Granted Patent B2

US 12,527,620 · App. 18/674,565 · Granted Jan 20, 2026

Inventor: Steven R. Mickelsen (Iowa City, IA)

Assignee: Boston Scientific Scimed, Inc.

A61B18/1492A61B5/0538A61N1/327A61N7/022A61B2017/00026A61B2017/00154A61B2018/0022A61B2018/00267A61B2018/00351A61B2018/00404A61B2018/00577A61B2018/00613A61B2018/00654A61B2018/00827A61B2018/00839A61B2018/00875A61B2018/00892A61B2018/00994A61B2018/124A61B2018/1467A61B18/1815A61B2218/002A61B2576/023A61N1/0412

Abstract

Claims (38)

1 . A method for conducting bipolar pulsed field ablation of cardiac tissue through a process of irreversible electroporation, the method comprising:

guiding a catheter to a pulmonary outflow tract of the cardiac tissue, the catheter comprising an elongate member defining a proximal end and a distal end, the catheter comprising a plurality of electrodes disposed at the distal end;

moving the plurality of electrodes between a first configuration in which the plurality of electrodes are aligned with the length of the elongate member and a second configuration in which the plurality of electrodes are disposed radially outward of the elongate member;

employing an electroporation system in electrical communication with the plurality of electrodes via one or more leads extending within the catheter, the electroporation system comprising a generator and a user interface, the user interface configured to display a graphical icon of each of the plurality of electrodes disposed at the distal end of the elongate member, the icons indicating the electrodes of the plurality of electrodes to be used for ablation;

determining, via the electroporation system, an impedance across respective pairs of anode-cathode electrodes of the plurality of electrodes to generate an impedance map;

ruling out for ablation, via the electroporation system, one or more of the pairs of anode-cathode electrodes in the plurality of electrodes based on the impedance map;

generating, via the generator, at least one sequence of biphasic voltage pulses having at least one amplitude, the at least one amplitude between about 0.5 kV to about 10 kV; and

applying, via the electroporation system, the at least one sequence of biphasic voltage pulses to one or more others of the pairs of anode-cathode electrodes of the plurality of electrodes to thereby generate an electric field of sufficient strength to cause irreversible electroporation of the cardiac tissue proximate the distal end of the elongate member at the pulmonary outflow tract.

2 . The method of claim 1 , further comprising selecting, by an operator via the user interface, one or more electrodes to be used for ablation.

3 . The method of claim 2 , wherein the user interface comprises a touchscreen and the selecting operation is performed via graphical buttons displayed on the touchscreen.

4 . The method of claim 1 , wherein a waveform of the at least one sequence of voltage pulses is displayed on the user interface.

5 . The method of claim 1 , further comprising generating the impedance map based on voltage and current readings across the pairs of anode-cathode electrodes of the plurality of electrodes.

6 . A method for conducting bipolar pulsed field ablation of cardiac tissue through a process of irreversible electroporation, the method comprising:

positioning a catheter adjacent the cardiac tissue, the catheter comprising an elongate member defining a proximal end and a distal end, the catheter comprising a plurality of electrodes disposed at the distal end;

connecting an electroporation system in electrical communication with the plurality of electrodes, the electroporation system comprising a generator and a user interface, the user interface configured to display a graphic of each of the plurality of electrodes and indicate a set of electrodes of the plurality of electrodes are to be used for ablation;

determining, via the electroporation system, an impedance across each of a plurality of pairs of anode-cathode electrodes of the plurality of electrodes;

automatically selecting for ablation, via the electroporation system, one or more pairs of anode-cathode electrodes of the plurality of electrodes at which the impedance is less than about 300 Ohms;

generating, via the generator, at least one sequence of biphasic voltage pulses having at least one amplitude, the at least one amplitude between about 0.5 kV to about 10 kV; and

applying, via the electroporation system, the at least one sequence of biphasic voltage pulses to the selected one or more pairs of anode-cathode electrode of the plurality of electrodes to thereby generate an electric field of sufficient strength to cause irreversible electroporation of the cardiac tissue proximate the distal end of the elongate member.

7 . The method of claim 6 , wherein the catheter further comprises a slidable first member and a second member carrying the plurality of electrodes, the second member having a first end attached to the distal end of the elongate member and an opposite second end coupled with the first member, further wherein movement of the first member relative to the distal end of the elongate member causes the second member to move to a position in which the plurality of electrodes are disposed radially outward of a longitudinal axis of the elongate member.

8 . The method of claim 6 , further comprising using the catheter to generate a mitral isthmus line in the cardiac tissue.

9 . The method of claim 6 , wherein the set of electrodes to be used for ablation includes at least six electrodes.

10 . The method of claim 6 , wherein the plurality of electrodes includes at least nine electrodes.

11 . The method of claim 6 , wherein the user interface is configured to receive a selection by an operator of one or more electrodes to be used for ablation.

12 . The method of claim 11 , wherein the user interface is configured to receive a selection by an operator of one or more electrodes that will not be used for ablation.

13 . A method for conducting bipolar pulsed field ablation of cardiac tissue of a heart of a patient through a process irreversible electroporation, the method comprising:

positioning a catheter comprising an elongate member defining a proximal end and a distal end, the catheter comprising a plurality of electrodes movably coupled with the distal end;

coupling an electroporation system in electrical communication with the plurality of electrodes, the electroporation system comprising a generator and a user interface, the user interface configured to display at least one graphical icon of the plurality of electrodes disposed at the distal end of the elongate member, the at least one graphical icon indicating whether each electrode of the plurality of electrodes is active or inactive;

determining, via the electroporation system, an impedance across each of a plurality of anode-cathode pairs of electrodes from the plurality of electrodes;

selecting, via the electroporation system, the anode-cathode pairs of electrodes from the plurality of electrodes having a respective impedance less than or equal to 300 Ohms;

ruling out for ablation, via the electroporation system, anode-cathode pairs of electrodes from the plurality of electrodes having a respective impedance greater than 300 Ohms;

generating, via the generator, at least one sequence of biphasic voltage pulses having at least one amplitude, the at least one amplitude between about 0.5 kV to about 10 kV; and

applying, via the electroporation system, the at least one sequence of biphasic voltage pulses to the selected anode-cathode pairs of electrodes of the plurality of electrodes to thereby generate an electric field of sufficient strength to cause irreversible electroporation of the cardiac tissue proximate the distal end of the elongate member.

14 . The method of claim 13 , wherein the active electrodes of the plurality of electrodes includes fewer than all of the plurality of electrodes.

15 . The method of claim 13 , wherein the user interface is configured to receive a selection by an operator of the active electrodes.

16 . The method of claim 13 , further comprising synchronizing the generator output with a cardiac cycle of the heart of the patient.

17 . The method of claim 16 , wherein the at least one sequence of biphasic voltage pulses are applied to the selected anode-cathode pairs of electrodes during a pre-specified interval of the cardiac cycle of the heart of the patient.

18 . The method of claim 13 , wherein the at least one amplitude is between about 1 kV and about 2 kV.

Assignments (3)

Continuity (6)

References Cited (400)