustrated in FIG. 1. In some embodiments, the transducerbased device 300 or the transducer-based device 200 may be considered part of the transduceractivation system 322 or 100. However, the transducer- activation system 322 (which may be an implementation of system 100 in some embodiments) is not limited to including or interacting with either of the particular transducer-based devices 200, 300, and may include or interact with one or more other types of transducer-based devices, according to some embodiments.

[0143] The transducer-activation device system 322 may include a controller 324 that includes a data processing device system 310 (which may be a particular implementation of data processing device system 110 from FIG. 1) and a memory device system 330 (which may be a particular implementation of the memory device system 130 from FIG. 1) that stores data and instructions that are executable by the data processing device system 310 to process information received from transducer-based device 300 or to control operation of transducer-based device 300, for example, activating various selected transducers 306 to ablate tissue (e.g., via PF A) according to various embodiments including at least those described below with respect to FIG. 5. Controller 324 may include one or more controllers.

[0144] Transducer-activation device system 322 includes an input-output device system 320 (which may be a particular implementation of the input-output device system 120 from FIG. 1) communicatively connected to the data processing device system 310 (e.g., via controller 324 in some embodiments). Input-output device system 320 may include a sensing device system 325 configured to detect various characteristics including, but not limited to, at least one of tissue characteristics (e.g., electrical characteristics such as tissue impedance, tissue conductivity, tissue type, tissue thickness) and thermal characteristics. In this regard, the sensing device system 325 may include one, some, or all of the transducers 306 (or 406 of FIG. 4) of the transducer-based device 300, including the internal components of such transducers shown in FIG. 4, such as the electrodes 415 and temperature sensors 408.

[0145] Transducer-activation device system 322 may also include an energy source device system circuit 340 (which may be a PFA power supply system or pulse generator in some embodiments) including one or more energy source devices (e.g., one or more power delivery drivers 344 (two shown in FIGS. 3A and 3B as 344a, 344b) in some embodiments) selectively connectable (e.g., via electrical switches) to transducers 306. In this regard, although various ones of FIGS. 3 show a communicative connection between the energy source device system circuit 340 and the controller 324 (and its data processing device system 310), the energy source device system circuit 340 may also be connected (e.g., via electrical switches) to the transducers 306 via a communicative connection that is independent of the communicative connection between the energy source device system circuit 340 and the controller 324 (and its data processing device system 310). For example, the energy source device system circuit 340 may receive control signals via the communicative connection with the controller 324 (and its data processing device system 310), and, in response to such control signals, provide energy to one or more of the transducers 306 via a communicative connection with such transducers 306 (e.g., via one or more electrical switches and communication lines through catheter body or shaft 314, elongated cable 316 or catheter sheath 312) that does not pass through the controller 324. In this regard, the energy source device system circuit 340 may provide results of its delivering energy to, receiving energy from, or both delivering energy to and receiving energy from one or more of the transducers 306 to the controller 324 (and its data processing device system 310) via the communicative connection between the energy source device system circuit 340 and the controller 324.

[0146] The energy source device system circuit 340 may, for example, be connected to various selected transducers 306 or electrodes thereof to selectively provide energy, e.g., via one or more power delivery drivers 344, in the form of electrical current or power (e.g., PFA energy) to cause ablation of tissue. In some embodiments, a power delivery driver may be a circuit used to deliver electrical power to a load. In some embodiments, the load may be a transducer set (e.g., electrode set). In some embodiments, the load may be tissue, such as tissue proximate a transducer set. A power delivery driver may include a circuit that is controllable to produce a specified voltage output (e.g., high voltage pulses), in some embodiments. In some embodiments, a power delivery driver may include a circuit that is controllable to produce a specified current output (e.g., the power delivery driver may adjust its output voltage as required to achieve a specified current). The energy source device system circuit 340 may selectively provide energy, e.g., via one or more power delivery drivers 344, in the form of electrical current to various selected transducers 306 or electrodes thereof and such transducers 306 or electrodes thereof may measure a temperature characteristic, an electrical characteristic, or both at a respective location at least proximate each of the various transducers 306 utilizing energy provided by the energy source device system circuit 340. The energy source device system circuit 340 may include various electrical current or voltage sources, such as power delivery drivers 344, as energy source devices.

[0147] It is understood that input-output device system 320 may include various systems. In some embodiments, input-output device system 320 may include energy source device system circuit 340, transducer-based device 300, or both energy source device system circuit 340 and transducer-based device 300 by way of non-limiting example. Input-output device system 320 may include the memory device system 330 in some embodiments.

[0148] In other example embodiments, other structures besides those shown in FIGS. 2, 3A, 3B, and 4 may be employed to support or carry transducers of a transducer-based device, such as a transducer-based catheter. For example, an elongated catheter member may be used to distribute the transducers in a linear or curvilinear array. Basket catheters or balloon catheters may be used to distribute the transducers in a two-dimensional or three-dimensional array.

[0149] According to some embodiments of the present invention, the system 100 (FIG. 1) includes some, or all, of the system 200 shown in FIG. 2, or vice versa. In some embodiments, the system 100 includes some, or all, of the system 300 in FIGS. 3, or vice versa. In this regard, the system 200, the system 300, or each of the system 200 and the system 300 may be a particular implementation of the system 100, according to some embodiments. Some or all of the controller 324, energy source device system circuit 340, or input-output device system 320 described with respect to FIGS. 3 may also be implemented with the system 200 in FIG. 2, in some embodiments. Each of at least part of the transducer or electrode-based device system 400 in FIG. 4 may be part of the system 100, the system 200, or the system 300, according to various embodiments.

[0150] FIG. 5 includes a processing flow diagram, which may implement various embodiments of methods 500 by way of associated program instructions, according to some example embodiments. In various example embodiments, a memory device system (e.g., memory device system 130 or 330, otherwise stated herein at times as “130, 330”) is communicatively connected to a data processing device system (e.g., data processing device systems 110 or 310, otherwise stated herein at times as “110, 310”) and stores a program that configures the data processing device system to cause the data processing device system to execute various embodiments of methods 500 via interaction with at least, for example, a transducer-based or electrode-based device (e.g., transducer-based / electrode-based devices 200, 300, or 400 in various embodiments). In some embodiments, the program may include instructions configured to perform, or to cause to be performed, various ones of the instructions associated with execution of various embodiments of methods 500. In some embodiments, methods 500 may include additional blocks not shown in FIG. 5, such as, e.g., one or more blocks associated with user or machine selection of one or more transducers or electrodes of a transducer-based device system (e.g., transducer-based / electrode -based devices 200, 300, or 400 in some embodiments) to which the at least one pulse train associated with blocks 502, 504, and 508, discussed below, is to be provided, e.g., to cause PFA of tissue of a bodily cavity. At least U.S. Patent No. 10,368,936, issued August 6, 2019 and U.S. Patent No. 11,633,238, issued April 25, 2023 include disclosures about various techniques for user and machine selection of transducers / electrodes to cause tissue ablation.

[0151] According to some embodiments, methods 500 may include block 502 associated with program instructions (e.g., pulse train provision instructions provided by a program) configured to cause a data processing device system (e.g., 110, 310) to cause or control, via an input-output device system (e.g., input-output device system 120, 320), a pulse generator (e.g., energy source device system circuit 340) to output a pulse train configured to cause pulsed field tissue ablation. According to various embodiments, the input-output device system 120, 320 is communicatively connected to the data processing device system 110, 310, and the input-output device system 120, 320 is further connectable or is connected to the pulse generator (e.g., energy source device system circuit 340) to provide pulsed field ablation (PF A) energy to at least some transducers of a plurality of transducers (e.g., transducers 220, 306, 406) supported by a structure (e.g., structure 308) of a catheter or catheter device system (e.g., catheter device system 200, 300, 400). In some embodiments, the output pulse train per block 502 may be provided by the pulse generator to a transducer set from the plurality of transducers (e.g., 220, 306, 406). In some embodiments, the data processing device system 110, 310 may be configured by the program at least to cause delivery of the pulse train per block 502 to or from a transducer set from the plurality of transducers (e.g., 220, 306, 406). In some embodiments, each of one or more pulse trains output per block 502 is delivered to a transducer set (i.e., at least one transducer) from the plurality of transducers (e.g., 220, 306, 406) of a transducer-based device (e.g., catheter device system (e.g., 200, 300, 400)). In some embodiments, each of one or more pulse trains output per block 502 is delivered to a same transducer set or to a respective transducer set. In some embodiments, the same or respective transducer set is only one transducer. In some embodiments, the same or respective transducer set is a pair of transducers. In some embodiments, the same or respective transducer set is more than two transducers. In this regard, in some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program at least to cause, via the input-output device system (e.g., 120, 320), a sequence of pairs of consecutive pulses (e.g., biphasic, monophasic, or both) of a pulse train output per block 502 to be delivered to a transducer set (i.e., at least one transducer) from the plurality of transducers (e.g., 220, 306, 406) of a transducer-based device (e.g., catheter device system (e.g., 200, 300, 400)). In some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program at least to cause, via the input-output device system (e.g., 120, 320), a sequence of pairs of consecutive pulses (e.g., biphasic, monophasic, or both) of a pulse train output per block 502 to be delivered to a same transducer set or to a respective transducer set (e.g., 220, 306, 406) of a transducer-based device (e.g., catheter device system (e.g., 200, 300, 400)) communicatively connected to the input-output device system (e.g., 120, 320). In some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program at least to cause, via the input-output device system (e.g., 120, 320), each voltage pulse in a sequence of consecutive pulses (e.g., biphasic, monophasic, or both) of a pulse train output per block 502 to be delivered to a respective set of transducers (e.g., 220, 306, 406) in a plurality of transducers of a transducer-based device (catheter device system (e.g., 200, 300, 400)) communicatively connected to the input-output device system (e.g., 120, 320). In some embodiments, each respective set of transducers in the plurality of sets of transducers includes at least one transducer not included in any other set of transducers in the sequence of sets of transducers. For instance, in some embodiments, if a pulse train consecutively includes a first pulse set (i.e., including one or more pulses, such as biphasic pulses in some embodiments), a second pulse set, and a third pulse set, the first pulse set may be delivered to a first transducer, the second pulse set may be delivered to a second transducer, and the third pulse set may be delivered to a third transducer from a plurality of transducers (e.g., 220, 306, 406) of a transducer-based device (e.g., catheter device system (e.g., 200, 300, 400)), where the first transducer, second transducer, and third transducer are considered a plurality of (or a sequence of) transducer sets.

[0152] According to various embodiments, each pulse train output per block 502 includes a plurality of voltage pulses that are provided or desired to be provided. Each pulse train output per block 502 may also have an associated particular time interval in which the plurality of voltage pulses are provided or desired to be provided. In some embodiments, the pulses in each pulse train output per block 502 of the at least one pulse train have pulse waveform characteristics. According to various embodiments, such pulse waveform characteristics may include pulse rise time, pulse fall time, pulse duration, pulse amplitude, pulse shape, or a combination thereof. In some embodiments, biphasic pulses are employed. In some embodiments, monophasic pulses are employed. In some embodiments, a mixture of biphasic pulses and monophasic pulses are employed.

[0153] As described in more detail below, in some embodiments of methods 500, block 502 is repeated per the sequence of decision diamond 504 (with answer “No”) and block 508, such that multiple pulse trains are output by the pulse generator (e.g., energy source device system circuit 340) in a sequence, or in some embodiments, a regularly repeating sequence. Multiple pulse trains may be employed for various reasons. For example, a relatively large number of pulses may be required for effective treatment, but deleterious thermal, hemodynamic, or microbubble generation effects may occur if all the pulses in the relatively large number of pulses were to be continuously provided. By breaking up the relatively large number of pulses into a sequence of pulse trains with each pulse train in the sequence of pulse trains spaced or separated (a) by a respective rest period (e.g., a respective inter-pulse-train delay) from an immediately preceding pulse train, if present in the sequence of pulse trains, (b) by a respective rest period (e.g., a respective inter-pulse-train delay) from an immediately succeeding pulse train, if present in the sequence of pulse trains, or each of (a) and (b), the rest periods or inter-pulse-train delays may be sufficiently large (e.g., 1 or more seconds) to alleviate or lessen the above-mentioned and other potentially deleterious effects.

[0154] According to some embodiments, each inter-pulse-train delay is longer in duration than various delays between successive pulses within a given one of the pulse trains. For example, each provided pulse train may include a plurality of biphasic voltage pulses, the plurality of biphasic voltage pulses (described in further detail below) including a first biphasic voltage pulse, a second biphasic voltage pulse that sequentially or consecutively follows the first biphasic voltage pulse, and an inter-biphasic-pulse delay (which may also be referred to as an inter-pulse delay in the case of biphasic pulses) that spaces or separates (e.g., temporally spaces or separates) the second biphasic voltage pulse from the first biphasic voltage pulse. According to various embodiments, each respective inter-pulse-train delay is longer in duration than the inter-biphasic -pulse delay. According to various embodiments, the biphasic voltage pulses are successively arranged in the pulse train with the biphasic voltage pulses of each pair of successive biphasic voltage pulses in the pulse train spaced or separated from one another by a respective inter-biphasic -pulse delay. According to various embodiments, each respective interpulse-train delay is longer in duration than each respective inter-biphasic -pulse delay. In some embodiments, each provided pulse train may include a plurality of first monophasic voltage pulses, each first monophasic voltage pulse of the plurality of first monophasic voltage pulses having a same first polarity. In some embodiments, the first monophasic voltage pulses of the plurality of the first monophasic voltage pulses may be successively arranged in the pulse train with the monophasic voltage pulses of each pair of successive first monophasic voltage pulses spaced or separated (e.g., temporally spaced or separated) from one another by a respective first inter-monophasic-pulse delay. According to some embodiments, each respective inter-pulsetrain delay is longer in duration than each respective first inter-monophasic-pulse delay. In some embodiments, each provided pulse train may include a plurality of second monophasic voltage pulses arranged in a sequence of second monophasic voltage pulses, each second monophasic voltage pulse of the sequence of second monophasic voltage pulses having a same second polarity opposite the first polarity. In some embodiments, the second monophasic voltage pulses of the plurality of the second monophasic voltage pulses may be successively arranged in the pulse train with the monophasic voltage pulses of each pair of successive second monophasic voltage pulses spaced (e.g., temporally spaced or separated) from one another by a respective second inter-monophasic -pulse delay. In some embodiments, each respective interpulse-train delay is longer in duration than each respective first inter-monophasic-pulse delay, each respective second inter-monophasic-pulse delay, or each respective first inter-monophasic- pulse delay and each respective second inter-monophasic-pulse delay.

[0155] Provision of each of at least one pulse train in accordance with block 502 of methods 500 in FIG. 5 may take various forms. For example, as discussed above, some embodiments of the present invention vary waveform characteristics or parameters of each of one or more pulse trains (e.g., per block 502a described in more detail below), for instance, either by causing such waveform characteristics or parameters to be different or by randomly determining them in some embodiments, which may improve the electromagnetic compatibility of a device generating or delivering the waveforms (e.g., as compared to a device that is configured to provide constant waveform characteristics or parameters). According to various embodiments, the varied waveform characteristics or parameters may be pulse-to -pulse initiation intervals (e.g., as described in more detail below with respect to block 502al in FIG. 5), inter-pulse delays (which may also be referred to as inter-monophasic-pulse delays in various monophasic pulse embodiments or inter-biphasic-pulse delays in various biphasic pulse embodiments) (e.g., as described in more detail below with respect to block 502a2), pulse on-times (e.g., as described in more detail below with respect to block 502a3), pulse widths (e.g., as described in more detail below with respect to block 502a4), inter-phase delays (which may also be referred to as between-phase delays or intra-biphasic-pulse delays in various biphasic pulse embodiments) (e.g., as described in more detail below with respect to block 502a5) or one or more combinations thereof. In some embodiments, inter-pulse-train delays between pulse trains are varied (e.g., per block 508 described in more detail below), for instance, by causing such delays to be different to potentially assist in improving electromagnetic compatibility, according to some embodiments. In some embodiments, inter-pulse-train delays between pulse trains are varied (e.g., per block 508 described in more detail below), for instance, by randomly determining them to potentially assist in improving electromagnetic compatibility, according to some embodiments. In this regard, in some embodiments of methods 500, block 502 may include block 502a as a possible implementation or implementation part of block 502. In some embodiments, block 502a is associated with program instructions (e.g., pulse train variation instructions provided by a program) configured to cause the data processing device system (e.g., 110, 310) to cause or control the pulse generator (e.g., energy source device system circuit 340) to vary waveform characteristics or parameters within the pulse train that is output per block 502. In some embodiments, such varying is implemented by the data processing device system (e.g., 110, 310) causing or controlling the waveform characteristics or parameters to be different (e.g., by determination) or by the data processing device system (e.g., 110, 310) randomly determining such waveform characteristics or parameters.

[0156] In some embodiments, the actual variations to be implemented for such waveform characteristics or parameters may be predetermined (e.g., prior to delivery of the current pulse train per block 502 or prior to initiating the current PFA application in some embodiments), or they may be determined, e.g., during or throughout at least part of delivery of the current pulse train per block 502 or prior to initiating the current PFA application in some embodiments. In this regard, in some embodiments in which the actual variations to be implemented are determined during delivery of the pulse train, block 502a may represent both (a) a determination, during delivery of the pulse train, of the actual variations to be implemented for the waveform characteristic(s) or parameter(s), and (b) a causing of the pulse train to continue to be delivered in accordance with the determined actual variations to be implemented for the waveform characteristic(s) or parameter(s). In some embodiments in which the actual variations to be implemented for such waveform characteristic(s) or parameter(s) are predetermined, block 502a may represent the causing of the pulse train to be delivered in accordance with the actual variations to be implemented for the waveform characteristic(s) or parameter(s) that were predetermined before delivery of the pulse train. The same applies to block 508, discussed in more detail below, where inter-pulse-train delays may be varied. In this regard, in some embodiments in which the actual variations to be implemented for such inter-pulse-train delays are determined during delivery of the pulse trains (or current PFA application), block 508 may represent both (a) a determination, during delivery of the pulse train, of the actual variations to be implemented for such inter-pulse-train delays, and (b) a causing of the pulse trains to continue to be delivered in accordance with the determined actual variations to be implemented for such inter-pulse-train delays. In some embodiments in which the actual variations to be implemented for such inter-pulse-train delays are predetermined, block 508 may represent the causing of the pulse trains to be delivered in accordance with the actual variations to be implemented for such inter-pulse-train delays that were predetermined before delivery of the pulse trains (or current PFA application).

