Abstract: A medical device including a catheter having a proximal portion and a distal portion. A plurality of electrodes is disposed along the distal portion, the plurality of electrodes including a first electrode pair having a first fixed polarity and a second electrode pair having a second fixed polarity different than the first fixed polarity. A first lumen extends through the distal portion, the first lumen includes a first conductor configured to connect to a first electrode of the first electrode pair and a second conductor configured to connect to a second electrode of the first electrode pair. A second lumen extends through the distal portion and separated from the first lumen, the second lumen includes a third conductor configured to connect to a first electrode of the second electrode pair and a fourth conductor configured to connect to a second electrode of the second electrode pair.

Abstract: Devices, systems, and methods for more efficiently ablating tissue with pulsed field ablation energy while minimizing collateral injury to non-target tissue. In one embodiment, a system for ablating tissue at a treatment site comprises: an energy delivery device; and a control unit including: a source of impedance-modifying fluid in fluid communication with the energy delivery device; an energy generator in electrical communication with the energy delivery device, the energy generator being configured to transmit energy to the energy delivery device and the energy delivery device being configured to deliver energy to the treatment site; and processing circuitry configured to control delivery of the impedance-modifying fluid from the energy delivery device to the treatment site. In one embodiment, a method for ablating tissue comprises delivering an impedance-modifying fluid to a treatment site and delivering pulsed field ablation energy to the treatment site.

Abstract: The present invention relates to a method, device, and system for improved mapping and/or ablation of a tissue. The device may generally include an elongate body and a distal assembly affixed to the elongate body that includes a treatment electrode having a conductive mapping region and a selectively conductive ablation region that is conductive of high-frequency current and substantially non-conductive of low-frequency current. Alternatively, the device may generally include a treatment electrode having a conductive mapping or ablation region and a region that is coated with an electrically insulated but thermally conductive layer.

Abstract: A medical device including a catheter having a proximal portion and a distal portion. A plurality of electrodes is disposed along the distal portion, the plurality of electrodes including a first electrode pair having a first fixed polarity and a second electrode pair having a second fixed polarity different than the first fixed polarity. A first lumen extends through the distal portion, the first lumen includes a first conductor configured to connect to a first electrode of the first electrode pair and a second conductor configured to connect to a second electrode of the first electrode pair. A second lumen extends through the distal portion and separated from the first lumen, the second lumen includes a third conductor configured to connect to a first electrode of the second electrode pair and a fourth conductor configured to connect to a second electrode of the second electrode pair.

Abstract: A method and system for mapping tissue and producing lesions for the treatment of cardiac arrhythmias in a non-thermal and optimal manner, minimizing the amount of energy required to selectively stun or ablate the target tissues. Energy may be delivered only at the moment(s) of best device position and proximity of an electrode to target tissue, and only during a time in the cardiac cycle determined to be optimal for reversible or irreversible effects. A method may include determining timing of the cardiac cycle and an optimal time within the cardiac cycle for energy delivery, evaluating proximity between at least one energy delivery electrode and the target tissue, and delivering pulsed field energy from the at least one energy delivery electrode to the target tissue when, during the optimal time for energy delivery, the at least one energy delivery electrode is in close proximity with the target tissue.

Abstract: Systems and methods to confirm safe delivery of treatment energy to a patient by identifying a presence of a fault in an energy delivery pathway and identifying a location of the fault within the device. The system includes a processing unit configured to calculate blood impedances external to the device based on known impedance characteristics of the device, and then to calculate impedances within the device during energy delivery based on the calculated blood impedances. The processing unit prevents the delivery of energy in an energy delivery pathway that is determined to be compromised. The processing unit is also configured to compare times for two different frequencies to travel a predetermined distance, the difference in the times corresponding to a location of a fault within the energy delivery pathway.

