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: 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: 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: 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 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: 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: 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 medical system includes a generator configured to generate pulsed electric field (PEF) energy. A medical device is in electrical communication with the generator and has a plurality of electrodes configured to deliver the PEF energy to a target tissue to create electroporated regions in the target tissue. A delivery element tracking system is in communication with the generator and the medical device. The tracking system has processing circuitry configured to: measure a position of at least one of the plurality of electrodes prior to delivery of PEF energy to the target tissue with respect to the target tissue and correlate a PEF field distribution based on the delivery of PEF energy to the target tissue to determine or modify at least one metric of a therapeutic effect from the PEF delivery at positions other than the measured location of the plurality of electrodes.

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: 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.

Abstract: An example method for performing pulsed field ablation (PFA) includes determining, by a controller connected to a particular catheter and at a first time, to perform PFA using a linear PFA mode; responsive to determining to use the linear PFA mode, outputting, by the controller and to electrodes of the particular catheter, energy to cause the electrodes to generate a field with a geometry that is linear along an active portion of the particular catheter; determining, by the controller and at a second time, to perform PFA using a focal PFA mode; and responsive to determining to use the focal PFA mode, outputting, by the controller and to the electrodes of the particular catheter, energy to cause the electrodes to generate a field with a geometry that is focused at a tip of the particular catheter.

Abstract: Implantable medical device including a pulsed-voltage generator and one or more implantable electrical leads. In one example, the implantable medical device supports the defibrillator and ablation modalities characterized by different respective sets of waveform parameters, such as the pulse amplitude and width. In some examples, the implantable medical device also supports a pacing modality. The electrodes used for the different modalities are variously selected from a plurality of electrodes located in distal portions of the implantable electrical leads and on the exterior surface of the implantable device box. An electronic controller of the implantable medical device is wirelessly programmable to appropriately control, e.g., in a patient-specific manner, operations of the pulsed-voltage generator and transitions between different modalities.

Abstract: A method and system for directed pulsed electric field (PEF) ablation are disclosed. In one aspect, an irreversible electroporation (IRE) system includes processing circuitry configured to select a first set of electrodes positioned to produce a first electric field in a first direction in a region of tissue of a patient, and select a second set of electrodes positioned to produce a second electric field in a second direction in the region of tissue. The processing circuitry is configured to transmit a first IRE pulse to the first set of electrodes to cause emission of the first electric field and transmit a second IRE pulse to the second set of electrodes to cause emission of the second electric field. The first IRE pulse and the second IRE pulse are transmitted by the processing circuitry to control an electric field gradient along a path within the region of tissue.

Abstract: A method of delivering pulsed electric field energy to perform ablation of a tissue includes providing a pulse train to an electrode. The pulse train may include a first set of pulses with a first pulse width to generate first electric field and a second set of pulses with a second pulse width greater than the first pulse width to generate a second electric field. The electrode may be positioned at a same position during generation of the first electric field and the second electric field. The first electric field may be configured to have a higher electroporation effect on the first elongated cells having a first orientation than on second elongated cells having a second orientation. The second electric field may be configured to have a higher electroporation effect on the second cells than on the first cells.

Abstract: Devices, systems, and methods relating to a low-voltage, pre-treatment pulse routine for evaluating a potential for non-target tissue damage from the delivery of energy, such as electroporation energy to an area of target tissue. In one embodiment, a medical system includes a medical device having a treatment element; and a control unit in communication with the medical device, the control unit being configured to: deliver a low-voltage, pre-treatment pulse routine through the treatment element to an area of target tissue; determine whether the low-voltage, pre-treatment pulse routine has a stimulation effect on an area of non-target tissue; and deliver an ablation energy routine through the treatment element to the area of target tissue when the control unit determines that the low-voltage, pre-treatment pulse routine does not have a stimulation effect on the area of non-target tissue.

Abstract: Methods and systems for monitoring and modifying pulsed field ablation (PFA) energy delivery to prevent patient safety risks and/or delivery device failure. In particular, some embodiments provide methods and systems for detecting and preventing arcs and arc-induced plasma, and their causal events, during delivery of pulsed field ablation energy, as well as methods and systems for identifying conditions leading to potential delivery device failure and correcting charge imbalance or asymmetry.

Abstract: A device, system, and method for delivering energy to tissue. In particular, the present invention relates to a system and method for enhancing lesion formation without arrhythmogenic effects within relatively thick target tissues, such as the ventricles of the heart. In one embodiment, charge-neutral pulses and non-charge-neutral pulses may be delivered to induce the formation of electrolytic compounds that enhance cell death at the treatment site. Additionally or alternatively, tissue at the treatment site may be heated to sub-lethal temperature before ablating the tissue.

Abstract: A method of delivering pulsed electrical energy to a target tissue region includes delivering a first therapeutic pulse, the delivering of the first therapeutic pulse includes delivering a first pulse for a first time period, the first pulse having a first voltage amplitude. A second pulse is delivered immediately after the first pulse for a second time period, the second pulse having a second voltage amplitude configured to electroporate the target tissue region, the second time period being less than the first time period. A third pulse is delivered without delay after the second pulse for a third time period, the third pulse having a third voltage amplitude being at least one from the group consisting of substantially the same as the first amplitude, larger than the first amplitude, and less than the first amplitude.