CROSS-REFERENCE TO RELATED APPLICATION

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STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

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TECHNICAL FIELD

This disclosure relates to a method and system for determining electroporation parameters based on desired lesion characteristics.

BACKGROUND

Electroporation is the application of an electric field to cells in order to increase the permeability of the cell membrane. Pulsed field ablation (“PFA”) which can cause reversible or irreversible electroporation, is a non-thermal ablation technique that creates lesions in desired areas to treat conditions such as cardiac arrhythmias, and to ablate areas of tissues and/or organs in the body. For treating cardiac arrhythmias, for example, PFA can be performed to modify tissue, such as to stop aberrant electrical propagation and/or disrupt aberrant electrical conduction through cardiac tissue.

PFA includes application of short pulsed electric fields (PEF), which may reversibly or irreversibly destabilize cell membranes through electropermeablization, but generally do not affect the structural integrity of the tissue components, including the acellular cardiac extracellular matrix. The nature of PFA allows for very brief periods of therapeutic energy delivery, on the order of tens or hundreds of milliseconds in duration. Further, when targeting cardiomyocytes, PFA may not cause collateral damage to non-targeted tissue as frequently or as severely as thermal ablation techniques. Additionally, therapeutic agents may be preferentially introduced into the cells of targeted tissue that are exposed to PEF having reversible membrane permeabilization.

In PFA systems, the user programs, or otherwise manually enters, the desired parameters of the PEF delivered to the tissue into an electrosurgical generator configured to deliver electrical energy to the target tissue through an electrosurgical hand piece. That is, for a given delivery tool, target tissue, or environment, the user may select from waveform parameters such as the amplitude, size, shape, frequency, and repetition of the waveform. Upon entry of those parameters, the size of the lesion may be determined. In such an application, the size of the lesion (or affected area) such as the depth or breadth of the affected area is often the desired result. However, no system or method exists that allows the users to input into the electrosurgical generator the desired characteristics of a lesion for a particular tissue, such as length, width, and depth for use with PFA. For cardiac ablation energy delivery electrodes designed for placement on the endocardial surface or epicardial surface of the heart, achieving a desired depth or extent of lesion formation into the tissue is generally the objective. Alternative electrodes may be designed to ablate from within a confined space within the tissue, such as within the vasculature. In such placements, the electric field and resulting lesion extends radially outward from the electrode array, producing a lesion of a specific diameter surrounding the electrodes.

SUMMARY

The present application advantageously provides for 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).

In another aspect of this embodiment, the method includes coupling an electrosurgical device having a plurality of electrodes with the electrosurgical generator, the plurality of electrodes being configured to deliver electroporation pulses between an adjacent one of the plurality of electrodes.

In another aspect of this embodiment, wherein the predetermined modeling data (xi) is a function of the predetermined waveforms parameters (yi) and the user inputted desired lesion characteristic (ui).

In another aspect of this embodiment, wherein the electrosurgical generator is configured to electrically couple with an electrosurgical medical device having a plurality of electrodes configured to deliver electroporation pulses between adjacent electrodes of the plurality of electrodes, and wherein the waveform parameters (yi) include at least one from the group consisting of a number of pulses, a duration of each pulse, a number of pulse trains, an applied voltage, electrode polarity configuration, and inter-pulse timing.

In another aspect of this embodiment, wherein the user inputted desired lesion characteristic (ui) includes at least one of the group consisting of lesion depth, lesion surface area, lesion width, and lesion length.

In another aspect of this embodiment, the method further includes delivering between 30-140 electroporation pulses to the cardiac tissue.

In another aspect of this embodiment, wherein a pulse width between each of the delivered electroporation pulse is between 3-6 μs.

In another aspect of this embodiment, wherein the electroporation pulses are delivered in at least 4 pulse trains.

In another aspect of this embodiment, wherein the determined at least one corresponding pulsed field ablation waveform parameter is at least one from the group consisting of an applied voltage amplitude and an applied electric field of the pulsed field ablation waveform.

In another aspect of this embodiment, wherein the method further includes determining whether the determined applied voltage amplitude is within a predetermined voltage threshold, and wherein the method further includes reducing the applied voltage amplitude when the determined applied voltage amplitude is above the predetermined voltage threshold.

In another aspect of this embodiment, wherein the user inputted desired lesion characteristic (ui) is lesion depth, and wherein the method further includes setting accepting a user inputted range of lesion depth between 1 mm and 8 mm.

In another embodiment, an electrosurgical generator configured to deliver pulsed field ablation pulses to electroporate cardiac tissue includes a processor having processing circuitry 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).

In another aspect of this embodiment, wherein the generator is further configured to electrically couple with an electrosurgical device having a plurality of electrodes, the plurality of electrodes being configured to deliver electroporation pulses between an adjacent one of the plurality of electrodes.

In another aspect of this embodiment, wherein the predetermined modeling data (xi) is a function of the predetermined waveforms parameters (yi) and the user inputted desired lesion characteristic (ui).

In another aspect of this embodiment, wherein the electrosurgical generator is configured to electrically couple with an electrosurgical medical device having a plurality of electrodes configured to deliver electroporation pulses between adjacent electrodes of the plurality of electrodes, and wherein the waveform parameters (yi) include at least one from the group consisting of a number of pulses, a duration of each pulse, a number of pulse trains, an applied voltage, electrode polarity configuration, and inter-pulse timing.

In another aspect of this embodiment, wherein the user inputted desired lesion characteristic (ui) includes at least one of the group consisting of lesion depth, lesion surface area, lesion width, and lesion length.

In another aspect of this embodiment, wherein the determined at least one corresponding pulsed field ablation waveform parameter is at least one from the group consisting of an applied voltage amplitude and an applied electric field of the pulsed field ablation waveform.

In another aspect of this embodiment, the processing circuitry is further configured to determine whether the applied voltage amplitude is within a predetermined voltage threshold, and wherein the processing circuitry is further configured to reduce the applied voltage amplitude when the determined applied voltage amplitude is above the predetermined voltage threshold

In another aspect of this embodiment, wherein the user inputted desired lesion characteristic (ui) is lesion depth, and wherein the processing circuitry is configured to accept a user inputted range of lesion depth between 1 mm and 8 mm.

In yet another embodiment, an electrosurgical generator configured to deliver pulsed field ablation pulses to electroporate cardiac tissue includes a processor having processing circuitry configured to: load predetermined waveform parameters (yi); load predetermined modeling data (xi); accept entry of a user inputted desired lesion characteristic (ui); determine an applied voltage amplitude based on (ui), (yi); and (xi). The generator is configured to electrically couple with an electrosurgical device having a plurality of electrodes, the plurality of electrodes being configured to deliver electroporation pulses between an adjacent one of the plurality of electrodes, the plurality of electrodes being configured to define a substantially circumferential configuration. The processing circuitry is further configured to determine whether the applied voltage amplitude is within a predetermined voltage threshold, and wherein the processing circuitry is further configured to reduce the applied voltage amplitude when the determined applied voltage amplitude is above the predetermined voltage threshold.