[0157] An example of the varying associated with block 502a will now be described with respect to FIG. 6, which illustrates an example of a pulse train 600 output per some embodiments of block 502 and 502a. The pulse train 600 is illustrated in FIG. 6 in two ways, one as a signal waveform 600a, and the other as a table 600b showing particular waveform characteristics or parameters of the pulse train 600. Subsequent examples of various pulse trains described below with respect to FIGS. 7-9 utilize only the table view for simplicity, but each table could equivalently be presented as a signal waveform. In this regard, signal waveforms produced according to the tables of FIGS. 7-9 follow the same polarity sequencing shown in FIG. 6, i.e., positive pulse followed by negative pulse for each biphasic pulse, according to some embodiments. On the other hand, FIGS. 10-12 illustrate examples of pulse trains as signal waveforms without the table views. Also, although FIG. 6 only shows a portion of the pulse train 600, it should be understood that such pulse train 600 may include additional pulses not shown before, after, or before and after the pulses that are illustrated. The ellipses 600c shown in FIG. 6 are present to highlight this point. The same applies to each of the other pulse trains represented in the figures. Further, a time axis is not shown for the pulse sequences described in each of FIGS. 6-12 and, thus, time may be considered to progress in either direction along such pulse sequences, according to various embodiments. In this regard, when it is indicated herein that one pulse follows, is subsequent to, or is after another pulse, or the like, or vice versa, such temporal indications may be interpreted in either direction along the pulse sequences illustrated, according to various embodiments, depending on the direction chosen for the time axis and whether “newer” is considered “first in line” or “last in line”. For example, if a time axis for FIG. 6 is chosen such that pulses to the left are newer than pulses to the right (i.e., first biphasic pulse 602a is considered to be newer than second biphasic pulse 602b), then it may be considered in some interpretations (e.g., if “newest” is considered “first in line”) that second biphasic pulse 602b follows, is subsequent to, and is after the (newest / first in line) first biphasic pulse 602a. Or, in this case, if “newest” is considered “last in line”, then it may be considered that the (newest / last in line) first biphasic pulse 602a follows, is subsequent to, and is after the second biphasic pulse 602b. On the other hand, if a time axis for FIG. 6 is chosen such that pulses to the right are newer than pulses to the left (i.e., second biphasic pulse 602b is considered to be newer than first biphasic pulse 602a), and if “newest” is considered “first in line”, then it may be considered in some interpretations that the first biphasic pulse 602a follows, is subsequent to, and is after the (newest / first in line) second biphasic pulse 602b. Or, in this case, if “newest” is considered “last in line”, then it may be considered in some interpretations that the (newest / last-in-line) second biphasic pulse 602b follows, is subsequent to, and is after the first biphasic pulse 602a. Further, the examples of FIGS. 6-12 are intended to illustrate various features of various embodiments of the present invention and may apply to waveforms of various frequencies and voltages and other waveform characteristics.

[0158] Accordingly, unitless quantities generally are employed in the examples of FIGS. 6-12, and such drawings are not necessarily to scale, and where a waveform is illustrated, it may not necessarily exactly reflect the ratios of the numbers employed in its corresponding table, where present. However, in some embodiments at least in the PFA context to treat atrial fibrillation, pulse widths (e.g., a positive pulse width or a negative pulse width of a biphasic pulse) and inter-phase delays typically may be in microseconds (e.g., about 10 microseconds or less in some embodiments), inter-pulse delays may be in microseconds to milliseconds (e.g., on the order of tens of microseconds to approximately 25 milliseconds in some embodiments) and pulse-to- pulse initiation intervals typically are in milliseconds (e.g., on the order of approximately 35 milliseconds or less in some embodiments), and pulse train sequence durations typically are in seconds. Further, while FIG. 6 and each of FIGS. 7-12 represents a particular sequence of pulses in a pulse train with various waveform characteristics being varied, respectively, it should be understood that one or more or all of such variations need not be utilized in various embodiments. For example, various embodiments may utilize one or more waveform characteristic variations per block 502al, block 502a2, block 502a3, block 502a4, block 502a5, or a combination thereof. Such blocks 502al, 502a2, 502a3, 502a4, 502a5 are discussed in more detail below. Further, additional variations may be employed, such as variations in pulse polarity sequences discussed in more detail below with respect to at least FIGS. 10 and 12, which, in some embodiments, may be utilized in isolation or may be used in combination with one or more of the waveform characteristic variations per block 502al, block 502a2, block 502a3, block 502a4, block 502a5.

[0159] In some embodiments, a pulse train output per block 502 in FIG. 5 includes a sequence of pairs of consecutive biphasic pulses. In some embodiments, a pulse train output per block 502 in FIG. 5 includes a sequence of at least three pairs of consecutive biphasic pulses. In some embodiments, a pulse train output per block 502 in FIG. 5 includes a sequence of at least four pairs of consecutive biphasic pulses. In some embodiments, each pulse train output per a respective iteration of block 502 in FIG. 5 includes a sequence of pairs of consecutive biphasic pulses. In some embodiments, each of at least one pulse train output per a respective iteration of block 502 in FIG. 5 includes a sequence of at least three pairs of consecutive biphasic pulses. In some embodiments, each of at least one pulse train output per a respective iteration of block 502 in FIG. 5 includes a sequence of at least four pairs of consecutive biphasic pulses. In the example of FIG. 6, the pulse train 600 includes a sequence of at least five respective pairs of consecutive biphasic pulses, 604a, 604b, 604c, 604d, 604e, respectively, such five pairs being made of a sequence of six consecutive biphasic pulses 602a, 602b, 602c, 602d, 602e, 602f. Although biphasic pulses are illustrated in the example pulse train 600, other embodiments may include monophasic pulses of a same polarity or a combination of monophasic and biphasic pulses.

[0160] In some embodiments of a pulse train including biphasic pulses output per block 502, each biphasic pulse includes a respective positive pulse and a respective negative pulse. For instance, in the example of FIG. 6, first biphasic pulse 602a includes a positive pulse 602al and a negative pulse 602a2. A respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combine to form a respective on- time of the biphasic pulse. For instance, in the example of FIG. 6, positive pulse 602al of the first biphasic pulse 602a has a positive pulse width 608al (equivalent to the duration of the positive pulse 602al), and negative pulse 602a2 of the first biphasic pulse 602a has a negative pulse width 608a2 (equivalent to the duration of the negative pulse 602a2). The sum of the positive pulse width 608al and the negative pulse width 608a2 is the on-time 610a for the first biphasic pulse 602a. Similarly, for the second biphasic pulse 602b, the sum of the positive pulse width 608b 1 and the negative pulse width 608b2 is the on-time 610b for the second biphasic pulse 602b.

[0161] In some embodiments of a pulse train including biphasic pulses output per block 502, each biphasic pulse includes a respective inter-phase delay between the pulses of opposite polarity in the respective biphasic pulse. For instance, in the example of FIG. 6, first biphasic pulse 602a includes a respective first inter-phase delay 606a between its positive pulse 602al and negative pulse 602a2. FIG. 6 also calls out that second biphasic pulse 602b includes a respective second inter-phase delay 606b.

[0162] In some embodiments, each respective pair of biphasic pulses in a particular sequence of pairs of consecutive biphasic pulses in each of at least one pulse train output per block 502 includes a respective inter-pulse delay between the respective pair of biphasic pulses within the pulse train. An inter-pulse delay may be defined as extending from a completion of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of an immediately successive second biphasic pulse in the respective pair of consecutive biphasic pulses. For instance, in the example of FIG. 6, an inter-pulse delay 612a exists between the first biphasic pulse 602a and the second biphasic pulse 602b. Stated differently, the first biphasic pulse 602a and the second biphasic pulse 602b may be considered a first pair of biphasic pulses 604a in the sequence of pairs 604a, 604b, 604c, 604d, 604e of consecutive biphasic pulses of the pulse train 600, such that the first pair of biphasic pulses 604a includes first inter-pulse delay 612a within it. In this regard, the inter-pulse delay 612a may be described as extending from a completion of the first biphasic pulse 602a in the respective pair 604a of consecutive biphasic pulses to an initiation of the second biphasic pulse 602b in the respective pair 604a of consecutive biphasic pulses. The example of FIG. 6 also calls out that the second pair of biphasic pulses 604b includes second inter-pulse delay 612b within it.

[0163] In some embodiments, each respective pair of biphasic pulses in a particular sequence of pairs of consecutive biphasic pulses in each of at least one pulse train output per block 502 includes a respective pulse-to -pulse initiation interval between the respective pair of biphasic pulses within the pulse train. For instance, the example of FIG. 6 calls out that the first respective pair of biphasic pulses 604a includes a respective first pulse-to-pulse initiation interval 614a and that the second respective pair of biphasic pulses 604b includes a respective second pulse-to-pulse initiation interval 614b. In this regard, a pulse-to-pulse initiation interval may be defined as extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses. Stated differently, a pulse-to-pulse initiation interval may be defined as the sum of: (1) the duration of the pulse of the first polarity of the first biphasic pulse in the pair, (2) the inter-phase delay between the pulses of the first biphasic pulse in the pair, (3) the duration of the pulse of the second (opposite) polarity of the first biphasic pulse in the pair, and (4) the inter-pulse delay between the biphasic pulses in the pair. For instance, in the example of FIG. 6, the pulse-to-pulse initiation interval 614a for the first respective pair of biphasic pulses 604a is the sum of the positive pulse width 608al, the first inter-phase delay 606a, the negative pulse width 608a2, and the first inter-pulse delay 612a. In this regard, it can be seen that the pulse-to-pulse initiation interval may be varied by varying various ones of its constituent elements ( l)-(4) in a manner where such variations do not cancel each other out.

[0164] Accordingly, in some embodiments, for each of at least one pulse train output per block 502 in FIG. 5, the data processing device system (e.g., 110, 310) may be configured, e.g., by program instructions associated with block 502al within block 502a to cause the pulse generator (e.g., energy source device system circuit 340) to cause durations of at least some respective pulse-to-pulse initiation intervals in the pulse train’s sequence of consecutive biphasic pulses to be different from each other or to be randomized. For instance, in the example of FIG. 6, the pulse train 600 includes a sequence of six consecutive biphasic pulses, where the pulse-to-pulse initiation intervals are all different from each other, as particularly shown in the last row of the table shown in FIG. 6. As described earlier, such variation may improve electromagnetic compatibility of a device generating or delivering the corresponding waveforms (e.g., as compared to a device that is configured to provide constant waveform characteristics or parameters), according to some embodiments.

[0165] In some embodiments associated with block 502al, each respective pulse-to-pulse initiation interval in a sequence of pairs (e.g., at least three pairs in some embodiments) of consecutive biphasic pulses in a pulse train output per block 502 is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse-to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse-to-pulse initiation interval, if present. For instance, in the example of FIG. 6, second pulse-to-pulse initiation interval 614b (6 units in duration in the table of FIG. 6) in the second pair of biphasic pulses 604b is longer in duration than the pulse-to-pulse initiation intervals for each of the first pair of biphasic pulses 604a (4.5 units in duration in the table of FIG. 6) and the third pair of biphasic pulses 604c (5.75 units in duration in the table of FIG. 6) in the sequence of three pairs 604a, 604b, 604c of biphasic pulses in the pulse train 600. Also in the example of FIG. 6, first pulse-to-pulse initiation interval 614a (4.5 units in duration in the table of FIG. 6) in the first pair of biphasic pulses 604a is shorter in duration than the second pulse-to-pulse initiation interval 614b (6 units in duration in the table of FIG. 6), and there is no immediately preceding pulse-to-pulse initiation interval before first pulse-to-pulse initiation interval 614a in the particular sequence of three pairs 604a, 604b, 604c of biphasic pulses.

[0166] In some embodiments, associated with block 502al, the respective durations of the respective pulse-to-pulse initiation intervals in a sequence of pairs (e.g., at least three pairs in some embodiments) of consecutive biphasic pulses in a pulse train output per block 502 are within a determined (maximum) percentage (difference) of each other. In some embodiments, the determined (maximum) percentage (difference) is a particular percentage within a range of 1% to 45%, or 2% to 45%, or 3% to 45%, or 3.5% to 45%, or 1% to 40%, or 2% to 40%, or 3% to 40%, or 3.5% to 40%, with each range including all sub-ranges in between. In some embodiments, the determined percentage is 1.2%, such that the respective pulse-to-pulse initiation intervals in a sequence of pairs (e.g., at least three in some embodiments) of consecutive biphasic pulses are within 1.2% of each other. For instance, in some embodiments, at the output of the energy source device system circuit 340 or at the electrode set in a case in which the electrode set receives all pulses of a sequence of pulses provided by the energy source device system circuit 340, the pulse-to-pulse initiation intervals may range from approximately 3.1 ms to 4.25 ms. Accordingly, 3.1 ms to 4.25 ms is approximately a 37% increase, but a 45% or 40% upper limit for a determined maximum percentage difference may be utilized in some embodiments. In some embodiments in which pulses in a sequence of, e.g., seven, pulses provided by the energy source device system circuit are distributed to a sequence of, e.g., seven different electrode sets respectively, the pulse-to-pulse initiation interval at each respective electrode set may range from approximately 29.2 ms to 29.97 ms in some embodiments, or approximately a 2.6% change from one biphasic pulse to the next biphasic pulse at a respective electrode set. If the sequence of electrode sets is reduced, e.g., from seven to six in some embodiments, where each pulse of a sequence of six pulses like that shown in FIG. 6 may be distributed to a respective electrode set, the percentage may increase from the aforementioned 2.6% to 3.5%, in some embodiments. Accordingly, at least a 2.6% or 3.5% upper limit for a determined maximum percentage difference may be utilized in some embodiments. In some embodiments, the upper limit may be reduced to 1%. Combining such an 1% upper limit with the aforementioned 45% upper limit, for instance, provides the aforementioned example where the determined (maximum) percentage (difference) is a particular percentage within a range of 1% to 45%, according to some various embodiments. In this regard, it should be noted that if sequences of pulses are distributed to different numbers of electrode sets, percentage variation among pulse-to-pulse initiation intervals may correspondingly change. Further in this regard, it should be noted that embodiments associated with FIG. 6 need not have various biphasic pulses delivered to any particular number of different electrode sets. Further, some embodiments associated with FIG. 6 may have all biphasic pulses delivered to the same electrode set.

[0167] In some embodiments, the determination of the (maximum) percentage (difference) may be predetermined or fixed while the values of the corresponding parameter (e.g., the respective pulse-to-pulse initiation intervals in the present example) are varied but retained within that percentage difference. In other embodiments, the determination of the (maximum) percentage (difference) itself may include a random determination or other variation, such that there is variation in the percentage difference in addition to varying the values of the corresponding parameter while retaining such values within the percentage difference.

[0168] The baseline utilized for determining the percentage differences may be chosen from a number of possibilities according to various embodiments. In some embodiments, the baseline may be chosen as the pulse-to-pulse initiation interval of the immediately preceding pulse pair in the sequence. For instance, if the determined percentage is 1.2%, and if the sequence of pairs is a sequence of three pairs, such that the first pulse-to-pulse initiation interval is X units in duration, the second pulse-to-pulse initiation interval is Y units in duration, and the third pulse- to-pulse initiation interval is Z units in duration, then the data processing device system (e.g., 110, 310) may be configured per some embodiments of block 502al to ensure that Y is within 1.2% of X and that Z is within 1.2% of Y. In some embodiments, the baseline may be chosen as the average of all prior pulse-to-pulse initiation intervals in the sequence of pairs of consecutive biphasic pulses. For instance, if the determined percentage is 1.2%, and if the sequence of pairs is a sequence of three pairs, such that the first pulse-to-pulse initiation interval is X units in duration, the second pulse-to-pulse initiation interval is Y units in duration, and the third pulse- to-pulse initiation interval is Z units in duration, then the data processing device system (e.g., 110, 310) may be configured per some embodiments of block 502al to ensure that Y is within 1.2% of X and that Z is within 1.2% of the average of X and Y. In some embodiments, the baseline may be chosen as the minimum of all prior pulse-to-pulse initiation intervals in the sequence of pairs of consecutive biphasic pulses. For instance, if the determined percentage is 1.2%, and if the sequence of pairs is a sequence of three pairs, such that the first pulse-to-pulse initiation interval is X=1000 units in duration, the second pulse-to-pulse initiation interval is Y=999 units in duration, and the third pulse-to-pulse initiation interval is Z=1001 units in duration, then the data processing device system (e.g., 110, 310) may be configured per some embodiments of block 502al to ensure that Y is within 1.2% of X and that Z is within 1.2% of Y, since Y=999 units is the minimum of X=1000 units and Y=999 units. In some embodiments, the baseline may be chosen as the maximum of all prior pulse-to-pulse initiation intervals in the sequence of pairs of consecutive biphasic pulses. For instance, if the determined percentage is 1.2%, and if the sequence of pairs is a sequence of three pairs, such that the first pulse-to-pulse initiation interval is X=1000 units in duration, the second pulse-to-pulse initiation interval is Y=999 units in duration, and the third pulse-to-pulse initiation interval is Z=1001 units in duration, then the data processing device system (e.g., 110, 310) may be configured per some embodiments of block 502al to ensure that Y is within 1.2% of X and that Z is within 1.2% of X, since X=1000 units is the maximum of X=1000 units and Y=999 units. Other embodiments may take other approaches for choosing the baseline.

[0169] In some embodiments, the respective durations of the respective pulse-to-pulse initiation intervals in a sequence of pairs (e.g., at least three pairs in some embodiments) of consecutive biphasic pulses in a pulse train output per block 502, 502al are at least a minimum percentage difference from each other. The baseline for determining such percentage difference may be chosen in any of the manners described above or in other manners, according to various embodiments. In some embodiments, the minimum percentage difference is a particular percentage within a range of 0.2% to 3.5%, or 0.2% to 3%, or 0.3% to 3.5%, or 0.3% to 3% (with each range including all sub-ranges in between), so long as the maximum percentage difference is greater than the minimum percentage difference by at least a determined buffer percentage. For instance, in some embodiments, the minimum difference from one pulse-to- pulse initiation interval to the next is approximately 0.1075 ms, which may lead to approximately a 3% minimum percentage change at the output of the energy source device system circuit 340 or at an electrode set that receives all pulses in a sequence of pulses from the energy source device system circuit 340 (e.g., assuming approximately a 3.5833 ms baseline pulse-to-pulse initiation interval at the output of the energy source device system circuit 340 in some embodiments), or approximately a 0.3% minimum percentage change at a respective electrode set that, for example, receives every tenth pulse in a sequence of pulses from the energy source device system circuit 340 (e.g., assuming approximately a 35.833 ms baseline pulse-to-pulse initiation interval at the output of a respective electrode set of ten electrode sets that receive a respective one of the ten pulses in the sequence in this example in some embodiments), according to some embodiments. In this regard, as noted above, if sequences of pulses are distributed to different numbers of electrode sets, percentage variation among pulse- to-pulse initiation intervals may correspondingly change. In some embodiments, the respective durations of the respective pulse-to-pulse initiation intervals in a sequence of pairs (e.g., at least three pairs in some embodiments) of consecutive biphasic pulses in a pulse train output per block 502 are both at least a minimum percentage difference from each other and within a maximum percentage difference of each other. The baseline for determining such percentage differences may be chosen in any of the manners described above or in other manners, according to various embodiments. As discussed above, in some embodiments, the determination of the particular percentage may be predetermined or fixed, or may include a random determination or other variation.

