IP Library › Granted Patent US 12,496,128
Granted Patent B2
US 12,496,128 · App. 18/674,533 · Granted Dec 16, 2025

Methods and apparatus for selective tissue ablation

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
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Quick Facts
Patent No.
US 12,496,128
App. No.
18/674,533
Granted
Dec 16, 2025
Kind
B2
Abstract

Catheter systems and methods for the selective and rapid application of DC voltage to drive irreversible electroporation are disclosed herein. In some embodiments, an apparatus includes a voltage pulse generator and an electrode controller. The voltage pulse generator is configured to produce a pulsed voltage waveform. The electrode controller is configured to be operably coupled to the voltage pulse generator and a medical device including a series of electrodes. The electrode controller includes a selection module and a pulse delivery module. The selection module is configured to select a subset of electrodes from the series of electrodes. The selection module is configured identify at least one electrode as an anode and at least one electrode as a cathode. The pulse delivery module is configured to deliver an output signal associated with the pulsed voltage waveform to the subset of electrodes.

Claims (35)

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

a catheter comprising an elongate member defining a proximal end and a distal end and a plurality of electrodes disposed at the distal end;

wherein the plurality of electrodes are configured to be 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;

an electroporation system configured for 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, wherein the graphical icons indicate the electrodes of the plurality of electrodes to be used for ablation;

wherein the electroporation system is configured to determine an impedance across each of a plurality of pairs of anode-cathode electrodes of the plurality of electrodes and to select the anode-cathode pairs of electrodes from the plurality of electrodes having a respective impedance less than about 300 Ohms;

wherein the generator is configured to generate 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;

wherein the electroporation system is configured to rule out for ablation pairs of anode-cathode electrodes of the plurality of electrodes having a respective impedance greater than about 300 Ohms and to apply the at least one sequence of biphasic voltage pulses to the selected 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.

2 . The system of claim 1 , wherein the user interface is configured to receive a selection of one or more electrodes to be used for ablation.

3 . The system of claim 2 , wherein the user interface comprises a touchscreen and is configured to display graphical buttons on the touchscreen.

4 . The system of claim 2 , wherein the user interface is configured to receive a selection of the pairs of anode-cathode electrodes from the plurality of electrodes.

5 . The system of claim 1 , wherein the user interface is configured to display a waveform of the at least one sequence of voltage pulses.

6 . The system of claim 1 , wherein the user interface is configured to generate an impedance map based on voltage and current readings across the pairs of anode-cathode electrodes of the plurality of electrodes.

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

a catheter comprising an elongate member defining a proximal end and a distal end, the catheter further comprising a slidable first member and a second member carrying a 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;

an electroporation system configured for 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 to be used for ablation;

wherein the electroporation system is configured to determine an impedance across each of a plurality of pairs of anode-cathode electrodes of the plurality of electrodes;

wherein the generator is configured to generate 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;

wherein the electroporation system is configured to automatically select for ablation one or more pairs of anode-cathode electrodes of the plurality of electrodes at which the impedance is less than about 300 Ohms and to apply the at least one sequence of biphasic voltage pulses to the selected one or more 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, wherein anode-cathode pairs of electrodes from the plurality of electrodes having an impedance greater than about 300 Ohms are ruled out for ablation.

8 . The system of claim 7 , wherein the first member is configured to move relative to the distal end of the elongate member to cause 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.

9 . The system of claim 7 , wherein the electroporation system is configured to use all of the plurality of electrodes for ablation.

10 . The system of claim 7 , wherein the electroporation system is configured to use at least six of the plurality of electrodes for ablation.

11 . The system of claim 7 , wherein the plurality of electrodes includes at least nine electrodes.

12 . The system of claim 7 , wherein the user interface is configured to receive a selection of the set of electrodes to be used for ablation.

13 . The system of claim 12 , wherein the user interface is configured to receive a selection of a subset of electrodes that will not be used for ablation.

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

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

an electroporation system configured for 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;

wherein the electroporation system is configured to determine an impedance across each of a plurality of anode-cathode pairs of electrodes from the plurality of electrodes and to select the anode-cathode pairs of electrodes from the plurality of electrodes having a respective impedance less than or equal to 300 Ohms, wherein anode-cathode pairs of electrodes from the plurality of electrodes having a respective impedance greater than 300 Ohms are ruled out for ablation;

wherein the generator is configured to generate 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;

wherein the electroporation system is configured to apply 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.

15 . The system of claim 14 , wherein the active electrodes of the plurality of electrodes includes fewer than all of the plurality of electrodes.

16 . The system of claim 14 , wherein the user interface is configured to receive a selection of the active electrodes.

17 . The system of claim 14 , wherein the electroporation system is configured to synchronize the generator output with a cardiac cycle of the heart of the patient.

18 . The system of claim 17 , wherein the electroporation system is configured to apply the at least one sequence of biphasic voltage pulses to the selected anode-cathode pairs of electrodes during a pre-specified interval of the cardiac cycle of the heart of the patient.

19 . The system of claim 14 , wherein the at least one amplitude is between about 1 kV and about 2 kV.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 31, 2024
From: MICKELSEN, STEVEN R.
To: IOWA APPROACH, INC.
Reel/Frame 068139/0322 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 31, 2024
From: FARAPULSE, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 068139/0628 →
CHANGE OF NAME Recorded Jul 31, 2024
From: IOWA APPROACH, INC.
To: FARAPULSE, INC.
Reel/Frame 068204/0131 →
Continuity (6)
Continuation 17349299 · Jun 16, 2021
Continuation 15795062 · Oct 26, 2017
Continuation 15341512 · Nov 2, 2016
Continuation PCTUS2015029734 · May 7, 2015
Provisional Application 61996390 · May 7, 2014
Related Publication 20240315770A1 · Sep 26, 2024
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