Farapulse, Inc.

Boston Scientific Scimed, Inc.

Iowa Approach, Inc.

Raju Viswanathan

Gary Lee Long

Daniel J Foster

Jean-Luc Pageard

William J Bowers

Allan Zingeler

Brittney Hachey

Steven Richard Mickelsen

Benoit Thibault

Michael Alan Paré

Matthew Hein

Jonathan Allen

Colt Joseph Wilkins

Michael A ParÉ

William Bowers

Colt J Wilkins

An endocardial catheter comprises an outer shaft having an outer shaft lumen, an inner shaft slidably disposed within the outer shaft lumen, a spline assembly comprising a plurality of flexible splines each having a spline proximal end attached to a distal end of the outer shaft, an opposite spline distal end attached to a distal end of the inner shaft, and an electrode, wherein the plurality of splines collectively define an interior space of the spline assembly, and a foldable membrane disposed within the interior space of the spline assembly, the foldable membrane having an outer edge portion attached to one or more of the splines. The foldable membrane comprises an electrically insulative material.

Focal ablation devices with foldable elements, and systems and methods thereof

Systems, devices, and methods for electroporation ablation therapy are disclosed herein, including an inflatable member for positioning an ablation device within a pulmonary vein ostium. An apparatus can include first and second shafts moveable relative to one another, first and second electrodes configured to generate an electric field for ablating tissue, and an inflatable member disposed between the first and second electrodes. In some embodiments, the inflatable member is configured to transition from an undeployed configuration to a deployed configuration in response to movement of the first and second shafts. In some embodiments, the inflatable member in the deployed configuration can engage a wall of a pulmonary vein ostium and direct the electric field generated by the first and second electrodes toward the wall.

Systems, apparatuses, and methods for delivery of pulsed electric field ablative energy to endocardial tissue

Systems, devices, and methods for current control of energy delivery to ablate tissue are disclosed. A generator may include a set of electrode channels coupled to a set of electrodes during use. Each electrode channel from the set of electrode channels may include a first switch from a first set of switches and a second switch from a second set of switches. A set of energy sources may be coupled to a third set of switches. The third set of switches may be configured to switch from an OFF state to an ON state to couple the set of energy sources to the set of electrodes. A set of resistors may be coupled to the second set of switches. The second set of switches may be configured to switch from an OFF state to an ON state to couple the set of resistors to the set of electrodes.

Method and apparatus for controlled delivery of pulsed electric field ablative energy to tissue

An apparatus includes a shaft, the shaft including a plurality of stepped sections along the length of the shaft. The apparatus further includes a plurality of electrodes disposed along the length of the shaft, each electrode characterized by a geometric aspect ratio of the length of the electrode to the outer diameter of the electrode. Each electrode is located at a different stepped section of the plurality of stepped sections of the shaft and includes a set of leads. Each lead of the set of leads is configured to attain an electrical voltage potential of at least about 1 kV. The geometric aspect ratio of at least one electrode of the plurality of electrodes is in the range between about 3 and about 20.

Method and apparatus for rapid and safe pulmonary vein cardiac ablation

Systems, devices, and methods for electroporation ablation therapy are disclosed herein, with a cinch device for positioning an ablation catheter relative to tissue during a cardiac ablation procedure. In some embodiments, a distal end of a first device may be advanced into a proximal end of a first lumen of a second device. The first device may be advanced from a distal end of the first lumen and the first device may be looped around tissue of a patient. The first device may be advanced into a distal end of a second lumen of the second device. The distal end of the first device may be advanced from a proximal end of the second lumen. The proximal and distal ends of the first device may be advanced away from a proximal end of the second device to increase contact between the first device and the tissue.

Epicardial ablation catheter

Systems, apparatuses, and methods for electroporation ablation therapy are disclosed, with a protection device for protecting electronic circuitry, devices, and/or other components from induced currents and voltages generated during a cardiac ablation procedure. A system can include an ablation device near cardiac tissue of a heart. The system can further include a signal generator configured to generate a pulse waveform, where the signal generator coupled to the ablation device and configured to repeatedly deliver the pulse waveform to the ablation device in synchrony with a set of cardiac cycles of the heart. The system can further include a protection device configured to suppress induced current and voltage in an electronic device coupled to the protection device.

