Granted Patent B2

US 12,551,274 · App. 18/674,511 · Granted Feb 17, 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 (32)

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

positioning proximate the cardiac tissue a 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 via one or more leads extending within the catheter, the electroporation system comprising a generator;

selecting, via a user interface of the electroporation system, a first subset of anode-cathode electrodes and a second subset of anode-cathode electrodes from the plurality of electrodes;

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;

applying, via the electroporation system, the at least one sequence of biphasic voltage pulses to the first subset of anode-cathode electrodes and to the second subset of anode-cathode 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, wherein the at least one amplitude is a progressively changing amplitude such that the amplitude of the at least one sequence of biphasic voltage pulses applied to the second subset of anode-cathode electrodes is greater than the amplitude of the at least one sequence of biphasic voltage pulses applied to the first subset of anode-cathode electrodes.

2 . The method of claim 1 , wherein the catheter further comprises a guidewire extending within the elongate member.

3 . The method of claim 1 , further comprising synchronizing the generator output with either a paced stimulus applied to the cardiac tissue or to an external trigger signal.

4 . The method of claim 3 , wherein the at least one sequence of biphasic voltage pulses are applied to the first subset of anode-cathode electrodes and the second subset of anode-cathode electrodes during a pre-specified interval from the paced stimulus or the external trigger signal.

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

advancing toward the cardiac tissue a catheter comprising an elongate member defining a proximal end and a distal end, the catheter comprising at least a first electrode, a second electrode, a third electrode, a fourth electrode, a fifth electrode, and a sixth electrode, wherein the third electrode and the fourth electrode are disposed between the second electrode and the fifth electrode;

connecting an electroporation system in electrical communication with the the first electrode, the second electrode, the third electrode, the fourth electrode, the fifth electrode, and the sixth electrode, the electroporation system comprising a generator;

selecting, via a user interface of the electroporation system, the first electrode and the second electrode as anode-cathode electrodes;

selecting, via the user interface of the electroporation system, the fifth electrode and the sixth electrode as anode-cathode electrodes;

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;

applying, via the electroporation system, the at least one sequence of biphasic voltage pulses simultaneously to the first electrode and the second electrode and to the fifth electrode and the sixth electrode while the third electrode and the fourth electrode are inactive 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.

6 . The method of claim 5 , further comprising selecting, via the user interface of the electroporation system, the third electrode and the fourth electrode as anode-cathode electrodes.

7 . The method of claim 6 , further comprising generating a second 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 second sequence of biphasic voltage pulses to the third electrode and fourth electrode 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.

8 . The method of claim 6 , further comprising applying, via the electroporation system, the at least one sequence of biphasic voltage pulses to the third electrode and the fourth electrode.

9 . The method of claim 5 , wherein the at least one amplitude is between about 1 kV and about 2 kV.

10 . The method of claim 5 , wherein the electroporation system is capable of synchronizing the generator output with a cardiac cycle of the heart of the patient.

11 . The method of claim 10 , wherein the at least one sequence of biphasic voltage pulses are applied to the first and the second electrodes and to the fifth and the sixth electrodes during a pre-specified interval of the cardiac cycle of the heart of the patient.

12 . The method of claim 11 , wherein the cardiac cycle of the heart of the patient comprises a QRS interval and a QT interval, and wherein the pre-specified interval is between the QRS interval and the QT interval.

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

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

electrically connecting a generator with the plurality of electrodes, the generator configured to generate a first 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 a second sequence of biphasic voltage pulses having at least one amplitude, the at least one amplitude between about 0.5 kV to about 10 kV;

wherein an electrode controller is operably coupled with the generator, the electrode controller including a pulse delivery module;

selecting a first subset of anode-cathode electrodes from the plurality of electrodes and a second subset of anode-cathode electrodes from the plurality of electrodes, wherein the second subset of anode-cathode electrodes differs from the first subset of anode-cathode electrodes;

simultaneously applying, via the pulse delivery module, the first sequence of biphasic voltage pulses to the first subset of anode-cathode electrodes and the second sequence of biphasic voltage pulses to the second subset of anode-cathode electrodes.

14 . The method of claim 13 , wherein the plurality of electrodes are movable 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.

15 . The method of claim 13 , wherein the plurality of electrodes comprises five or more electrodes and wherein first subset of anode-cathode electrodes and the second subset of anode-cathode electrodes respectively consist of two electrodes.

16 . The method of claim 13 , further comprising selecting a third subset of anode-cathode electrodes from the plurality of electrodes, wherein the third subset of anode-cathode electrodes differs from the second subset of anode-cathode electrodes and from the first subset of anode-cathode electrodes.

Assignments (3)

Continuity (6)

References Cited (400)