[0170] As described above, the variations of waveform characteristics per various embodiments of blocks 502a, 502al, 502a2, 502a3, 502a4, and 502a5 may be determined and, in some embodiments, the determination includes a randomized determination. In some embodiments in which the waveform characteristic(s) variations are randomized but limited to be at least a minimum difference, within a maximum difference, or both at least a minimum difference and within a maximum difference, the data processing device system (e.g., 110, 310) may be configured to execute a random number generator that generates a random variation within the acceptable range of variation. For instance, in some embodiments in which durations of the pulse-to-pulse initiation intervals of adjacent or successive pulses in a pulse train output per block 502 must be within a range of at least 0.5% but no more than 2% of each other, the data processing device system (e.g., 110, 310) may be configured to accept only a value output from a random number generator that produces a variation within the acceptable difference range of 0.5% to 2%.

[0171] The variation boundaries described above and otherwise herein may be applied to each of any waveform characteristic, not just to pulse-to-pulse initiation intervals. Further, such waveform characteristic variation boundaries need not be applied only to adjacent or successive pulses in a pulse train or among pulses in a group of consecutive pulses in a pulse train, and may be applied as minimum, maximum, or minimum and maximum variations between any two or more pulses in a pulse train, according to some embodiments. For instance, such a variation boundary may be applied to allow no more than a maximum total variation among any two pulses in a pulse train. Such a configuration can prevent waveform characteristics from departing from acceptable ranges across an entire pulse train.

[0172] By configuring the data processing device system (e.g., 110, 310) according to a program (e.g., associated with at least some embodiments of block 502a) to enforce a percentage minimum, maximum, or both minimum and maximum difference between determined respective waveform characteristic variations among pulses in a pulse train, a suitable variation of waveform characteristics may, in some embodiments, be achieved to promote electromagnetic compatibility, while also ensuring that suitably consistent treatment results also may be achieved.

[0173] In some embodiments associated with block 502a, variation among waveform characteristics may impact a duration of the associated pulse train. In some embodiments, such variation is controlled by the data processing device system (e.g., 110, 310) to ensure that the pulse train’s overall duration is within an acceptable range. For example, in some embodiments associated with block 502al, during the process of determining the actual variations to be implemented, the data processing device system (e.g., 110, 310) may be configured to track the current duration of the pulse train and the number of remaining pulses in the pulse train, and repeatedly redefine a percentage minimum, maximum, or both minimum and maximum pulse- to-pulse initiation interval variation percentage among successive remaining pulses to ensure that the final duration of the pulse train remains within an acceptable determined range. By controlling waveform characteristic variations in this manner, electromagnetic compatibility may still be enhanced with the variations, while ensuring that overall pulse train durations remain within acceptable ranges to assist compliance with an overall treatment protocol. In this regard, in some embodiments, the respective durations of the respective pulse-to-pulse initiation intervals in a sequence of pairs (e.g., a sequence of three pairs in some embodiments) of consecutive biphasic pulses are controlled by the data processing device system so as to meet a minimum, so as not to exceed a maximum, or so as to meet a minimum and so as not to exceed a maximum pulse train duration. Such waveform characteristic variation control need not be limited to pulse-to-pulse initiation interval variation control, and may apply to each of any other pulse train characteristic according to various embodiments.

[0174] As illustrated by blocks 502a2, 502a3, 502a4, and 502a5 in FIG. 5, each of one or more other waveform characteristics may be varied in addition to or in lieu of variation of pulse-to- pulse initiation intervals per block 502al.

[0175] In some embodiments, for each of at least one pulse train output per block 502 in FIG. 5, the data processing device system (e.g., 110, 310) may be configured, e.g., by program instructions associated with block 502a2 within block 502a to cause the pulse generator (e.g., energy source device system circuit 340) to cause durations of at least some respective interpulse delays in the pulse train’s sequence of consecutive biphasic pulses to be different from each other or to be randomized. For instance, in the example of FIG. 6, the pulse train 600 includes a sequence of six consecutive biphasic pulses, where the inter-pulse delays are all different from each other, as particularly shown in the third-to-last row (labeled as “Inter- Pulse Delay”) of the table shown in FIG. 6. As described earlier, such variation may improve electromagnetic compatibility of a device generating or delivering the corresponding waveforms (e.g., as compared to a device that is configured to provide constant waveform characteristics or parameters). In this regard, in some embodiments, at least some of the respective inter-pulse delays are different in duration from each other. In the example of FIG. 6, at least inter-pulse delay 612a is different in duration than inter-pulse delay 612b.

[0176] In some embodiments associated with block 502a2, each respective inter-pulse delay in the sequence of pairs (e.g., three pairs in some embodiments) of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding inter-pulse delay, if present, and (ii) an immediately following inter-pulse delay, if present, or (b) shorter in duration than each of (iii) an immediately preceding inter-pulse delay, if present, and (iv) an immediately following inter-pulse delay, if present. For instance, in the example of FIG. 6, second interpulse delay 612b (3 units in duration in the table of FIG. 6) in the second pair of biphasic pulses 604b is longer in duration than the inter-pulse delays 612a, 612c for each of the first pair of biphasic pulses 604a (2 units in duration in the table of FIG. 6) and the third pair of biphasic pulses 604c (1 unit in duration in the table of FIG. 6) in the sequence of three pairs 604a, 604b, 604c of biphasic pulses in the pulse train 600. Also in the example of FIG. 6, first inter-pulse delay 612a (2 units in duration in the table of FIG. 6) in the first pair of biphasic pulses 604a is shorter in duration than the second inter-pulse delay 612b (3 units in duration in the table of FIG. 6), and there is no immediately preceding inter-pulse delay before the first inter-pulse delay 612a in the particular sequence of three pairs 604a, 604b, 604c of biphasic pulses.

[0177] In some embodiments associated with block 502a2, the respective inter-pulse delay of a first respective pair of consecutive biphasic pulses in a sequence of biphasic pulses in a pulse train (e.g., output per block 502) is different in duration than the respective inter-pulse delay of a second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses. For instance, in the example of FIG. 6, the respective inter-pulse delay 612a of the first respective pair 604a of consecutive biphasic pulses 602a, 602b in the sequence of biphasic pulses 602a, 602b, 602c, 602d, 602e, 602f in a pulse train 600 is different in duration than the respective inter-pulse delay 612b of the second respective pair 604b of consecutive biphasic pulses 602b, 602c in the sequence of biphasic pulses (i.e., inter-pulse delay 612a is 2 units of duration and inter-pulse delay 612b is 3 units of duration in the table shown in FIG. 6). In some embodiments, the second respective pair of consecutive biphasic pulses (e.g., second respective pair 604b in the example of FIG. 6) in the sequence of biphasic pulses includes the second biphasic pulse (e.g., second biphasic pulse 602b) in the first respective pair (e.g., first respective pair 604a) of consecutive biphasic pulses and a third biphasic pulse (e.g., third biphasic pulse 602c) that consecutively follows the second biphasic pulse in the sequence of biphasic pulses.

[0178] In some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program (e.g., associated with some embodiments of block 502a2) at least to randomly determine a respective duration of each respective inter-pulse delay of at least some of the respective inter-pulse delays. In some embodiments, the at least some of the respective inter-pulse delays includes at least three consecutive respective inter-pulse delays, such that the data processing device system (e.g., 110, 310) is configured at least by the program (e.g., associated with some embodiments of block 502a2 at least to randomly determine a respective duration of each respective inter-pulse delay of the at least three consecutive respective interpulse delays. For instance, in the example of FIG. 6, at least the three consecutive respective inter-pulse delays 612a, 612b, 612c may be randomly determined in some embodiments. In some embodiments in which the at least three consecutive respective inter-pulse delays are randomly determined, the at least three consecutive respective inter-pulse delays may all be different from each other. For instance, in the example of FIG. 6, the respective inter-pulse delays 612a, 612b, 612c are all different from each other (i.e., 2 units in duration, 3 units in duration, and 1 unit in duration, respectively, in the table shown in FIG. 6).

[0179] As discussed above, according to some embodiments, one or more variation boundaries may be applied to (a) pulse-to-pulse initiation intervals as described above with respect to some embodiments of block 502al, (b) inter-pulse delays with respect to some embodiments of block 502a2, (c) pulse on-times with respect to some embodiments of block 502a3, (d) pulse widths with respect to some embodiments of block 502a4, (e) inter-phase delays with respect to some embodiments of block 502a5, or a combination of two or more of items (a)-(e). For example, in the case of inter-pulse delays, in some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program (e.g., associated with some embodiments of block 502a2) at least to determine the respective durations of the respective inter-pulse delays of at least some of the respective inter-pulse delays in a pulse train output per block 502a2 to be within a determined (maximum) percentage (difference) of each other. In some embodiments, as discussed above, the determination of the percentage may be predetermined or fixed, or may include a random determination or other variation. The baseline for determining the abovediscussed percentage difference may be chosen in any of the manners as described above with respect to pulse-to-pulse initiation intervals, or in other manners, according to various embodiments. In some embodiments, the determined (maximum) percentage difference for inter-pulse delays may be tied to or derived from the determined (maximum) percentage difference determined for the pulse-to-pulse initiation intervals, e.g., in accordance with the discussion above with respect to block 502al. For example, in some embodiments, assuming that the inter-pulse delay has a duration within a range of 70% to 98% of the duration of the pulse-to-pulse initiation interval, then the determined (maximum) percentage difference for the inter-pulse delays may result in a determined (maximum) duration difference for the inter-pulse delays that is within a range of 70% to 98% of the acceptable difference (in time) determined for the pulse-to-pulse initiation intervals. For instance, if the determined maximum difference in time (e.g., as determined in accordance with the determined (maximum) percentage difference discussion above with respect to block 502al) for a next pulse-to-pulse initiation interval (e.g., compared to the previous pulse-to-pulse initiation interval used as the baseline in this example) is 5 ms, for example, then, in some embodiments, the determined (maximum) difference in time for the next inter-pulse delay (e.g., compared to the previous inter-pulse delay used as the baseline in this example) may be a particular time within a range of 3.5 ms (i.e., 70% of 5 ms) to 4.9 ms (i.e., 98% of 5 ms), according to some embodiments. In some embodiments, the determined percentage (e.g., determined maximum percentage difference) may be 1.2% for the inter-pulse delays, such that at least some of the respective inter-pulse delays are within 1.2% of each other, according to some embodiments.

[0180] In some embodiments, the respective durations of the inter-pulse delays in a sequence of pairs (e.g., at least three pairs in some embodiments) of consecutive biphasic pulses in a pulse train output per block 502a2 are at least a minimum percentage difference from each other. The baseline for determining such percentage difference may be chosen in any of the manners as described above with respect to pulse-to-pulse initiation intervals, or in other manners, according to various embodiments. In some embodiments, the determined minimum percentage difference for inter-pulse delays may be tied to or derived from the determined minimum percentage difference determined for the pulse-to-pulse initiation intervals, e.g., in accordance with the discussion above with respect to block 502al. For example, in some embodiments, assuming that the inter-pulse delay has a duration within a range of 70% to 98% of the duration of the pulse-to-pulse initiation interval, then the minimum percentage difference for the interpulse delays may result in a determined minimum duration difference for the inter-pulse delays that is within a range of 70% to 98% of the acceptable difference in time determined for the pulse-to-pulse initiation intervals. For instance, if the determined minimum difference in time (e.g., as determined in accordance with the determined minimum percentage difference discussion above with respect to block 502al) for a next pulse-to-pulse initiation interval (e.g., compared to the previous pulse-to-pulse initiation interval used as the baseline in this example) is 1 ms, for example, then, in some embodiments, the determined minimum difference in time for the next inter-pulse delay (e.g., compared to the previous inter-pulse delay used as the baseline in this example) may be a particular time within a range of 0.7 ms (i.e., 70% of 1 ms) to 0.98 ms (i.e., 98% of 1 ms), according to some embodiments.

[0181] In some embodiments, the respective durations of the respective inter-pulse delays in a sequence of pairs (e.g., at least three pairs in some embodiments) of consecutive biphasic pulses in a pulse train output per block 502 are both at least a minimum percentage difference from each other and within a maximum percentage difference of each other. The baseline for determining such percentage differences may be chosen in any of the manners as described above with respect to pulse-to-pulse initiation intervals, or in other manners, according to various embodiments. In some embodiments, as discussed above, the determination of the particular percentage may be predetermined or fixed, or may include a random determination or other variation. As described above, the various variation boundaries may be applied to each of any waveform characteristic, according to various embodiments of the present invention. As discussed above, in some embodiments associated with block 502a, variation among waveform characteristics may impact a duration of the associated pulse train. In some embodiments, such variation is controlled by the data processing device system (e.g., 110, 310) to ensure that the pulse train’s overall duration is within an acceptable range. For example, in some embodiments associated with block 502a2, during the process of determining the actual variations to be implemented, the data processing device system (e.g., 110, 310) may be configured to track the current duration of the pulse train and the number of remaining pulses in the pulse train, and repeatedly redefine a percentage minimum, maximum, or both minimum and maximum inter-pulse delay variation percentage among successive remaining pulses to ensure that the final duration of the pulse train remains within an acceptable determined range. In this regard, in some embodiments, the respective durations of the respective inter-pulse delays in a sequence of pairs (e.g., a sequence of three pairs in some embodiments) of consecutive biphasic pulses are controlled by the data processing device system (e.g., 110, 310) so as to meet a minimum, so as not to exceed a maximum, or so as to meet a minimum and so as not to exceed a maximum pulse train duration. As described above, such waveform characteristic variation control need not be limited to any particular pulse train waveform characteristic such as interpulse delays, and may apply to each of any other pulse train waveform characteristic according to various embodiments. In some embodiments, for each of at least one pulse train output per block 502 in FIG. 5, the data processing device system (e.g., 110, 310) may be configured, e.g., by program instructions associated with block 502a3 within block 502a to cause the pulse generator (e.g., energy source device system circuit 340) to cause durations of at least some respective pulse on-times in the pulse train’s sequence of consecutive biphasic pulses to be different from each other or to be randomized. For instance, in the example of FIG. 6, the pulse train 600 includes a sequence of six consecutive biphasic pulses, where the on-times are all different from each other, as particularly shown in the second-to-last row of the table shown in FIG. 6. Such variation may be utilized to control or modify the frequency spectrum of the pulse train and, as described earlier, may in some contexts improve electromagnetic compatibility of a device generating or delivering the corresponding waveforms (e.g., as compared to a device that is configured to provide constant waveform characteristics or parameters).

[0182] In this regard, in some embodiments in which a pulse train output per block 502 includes biphasic pulses, each biphasic pulse in a sequence of pairs of consecutive biphasic pulses in the pulse train includes a respective positive pulse and a respective negative pulse. A respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combine to form a respective on-time of the biphasic pulse. For instance, in the example of FIG. 6, the first biphasic pulse 602a includes a respective positive pulse 602al and a respective negative pulse 602a2, where the respective duration or pulse width 608al of the respective positive pulse 602al and the respective duration or pulse width 608a2 of the respective negative pulse 602a2 combine (i.e., by summing such durations) to form or produce the on-time 610a of the first biphasic pulse 602a. In particular, as shown in the table included in FIG. 6 with respect to the first biphasic pulse 602a, the duration of the positive pulse 602al is 1 unit and the duration of the negative pulse 602a2 also is 1 unit, so the on-time 610a of the first biphasic pulse 602a is 2 units.

[0183] In some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program (e.g., associated with block 502a3) at least to determine the respective on- time of at least one biphasic pulse in each respective pair of consecutive biphasic pulses. In some embodiments, the determination of the respective on-time may include a random determination. For instance, with respect to the example of FIG. 6, the on-time 610a of the first biphasic pulse 602a, the on-time 610b of the second biphasic pulse 602b, or both the on-time 610a of the first biphasic pulse 602a and the on-time 610b of the second biphasic pulse 602b may be randomly determined. In this regard, in some embodiments, the respective on-time for each of at least one biphasic pulse in each respective pair 604a, 604b, 604c, 604d, 604e of biphasic pulses in the pulse train 600 may be randomly determined. In some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program (e.g., associated with block 502a3) at least to randomly determine the respective on-time of at least one biphasic pulse in each respective pair of consecutive biphasic pulses for which the respective inter-pulse delay duration is randomly determined. In this regard, for instance, more than one waveform characteristic may be randomly determined in a pulse train, in some embodiments.

[0184] In some embodiments associated with block 502a3 in FIG. 5, several of the respective on-times are different in duration from each other. For instance, as shown in the table example of FIG. 6, the on-times are all different for the biphasic pulses illustrated (i.e., 2 units, 1.5 units, 4 units, 2.5 units, 3.5 units, and 3 units, respectively). In this regard, in some embodiments, a duration of the respective on-time of a first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses of a pulse train (e.g., output per some embodiments of block 502) is different in duration than the respective on-time of the second biphasic pulse in the first respective pair of consecutive biphasic pulses. For instance, in the example of FIG. 6, the respective on-time 610a of the first biphasic pulse 602a in the first respective pair 604a of consecutive biphasic pulses in the sequence of biphasic pulses of the pulse train 600 is different in duration than the respective on-time 610b of the second biphasic pulse 602b in the first respective pair 604a of consecutive biphasic pulses (i.e., 2 units vs 1.5 units in duration, respectively).

[0185] In some embodiments associated with block 502a3, each respective on-time in a sequence of pairs (e.g., three pairs in some embodiments) of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding on-time, if present, and (ii) an immediately following on-time, if present, or (b) shorter in duration than each of (iii) an immediately preceding on-time, if present, and (iv) an immediately following on-time, if present. For instance, in the example of FIG. 6, second on-time 610b (1.5 units in duration in the table of FIG. 6) of the second biphasic pulse 602b is shorter in duration than each of the on- times 610a, 610c of each of the first biphasic pulse 602a (2 units in duration in the table of FIG. 6) and the third biphasic pulse 602c (4 units in duration in the table of FIG. 6) within the sequence of three pairs 604a, 604b, 604c of biphasic pulses in the pulse train 600. Also in the example of FIG. 6, first on-time 610a (2 units in duration in the table of FIG. 6) of the first biphasic pulse 602a is longer in duration than the second on-time 610b (1.5 units in duration in the table of FIG. 6), and there is no immediately preceding on-time before the first on-time 610a in the particular sequence of three pairs 604a, 604b, 604c of biphasic pulses.