Systems, apparatuses, and methods for filtering high voltage noise induced by pulsed electric field ablation

Systems, devices, and methods for electroporation ablation therapy are disclosed, with the system including a pulse waveform signal generator for medical ablation therapy, and an endocardial ablation device includes an inflatable member and at least one electrode for focal ablation pulse delivery to tissue. The signal generator may deliver voltage pulses to the ablation device in the form of a pulse waveform. The system may include a cardiac stimulator for generation of pacing signals and for sequenced delivery of pulse waveforms in synchrony with the pacing signal.

Systems, apparatuses, and methods for ventricular focal ablation

A system includes a pulse waveform generator and an ablation device coupled to the pulse waveform generator. The ablation device includes at least one electrode configured for ablation pulse delivery to tissue during use. The pulse waveform generator is configured to deliver voltage pulses to the ablation device in the form of a pulsed waveform. The pulsed waveform can include multiple levels of hierarchy, and multiple sets of electrodes can be activated such that their pulsed delivery is interleaved with one another.

Systems, apparatuses and methods for delivery of ablative energy to tissue

Systems, devices, and methods for electroporation ablation therapy are disclosed, with the system including a pulse waveform signal generator for medical ablation therapy that may be coupled to an ablation device including at least one electrode for ablation pulse delivery to tissue. The signal generator may generate and deliver voltage pulses to the ablation device in the form of a pulse waveform in a predetermined sequence where the signal generator may independently configure a set of electrodes of an ablation device. The signal generator may further perform active monitoring of a set of electrode channels and discharge excess energy using the set of electrode channels.

Systems, devices, and methods for signal generation

Systems, devices, and methods for electroporation ablation therapy are disclosed, with the device including a first jaw including a plurality of first electrodes and a second jaw including a plurality of second electrodes. The first jaw and the second jaw may be substantially rigid, elongate, and collectively define a longitudinal axis. The first jaw and the second jaw may be configured to engage tissue therebetween during use.

Systems, devices, and methods for ablation using surgical clamps

Systems, devices, and methods for electroporation ablation therapy are disclosed in the context of esophageal ablation. An ablation device may include a first catheter defining a longitudinal axis and a lumen therethrough. A balloon may be coupled to the first catheter. The balloon may be configured to transition between a deflated configuration and an inflated configuration. A second catheter may extend from a distal end of the first catheter lumen. A set of splines including electrodes formed on a surface of each of the splines may couple to the distal end of the first catheter lumen and a distal portion of the second catheter. The second catheter may be configured for translation along the longitudinal axis to transition the set of splines between a first configuration and a second configuration.

Systems, devices, and methods for delivery of pulsed electric field ablative energy to esophageal tissue

Systems, apparatus, and methods for ablation therapy are described herein, with a processor for confirming pacing capture or detecting ectopic beats. An apparatus includes a processor for receiving cardiac signal data captured by a set of electrodes, extracting a sliding window of the cardiac signal data, identifying a peak frequency over a subrange of frequencies associated with the extracted sliding window, detecting ectopic activity based at least on a measure of the peak frequency over the subrange of frequencies, in response to detecting ectopic activity, sending an indication of ectopic activity to a signal generator configured to generate pulsed waveforms for cardiac ablation such that the signal generator is deactivated or switched off from generating the pulsed waveforms. An apparatus can further include a processor for confirming pacing capture of the set of pacing pulses based on cardiac signal data.

Systems, apparatuses, and methods for detecting ectopic electrocardiogram signals during pulsed electric field ablation

Systems, tools and methods are disclosed for the selective and rapid application of DC voltage to drive irreversible electroporation, with the system controller capable of being configured to apply voltages to independently selected subsets of electrodes and capable of generating at least one control signal to maintain the temperature near an electrode head within a desired range of values. Electrode clamp devices are also disclosed for generating electric fields to drive irreversible electroporation while modulating temperature to elevate the irreversible electroporation threshold utilizing a variety of means such as cooling fluid or solid state thermoelectric heat pumps.

Method and apparatus for rapid and selective tissue ablation with cooling

Systems, devices, and methods for electroporation ablation therapy are disclosed, with the system including a signal generator for generating pre-ablation signals and pulse waveforms for medical ablation therapy that may be coupled to an ablation device including at least one electrode for ablation pulse delivery to tissue. The signal generator may generate and delivery pre-ablation signals to subsets of electrodes of the ablation device and measure currents associated with the delivery to determine whether the currents meet one or more predetermined criteria. The signal generator may also generate and deliver voltage pulses to the ablation device in the form of a pulse waveform after determining that the currents meet the one or more predetermined criteria.

Growing community of inventors

Mountain View, CA, United States of America

Raju Viswanathan