Abstract: Devices, systems, and methods for more efficiently ablating tissue with pulsed field ablation energy while minimizing collateral injury to non-target tissue. In one embodiment, a system for ablating tissue at a treatment site comprises: an energy delivery device; and a control unit including: a source of impedance-modifying fluid in fluid communication with the energy delivery device; an energy generator in electrical communication with the energy delivery device, the energy generator being configured to transmit energy to the energy delivery device and the energy delivery device being configured to deliver energy to the treatment site; and processing circuitry configured to control delivery of the impedance-modifying fluid from the energy delivery device to the treatment site. In one embodiment, a method for ablating tissue comprises delivering an impedance-modifying fluid to a treatment site and delivering pulsed field ablation energy to the treatment site.

Abstract: A pulsed field ablation medical device. Among other things, the medical device includes processing circuitry in communication with an electrosurgical generator and a plurality of electrodes. In one example, the processing circuitry is configured to determine a desired lesion characteristic; determine a first waveform parameter based on the desired lesion characteristic; deliver, via the plurality of electrodes, a first pulsed field waveform of the plurality of pulsed field waveforms based on the first waveform parameter to ablate the area of tissue; measure a second lesion characteristic based on a result of delivering the first pulsed field waveform; determine a second waveform parameter based on the second lesion characteristic; deliver, via the plurality of electrodes, a second pulsed field waveform of the plurality of pulsed field waveforms based on the second waveform parameter to ablate the area of tissue.

Abstract: The present invention relates to a method, device, and system for improved mapping and/or ablation of a tissue. The device may generally include an elongate body and a distal assembly affixed to the elongate body that includes a treatment electrode having a conductive mapping region and a selectively conductive ablation region that is conductive of high-frequency current and substantially non-conductive of low-frequency current. Alternatively, the device may generally include a treatment electrode having a conductive mapping or ablation region and a region that is coated with an electrically insulated but thermally conductive layer.

Abstract: Systems and methods to confirm safe delivery of treatment energy to a patient by identifying a presence of a fault in an energy delivery pathway and identifying a location of the fault within the device. The system includes a processing unit configured to calculate blood impedances external to the device based on known impedance characteristics of the device, and then to calculate impedances within the device during energy delivery based on the calculated blood impedances. The processing unit prevents the delivery of energy in an energy delivery pathway that is determined to be compromised. The processing unit is also configured to compare times for two different frequencies to travel a predetermined distance, the difference in the times corresponding to a location of a fault within the energy delivery pathway.

Abstract: Methods and systems for combining ablation therapy with navigation of the ablation device. An ablation system may be configured for use with one of two methods to prevent loss of navigation signals during ablation energy delivery. In the first method, ablation energy signals are filtered from the navigation signal. In the second method, the delivery of ablation energy is sequenced with the delivery of navigation energy such that ablation energy and navigation energy are not delivered at the same time and navigation signals received by the system are time-division multiplexed to reconstruct the navigation signals and determine a location of the device within the patient.

Abstract: A system and method for the safe delivery of treatment energy to a patient, which includes verification of system integrity before, during, or after the delivery of treatment energy and provides several mechanisms for rapid termination of the delivery of potentially harmful energy to the patient when a fault condition in the device and/or system is identified. The system may include an energy generator having processing circuitry to determine if there is a fault condition in the system and to automatically terminate a delivery of treatment energy when the processing circuitry determines there is a fault condition. The method may generally include performing a series of pre-checks, synchronizing a treatment energy delivery to the proper segment of the heart's depolarization pattern, configuring the system for treatment energy delivery, delivering the treatment energy, and performing post-treatment evaluation.

Abstract: A method and system for mapping tissue and producing lesions for the treatment of cardiac arrhythmias in a non-thermal and optimal manner, minimizing the amount of energy required to selectively stun or ablate the target tissues. Energy may be delivered only at the moment(s) of best device position and proximity of an electrode to target tissue, and only during a time in the cardiac cycle determined to be optimal for reversible or irreversible effects. A method may include determining timing of the cardiac cycle and an optimal time within the cardiac cycle for energy delivery, evaluating proximity between at least one energy delivery electrode and the target tissue, and delivering pulsed field energy from the at least one energy delivery electrode to the target tissue when, during the optimal time for energy delivery, the at least one energy delivery electrode is in close proximity with the target tissue.