[0186] As discussed above, according to some embodiments, one or more variation boundaries may be applied to (a) pulse-to-pulse initiation intervals as described above with respect to some embodiments of block 502al, (b) inter-pulse delays with respect to some embodiments of block 502a2, (c) pulse on-times with respect to some embodiments of block 502a3, (d) pulse widths with respect to some embodiments of block 502a4, (e) inter-phase delays with respect to some embodiments of block 502a5, or a combination of two or more of items (a)-(e). For example, in the case of on-times, in some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program (e.g., associated with some embodiments of block 502a3) at least to determine the respective durations of the respective on-times of at least some of the respective on-times in a pulse train output per block 502a3 to be within a determined (maximum) percentage (difference) of each other. In some embodiments, as discussed above, the determination of the percentage may be predetermined or fixed, or may include a random determination. The baseline for determining such percentage difference may be chosen in any of the manners as described above with respect to pulse-to-pulse initiation intervals, or in other manners, according to various embodiments. In some embodiments, the determined (maximum) percentage difference for on-times may be tied to or derived from the determined (maximum) percentage difference determined for the pulse-to-pulse initiation intervals, e.g., in accordance with the discussion above with respect to block 502al. For example, in some embodiments, assuming that an on-time has a duration within a range of 0.01% to 0.3% of the duration of the pulse-to-pulse initiation interval, then the determined (maximum) percentage difference for the on-times may result in a determined (maximum) duration difference for the on-times that is within a range of 0.01% to 0.3% of the acceptable difference (in time) determined for the pulse- to-pulse initiation intervals. For instance, if the determined maximum difference in time (e.g., as determined in accordance with the determined (maximum) percentage difference discussion above with respect to block 502al) for a next pulse-to-pulse initiation interval (e.g., compared to the previous pulse-to-pulse initiation interval used as the baseline in this example) is 1 ms, for example, then, in some embodiments, the determined (maximum) difference in time for the next on-time (e.g., compared to the previous on-time used as the baseline in this example) may be a particular time within a range of 0.1 ps (i.e., 0.01% of 1 ms) to 3 ps (i.e., 0.3% of 1 ms), according to some embodiments.

[0187] In some embodiments, the determined percentage (e.g., determined maximum percentage difference) may be within a range of 0.5% to 20% for the on-times, according to some embodiments, with such range including all sub-ranges in between. For instance, if the determined percentage is 10%, at least some of the on-times would be limited to being within 10% of each other.

[0188] In some embodiments, the respective durations of the on-times in a sequence of pairs (e.g., at least three pairs in some embodiments) of consecutive biphasic pulses in a pulse train output per block 502a3 are at least a minimum percentage difference from each other. The baseline for determining such percentage difference may be chosen in any of the manners as described above with respect to pulse-to-pulse initiation intervals, or in other manners, according to various embodiments. In some embodiments, the determined minimum percentage difference for on-times may be tied to or derived from the determined minimum percentage difference determined for the pulse-to-pulse initiation intervals, e.g., in accordance with the discussion above with respect to block 502al. For example, in some embodiments, assuming that an on-time has a duration within a range of 0.01% to 0.3% of the duration of the pulse-to- pulse initiation interval, then the minimum percentage difference for the on-times may result in a determined minimum duration difference for the on-times that is within a range of 0.01% to 0.3% of the acceptable difference in time determined for the pulse-to-pulse initiation intervals. For instance, if the determined minimum difference in time (e.g., as determined in accordance with the determined minimum percentage difference discussion above with respect to block 502al) for a next pulse-to-pulse initiation interval (e.g., compared to the previous pulse-to-pulse initiation interval used as the baseline in this example) is 0.1 ms, for example, then, in some embodiments, the determined minimum difference in time for the next on-time (e.g., compared to the previous on-time used as the baseline in this example) may be a particular time within a range of 0.01 ps (i.e., 0.01% of 0.1 ms) to 0.3 ps (i.e., 0.3% of 0.1 ms), according to some embodiments. In some embodiments, the determined minimum percentage difference is within a range of 0.1% to 1% for the on-times, according to some embodiments, with such range including all sub-ranges in between. For instance, if such determined percentage is 0.5%, then at least some of the on-times would vary by at least 0.5% from each other.

[0189] In some embodiments, the respective durations of the respective on-times in a sequence of pairs (e.g., at least three pairs in some embodiments) of consecutive biphasic pulses in a pulse train output per block 502 are both at least a minimum percentage difference from each other and within a maximum percentage difference of each other. The baseline for determining such percentage differences may be chosen in any of the manners as described above with respect to pulse-to-pulse initiation intervals, or in other manners, according to various embodiments. In some embodiments, as discussed above, the determination of the particular percentage may be predetermined or fixed, or may include a random determination or other variation. As described above, the various variation boundaries may be applied to each of any waveform characteristic, according to various embodiments of the present invention.

[0190] As discussed above, in some embodiments associated with block 502a, variation among waveform characteristics may impact a duration of the associated pulse train. In some embodiments, such variation is controlled by the data processing device system (e.g., 110, 310) to ensure that the pulse train’s overall duration is within an acceptable range. For example, in some embodiments associated with block 502a3, during the process of determining the actual variations to be implemented, the data processing device system (e.g., 110, 310) may be configured to track the current duration of the pulse train and the number of remaining pulses in the pulse train, and repeatedly redefine a percentage minimum, maximum, or both minimum and maximum on-time variation percentage among successive remaining pulses to ensure that the final duration of the pulse train remains within an acceptable determined range. In this regard, in some embodiments, the respective durations of the respective on-times in a sequence of consecutive biphasic pulses are controlled by the data processing device system (e.g., 110, 310) so as to meet a minimum, so as not to exceed a maximum, or so as to meet a minimum and so as not to exceed a maximum pulse train duration. As described above, such waveform characteristic variation control need not be limited to any particular pulse train characteristic such as on-times, and may apply to each of any other pulse train characteristic according to various embodiments. For instance, in some embodiments, pulse widths may be varied irrespective of whether such variation results in variation in on-times. In this regard, in some embodiments, for each of at least one pulse train output per block 502 in FIG. 5, the data processing device system (e.g., 110, 310) may be configured, e.g., by program instructions associated with block 502a4 within block 502a to cause the pulse generator (e.g., energy source device system circuit 340) to cause durations of at least some respective pulse widths in the pulse train’s sequence of consecutive biphasic pulses to be different from each other or to be randomized. For instance, in the example of FIG. 6, the pulse train 600 includes a sequence of six consecutive biphasic pulses, where the respective positive pulse widths and respective negative pulse widths of each of at least some of the biphasic pulses are different from each, as particularly shown in the first and third rows of the table shown in FIG. 6. As described earlier, such variation may improve electromagnetic compatibility of a device generating or delivering the corresponding waveforms (e.g., as compared to a device that is configured to provide constant waveform characteristics or parameters). According to various embodiments, variations in such pulse widths may occur in a manner consistent with the above-description of the variations of the on-times, which are made up of respective pulse widths.

[0191] In some embodiments, for each of at least one pulse train output per block 502 in FIG. 5, the data processing device system (e.g., 110, 310) may be configured, e.g., by program instructions associated with block 502a5 within block 502a to cause the pulse generator (e.g., energy source device system circuit 340) to cause durations of at least some respective interphase delays in the pulse train’s sequence of consecutive biphasic pulses to be different from each other, which in some embodiments, may be by way of a random determination. For instance, in the example of FIG. 6, the pulse train 600 includes a sequence of six consecutive biphasic pulses, where the inter-phase delays are all different from each other, as particularly shown in the second row of the table shown in FIG. 6. As described earlier, such variation may improve electromagnetic compatibility.

[0192] In some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program (e.g., associated with block 502a5) at least to determine the respective inter-phase delay of each of at least some biphasic pulses in a pulse train output per block 502. In some embodiments, the determination of the respective inter-phase delays may include a random determination. With respect to the example of FIG. 6, for instance, the respective interphase delay of each of at least one biphasic pulse in the pulse train 600 may be randomly determined. In some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program (e.g., associated with block 502a5) at least to randomly determine a respective duration of the respective inter-phase delay of at least one biphasic pulse in each respective pair of consecutive biphasic pulses for which the respective inter-pulse delay duration is randomly determined. For instance, with respect to the example of FIG. 6, if the inter-pulse delay duration 612a is randomly determined for the respective pair 604a of biphasic pulses, then the first inter-phase delay 606a, the second inter-phase delay 606b, or both the first inter-phase delay 606a and the second inter-phase delay 606b may also be randomly determined. In this regard, in some embodiments, more than one waveform characteristic may be randomly determined in a pulse train, in some embodiments. Randomizing more than one waveform characteristic in a pulse train may improve pulse variability and may improve electromagnetic compatibility of a device generating or delivering the corresponding waveforms (e.g., as compared to a device that is configured to provide constant waveform characteristics or parameters), according to some embodiments.

[0193] In some embodiments, at least some of the respective inter-phase delays in a sequence of at least three pairs of consecutive biphasic pulses are different in duration from each other. For instance, in the example of FIG. 6, at least in the sequence of three pairs 604a, 604b, 604c of biphasic pulses in the pulse train 600, inter-phase delay 606a of the first biphasic pulse 602a in the first pair 604a of biphasic pulses has a different duration (0.5 units in the table shown in FIG. 6) than that of inter-phase delay 606b (1.5 units in the table shown in FIG. 6) of the second biphasic pulse 602b in the first pair 604a of biphasic pulses. In some embodiments, the respective inter-phase delay of a first biphasic pulse in a first respective pair of consecutive biphasic pulses in a sequence of biphasic pulses in a pulse train is different in duration than the respective inter-phase delay of a second biphasic pulse in the first respective pair of consecutive biphasic pulses in the pulse train. For instance, in the example of FIG. 6, the respective interphase delay 606a of the first biphasic pulse 602a in the first respective pair 604a of consecutive biphasic pulses in the sequence of biphasic pulses including biphasic pulses 602a, 602b, 602c, 602d, 602e, 602f in the pulse train 600 is different in duration than the respective inter-phase delay 606b of the second biphasic pulse 602b in the first respective pair 604a of consecutive biphasic pulses in the pulse train 600.

[0194] In some embodiments, each respective inter-phase delay in a sequence of pairs (e.g., three pairs in some embodiments) of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding inter-phase delay, if present, and (ii) an immediately following inter-phase delay, if present, or (b) shorter in duration than each of (iii) an immediately preceding inter-phase delay, if present, and (iv) an immediately following interphase delay, if present. For instance, in the example of FIG. 6, second inter-phase delay 606b (1.5 units in duration in the table of FIG. 6) of second biphasic pulse 602b is longer in duration than the inter-phase delays 606a, 606c (0.5 units and 0.75 units in duration, respectively, in the table of FIG. 6) of the first biphasic pulse 602a and the third biphasic pulse 602c, respectively, in the sequence of three pairs 604a, 604b, 604c of consecutive biphasic pulses in the pulse train 600. A counterpart statement can be made for third inter-phase delay 606c, which is shorter in duration than its immediately preceding inter-phase delay 606b and its immediately following inter-phase delay 606d. Also in the example of FIG. 6, first inter-phase delay 606a (0.5 units in duration in the table of FIG. 6) of the first biphasic pulse 602a is shorter in duration than the second inter-phase delay 606b (1.5 units in duration in the table of FIG. 6), and there is no immediately preceding inter-phase delay before first inter-phase delay 606a, e.g., when considering only the particular sequence of three pairs 604a, 604b, 604c of consecutive biphasic pulses in the pulse train 600 in this particular example (although other embodiments may consider additional or all pairs of pulses in a pulse train). A counterpart statement can be made for fourth inter-phase delay 606d, which is longer in duration than its immediately preceding inter-phase delay 606c, and there is no immediately following inter-phase delay present in this particular sequence of three pairs 604a, 604b, 604c of consecutive biphasic pulses in the pulse train 600.

[0195] As discussed above, according to some embodiments, one or more variation boundaries may be applied to (a) pulse-to-pulse initiation intervals as described above with respect to some embodiments of block 502al, (b) inter-pulse delays with respect to some embodiments of block 502a2, (c) pulse on-times with respect to some embodiments of block 502a3, (d) pulse widths with respect to some embodiments of block 502a4, (e) inter-phase delays with respect to some embodiments of block 502a5, or a combination of two or more of items (a)-(e). For example, in the case of inter-phase delays, in some embodiments, the data processing device system (e.g., 110, 310) is configured at least by the program (e.g., associated with some embodiments of block 502a5) at least to determine the respective durations of the respective inter-phase delays of at least some of the respective inter-phase delays in a pulse train output per block 502 to be within a predetermined or randomly determined (maximum) percentage (difference) of each other. In some embodiments, as discussed above, the determination of the percentage may be predetermined or fixed, or may include a random determination or other variation. The baseline for determining such percentage difference may be chosen in any of the manners as described above with respect to pulse-to-pulse initiation intervals, or in other manners, according to various embodiments. In some embodiments, the determined (maximum) percentage difference for inter-phase delays may be tied to or derived from the determined (maximum) percentage difference determined for the pulse-to-pulse initiation intervals, e.g., in accordance with the discussion above with respect to block 502al. For example, in some embodiments, assuming that an inter-phase delay has a duration within a range of 0.05% to 0.2% of the duration of the pulse-to-pulse initiation interval, then the determined (maximum) percentage difference for the inter-phase delays may result in a determined (maximum) duration difference for the inter-phase delays that is within a range of 0.05% to 0.2% of the acceptable difference (in time) determined for the pulse-to-pulse initiation intervals. For instance, if the determined maximum difference in time (e.g., as determined in accordance with the determined (maximum) percentage difference discussion above with respect to block 502al) for a next pulse-to-pulse initiation interval (e.g., compared to the previous pulse-to-pulse initiation interval used as the baseline in this example) is 1 ms, for example, then, in some embodiments, the determined (maximum) difference in time for the next inter-phase delay (e.g., compared to the previous inter-phase delay used as the baseline in this example) may be a particular time within a range of 0.5 ps (i.e., 0.05% of 1 ms) to 2 ps (i.e., 0.2% of 1 ms), according to some embodiments.

[0196] In some embodiments, the determined percentage (e.g., determined maximum percentage difference) may be within a range of 0.5% to 20% for the inter-phase delays, according to some embodiments, with such range including all sub-ranges in between. For instance, if the determined percentage is 10%, then at least some of the inter-phase delays would be limited to being within 10% of each other.

[0197] In some embodiments, the respective durations of the inter-phase delays in a sequence of pairs (e.g., at least three pairs in some embodiments) of consecutive biphasic pulses in a pulse train output per block 502 are at least a minimum percentage difference from each other. The baseline for determining such percentage difference may be chosen in any of the manners as described above with respect to pulse-to-pulse initiation intervals, or in other manners, according to various embodiments. In some embodiments, the determined minimum percentage difference for inter-phase delays may be tied to or derived from the determined minimum percentage difference determined for the pulse-to-pulse initiation intervals, e.g., in accordance with the discussion above with respect to block 502al. For example, in some embodiments, assuming that an inter-phase delay has a duration within a range of 0.05% to 0.2% of the duration of the pulse-to-pulse initiation interval, then the minimum percentage difference for the inter-phase delays may result in a determined minimum duration difference for the inter-phase delays that is within a range of 0.05% to 0.2% of the acceptable difference in time determined for the pulse-to-pulse initiation intervals. For instance, if the determined minimum difference in time (e.g., as determined in accordance with the determined minimum percentage difference discussion above with respect to block 502al) for a next pulse-to-pulse initiation interval (e.g., compared to the previous pulse-to-pulse initiation interval used as the baseline in this example) is 0.1 ms, for example, then, in some embodiments, the determined minimum difference in time for the next inter-phase delay (e.g., compared to the previous inter-phase delay used as the baseline in this example) may be a particular time within a range of 0.05 ps (i.e., 0.05% of 0.1 ms) to 0.2 ps (i.e., 0.2% of 0.1 ms), according to some embodiments.

[0198] In some embodiments, the determined minimum percentage difference is within a range of 0.1% to 1% for the inter-phase delays, according to some embodiments, with such range including all sub-ranges in between. For instance, if such determined percentage is 0.5%, then at least some of the inter-phase delays would vary by at least 0.5% from each other.

[0199] In some embodiments, the respective durations of the respective inter-phase delays in a sequence of pairs (e.g., at least three pairs in some embodiments) of consecutive biphasic pulses in a pulse train output per block 502 are both at least a minimum percentage difference from each other and within a maximum percentage difference of each other. The baseline for determining such percentage differences may be chosen in any of the manners as described above with respect to pulse-to-pulse initiation intervals, or in other manners, according to various embodiments. In some embodiments, as discussed above, the determination of the particular percentage may be predetermined or fixed, or may include a random determination or other variation. As described above, the various variation boundaries may be applied to each of any waveform characteristic, according to various embodiments of the present invention.

[0200] As discussed above, in some embodiments associated with block 502a, variation among waveform characteristics may impact a duration of the associated pulse train. In some embodiments, such variation is controlled by the data processing device system (e.g., 110, 310) to ensure that the pulse train’s overall duration is within an acceptable range. For example, in some embodiments associated with block 502a5, during the process of determining the actual variations to be implemented, the data processing device system (e.g., 110, 310) may be configured to track the current duration of the pulse train and the number of remaining pulses in the pulse train, and repeatedly redefine a percentage minimum, maximum, or both minimum and maximum inter-phase delay variation percentage among successive remaining pulses to ensure that the final duration of the pulse train remains within an acceptable determined range. In this regard, in some embodiments, the respective durations of the respective inter-phase delays in a sequence of consecutive biphasic pulses are controlled by the data processing device system (e.g., 110, 310) so as to meet a minimum, so as not to exceed a maximum, or so as to meet a minimum and so as not to exceed a maximum pulse train duration. As described above, such waveform characteristic variation control need not be limited to any particular pulse train characteristic such as inter-phase delays, and may apply to each of any other pulse train characteristic according to various embodiments.

[0201] In some embodiments, one or more waveform characteristics of a pulse train are held constant, while one or more other waveform characteristics are varied per various embodiments of block 502a. By holding one or more waveform characteristics constant while varying one or more other waveform characteristics, control or modification of the frequency spectrum of the pulse train may be achieved, which may in some contexts improve electromagnetic compatibility, while also ensuring that one or more desired waveform characteristics remain fixed to assist in treatment stability.

