Medtronic, Inc.

Medtronic Cryocath LP

Brian T Howard

Mark T Stewart

Timothy G Laske

John Vandanacker

Catherine R Condie

Paul Anthony Iaizzo

Michael D Eggen

Steven J Fraasch

Trenton Jay Rehberger

Qin Zhang

Lars M Mattison

Louis Jacob

Paul S Lam

Steven V Ramberg

Gonzalo Martinez

Alexander J Hill

Lynn A Davenport

Bushan K Purushothaman

Megan M Schmidt

Ryan P Goff

Damijan Miklavcic

Sara A Frantz

Jeremy M Stimack

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.

Variable impedance paths for delivery of electric fields

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.

Profile parameter selection algorithm for electroporation

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.

Methods of ensuring pulsed field ablation generator system electrical safety

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.

Safety default return path for electric field therapy

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.

Focal pulsed field ablation devices and methods

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 (y); load predetermined modeling data (x); accept entry of a user inputted desired lesion characteristic (u); and determine at least one corresponding pulsed field ablation waveform parameter based on (u), (y); and (x).

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.

Ablation check pulse routine and integration for electroporation

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.

Methods of recognizing and eliminating arcs and arc induced plasma during energy delivery in tissue

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.

Stacked potential electroporation

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.

Directionally focused ablation device

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.

Catheter electrodes for energy management

A method, system, and device for electroporation. A system may include a medical device with a plurality of electrodes borne on an expandable element and an energy generator in communication with the electrodes. The energy generator may have processing circuitry configured to selectively deliver electroporation energy to at least one of the electrodes. The processing circuitry may determine whether an alert condition is present and, if so, cease the delivery of electroporation energy to one or more electrodes identified as the cause of the alert condition and/or prevent the delivery of electroporation energy to the one or more electrodes identified as the cause of the alert condition. The energy generator may also be configured to deliver electroporation energy in a sequence of a plurality of energy delivery patterns to enhance lesion formation.

Expandable elements for delivery of electric fields

Devices, systems, and methods for reverse irrigation of an ablation or treatment site. In one embodiment, a reverse irrigation device comprises at least one ablation electrode and at least one reverse irrigation port, the at least one reverse irrigation port being located at at least one of immediately proximate the at least one ablation electrode and on the at least one ablation electrode, the at least one reverse irrigation port being configured to be in fluid communication with a fluid removal component. A medical system may include an ablation system and a reverse irrigation system that are configured to operate synchronously such that the reverse irrigation system is activated to remove fluid from the ablation site during a period of time during which the ablation system is activated to deliver ablation energy through the at least one ablation electrode to the ablation site.

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Hugo, MN, United States of America

Brian T Howard