Abstract: A method of determining a pulsed field ablation waveform parameter for creating a desired lesion characteristic in cardiac tissue. The method of provides an electrosurgical generator configured to deliver electroporation pulses, the generator configured to: load predetermined waveform parameters (yi); load predetermined modeling data (xi); accept entry of a user inputted desired lesion characteristic (ui); and determine at least one corresponding pulsed field ablation waveform parameter based on (ui), (yi); and (xi).

Abstract: Methods and systems for combining ablation therapy with navigation of the ablation device. An ablation system may be configured for use with one of two methods to prevent loss of navigation signals during ablation energy delivery. In the first method, ablation energy signals are filtered from the navigation signal. In the second method, the delivery of ablation energy is sequenced with the delivery of navigation energy such that ablation energy and navigation energy are not delivered at the same time and navigation signals received by the system are time-division multiplexed to reconstruct the navigation signals and determine a location of the device within the patient.

Abstract: A medical device includes an elongate body, an expandable treatment element, a plurality of flexible shafts, and a plurality of electrodes. The elongate body has a proximal portion and a distal portion opposite the proximal portion. The expandable treatment element is coupled to the elongate body to receive a fluid and, in some examples, is anchored to the plurality of flexible shafts with a plurality of retention elements. In some examples, each flexible shaft of the plurality of flexible shafts has a braided configuration. Each electrode of the plurality of electrodes is attached and electrically coupled to a respective flexible shaft of the plurality of flexible shafts.

Abstract: A method and a pulsed electric field (PEF) ablation instrument are provided. According to one aspect, a method in a PFA generator includes receiving electrical responses for each of at least one non-therapeutic waveform. The process also includes determining an electric field distribution based at least in part on the received electrical responses. The process further includes selecting a non-therapeutic waveform that produces an electric field distribution that satisfies criteria. The process also includes mapping the selected non-therapeutic waveform to an ablative waveform.

Abstract: An example system for use in ablating target tissue includes memory configured to store anatomical and/or physiological information of a patient and processing circuitry communicatively coupled to the memory. The processing circuitry is configured to, based on the anatomical information and/or the physiological information, determine ablation parameters, the ablation parameters including a suggested positioning of at least energy delivery element of at least one catheter and/or an amount of energy to be delivered via the at least one energy delivery element to the target tissue during ablation. The processing circuitry is configured to output, for display, a representation of at least one of a suggested positioning of the at least one energy delivery element during the ablation, a representation of the target tissue, or a representation of the predicted tissue volume that will be ablated after delivery of ablation energy.

Abstract: A medical device comprising an elongate body having a proximal portion, a distal portion, a distal end, a longitudinal axis, and a radius, a plurality of deployable arms, the deployable arms being movably coupled to the elongate body, and at least one arm from the plurality of deployable arms having at least one electrically conductive surface. The plurality of deployable arms being movable from a collapsed configuration to an expanded configuration. In the collapsed configuration, the plurality of deployable arms are approximately parallel to the longitudinal axis. In the expanded configuration, the at least one electrically conductive surface is distal facing and is positioned radially from the longitudinal axis by a distance that is greater than the radius of the elongate body.

Abstract: An example catheter for performing pulsed field ablation (PFA) includes: an elongated structure defining a longitudinal axis; a plurality of electrodes carried on a distal portion of the elongated structure, the plurality of electrodes comprising: a tip electrode positioned at a distal tip of the elongated structure; a tip ring electrode adjacent to the tip electrode; a pair of ring electrodes; and one or more additional electrodes, wherein the pair of ring electrodes is disposed longitudinally along the elongated structure between the tip ring electrode and the one or more additional electrodes.