[0202] For instance, in some embodiments, pulse-to-pulse initiation intervals are held constant through some or all of a pulse train, while one or more other waveform characteristics are varied per various embodiments of block 502a. By holding pulse-to-pulse initiation intervals constant and varying one or more other waveform characteristics, the timings of pulse delivery can be consistent, which may be beneficial in some treatment contexts, while varying one or more other waveform characteristics may improve electromagnetic compatibility.

[0203] FIG. 7 illustrates an example of such a pulse train 700 that holds pulse-to-pulse initiation intervals constant while varying other waveform characteristics. In this regard, pulse train 700 may be output per some embodiments of block 502 and 502a. In contrast to FIG. 6, the pulse train 700 is illustrated in FIG. 7 only as a table showing waveform characteristics or parameters of the pulse train 700 for simplicity. In addition, although FIG. 7 only represents a portion of the pulse train 700, it should be understood that such pulse train 700 may include additional pulses not shown before, after, or before and after the pulses that are represented.

[0204] In the example of FIG. 7, pulse train 700 includes pulse-to-pulse initiation interval 714a between first respective pair 704a of consecutive biphasic pulses 702a, 702b and pulse-to-pulse initiation interval 714b between second respective pair 704b of consecutive biphasic pulses 702b, 702c, where pulse-to-pulse initiation intervals 714a, 714b are equal in duration (5.5 units in FIG. 7). While the pulse-to-pulse initiation intervals 714a, 714b are held constant, other waveform characteristics are varied in an ultimately offsetting manner to maintain the constant pulse-to-pulse initiation intervals 714a, 714b in the example of FIG. 7. For instance, in some embodiments, the respective inter-pulse delay 712a (3 units in duration in the example of FIG. 7) of the first respective pair 704a of consecutive biphasic pulses 702a, 702b in the sequence of biphasic pulses 702a, 702b, 702c is longer in duration as compared to the respective inter-pulse delay 712b (1.5 units in duration in the example of FIG. 7) of the second respective pair 704b of consecutive biphasic pulses 702b, 702c in the sequence of biphasic pulses, and the respective on-time 710a and the respective inter-phase delay 706a of the first biphasic pulse 702a have a combined duration (2.5 units in combined duration in the example of FIG. 7) that is shorter as compared to a combined duration (4 units in combined duration in the example of FIG. 7) of the respective on-time 710b and the respective inter-phase delay 706b of the second biphasic pulse 702b. In some embodiments, as shown for instance in the example of FIG. 7, the respective on- time 710a (2 units in duration in the example of FIG. 7) of the first biphasic pulse 702a is shorter in duration as compared to the respective on-time 710b (3 units in duration in the example of FIG. 7) of the second biphasic pulse 702b. In some embodiments, as shown for instance in the example of FIG. 7, the respective inter-phase delay 706a (0.5 units in duration in the example of FIG. 7) of the first biphasic pulse 702a is shorter in duration as compared to the respective interphase delay 706b (1 unit in duration in the example of FIG. 7) of the second biphasic pulse 702b. In this regard, all of these variations of waveform characteristics other than the pulse-to- pulse initiation intervals ultimately offset each other so as to maintain the constant pulse-to- pulse initiation intervals 714a, 714b shown in the example of FIG. 7 according to some embodiments.

[0205] FIG. 8 illustrates another example of a pulse train that holds a waveform characteristic constant in at least a portion of the pulse train while varying one or more other waveform characteristics. In particular, the pulse train 800 in the example of FIG. 8 holds constant pulse- to-pulse initiation intervals and inter-pulse delays, while varying pulse widths, inter-phase delays, and on-times. In this regard, pulse train 800 may be output per some embodiments of block 502 and 502a. In contrast to FIG. 6, the pulse train 800 is illustrated in FIG. 8 only as a table showing waveform characteristics or parameters of the pulse train 800 for simplicity. In addition, although FIG. 8 only represents a portion of the pulse train 800, it should be understood that such pulse train 800 may include additional pulses not shown before, after, or before and after the pulses that are represented.

[0206] In the example of FIG. 8, pulse train 800 includes pulse-to -pulse initiation interval 814a between first respective pair 804a of consecutive biphasic pulses 802a, 802b and pulse-to-pulse initiation interval 814b between second respective pair 804b of consecutive biphasic pulses 802b, 802c, where pulse-to-pulse initiation intervals 814a, 814b are equal in duration (5.5 units in FIG. 8). Pulse train 800 also includes inter-pulse delay 812a between first respective pair 804a of consecutive biphasic pulses 802a, 802b and inter-pulse delay 812b between second respective pair 804b of consecutive biphasic pulses 802b, 802c, where inter-pulse delays 812a, 812b are equal in duration (2 units in FIG. 8). While the pulse-to-pulse initiation intervals 814a, 814b, as well as the inter-pulse delays 812a, 812b, are held constant, other waveform characteristics are varied in an ultimately offsetting manner to maintain the constant pulse-to-pulse initiation intervals 814a, 814b and the constant inter-pulse delays 812a, 812b in the example of FIG. 8. For instance, in some embodiments as shown in the example of FIG. 8, the respective on-time 810a of the first biphasic pulse 802a is longer in duration than the respective on-time 810b of the second biphasic pulse 802b (3 units compared to 2 units, respectively, in duration in the example of FIG. 8). In some embodiments, although not shown in the example of FIG. 8, the respective on-time of the second biphasic pulse may be longer in duration than the respective on-time of the first biphasic pulse. In some embodiments, as shown for instance in the example of FIG. 8, the respective inter-phase delay 806b of the second biphasic pulse 802b is longer in duration than the respective inter-phase delay 806a of the first biphasic pulse 802a (1.5 units compared to 0.5 units, respectively, in duration in the example of FIG. 8). In some embodiments, although not shown in the example of FIG. 8, the respective inter-phase delay of the first biphasic pulse may be longer in duration than the respective inter-phase delay of the second biphasic pulse. In regard to the waveform characteristic variations shown in FIG. 8, all of such variations ultimately offset each other so as to maintain the constant pulse-to-pulse initiation intervals 814a, 814b and the constant inter-pulse delays 812a, 812b shown in the example of FIG. 8 according to some embodiments.

[0207] FIG. 10 provides an example of a pulse train 1000 output per some embodiments of block 502 and 502a, where polarities of biphasic voltage pulses are varied as well as inter-pulse (or inter-biphasic-pulse) delays also are varied, which, among other benefits, may improve electromagnetic compatibility of a device generating or delivering the corresponding waveforms at least in some contexts (e.g., as compared to a device that is configured to provide constant waveform characteristics or parameters).

[0208] In the example of FIG. 10, a pulse train 1000 includes a plurality of biphasic voltage pulses 1002 sequentially or consecutively arranged in the pulse train 1000. As shown in the example sequence of pulses of the pulse train 1000 in FIG. 10, the plurality of biphasic voltage pulses 1002 may include at least multiple pairs of biphasic voltage pulses.

[0209] According to some embodiments, each of the biphasic voltage pulses 1002 in the plurality of biphasic voltage pulses includes a first monophasic voltage pulse having a first polarity and a second monophasic voltage pulse having a second polarity opposite the first polarity. For example, in FIG. 10, each of the shown biphasic voltage pulses 1002a, 1002b, 1002c, 1002d, 1002e, 1002f, and 1002END (collectively referred to as biphasic voltage pulses 1002) includes a first monophasic voltage pulse having a first polarity and a second monophasic voltage pulse having a second polarity opposite the first polarity. For example, the first biphasic voltage pulse 1002a includes a first monophasic voltage pulse 1002a+ having a positive polarity (i.e., the upward direction in each of FIGS. 6 and 10-12 when viewing the waveforms in a horizontal orientation) and a second monophasic voltage pulse 1002a- having a negative polarity (i.e., the downward direction in each of FIGS. 6 and 10-12 when viewing the waveforms in a horizontal orientation). And, for example, the second biphasic voltage pulse 1002b includes a first monophasic voltage pulse 1002b- having a negative polarity and a second monophasic voltage pulse 1002b+ having a positive polarity, such that the polarity sequence of the first biphasic voltage pulse 1002a is opposite that of the second biphasic voltage pulse 1002b in this example.

[0210] According to some embodiments, the first monophasic pulses of the biphasic voltage pulses 1002 have a same duration, and the second monophasic voltage pulses of the biphasic voltage pulses 1002 have a same duration (e.g., as shown in FIG. 10). In some embodiments, the respective first monophasic voltage pulse and the respective second monophasic voltage pulse of each biphasic voltage pulse 1002 have a same duration. In some embodiments associated at least with FIG. 10, the first monophasic voltage pulses and the second monophasic voltage pulses of the biphasic voltage pulses 1002 have a same duration. Other biphasic voltage pulse characteristics, such as pulse amplitude and inter-biphasic pulse delays, may be the same or different among the various biphasic voltage pulses 1002, according to various embodiments associated at least with FIG. 10.

[0211] According to various embodiments, the biphasic voltage pulses 1002 are successively arranged in the pulse train 1000 with the biphasic voltage pulses 1002 of each pair of successive biphasic voltage pulses 1002 in the pulse train 1000 spaced or separated from one another by a respective inter-biphasic -pulse delay 1012. According to some embodiments, the respective inter-biphasic -pulse delay 1012 between the biphasic voltage pulses 1002 of each pair of successive ones of the biphasic voltage pulses 1002 in the pulse train 1000 is different than the respective inter-biphasic -pulse delay 1012 between the biphasic voltage pulses 1002 of (a) an immediately preceding pair of successive ones of the biphasic voltage pulses 1002 in the pulse train 1000, if present, and (b) an immediately succeeding pair of successive ones of the biphasic voltage pulses 1002 in the pulse train 1000, if present. For example, in FIG. 10, the respective inter-biphasic -pulse delay 1012a between the successive pair of biphasic voltage pulses 1002c and 1002d has a different duration (e.g., shorter in this example embodiment) as compared with (i) the respective inter-biphasic-pulse delay 1012b between the biphasic voltage pulses 1002b and 1002c that form the pair of the successive biphasic voltage pulses 1002 that sequentially or consecutively precedes the successive pair of biphasic voltage pulses 1002c and 1002d, and (ii) the respective inter-biphasic-pulse delay 1012b between the biphasic voltage pulses 1002d and 1002e that form the pair of the successive biphasic voltage pulses 1002 that sequentially or consecutively succeeds the successive pair of biphasic voltage pulses 1002c and 1002d. The same situation occurs with the respective inter-biphasic-pulse delay 1012b between the pair of successive biphasic voltage pulses 1002b and 1002c, as this respective inter-biphasic-pulse delay 1012b has a different duration (e.g., longer in this example embodiment) as compared with (iii) the respective inter-biphasic-pulse delay 1012a between the biphasic voltage pulses 1002a and 1002b that form the pair of the successive biphasic voltage pulses 1002 that sequentially or consecutively precedes the pair of successive biphasic voltage pulses 1002b and 1002c, and (iv) the respective inter-biphasic-pulse delay 1012a between the biphasic voltage pulses 1002c and 1002d that form the pair of the successive biphasic voltage pulses 1002 that sequentially or consecutively succeeds the pair of successive biphasic voltage pulses 1002b and 1002c. The pair of biphasic voltage pulses 1002a and 1002b is the initial pair of successive biphasic voltage pulses 1002 in the pulse train 1000, and, as such, no preceding pair of successive biphasic voltage pulses 1002 is present in the pulse train 1000. However, the first pair of successive biphasic voltage pulses 1002a and 1002b is sequentially or consecutively succeeded by the pair of successive biphasic voltage pulses 1002b and 1002c whose respective inter-biphasic -pulse delay 1012b has a duration that is different (e.g., longer) than the inter-biphasic-pulse delay 1012a associated with the first pair of successive biphasic voltage pulses 1002a and 1002b. This relationship continues for each pair of successive biphasic voltage pulses 1002 of pulse train 1000 shown in FIG. 10.

[0212] According to some embodiments, varying the inter-biphasic-pulse delays 1012 may, according to some embodiments and in some contexts or use cases, may allow improved control over the temporal spacing of same polarity pulses to be sufficient to reset membrane charges and avoid a potentially adverse additive effect from repeat same-polarity applications, and may allow improved control to reset thermal and electrolytic environments around the applying electrode(s), potentially reducing the risk of microbubble formation.

[0213] According to some embodiments, the pulse train 1000 may include a sequence of the respective inter-biphasic -pulse delays 1012, such that the successive respective inter-biphasic- pulse delays 1012 in the sequence of the respective inter-biphasic-pulse delays 1012 cycle between a first duration and a second duration, which, in at least some contexts, may improve electromagnetic compatibility, in addition to varying polarities among the biphasic voltage pulses, which may also assist in improving electromagnetic compatibility. For example, in FIG. 10, the sequence of respective inter-biphasic-pulse delays 1012 cycles between inter-biphasic - pulse delays 1012a (e.g., having a relatively short duration) and inter-biphasic-pulse delays 1012b (e.g., having a relatively long duration). According to some embodiments, each of the first duration and the second duration may be between 300 microseconds and 1000 microseconds. According to some embodiments, each of the first duration and the second duration may be between 0.5 milliseconds and 15 milliseconds. According to some embodiments, each of the first duration and the second duration is between 15 milliseconds and 30 milliseconds. According to some embodiments, each of the first duration and the second duration is between 30 milliseconds and 100 milliseconds. In some embodiments, each of the first duration and the second duration is at least 100 milliseconds. In some embodiments, each of the first duration and the second duration is at least 100 milliseconds with an upper bound limited, e.g., in some embodiments, by clinical speed requirements (e.g., to reduce procedure time). For example, in some embodiments, the 1.5 seconds upper bound may be associated with delivering at least 400 pulses while keeping treatment time at 10 minutes or less. In other embodiments, the upper bound of the inter-biphasic-pulse delay may be associated with a heart rate. For instance, in some embodiments, such as embodiments associated with delivery of pulses synchronously with the cardiac cycle, each of the first duration and the second duration is between 100 milliseconds and 1.5 seconds, which, in some contexts for example, may correspond to a heart rate of 40 bpm, where an electrophysiology (“EP”) technician may start pacing or at which the EP technician may have a pacemaker set during the treatment procedure (e.g., in order to avoid an unacceptably low heart rate).

[0214] According to some embodiments, the pulse train 1000 includes a first biphasic voltage pulse (e.g., as exemplified by biphasic voltage pulse 1002a in FIG. 10) that includes a first monophasic voltage pulse (e.g., as exemplified by monophasic voltage pulse 1002a+) followed by a second monophasic voltage pulse (e.g., as exemplified by monophasic voltage pulse 1002a- ), the first monophasic voltage pulse having a first polarity (e.g., a positive polarity in the example of monophasic voltage pulse 1002a+) and the second monophasic voltage pulse having a second polarity (e.g., a negative polarity in the example of monophasic voltage pulse 1002a-) opposite the first polarity. According to some embodiments, the pulse train 1000 includes a second biphasic voltage pulse (e.g., as exemplified by biphasic voltage pulse 1002b in FIG. 10) that includes a third monophasic voltage pulse (e.g., as exemplified by monophasic voltage pulse 1002b-) followed by a fourth monophasic voltage pulse (e.g., as exemplified by monophasic voltage pulse 1002b+), the third monophasic voltage pulse having the second polarity (i.e., the negative polarity in this particular example) and the fourth monophasic voltage pulse having the first polarity (i.e., the positive polarity in this particular example).

[0215] According to various embodiments, the plurality of biphasic voltage pulses 1002 in the pulse train 1000 may include (a) a first plurality of biphasic voltage pulses (e.g., biphasic voltage pulses 1002c, 1002e, and 1002END in the example of FIG. 10), each biphasic voltage pulse in the first plurality of biphasic voltage pulses having the same biphasic pulse waveform characteristics (e.g., at least from a monophasic pulse polarity order perspective) as the first biphasic voltage pulse (e.g., biphasic voltage pulse 1002a) described above, and (b) a second plurality of biphasic voltage pulses (e.g., biphasic voltage pulses 1002d and 1002d in the example of FIG. 10), each biphasic voltage pulse in the second plurality of biphasic voltage pulses having the same biphasic pulse waveform characteristics (e.g., at least from a monophasic pulse polarity order perspective) as the second biphasic voltage pulse (e.g., biphasic voltage pulse 1002b) described above. According to some embodiments, the pulses of the first plurality of biphasic voltage pulses (e.g., at least biphasic voltage pulses 1002c and 1002e) alternate or are interleaved with the pulses of the second plurality of biphasic voltage pulses (e.g., at least biphasic voltage pulses 1002d and 1002f). For instance, in some embodiments, the plurality of biphasic voltage pulses (e.g., biphasic voltage pulses 1002) includes an interleaving of a first plurality of biphasic voltage pulses (e.g., including at least biphasic voltage pulse 1002a and biphasic voltage pulse 1002c in the example of FIG. 10) and a second plurality of biphasic voltage pulses (e.g., including at least biphasic voltage pulse 1002b and biphasic voltage pulse 1002d in the example of FIG. 10), each biphasic voltage pulse in the first plurality of biphasic voltage pulses having a sequence of a first particular monophasic voltage pulse (e.g., monophasic voltage pulse 1002a+ in the case of biphasic voltage pulse 1002a) of the first polarity followed by a second particular monophasic voltage pulse (e.g., monophasic voltage pulse 1002a- in the case of biphasic voltage pulse 1002a) of the second polarity, and each biphasic voltage pulse in the second plurality of biphasic voltage pulses having a sequence of a third particular monophasic voltage pulse (e.g., monophasic voltage pulse 1002b- in the case of biphasic voltage pulse 1002b) of the second polarity followed by a fourth particular monophasic voltage pulse (e.g., monophasic voltage pulse 1002b+ in the case of biphasic voltage pulse 1002b) of the first polarity.

[0216] In some embodiments, the monophasic voltage pulses of successive biphasic voltage pulses in the pulse train have the same polarity order while varying inter-pulse (or inter- biphasic-pulse) delays, which, among other benefits, may improve electromagnetic compatibility at least in some contexts. For example, in FIG. 11, each biphasic voltage pulse 1102 of a group of successive biphasic voltage pulses in pulse train 1100 includes a first monophasic voltage pulse (e.g., monophasic voltage pulse 1102+) having a first particular polarity (e.g., positive in this example) followed by a second monophasic voltage pulse (e.g., monophasic voltage pulse 1102-) having a second particular polarity (e.g., negative in this example) opposite the first particular polarity, according to some embodiments. According to some embodiments associated at least with FIG. 11, the first monophasic voltage pulses 1102+ of the biphasic voltage pulses 1102 have a same duration. According to some embodiments associated at least with FIG. 11, the second monophasic voltage pulses 1102- of the biphasic voltage pulses 1102 have a same duration. In some embodiments associated at least with FIG. 11, the first monophasic voltage pulses 1102+ and the second monophasic voltage pulses 1102- of the biphasic voltage pulses 1102 have a same duration. In other embodiments, the first monophasic voltage pulses have a negative polarity and the second monophasic voltage pulses have a positive polarity. Other biphasic voltage pulse characteristics such as pulse amplitude and inter-biphasic pulse delays may be the same or different among the various biphasic voltage pulses 1102, according to various embodiments associated at least with FIG. 11.

