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: Methods of and systems for ablating cardiac tissue is disclosed. One example method includes monitoring an electrical signal of a heart of a patient. The electrical signal represents the heart beating. The method further includes determining, with an electronic processor and based on the electrical signal, an end-diastolic time period at an end of a diastolic time period during which diastole of the heart has occurred during a previous cardiac cycle. The method further includes determining, with the electronic processor and based on the electrical signal, that another cardiac cycle has begun. The method further includes causing, with the electronic processor, an electrode to deliver pulsed field ablation (PFA) energy to the heart during at least a portion of a time in which the end-diastolic time period of the another cardiac cycle is expected to occur.

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: 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: Evaluating a cardiac lesion formed by an ablation procedure, by receiving, by processing circuitry and following conclusion of delivery of ablation energy, a bioelectrical signal from an electrode proximate to a target location of cardiac tissue for the cardiac lesion; determining, by the processing circuitry, one or more characteristics of the received bioelectrical signal in a frequency band of the received bioelectrical signal; and estimating, by the processing circuitry, an efficacy of the cardiac lesion based on a comparison of the determined amplitude of the bioelectrical signal and a threshold amplitude.

Abstract: A medical device having an elongate body with a proximal portion, a distal portion, and defining a lumen therethrough. The medical device has an expandable element coupled to the distal portion of the elongate body, the expandable element defining a proximal portion, a distal portion opposite the proximal portion and an intermediate portion disposed between the proximal portion and the distal portion. The expandable element also has an inner surface and an outer surface opposite the inner surface. The medical device has a plurality of cutting members, each cutting member being coupled with the outer surface of the expandable element, each cutting member having a proximal end and a distal end opposite the proximal end, the proximal end being proximate the proximal portion of the expandable element and the distal end being proximate to the intermediate portion of the expandable element.

Abstract: A system for hepatic nerve denervation includes a medical device and a generator in communication with the medical device. The medical device includes an elongate body having a proximal portion and a distal portion opposite the proximal portion, and a plurality of treatment electrodes coupled to the distal portion. The distal portion is configured to be in contact with an area of target tissue. The area of target tissue is an area of tissue within the hepatic artery. The generator is configured to generate and deliver at least one pulse train of energy to the plurality of treatment electrodes to ablate the area of target tissue.

Abstract: A method includes cutting a septal wall between a right atrium and left atrium of a heart of a patient to form a multi-cuspid valvular shunt, and ablating septal wall tissue of at least a portion of the multi-cuspid valvular shunt to cause the ablated portion of the multi-cuspid valvular shunt to be biostable.

Abstract: A medical device including an elongate body having a proximal portion and a distal portion. A plurality of active electrodes is coupled to the distal portion of the elongate body and being configured to electrically couple to a source of pulsed electric field energy. At least one passive electrode is coupled to the elongate body and is not configured to electrically couple to the source of pulsed electric field energy, the at least one passive electrode being configured to passively extend or focus an electric field generated by the plurality of active electrodes.

Abstract: A method and pulsed field ablation (PFA) system configured to provide variable impedance paths for delivery of electric fields to patient tissue using a PFA catheter are disclosed. According to one aspect, a method includes determining a current for each of a plurality of circuit paths, each circuit path including two electrodes. Each current may be determined based at least in part on: a desired voltage between the two electrodes; a tissue impedance between the two electrodes; and a parasitic impedance associated with the circuit path. The method also includes determining at least one of an excitation voltage and an input resistance for each circuit path of the plurality of circuit paths based at least in part on the determined current for the circuit path, parasitic impedances associated with the circuit path and a tissue impedance between the two electrodes in the circuit path.

Abstract: A method and a medical device for determining efficacy of a pulsed electric field (PEF) ablation procedure are disclosed. According to one aspect, the method includes generating at least one pulsed electric field (PEF) pulse to be delivered to at least one electrode of a plurality of electrodes, the at least one electrode being at a distal end of a PEF ablation catheter and being positionable in proximity to a target region of tissue to be ablated. The method also includes determining an index of completeness indicative of a completeness of ablation of the target region of tissue based at least in part on a change in a parameter compared to an expected change in the parameter, the change in the parameter being caused at least in part on an extent of ablation of the target region.

Abstract: A lesion characterization process is disclosed. According to one aspect, a method includes obtaining measurements of at least one of an impedance magnitude, impedance phase, a temperature, and electrical properties of tissue of the lesion. The method further includes determining at least one lesion property including at least one of a depth of the lesion, percent transmurality of the lesion, lesion surface area and lesion volume based on at least one of the obtained measurements.

Abstract: The present invention advantageously provides a molding device with conductive material for creating a catheter balloon with conductive elements, and methods and systems for manufacturing the catheter balloon with conductive elements. An exemplary method for coupling a plurality of conductive elements to an expandable element may include placing a first portion of a mold proximate a second portion of the mold to define a casting cavity. Conductive material may be deposited into the casting cavity. Polymeric material may be inserted into the casting cavity. The first portion of the mold may be secured to the second portion of the mold. The polymeric material may be expanded to place the polymeric material in contact with the conductive material.

Abstract: A method of ablating tissue with pulse field ablation energy includes generating a single pulse of energy between a first set of one or more conducting elements of a first polarity and a second set of one or more conducting elements of a second polarity, the single pulse of energy having a first pulse width and consecutively generating pulses of energy with opposite polarity to that of the single pulse of energy, the pulses having a collective pulse width equal to the first pulse width.

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.