Abstract: The present invention generally relates to golf bags having a lightweight and durable top frame assembly. The lightweight top frame assembly can have handle and leg sub-assemblies. Three-dimensional printing methods can be used to form the top frame assembly or any portion thereof. The golf bags may include a cord assembly extending across the top frame to form one or more club dividers for organizing golf clubs.

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: 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 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: 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: 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: 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: 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: 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.

Abstract: Methods, systems, and devices for enhancing the efficiency and efficacy of energy delivery and tissue mapping. One system includes a treatment element having a plurality of electrodes and an energy generator that is configured to deliver electric energy pulses to the electrodes in a variety of patterns. For example, electrodes may be arranged in closely spaced pairs. The energy generator may deliver mapping energy to each electrode in each pair individually to map tissue and may deliver ablation energy to the electrodes in each pair together, such that each pair is treated like a single electrode, to deliver ablation energy, such as bipolar ablation energy between adjacent pairs. One system includes at least one concave electrode, the configuration of which concentrates the energy and drives it deeper into the tissue. One system includes neutral electrodes between active electrodes, the energy generator selectively coupling the neutral electrodes to alter the ablation pattern.

Abstract: A medical device for directionally focusing energy to a treatment site, the medical device including a shaft having an elongated body defining a proximal portion and a distal portion opposite the proximal portion, the distal portion including at least one electrode having a contact portion and a permeable sheath at least partially surrounding the at least one electrode, the permeable sheath and the at least one electrode defining an insulation cavity, the permeable sheath being impermeable to an insulation material introduced to the insulation cavity from a fluid source configured to be coupled to the shaft.

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 method, system, and device for electroporation. A method for electroporating tissue, the method may include positioning a medical device having a plurality of electrodes proximate an area of tissue, delivering electroporation energy to the plurality of electrodes with an energy generator, receiving data from the plurality of electrodes, determining whether an alert condition is present based upon the data received from the plurality of electrodes, and at least one of cease a delivery of electroporation energy to the plurality of electrodes and prevent the delivery of electroporation energy to the plurality of electrodes when a processing circuitry determines that an alert condition is present.