[0217] According to various embodiments associated at least with FIG. 11, the biphasic voltage pulses 1102 are successively arranged in the pulse train 1100 with the biphasic voltage pulses 1102 of each pair of successive biphasic voltage pulses 1102 in the pulse train 1100 spaced or separated from one another by a respective inter-biphasic-pulse delay 1112. In a manner similar to the discussion above with respect to various embodiments associated at least with FIG. 10, in FIG. 11 the respective inter-biphasic-pulse delay 1112 between the biphasic voltage pulses 1102 of each pair of successive ones of the biphasic voltage pulses 1102 in the pulse train 1100 is different than the respective inter-biphasic-pulse delay 1112 between the biphasic voltage pulses 1102 of (a) and immediately preceding pair of successive ones of the biphasic voltage pulses 1102 in the pulse train, if present, and (b) an immediately succeeding pair of successive ones of the biphasic voltage pulses 1102 in the pulse train 1100, if present. For example, in FIG. 11, the inter-biphasic -pulse delays 1112 successively cycle between an inter-biphasic-pulse delay 1112a having a relatively short duration and an inter-biphasic-pulse delay 1112b having a relatively long duration. Such a configuration with differing inter-biphasic pulse delays like delays 1112a, 1112b for pulsed field ablation, according to some embodiments and in some contexts or use cases, may allow improved control over the temporal spacing of same polarity pulses to be sufficient to reset membrane charges and avoid a potentially adverse additive effect from repeat same-polarity applications, and may allow improved control to reset thermal and electrolytic environments around the applying electrode(s), potentially reducing the risk of microbubble formation, and may improve electromagnetic compatibility. It is noted that the respective inter- biphasic-pulse delays 1112a are shown with the same duration in each FIGS. 10 and 11 according to some embodiments, but in other embodiments, they may have different durations, such as shown with the varying inter-pulse delays of at least FIG. 6. In a similar manner, the respective inter-biphasic -pulse delays 1112b are shown with the same duration in each FIGS. 10 and 11 according to some embodiments, but in other embodiments, they may have different durations, such as shown with the varying inter-pulse delays of at least FIG. 6.

[0218] In some embodiments associated at least with FIGS. 10 and 11, (i) the first monophasic voltage pulse of each biphasic voltage pulses of the plurality of biphasic voltage pulses 1002, 1102 for FIGS. 10 and 11, respectively, has a duration between 1 microsecond and 8 microseconds, (ii) the second monophasic voltage pulse of each biphasic voltage pulse of the plurality of biphasic voltage pulses 1002, 1102 for FIGS. 10 and Ir respectively, has a duration between 1 microsecond and 8 microseconds, or both (i) and (ii). In some embodiments associated at least with FIGS. 10 and 11, (i) the first monophasic voltage pulse of each of at least some of the biphasic voltage pulses of the plurality of biphasic voltage pulses 1002, 1102 for FIGS. 10 and 11, respectively, has a pulse amplitude between 200 V and 3000 V, (ii) the second monophasic voltage pulse of each of the at least some of the biphasic voltage pulses of the plurality of biphasic voltage pulses 1002, 1102 for FIGS. 10 and 11, respectively, has a pulse amplitude between 200 V and 3000 V, or both (i) and (ii). In some embodiments associated at least with FIGS. 10 and 11, each of the biphasic voltage pulses of the plurality of biphasic voltage pulses 1002, 1102 for FIGS. 10 and 11, respectively, may include an intra-biphasic- pulse delay 1006, 1106 for FIGS. 10 and 11, respectively, between the first monophasic voltage pulse and the second monophasic voltage pulse.

[0219] According to some embodiments, the intra-biphasic-pulse delay 1006, 1106 for FIGS. 10 and 11, respectively, of each particular biphasic voltage pulse of at least some of the biphasic voltage pulses in the plurality of biphasic voltage pulses 1002, 1102 for FIGS. 10 and 11 , respectively, has a duration that is less than a duration of each inter-biphasic-delay 1012, 1112 for FIGS. 10 and 11, respectively, between the biphasic voltage pulses of any pair of successive ones of the biphasic voltage pulses in the pulse train that includes the particular biphasic voltage pulse. For example, in at least FIGS. 10 and 11, each of the biphasic voltage pulses 1002, 1102 for FIGS. 10 and 11, respectively, includes an intra-biphasic -pulse delay 1006, 1106 for FIGS. 10 and 11, respectively, between its respective first monophasic voltage pulse and its respective second monophasic voltage pulse. According to various embodiments associated at least with FIGS. 10 and 11, each intra-biphasic-pulse delay 1006, 1106 for FIGS. 10 and 11, respectively, of any particular one of the biphasic pulses 1002, 1102 for FIGS. 10 and 11, respectively, is shorter in duration than a duration of the associated inter-biphasic-pulse delay 1012a, 1112a for FIGS. 10 and 11, respectively, if present or the associated inter-biphasic-pulse delay 1012b, 1112b for FIGS. 10 and 11, respectively, if present.

[0220] In some embodiments, the intra-biphasic-pulse delay 1006, 1106 for FIGS. 10 and 11, respectively, of each of at least some of the biphasic voltage pulses of the plurality of biphasic voltage pulses 1002, 1102 for FIGS. 10 and 11, respectively, may have a duration between 0 and 8 microseconds. In some embodiments, respective inter-biphasic-pulse delay 1012, 1112 for FIGS. 10 and 11, respectively, has a duration between 300 microseconds and 1000 microseconds. In some embodiments, each respective inter-biphasic-pulse delay 1012, 1112 for FIGS. 10 and 11, respectively, may have a duration between 0.5 milliseconds and 15 milliseconds. In some embodiments, each respective inter-biphasic-pulse delay 1012, 1112 for FIGS. 10 and 11, respectively, may have a duration between 15 milliseconds and 30 milliseconds. In some embodiments, each respective inter-biphasic-pulse delay 1012, 1112 for FIGS. 10 and 11, respectively, may have a duration between 30 milliseconds and 100 milliseconds. In some embodiments, each respective inter-biphasic-pulse delay 1012, 1112 for FIGS. 10 and 11, respectively, may have a duration of at least 100 milliseconds. In some embodiments, each respective inter-biphasic-pulse delay 1012, 1112 for FIGS. 10 and 11, respectively, may have a duration of at least 100 milliseconds with an upper bound limited, e.g., in some embodiments, by clinical speed requirements (e.g., to reduce procedure time). For example, in some embodiments, the 1.5 seconds upper bound may be associated with delivering at least 400 pulses while keeping treatment time at 10 minutes or less. In other embodiments, the upper bound of the inter-biphasic-pulse delay may be associated with a heart rate. For instance, in some embodiments, such as embodiments associated with delivery of pulses synchronously with the cardiac cycle, each respective inter-biphasic-pulse delay 1012, 1112 for FIGS. 10 and 11, respectively, may be between 100 milliseconds and 1.5 seconds, which, in some contexts for example, may correspond to a heart rate of 40 bpm, where an electrophysiology (“EP”) technician may start pacing or at which the EP technician may have a pacemaker set during the treatment procedure (e.g., in order to avoid an unacceptably low heart rate). In some embodiments associated at least with FIGS. 10 and 11, a biphasic pulse width of each biphasic voltage pulse of the plurality of biphasic voltage pulses 1002, 1102 for FIGS. 10 and 11, respectively, has a same duration. In this regard, according to some embodiments, the biphasic pulse width may be considered to be the width of a particular biphasic voltage pulse from the start of its initial or first monophasic pulse to the end of its concluding or second monophasic pulse. In some embodiments, the particular biphasic voltage pulse may, or may not, include an intra-biphasic-pulse delay.

[0221] In some embodiments that employ a varied polarity pattern among biphasic or other multiphasic pulses like the example of FIG. 10, at least some of these embodiments may vary one or more other waveform characteristics or parameters, such as pulse-to-pulse initiation intervals (e.g., per block 502al in FIG. 5), inter-pulse delays (e.g., per block 502a2), on-times (e.g., per block 502a3), pulse widths (e.g., per block 502a4), inter-phase delays (e.g., per block 502a5), or a combination thereof. For instance, the example of FIG. 10 varies pulse polarity pattern and inter-biphasic-pulse delays. For another example, FIG. 12 shows a variation of pulse polarity pattern and pulse width. For instance, in the example of FIG. 12, (a) the first monophasic voltage pulse (corresponding to pulse 1202a+ in the example of FIG. 12) and the second monophasic voltage pulse (corresponding to pulse 1202a- in the example of FIG. 12) may have different pulse durations (e.g., different pulse durations 1208a+ and 1208a-, respectively, in the example of FIG. 12), (b) the third monophasic voltage pulse (corresponding to pulse 1202b- in the example of FIG. 12) and the fourth monophasic voltage pulse (corresponding to pulse 1202b+ in the example of FIG. 12) may have different pulse durations (e.g., different pulse durations 1208b- and 1208b+, respectively, in the example of FIG. 12), or (a) and (b). In some embodiments, the first monophasic voltage pulse, the second monophasic voltage pulse, the third monophasic voltage pulse, and the fourth monophasic voltage pulse may have a different pulse duration than the respective pulse duration of each of the other monophasic voltage pulses of the first monophasic voltage pulse, the second monophasic voltage pulse, the third monophasic voltage pulse, and the fourth monophasic voltage pulse. For instance, in the example of FIG. 12, the pulse durations 1208a+, 1208a-, 1208b-, and 1208b+ are all different. Although the example of FIG. 12 shows what may be relatively large proportional differences in pulse durations for ease of visual differentiation in some embodiments, other embodiments may have variations in pulse durations that are less pronounced. Further, although all the pulses in FIG. 12 are shown with the same pulse amplitude according to some embodiments, different pulse amplitudes may also be employed according to other embodiments. For example, the voltage of each pulse may be adjusted such that the product of voltage and pulse duration is nominally equal for each of the pulses, according to some embodiments.

[0222] In this regard, although not explicitly listed within box 502a of FIG. 5, variation of polarity pattern among biphasic or other multiphasic pulses like the examples of FIGS. 10 and 12 may be considered a variation of a waveform characteristic or pattern. Turning now to a discussion on pulse train durations, as discussed above, according to some embodiments associated with block 502a in FIG. 5, variation among waveform characteristics may impact a duration of the associated pulse train. In some embodiments, block 502 and its variations applied to waveform characteristics per block 502a are repeated for a sequence of pulse trains, which can result in the pulse generator (e.g., energy source device system circuit 340) outputting pulse trains having different durations, according to some embodiments. For instance, in some embodiments of methods 500, the data processing device system (e.g., 110, 310) may be configured at least by the program instructions associated with decision diamond 504 at least to do determine, for each pulse train output per block 502, whether such pulse train is the last pulse train to be output, e.g., according to a treatment protocol. If the determination is that such pulse train is the last pulse train to be output (i.e., the “Yes” branch exiting decision diamond 504), then the current pulsed field ablation (“PF A”) application is concluded per block 506. On the other hand, if the determination in decision diamond 504 is that such pulse train is not the last pulse train to be output (i.e., the “No” branch exiting decision diamond 504), then processing proceeds to block 508. In some embodiments, the data processing device system (e.g., 110, 310) may be configured at least by program instructions associated with block 508 to cause, via the input-output device system (e.g., 120, 320), the pulse generator (e.g., energy source device system circuit 340) to produce an interpulse-train (also referred to as an “inter-train”) delay before processing proceeds back to block 502 where the next pulse train is output by the pulse generator. In some embodiments, intertrain delays produced per block 508 may be varied under control of the data processing device system (e.g., 110, 310) and the pulse generator (e.g., energy source device system circuit 340), e.g., by adopting corresponding various principles and configurations discussed above with respect to block 502a to achieve, e.g., a proper balance between signal waveform variability and consistency / stability of PFA treatment application. As discussed above, the actual inter-pulsetrain delays to be implemented to achieve desired variation in some embodiments may be predetermined, e.g., before delivery of the current PFA application, or may be determined during delivery of the current PFA application.

[0223] In this regard, the example of FIG. 9 illustrates portions of two pulse trains 900, 950 of different durations 916 (21.5 units), 966 (21 units), respectively, that may be generated according to some embodiments of the loop of blocks 502, 504, 508 of methods 500. In contrast to FIG. 6, each of the pulse trains 900, 950 is illustrated in FIG. 9 only as a table showing waveform characteristics or parameters of the respective pulse train for simplicity. In addition, although FIG. 9 only represents respective portions of the pulse trains 900, 950, it should be understood that such each pulse train 900, 950 may include additional pulses not shown before, after, or before and after the pulses that are represented.

[0224] In some embodiments, each of a first pulse train (e.g., pulse train 900) and a second pulse train (e.g., pulse train 950) includes a respective sequence of at least three pairs of consecutive biphasic pulses. In the example of FIG. 9, the pulse train 900 includes a respective sequence of at least four pairs 904a, 904b, 904c, 904d of consecutive biphasic pulses. Similarly, the pulse train 950 includes a respective sequence of at least four pairs 954a, 954b, 954c, 954d of consecutive biphasic pulses. In the pulse train 900, the pairs 904a, 904b, 904c, 904d of biphasic pulses collectively include biphasic pulses 902a, 902b, 902c, 902d, 902e and, in the pulse train 950, the pairs 954a, 954b, 954c, 954d of biphasic pulses collectively include biphasic pulses 952a, 952b, 952c, 952d, 952e.

[0225] In some embodiments, (a) durations of the respective positive pulses of the biphasic pulses in both respective sequences of pairs (e.g., at least three or four pairs in some embodiments) of consecutive biphasic pulses are all equal to each other, (b) durations of the respective negative pulses of the biphasic pulses in both respective sequences of pairs (e.g., at least three or four pairs in some embodiments) of consecutive biphasic pulses are all equal to each other, or (a) and (b). For instance, in the example of FIG. 9, the pulse widths of the respective positive pulses 908al, 908bl, 908cl, 908dl, 908el, 958al, 958bl, 958cl, 958dl, 958el are all equal to each other.

[0226] In some embodiments, the respective pulse-to-pulse initiation intervals in the respective sequence of pairs (e.g., at least three or four pairs in some embodiments) of consecutive biphasic pulses in the first pulse train form a first pattern of pulse-to-pulse initiation intervals, and the respective pulse-to-pulse initiation intervals in the respective sequence of pairs (e.g., at least three or four pairs in some embodiments) of consecutive biphasic pulses in the second pulse train form a second pattern of pulse-to-pulse initiation intervals, the second pattern of pulse-to- pulse initiation intervals different than the first pattern of pulse-to-pulse initiation intervals. For instance, in the example of FIG. 9, the first pulse train 900 forms a first pattern of pulse-to-pulse initiation intervals 914a, 914b, 914c, 914d (5 units, 4 units, 5.5 units, and 4.5 units in duration, respectively, in FIG. 9), and the second pulse train 950 forms a second pattern of pulse-to-pulse initiation intervals 964a, 964b, 964c, 964d (4.5 units, 5 units, 4.5 units, and 4.5 units in duration, respectively, in FIG. 9), where the second pattern of pulse-to-pulse initiation intervals is different than the first pattern of pulse-to-pulse initiation intervals.

[0227] In some embodiments, the first pattern of pulse-to-pulse initiation intervals includes a first pulse-to-pulse initiation interval consecutively followed by a second pulse-to-pulse initiation interval, consecutively followed by a third pulse-to-pulse initiation interval, and the second pattern of pulse-to-pulse initiation intervals includes a first pulse-to-pulse initiation interval consecutively followed by a second pulse-to-pulse initiation interval, consecutively followed by a third pulse-to-pulse initiation interval. For instance, in the example of FIG. 9, the first pattern of pulse-to-pulse initiation intervals includes a first pulse-to-pulse initiation interval 914a consecutively followed by a second pulse-to-pulse initiation interval 914b, consecutively followed by a third pulse-to-pulse initiation interval 914c, and the second pattern of pulse-to- pulse initiation intervals includes a first pulse-to-pulse initiation interval 964a consecutively followed by a second pulse-to-pulse initiation interval 964b, consecutively followed by a third pulse-to-pulse initiation interval 964c. In some embodiments, the first pulse-to-pulse initiation interval, the second pulse-to-pulse initiation interval, and the third pulse-to-pulse initiation interval in the first pattern of pulse-to-pulse initiation intervals occupy the same corresponding positions in the first pulse train as the first pulse-to-pulse initiation interval, the second pulse-to- pulse initiation interval, and the third pulse-to-pulse initiation interval in the second pattern of pulse-to-pulse initiation intervals occupy in the second pulse train. For instance, in some embodiments of the example of FIG. 9, the first pulse-to-pulse initiation interval 914a, the second pulse-to-pulse initiation interval 914b, and the third pulse-to-pulse initiation interval 914c may be the very first, second, and third pulse-to-pulse initiation intervals, respectively, in the pulse train 900, while the first pulse-to-pulse initiation interval 964a, the second pulse-to- pulse initiation interval 964b, and the third pulse-to-pulse initiation interval 964c may also be the very first, second, and third pulse-to-pulse initiation intervals, respectively, in the pulse train 950. However, in other embodiments, such pulse-to-pulse initiation intervals may respectively occupy other corresponding pulse-to-pulse initiation interval positions in the respective pulse trains 900, 950. In some embodiments in which the first, second, and third pulse-to-pulse initiation intervals of each pulse train 900, 950 occupy the same corresponding pulse-to-pulse initiation interval positions in their pulse train, the first pulse-to-pulse initiation interval in the first pattern of pulse-to-pulse initiation interval may be different than the first pulse-to-pulse initiation interval in the second pattern of pulse-to-pulse initiation intervals. For instance, in the example of FIG. 9, the first pulse-to-pulse initiation interval 914a in the first pulse train 900 has a duration of 5 units, which is different than the 4.5 unit duration of the first pulse-to-pulse initiation interval 964a in the second pulse train 950.

[0228] The patterns of pulse-to-pulse initiation intervals among pulse trains may be different pursuant to the variations caused by the data processing device system (e.g., 110, 310) per various embodiments and iterations of block 502a. For instance, the pulse-to-pulse initiation intervals among pulse trains may be different due to variations in inter-pulse delays per block 502a2, on-times per block 502a3, pulse widths per block 502a4, inter-phase delays 502a5, or a combination thereof, according to some embodiments.

[0229] For example, in some embodiments, the second pattern of pulse-to-pulse initiation intervals differs from the first pattern of pulse-to-pulse initiation intervals at least because each of at least one of the respective inter-pulse delays in the respective sequence of pairs (e.g., at least three or four pairs in some embodiments) of consecutive biphasic pulses in the first pulse train is different than every respective inter-pulse delay in the respective sequence of pairs (e.g., at least three or four pairs in some embodiments) of consecutive biphasic pulses in the second pulse train. In the example of FIG. 9, inter-pulse delay 912c between the third pair 904c of biphasic pulses in the sequence of pairs 904a, 904b, 904c, 904d of consecutive biphasic pulses in the first pulse train 900 is different than every respective inter-pulse delay 962a, 962b, 962c, 962d in the sequence of pairs 954a, 954b, 954c, 954d of consecutive biphasic pulses in the second pulse train 950.

[0230] In some embodiments in which (a) durations of the respective positive pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other (e.g., as is the case in the example of FIG. 9), (b) durations of the respective negative pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, but not both (a) and (b), the second pattern of pulse- to-pulse initiation intervals differs from the first pattern of pulse-to-pulse initiation intervals at least because each of at least one of the respective on-times in the respective sequence of pairs (e.g., at least three or four pairs in some embodiments) of consecutive biphasic pulses in the first pulse train is different than every respective on-time in the respective sequence of pairs (e.g., at least three or four pairs in some embodiments) of consecutive biphasic pulses in the second pulse train. For instance, in the example of FIG. 9, the respective on-time 910b in the respective sequence of pairs 904a, 904b, 904c, 904d of consecutive biphasic pulses in the first pulse train 900 is different than every respective on-time 960a, 960b, 960c, 960d, 960e in the respective sequence of pairs 954a, 954b, 954c, 954d of consecutive biphasic pulses in the second pulse train 950.

[0231] In some embodiments, the second pattern of pulse-to-pulse initiation intervals differs from the first pattern of pulse-to-pulse initiation intervals at least because each of at least one of the respective inter-phase delays in the respective sequence of (e.g., at least three or four pairs in some embodiments) pairs of consecutive biphasic pulses in the first pulse train is different than every respective inter-phase delay in the respective sequence of pairs (e.g., at least three or four pairs in some embodiments) of consecutive biphasic pulses in the second pulse train. For instance, in the example of FIG. 9, the respective inter-phase delay 906a in the respective sequence of pairs 904a, 904b, 904c, 904d of consecutive biphasic pulses in the first pulse train 900 is different than every respective inter-phase delay 956a, 956b, 956c, 956d, 956e in the respective sequence of pairs 954a, 954b, 954c, 954d of consecutive biphasic pulses in the second pulse train 950.

[0232] In some embodiments, as noted above, pulse trains generated per various embodiments of block 502 may have different durations due at least in part to the waveform characteristic variations provided by various embodiments of block 502a in FIG. 5. Such an example instance is illustrated in FIG. 9, where the first pulse train 900 has a different duration 916 (21.5 units in FIG. 9) than the duration 966 (21 units in the example of FIG. 9) of the second pulse train 950. In this regard, as discussed above, the data processing device system (e.g., 110, 310) may be configured by program instructions associated with block 502a to control the variations of the waveform characteristics of a pulse train to ensure that the pulse train’s final duration upon conclusion of the pulse train is within acceptable one or more pulse train boundaries (e.g., maximum duration, minimum duration, or both according to some embodiments). Accordingly, the data processing device system (e.g., 110, 310) may be configured, when determining an acceptable pulse train duration range, to consider the duration(s) of one or more of the preceding pulse trains to ensure that the duration of the next pulse train is within an acceptable range of one or more of the preceding pulse trains. Such a consideration may allow for sufficient variability among signal waveforms, while ensuring that pulse train durations do not vary so much as to jeopardize treatment efficacy.

[0233] Accordingly, in some embodiments, respective durations of successive first and second pulse trains are within a particular percentage of each other. The baseline for determining such percentage difference may be chosen in any of the manners as described above with respect to pulse-to-pulse initiation intervals, but with respect to pulse trains instead of pulses, or the baseline may be chosen in other manners, according to various embodiments. In some embodiments, the particular percentage is in the range of 0.1% to 30% including all sub-ranges in between, according to various embodiments. In some embodiments, the particular percentage is 10%, such that pulse train duration variation is within 10%. In the example of FIG. 9, in a case where the second pulse train 950 successively follows first pulse train 900, e.g., in an active treatment protocol, the duration 966 of the second pulse train 950 is within approximately 2.3% of the duration 916 of the first pulse train 900 (i.e., the 21 unit duration 966 of the second pulse train 950 is approximately 97.7% of the 21.5 unit duration 916 of the first pulse train 900, and therefore the duration 966 represents approximately a 2.3% decrease in duration over the duration 916), according to some embodiments.

[0234] For another example, in some embodiments, the data processing device system (e.g., 110, 310) is configured at least by program instructions associated with block 502a at least to randomly determine the respective durations of one or more waveform characteristics (e.g., per one or more of blocks 502al, 502a2, 502a3, 502a4, 502a5) in a second pulse train so as not to exceed a maximum difference in duration of the second pulse train from a duration of a first pulse train (e.g., that immediately precedes the second pulse train in some embodiments). For instance, in some embodiments, the data processing device system (e.g., 110, 310) is configured at least by program instructions associated with block 502a at least to randomly determine the respective durations of, e.g., one or more inter-pulse delays (e.g., per block 502a2) of a second pulse train (e.g., pulse train 950 in the example of FIG. 9) so as not to exceed a maximum difference in duration of the second pulse train (e.g., pulse train 950) from a duration of a first pulse train (e.g., pulse train 900).

[0235] Subsets or combinations of various embodiments described above provide further embodiments. These and other changes can be made to the invention in light of the above detailed description and still fall within the scope of the present invention. For instance, although the examples of FIGS. 6-12 show particular waveform characteristic variations, and are presented in the context of biphasic pulses, it should be understood that other embodiments apply to other waveform characteristic variations and to pulse trains including monophasic or other pulse types. In general, in the following claims, the terms used should not be construed to limit the invention to the specific embodiments disclosed in the specification. Accordingly, the invention is not limited by the disclosure, but instead its scope is to be determined entirely by the claims.

Claims

WHAT IS CLAIMED IS:

1. An ablation system comprising: an input-output device system; a pulse generator communicatively connected to the input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system, the data processing device system configured at least by the program at least to: cause, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of pairs of consecutive biphasic pulses including a respective inter-pulse delay extending from a completion of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, wherein the data processing device system is configured at least by the program at least to randomly determine a respective duration of each respective inter-pulse delay of at least some of the respective inter-pulse delays.

2. The ablation system of Claim 1, wherein durations of the respective inter-pulse delays of at least three consecutive respective inter-pulse delays in the sequence of pairs of consecutive biphasic pulses are all different from each other, the at least three consecutive respective interpulse delays including the at least some of the respective inter-pulse delays.

3. The ablation system of Claim 1, wherein the at least some of the respective interpulse delays comprise at least three consecutive respective inter-pulse delays, such that the data processing device system is configured at least by the program at least to randomly determine a respective duration of each respective inter-pulse delay of the at least three consecutive respective inter-pulse delays.

4. The ablation system of Claim 1 , wherein the data processing device system is configured at least by the program at least to cause, via the input-output device system, the sequence of pairs of consecutive biphasic pulses to be delivered to at least one transducer of atransducer-based device communicatively connected to the input-output device system.

5. The ablation system of Claim 1, wherein the biphasic pulses in the sequence of pairs of consecutive biphasic pulses are arranged in a sequence of consecutive biphasic pulses, and wherein the data processing device system is configured at least by the program at least to cause, via the input-output device system, each biphasic pulse in the sequence of consecutive biphasic pulses to be delivered to a respective set of transducers in a plurality of sets of transducers of a transducer-based device communicatively connected to the input-output device system, each respective set of transducers in the plurality of sets of transducers including at least one transducer not included in any other set of transducers in the plurality of sets of transducers.

6. The ablation system of Claim 1, wherein the pulse train is a second pulse train that consecutively follows a first pulse train generated by the pulse generator, wherein the data processing device system is configured at least by the program at least to randomly determine the respective durations of the respective inter-pulse delays of the at least some of the respective inter-pulse delays in the second pulse train so as not to exceed a maximum difference in duration of the second pulse train from a duration of the first pulse train.

7. The ablation system of Claim 1, wherein the pulse train is a second pulse train that consecutively follows a first pulse train generated by the pulse generator, wherein the data processing device system is configured at least by the program at least to randomly determine the respective durations of the respective inter-pulse delays in the second pulse train so as not to exceed a minimum difference in duration of the second pulse train from a duration of the first pulse train.

8. The ablation system of Claim 1, wherein the data processing device system is configured at least by the program at least to randomly determine the respective durations of the respective inter-pulse delays of the at least some of the respective inter-pulse delays to be within 1.2% of each other.

9. A method executed by a data processing device system according to a program storedby a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the method comprising: causing, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of pairs of consecutive biphasic pulses including a respective inter-pulse delay extending from a completion of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses; and randomly determining a respective duration of each respective inter-pulse delay of at least some of the respective inter-pulse delays.

10. One or more computer-readable storage mediums storing a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the program comprising: pulse generation instructions configured to cause, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of pairs of consecutive biphasic pulses including a respective inter-pulse delay extending from a completion of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses; and random determination instructions configured to cause random determination of a respective duration of each respective inter-pulse delay of at least some of the respective interpulse delays.

11. An ablation system comprising: an input-output device system; a pulse generator communicatively connected to the input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system, the data processing device system configured at least by the program at least to:cause, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of at least three pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of three pairs of consecutive biphasic pulses including a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, wherein each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse- to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse- to-pulse initiation interval, if present.

12. The ablation system of Claim 11, wherein the durations of the respective pulse-to- pulse initiation intervals in the sequence of three pairs of consecutive biphasic pulses are different from each other.

13. The ablation system of Claim 11 , wherein the sequence of at least three pairs of consecutive biphasic pulses is a sequence of at least four pairs of consecutive biphasic pulses, and wherein each respective pulse-to-pulse initiation interval in the sequence of four pairs of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse- to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse- to-pulse initiation interval, if present.

14. The ablation system of Claim 11, wherein the respective durations of the respective pulse-to-pulse initiation intervals in the sequence of three pairs of consecutive biphasic pulses are within 1.2% of each other.

15. The ablation system of Claim 11 , wherein the pulse train comprises a respective inter-pulse delay between each respectivepair of consecutive biphasic pulses in the sequence of three pairs of consecutive biphasic pulses, and wherein at least some of the respective inter-pulse delays are different in duration from each other.

16. The ablation system of Claim 11 , wherein the pulse train comprises a respective inter-pulse delay between each respective pair of consecutive biphasic pulses in the sequence of three pairs of consecutive biphasic pulses, and wherein each respective inter-pulse delay in the sequence of three pairs of consecutive biphasic pulses is either: (c) longer in duration than each of (v) an immediately preceding interpulse delay, if present, and (vi) an immediately following inter-pulse delay, if present, or (d) shorter in duration than each of (vii) an immediately preceding inter-pulse delay, if present, and (viii) an immediately following inter-pulse delay, if present.

17. The ablation system of Claim 11 , wherein each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses comprises a respective inter-phase delay, and wherein at least some of the respective inter-phase delays are different in duration from each other.

18. The ablation system of Claim 11 , wherein each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses comprises a respective inter-phase delay, and wherein each respective inter-phase delay in the sequence of three pairs of consecutive biphasic pulses is either: (c) longer in duration than each of (v) an immediately preceding interphase delay, if present, and (vi) an immediately following inter-phase delay, if present, or (d) shorter in duration than each of (vii) an immediately preceding inter-phase delay, if present, and (viii) an immediately following inter-phase delay, if present.

19. The ablation system of Claim 11 , wherein each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses comprises a respective inter-phase delay, and wherein the inter-phase delays are within 10% of each other.

20. The ablation system of Claim 11 , wherein each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses comprises a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combining to form a respective on-time of the biphasic pulse, and wherein several of the respective on-times are different in duration from each other.

21. The ablation system of Claim 11 , wherein each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses comprises a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combining to form a respective on-time of the biphasic pulse, and wherein each respective on-time in the sequence of three pairs of consecutive biphasic pulses is either: (c) longer in duration than each of (v) an immediately preceding on-time, if present, and (vi) an immediately following on-time, if present, or (d) shorter in duration than each of (vii) an immediately preceding on-time, if present, and (viii) an immediately following on-time, if present.

22. The ablation system of Claim 21, wherein the respective on-times for the biphasic pulses in the sequence of three pairs of consecutive biphasic pulses are within 10% of each other.

23. The ablation system of Claim 11 , wherein the data processing device system is configured at least by the program at least to cause, via the input-output device system, the sequence of at least three pairs of consecutive biphasic pulses to be delivered to at least one transducer of a transducer-based device communicatively connected to the input-output device system.

24. The ablation system of Claim 11 , wherein the sequence of at least three pairs of consecutive biphasic pulses are arranged in a sequence of consecutive biphasic pulses, and wherein the data processing device system is configured at least by the program at least to cause, via the input-output device system, each biphasic pulse in the sequence of consecutive biphasic pulses to be delivered to a respective set of transducers in a plurality of sets of transducers of atransducer-based device communicatively connected to the input-output device system, each respective set of transducers in the plurality of sets of transducers including at least one transducer not included in any other set of transducers in the sequence of sets of transducers.

25. The ablation system of Claim 11 , wherein the data processing device system is configured at least by the program at least to cause, via the input-output device system, the sequence of at least three pairs of consecutive biphasic pulses to be delivered to a particular transducer of a transducer-based device communicatively connected to the input-output device system.

26. A method executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the method comprising: causing, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of at least three pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of three pairs of consecutive biphasic pulses including a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, wherein each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse- to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse- to-pulse initiation interval, if present.

27. One or more computer-readable storage mediums storing a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the program comprising: pulse generation instructions configured to cause, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation, the pulsetrain comprising a sequence of at least three pairs of consecutive biphasic pulses, each respective pair of consecutive biphasic pulses in the sequence of three pairs of consecutive biphasic pulses including a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, wherein each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive biphasic pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse- to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse- to-pulse initiation interval, if present.

28. An ablation system comprising: an input-output device system; a pulse generator communicatively connected to the input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system, the data processing device system configured at least by the program at least to: cause, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of biphasic pulses, each biphasic pulse in the sequence of biphasic pulses comprising a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combining to form a respective on-time of the biphasic pulse, and each biphasic pulse in the sequence of biphasic pulses comprising a respective inter-phase delay, wherein each respective pair of consecutive biphasic pulses in the sequence of biphasic pulses includes: (i) a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, the respective pulse-to-pulse initiation intervals being equal in duration, and (ii) a respective inter-pulse delay extending from a completion of the first biphasic pulse in the respective pair of consecutive biphasic pulses to the initiation of the second biphasic pulse in the respective pair of consecutive biphasic pulses, and wherein, at least (a) a duration of the respective on-time of a first biphasic pulse in a firstrespective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective on-time of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, (b) the respective inter-phase delay of the first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-phase delay of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, or (c) the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-pulse delay of a second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses.

29. The ablation system of Claim 28, wherein both (a) and (b) occur, both (a) and (c) occur, both (b) and (c) occur, or all of (a), (b) and (c) occur.

30. The ablation system of Claim 28, wherein at least the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-pulse delay of the second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses, and wherein the second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses includes the second biphasic pulse in the first respective pair of consecutive biphasic pulses and a third biphasic pulse that consecutively follows the second biphasic pulse in the sequence of biphasic pulses.

31. The ablation system of Claim 30, wherein the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is longer in duration as compared to the respective inter-pulse delay of the second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses, and the respective on-time and the respective inter-phase delay of the first biphasic pulse have a combined duration that is shorter as compared to a combined duration of the respective on-time and the respective interphase delay of the second biphasic pulse.

32. The ablation system of Claim 31, wherein the respective on-time of the first biphasic pulse is shorter in duration as compared to the respective on-time of the second biphasic pulse.

33. The ablation system of Claim 31, wherein the respective inter-phase delay of the first biphasic pulse is shorter in duration as compared to the respective inter-phase delay of the second biphasic pulse.

34. The ablation system of Claim 28, wherein the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is equal in duration as compared to the respective inter-pulse delay of the second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses, and wherein the respective on-time of the first biphasic pulse is longer in duration than the respective on-time of the second biphasic pulse, or the respective on-time of the second biphasic pulse is longer in duration than the respective on-time of the first biphasic pulse.

35. The ablation system of Claim 28, wherein the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is equal in duration as compared to the respective inter-pulse delay of the second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses, and wherein the respective inter-phase delay of the first biphasic pulse is longer in duration than the respective inter-phase delay of the second biphasic pulse, or the respective inter-phase delay of the second biphasic pulse is longer in duration than the respective inter-phase delay of the first biphasic pulse.

36. A method executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the method comprising: causing, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of biphasic pulses, each biphasic pulse in the sequence of biphasic pulses comprising a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combining to form a respective on-time of the biphasic pulse, and each biphasic pulse in the sequence of biphasic pulses comprising a respective inter-phase delay, wherein each respectivepair of consecutive biphasic pulses in the sequence of biphasic pulses includes: (i) a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, the respective pulse-to-pulse initiation intervals being equal in duration, and (ii) a respective inter-pulse delay extending from a completion of the first biphasic pulse in the respective pair of consecutive biphasic pulses to the initiation of the second biphasic pulse in the respective pair of consecutive biphasic pulses, and wherein, at least (a) a duration of the respective on-time of a first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective on-time of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, (b) the respective inter-phase delay of the first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-phase delay of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, or (c) the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-pulse delay of a second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses.

37. One or more computer-readable storage mediums storing a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the program comprising: pulse generation instructions configured to cause, via the input-output device system, the pulse generator to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of biphasic pulses, each biphasic pulse in the sequence of biphasic pulses comprising a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse combining to form a respective on-time of the biphasic pulse, and each biphasic pulse in the sequence of biphasic pulses comprising a respective inter-phase delay, wherein each respective pair of consecutive biphasic pulses in the sequence of biphasic pulses includes: (i) a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, the respective pulse-to-pulse initiation intervals being equal in duration, and (ii) a respective inter-pulse delay extending froma completion of the first biphasic pulse in the respective pair of consecutive biphasic pulses to the initiation of the second biphasic pulse in the respective pair of consecutive biphasic pulses, and wherein, at least (a) a duration of the respective on-time of a first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective on-time of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, (b) the respective inter-phase delay of the first biphasic pulse in the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-phase delay of the second biphasic pulse in the first respective pair of consecutive biphasic pulses, or (c) the respective inter-pulse delay of the first respective pair of consecutive biphasic pulses in the sequence of biphasic pulses is different in duration than the respective inter-pulse delay of a second respective pair of consecutive biphasic pulses in the sequence of biphasic pulses.

38. An ablation system comprising: an input-output device system; a pulse generator communicatively connected to the input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system, the data processing device system configured at least by the program at least to: cause, via the input-output device system, the pulse generator to output at least a first pulse train and a second pulse train, wherein each of the first pulse train and the second pulse train is configured to cause pulsed field tissue ablation, wherein each of the first pulse train and the second pulse train comprises a respective sequence of at least three pairs of consecutive biphasic pulses, each biphasic pulse in each respective sequence of three pairs of consecutive biphasic pulses comprising a respective positive pulse and a respective negative pulse, wherein (a) durations of the respective positive pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, (b) durations of the respective negative pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, or (a) and (b), wherein each respective pair of consecutive biphasic pulses in each respective sequenceof three pairs of consecutive biphasic pulses includes a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, wherein the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train form a first pattern of pulse-to- pulse initiation intervals, and wherein the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train form a second pattern of pulse-to-pulse initiation intervals, the second pattern of pulse-to-pulse initiation intervals different than the first pattern of pulse-to-pulse initiation intervals.

39. The ablation system of Claim 38, wherein the first pulse train comprises a respective inter-pulse delay between each respective pair of consecutive biphasic pulses in the respective sequence of three pairs of consecutive biphasic pulses, wherein the second pulse train comprises a respective inter-pulse delay between each respective pair of consecutive biphasic pulses in the respective sequence of three pairs of consecutive biphasic pulses, and wherein the second pattern of pulse-to-pulse initiation intervals differs from the first pattern of pulse-to-pulse initiation intervals at least because each of at least one of the respective inter-pulse delays in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train is different than every respective inter-pulse delay in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train.

40. The ablation system of Claim 38, wherein (a) or (b) occurs, but not both (a) and (b), wherein each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the first pulse train comprises a respective positive pulse and a respective negative pulse, a respective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the first pulse train combining to form a respective on-time of the biphasic pulse, wherein each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the second pulse train comprises a respective positive pulse and a respective negative pulse, arespective duration of the respective positive pulse and a respective duration of the respective negative pulse of each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the second pulse train combining to form a respective on-time of the biphasic pulse, and wherein the second pattern of pulse-to-pulse initiation intervals differs from the first pattern of pulse-to-pulse initiation intervals at least because each of at least one of the respective on-times in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train is different than every respective on-time in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train.

41. The ablation system of Claim 38, wherein each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the first pulse train comprises a respective inter-phase delay, wherein each biphasic pulse in the sequence of three pairs of consecutive biphasic pulses in the second pulse train comprises a respective inter-phase delay, and wherein the second pattern of pulse-to-pulse initiation intervals differs from the first pattern of pulse-to-pulse initiation intervals at least because each of at least one of the respective inter-phase delays in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train is different than every respective inter-phase delay in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train.

42. The ablation system of Claim 38, wherein a duration of the first pulse train is different than a duration of the second pulse train.

43. The ablation system of Claim 42, wherein a duration of the first pulse train is within 10% of a duration of the second pulse train.

44. The ablation system of Claim 38, wherein the first pattern of pulse-to-pulse initiation intervals includes a first pulse-to- pulse initiation interval consecutively followed by a second pulse-to-pulse initiation interval, consecutively followed by a third pulse-to-pulse initiation interval, wherein the second pattern of pulse-to-pulse initiation intervals includes a first pulse-to- pulse initiation interval consecutively followed by a second pulse-to-pulse initiation interval, consecutively followed by a third pulse-to-pulse initiation interval,wherein the first pulse-to-pulse initiation interval, the second pulse-to -pulse initiation interval, and the third pulse-to-pulse initiation interval in the first pattern of pulse-to-pulse initiation intervals occupy same corresponding positions in the first pulse train as the first pulse- to-pulse initiation interval, the second pulse-to-pulse initiation interval, and the third pulse-to- pulse initiation interval in the second pattern of pulse-to-pulse initiation intervals occupy in the second pulse train, and wherein the first pulse-to-pulse initiation interval in the first pattern of pulse-to-pulse initiation intervals is different than the first pulse-to-pulse initiation interval in the second pattern of pulse-to-pulse initiation intervals.

45. The ablation system of Claim 38, wherein (c) the sequence of at least three pairs of consecutive biphasic pulses in the first pulse train is a sequence of at least four pairs of consecutive biphasic pulses, (d) wherein the sequence of at least three pairs of consecutive biphasic pulses in the second pulse train is a sequence of at least four pairs of consecutive biphasic pulses, or (c) and (d).

46. A method executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the method comprising: causing, via the input-output device system, the pulse generator to output at least a first pulse train and a second pulse train, wherein each of the first pulse train and the second pulse train is configured to cause pulsed field tissue ablation, wherein each of the first pulse train and the second pulse train comprises a respective sequence of at least three pairs of consecutive biphasic pulses, each biphasic pulse in each respective sequence of three pairs of consecutive biphasic pulses comprising a respective positive pulse and a respective negative pulse, wherein (a) durations of the respective positive pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, (b) durations of the respective negative pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, or (a) and (b), wherein each respective pair of consecutive biphasic pulses in each respective sequence of three pairs of consecutive biphasic pulses includes a respective pulse-to-pulse initiationinterval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, wherein the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train form a first pattern of pulse-to- pulse initiation intervals, and wherein the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train form a second pattern of pulse-to-pulse initiation intervals, the second pattern of pulse-to-pulse initiation intervals different than the first pattern of pulse-to-pulse initiation intervals.

47. One or more computer-readable storage mediums storing a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the program comprising: pulse generation instructions configured to cause, via the input-output device system, the pulse generator to output at least a first pulse train and a second pulse train, wherein each of the first pulse train and the second pulse train is configured to cause pulsed field tissue ablation, wherein each of the first pulse train and the second pulse train comprises a respective sequence of at least three pairs of consecutive biphasic pulses, each biphasic pulse in each respective sequence of three pairs of consecutive biphasic pulses comprising a respective positive pulse and a respective negative pulse, wherein (a) durations of the respective positive pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, (b) durations of the respective negative pulses of the biphasic pulses in both respective sequences of three pairs of consecutive biphasic pulses are all equal to each other, or (a) and (b), wherein each respective pair of consecutive biphasic pulses in each respective sequence of three pairs of consecutive biphasic pulses includes a respective pulse-to-pulse initiation interval extending from an initiation of a first biphasic pulse in the respective pair of consecutive biphasic pulses to an initiation of a second biphasic pulse in the respective pair of consecutive biphasic pulses, wherein the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the first pulse train form a first pattern of pulse-to-pulse initiation intervals, and wherein the respective pulse-to-pulse initiation intervals in the respective sequence of three pairs of consecutive biphasic pulses in the second pulse train form a second pattern of pulse-to-pulse initiation intervals, the second pattern of pulse-to-pulse initiation intervals different than the first pattern of pulse-to-pulse initiation intervals.

48. An ablation system comprising: an input-output device system; a pulse generator communicatively connected to the input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system, the data processing device system configured at least by the program at least to: cause the pulse generator, via the input-output device system, to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of at least three pairs of consecutive pulses, each respective pair of consecutive pulses in the sequence of three pairs of consecutive pulses including a respective pulse-to-pulse initiation interval extending from an initiation of a first pulse in the respective pair of consecutive pulses to an initiation of a second pulse in the respective pair of consecutive pulses, wherein each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse-to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse- to-pulse initiation interval, if present.

49. A method executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the method comprising: causing the pulse generator, via the input-output device system, to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of at least three pairs of consecutive pulses, each respective pair of consecutive pulses in the sequence of three pairs of consecutive pulses including a respective pulse-to-pulse initiation intervalextending from an initiation of a first pulse in the respective pair of consecutive pulses to an initiation of a second pulse in the respective pair of consecutive pulses, wherein each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse-to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse- to-pulse initiation interval, if present.

50. One or more computer-readable storage mediums storing a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to a pulse generator, and the program comprising: pulse generation instructions configured to cause the pulse generator, via the inputoutput device system, to output a pulse train configured to cause pulsed field tissue ablation, the pulse train comprising a sequence of at least three pairs of consecutive pulses, each respective pair of consecutive pulses in the sequence of three pairs of consecutive pulses including a respective pulse-to-pulse initiation interval extending from an initiation of a first pulse in the respective pair of consecutive pulses to an initiation of a second pulse in the respective pair of consecutive pulses, wherein each respective pulse-to-pulse initiation interval in the sequence of three pairs of consecutive pulses is either: (a) longer in duration than each of (i) an immediately preceding pulse-to-pulse initiation interval, if present, and (ii) an immediately following pulse-to-pulse initiation interval, if present, or (b) shorter in duration than each of (iii) an immediately preceding pulse-to-pulse initiation interval, if present, and (iv) an immediately following pulse- to-pulse initiation interval, if present.

51. A medical system comprising: a data processing device system; an input-output device system communicatively connected to the data processing device system, the input-output device system communicatively connectable to an energy source device system circuit configured to provide pulsed field ablation energy to at least some electrodes of a plurality of electrodes supported by a structure of a catheter; and a memory device system communicatively connected to the data processing devicesystem and storing a program executable by the data processing device system, the data processing device system configured by the program at least to: cause, via the input-output device system and via operation of at least the energy source device system circuit, provision of at least one pulse train, each pulse train of the at least one pulse train comprising a plurality of biphasic voltage pulses, wherein each biphasic voltage pulse in the plurality of biphasic voltage pulses comprises a first monophasic voltage pulse having a first polarity and a second monophasic voltage pulse having a second polarity opposite the first polarity, the first monophasic voltage pulses of the biphasic voltage pulses having a same duration and the second monophasic voltage pulses of the biphasic voltage pulses having a same duration, wherein the biphasic voltage pulses are successively arranged in the pulse train with the biphasic voltage pulses of each pair of successive biphasic voltage pulses in the pulse train spaced from one another by a respective inter-biphasic-pulse delay, and wherein the respective inter-biphasic-pulse delay between the biphasic voltage pulses of each pair of successive ones of the biphasic voltage pulses in the pulse train is different than the respective inter-biphasic -pulse delay between the biphasic voltage pulses of (a) an immediately preceding pair of successive ones of the biphasic voltage pulses in the pulse train, if present, and (b) an immediately succeeding pair of successive ones of the biphasic voltage pulses in the pulse train, if present.

52. The medical system of Claim 51, wherein the pulse train comprises a sequence of the respective inter-biphasic-pulse delays, wherein the successive respective inter-biphasic-pulse delays in the sequence of the respective inter-biphasic-pulse delays cycle between a first duration and a second duration.

53. The medical system of Claim 52, wherein each of the first duration and the second duration is between 300 microseconds and 1000 microseconds.

54. The medical system of Claim 52, wherein each of the first duration and the second duration is between 0.5 milliseconds and 15 milliseconds.

55. The medical system of Claim 52, wherein each of the first duration and the second duration is between 15 milliseconds and 30 milliseconds.

56. The medical system of Claim 52, wherein each of the first duration and the second duration is between 100 milliseconds and 1.5 seconds.

57. The medical system of Claim 51, wherein respective biphasic pulse widths of the plurality of biphasic voltage pulses have a same duration.

58. The medical system of Claim 51, wherein (i) the first monophasic voltage pulse of each biphasic voltage pulse of the plurality of biphasic voltage pulses has a duration between 1 microsecond and 8 microseconds, (ii) the second monophasic voltage pulse of each biphasic voltage pulse of the plurality of biphasic voltage pulses has a duration between 1 microsecond and 8 microseconds, or both (i) and (ii).

59. The medical system of Claim 51, wherein (i) the first monophasic voltage pulse of each of at least some of the biphasic voltage pulses of the plurality of biphasic voltage pulses has a pulse amplitude between 200 V and 3000 V, (ii) the second monophasic voltage pulse of each of the at least some of the biphasic voltage pulses of the plurality of biphasic voltage pulses has a pulse amplitude between 200 V and 3000 V, or both (i) and (ii).

60. The medical system of Claim 51 , wherein each of the biphasic voltage pulses of the plurality of biphasic voltage pulses comprises an intra-biphasic-pulse delay between the first monophasic voltage pulse and the second monophasic voltage pulse, and wherein the intra-biphasic-pulse delay of each particular biphasic voltage pulse of at least some of the biphasic voltage pulses in the plurality of biphasic voltage pulses has a duration that is less than a duration of the respective inter-biphasic-delay between any pair of successive biphasic voltage pulses in the pulse train.

61. The medical system of Claim 60, wherein the intra-biphasic-pulse delay of each of at least some of the biphasic voltage pulses of the plurality of biphasic voltage pulses has a duration between 0 and 8 microseconds.

62. The medical system of Claim 61, wherein each respective inter-biphasic-pulse delay has a duration between 300 microseconds and 1000 microseconds.

63. The medical system of Claim 61, wherein each respective inter-biphasic-pulse delay has a duration between 0.5 milliseconds and 15 milliseconds.

64. The medical system of Claim 61, wherein each respective inter-biphasic-pulse delay has a duration between 15 milliseconds and 30 milliseconds.

65. The medical system of Claim 61, wherein each respective inter-biphasic-pulse delay has a duration between 100 milliseconds and 1.5 seconds.

66. The medical system of Claim 51 , wherein the energy source device system circuit is configured to generate each pulse train of the at least one pulse train.

67. The medical system of Claim 51, wherein the data processing device system is configured by the program at least to cause delivery of the at least one pulse train from an electrode set of the plurality of electrodes.

68. The medical system of Claim 51, wherein the at least one pulse train comprises a plurality of pulse trains arranged in a regularly repeating sequence of pulse trains.

69. The medical system of Claim 51, wherein the at least one pulse train comprises a plurality of pulse trains arranged in a sequence of pulse trains, each pulse train in the sequence of pulse trains spaced (i) by a respective inter-pulse-train delay from an immediately preceding pulse train, if present in the sequence of pulse trains, (ii) by a respective inter-pulse-train delay from an immediately succeeding pulse train, if present in the sequence of pulse trains, or each of (i) and (ii), wherein each respective inter-pulse-train delay is greater in duration than each respective inter-biphasic -pulse delay.

70. The medical system of Claim 51, wherein the plurality of biphasic voltage pulses comprises (a) a first plurality of biphasic voltage pulses, each biphasic voltage pulse in the first plurality of biphasic voltage pulses having the same biphasic pulse waveform characteristics, and (b) a second plurality of biphasic voltage pulses, each biphasic voltage pulse in the second plurality of biphasic voltage pulses having the same biphasic pulse waveform characteristics, wherein the pulses of the first plurality of biphasic voltage pulses alternate with the pulses of the second plurality of biphasic voltage pulses.

71. The medical system of Claim 51, wherein the plurality of biphasic voltage pulses comprises an interleaving of a first plurality of biphasic voltage pulses and a second plurality of biphasic voltage pulses, each biphasic voltage pulse in the first plurality of biphasic voltage pulses having a sequence of a first particular monophasic voltage pulse of the first polarity followed by a second particular monophasic voltage pulse of the second polarity, and each biphasic voltage pulse in the second plurality of biphasic voltage pulses having a sequence of a third particular monophasic voltage pulse of the second polarity followed by a fourth particular monophasic voltage pulse of the first polarity.

72. A method executed by a data processing device system according to a program stored by a communicatively connected memory device system, the data processing device system also communicatively connected to an input-output device system, the input-output device system communicatively connected to an energy source device system circuit configured to provide pulsed field ablation energy to at least some electrodes of a plurality of electrodes supported by a structure of a catheter, and the method comprising: causing, via the input-output device system and via operation of at least the energy source device system circuit, provision of at least one pulse train, each pulse train of the at least one pulse train comprising a plurality of biphasic voltage pulses, wherein each biphasic voltage pulse in the plurality of biphasic voltage pulses comprises a first monophasic voltage pulse having a first polarity and a second monophasic voltage pulse having a second polarity opposite the first polarity, the first monophasic voltage pulses of the biphasic voltage pulses having a same duration and the second monophasic voltage pulses of the biphasic voltage pulses having a same duration, wherein the biphasic voltage pulses are successively arranged in the pulse train with the biphasic voltage pulses of each pair of successive biphasic voltage pulses in the pulse train spaced from one another by a respective inter-biphasic-pulse delay, and wherein the respective inter-biphasic-pulse delay between the biphasic voltage pulses of each pair of successive ones of the biphasic voltage pulses in the pulse train is different than the respective inter-biphasic -pulse delay between the biphasic voltage pulses of (a) an immediately preceding pair of successive ones of the biphasic voltage pulses in the pulse train, if present, and (b) an immediately succeeding pair of successive ones of the biphasic voltage pulses in the pulse train, if present.

73. One or more computer-readable storage mediums storing a program executable by a data processing device system communicatively connected to an input-output device system, the input-output device system communicatively connected to an energy source device system circuit configured to provide pulsed field ablation energy to at least some electrodes of a plurality of electrodes supported by a structure of a catheter, and the program comprising: provision instructions configured to cause, via the input-output device system and via operation of at least the energy source device system circuit, provision of at least one pulse train, each pulse train of the at least one pulse train comprising a plurality of biphasic voltage pulses, wherein each biphasic voltage pulse in the plurality of biphasic voltage pulses comprises a first monophasic voltage pulse having a first polarity and a second monophasic voltage pulse having a second polarity opposite the first polarity, the first monophasic voltage pulses of the biphasic voltage pulses having a same duration and the second monophasic voltage pulses of the biphasic voltage pulses having a same duration, wherein the biphasic voltage pulses are successively arranged in the pulse train with the biphasic voltage pulses of each pair of successive biphasic voltage pulses in the pulse train spaced from one another by a respective inter-biphasic-pulse delay, and wherein the respective inter-biphasic-pulse delay between the biphasic voltage pulses of each pair of successive ones of the biphasic voltage pulses in the pulse train is different than the respective inter-biphasic -pulse delay between the biphasic voltage pulses of (a) an immediately preceding pair of successive ones of the biphasic voltage pulses in the pulse train, if present, and (b) an immediately succeeding pair of successive ones of the biphasic voltage pulses in the pulse train, if present.

74. A computer program product comprising program code portions for performing the steps of method Claim 9, Claim 26, Claim 36, Claim 46, Claim 49, or Claim 72 when the computer program product is executed by a computing device.

75. The computer program product of Claim 74, stored on one or more computer readable storage mediums.

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