IP Library Granted Patent US 11,426,573
Granted Patent B2
US 11,426,573 · App. 16/875,076 · Granted Aug 30, 2022

Catheters, catheter systems, and methods for puncturing through a tissue structure and ablating a tissue region

Inventor: Steven Richard Mickelsen (Iowa City, IA)
Assignee: University of Iowa Research Foundation
A61M39/10A61B5/0538A61B5/4833A61B18/1206A61B18/1492A61B34/73A61M25/0127A61M25/0169A61M25/0606A61M25/09A61B17/22004A61B18/02A61B18/1815A61B18/20A61B2017/00876A61B2018/0075A61B2018/00363A61B2018/00375A61B2018/00577A61B2018/00613A61B2018/00839A61B2018/126A61B2018/128A61B2018/1467A61B2034/731A61B2217/005A61B2218/002A61M2025/0089
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Quick Facts
Patent No.
US 11,426,573
App. No.
16/875,076
Granted
Aug 30, 2022
Kind
B2
Abstract

A percutaneous catheter system for use within the human body and an ablation catheter for ablating a selected tissue region within the body of a subject. The percutaneous catheter system can include two catheters that are operatively coupled to one another by magnetic coupling through a tissue structure. The ablation catheter can include electrodes positioned within a central portion. The ablation catheter is positioned such that the central portion of a flexible shaft at least partially surrounds the selected tissue region. Each electrode of the ablation catheter can be activated independently to apply ablative energy to the selected tissue region. The ablation catheter can employ high impedance structures to change the current density at specific points. Methods of puncturing through a tissue structure using the percutaneous catheter system are disclosed. Also disclosed are methods for ablating a selected tissue region using the ablation catheter.

Claims (30)

1. A method, comprising:

selecting, from a set of electrodes of a catheter, subsets of electrodes each including at least one first electrode configured to have a first polarity and at least one second electrode configured to have a second polarity opposite the first polarity, the catheter being positioned external to a heart of a subject such that a central portion of the catheter at least partially encircles left pulmonary veins and right pulmonary veins of the heart, the set of electrodes disposed on the central portion of the catheter;

generating, via a signal generator, a pulsed waveform; and

delivering the pulsed waveform to the subsets of electrodes along one or more current paths that each extend from at least one first electrode of a subset of electrodes through an endocardial space of the heart and to at least one second electrode of the subset of electrodes, such that the subsets of electrodes generate one or more electric fields that cause irreversible electroporation of tissue.

2. The method of claim 1 , wherein each of the one or more current paths extends from at least one first electrode of a subset of electrodes, through a first wall portion of a left atrium of the heart, through the endocardial space of the heart, through a second wall portion of the left atrium of the heart, and to at least one second electrode of the subset of electrodes.

3. The method of claim 2 , wherein the delivering the pulsed waveform causes irreversible electroporation of tissue in the first wall portion and the second wall portion of the left atrium to create a lesion.

4. The method of claim 2 , wherein the delivering the pulsed waveform causes irreversible electroporation of tissue in a portion of the left atrium to create a circumferential lesion in the wall of the left atrium without repositioning the catheter.

5. The method of claim 2 , wherein the delivering the pulsed waveform causes irreversible electroporation of tissue in a portion of the left atrium to create a lesion collectively around one or more of the left pulmonary veins and the right pulmonary veins formed in the left atrium.

6. The method of claim 1 , wherein the pulsed waveform includes a set of biphasic impulses.

7. The method of claim 1 , wherein the delivering the pulsed waveform includes delivering the pulsed waveform in synchronization with a cardiac cycle of the subject.

8. The method of claim 1 , further comprising monitoring a cardiac cycle of the subject, the delivering the pulsed waveform including delivering the pulsed waveform in synchronization with the cardiac cycle of the subject.

9. The method of claim 1 , further comprising monitoring a cardiac cycle of the subject using one or more electrodes of the set of electrodes, the delivering the pulsed waveform including delivering the pulsed waveform in synchronization with the cardiac cycle of the subject.

10. The method of claim 1 , wherein the pulsed waveform includes one or more current impulses, the delivering the pulsed waveform including delivering the one or more current impulses for every heartbeat of the subject.

11. The method of claim 1 , wherein the subsets of electrodes are first subsets of electrodes, the pulsed waveform is a first pulsed waveform, and the delivering the pulsed waveform causes irreversible electroporation of tissue in a first portion of the left atrium, the method further comprising:

delivering a second pulsed waveform to a second subset of electrodes to cause irreversible electroporation of tissue in a second portion of the left atrium without repositioning the catheter.

12. The method of claim 1 , further comprising:

surgically creating an opening in a body of the subject to permit passage of the catheter; and

positioning the catheter external to the heart of the subject prior to delivering the pulsed waveform.

13. The method of claim 1 , wherein the central portion of the catheter is positioned in a pericardial space of the heart.

14. A method, comprising:

identifying one or more intended current paths for delivering a pulsed waveform to a set of electrodes of a catheter, the catheter being positioned external to a heart of a subject such that a central portion of the catheter at least partially encircles left pulmonary veins and right pulmonary veins of the heart, the set of electrodes disposed on the central portion of the catheter, each of the one or more intended current paths extending through an endocardial space of the heart;

selecting, from the set of electrodes and based on the one or more intended current vectors, subsets of electrodes each including at least one first electrode configured to have a first polarity and at least one second electrode configured to have a second polarity opposite the first polarity;

generating, via a signal generator, a pulsed waveform; and

delivering the pulsed waveform to the subsets of electrodes along one or more current paths corresponding to the one or more intended current paths, such that the subsets of electrodes generate one or more electric fields that cause irreversible electroporation of tissue.

15. The method of claim 14 , wherein each of the one or more current paths extends from at least one first electrode of a subset of electrodes, through a first wall portion of a left atrium of the heart, through the endocardial space of the heart, through a second wall portion of the left atrium of the heart, and to at least one second electrode of the subset of electrodes.

16. The method of claim 15 , wherein the delivering the pulsed waveform causes irreversible electroporation of tissue in the first wall portion and the second wall portion of the left atrium to create a lesion.

17. The method of claim 15 , wherein the delivering the pulsed waveform causes irreversible electroporation of tissue in a portion of the left atrium to create a circumferential lesion in the wall of the left atrium without repositioning the catheter.

18. The method of claim 15 , wherein the delivering the pulsed waveform causes irreversible electroporation of tissue in a portion of the left atrium to create a lesion collectively around one or more of the left pulmonary veins and the right pulmonary veins formed in the left atrium.

19. The method of claim 14 , wherein the pulsed waveform includes a set of biphasic impulses.

20. The method of claim 14 , wherein the delivering the pulsed waveform includes delivering the pulsed waveform in synchronization with a cardiac cycle of the subject.

Assignments (3)
RELEASE OF SECURITY INTEREST Recorded Apr 4, 2025
From: BOSTON SCIENTIFIC SCIMED, INC,
To: FARAPULSE, INC.
Reel/Frame 070738/0228 →
SECURITY INTEREST Recorded Aug 25, 2020
From: FARAPULSE, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 053596/0364 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2020
From: MICKELSEN, STEVEN RICHARD
To: UNIVERSITY OF IOWA RESEARCH FOUNDATION
Reel/Frame 052679/0309 →
Continuity (5)
Continuation 15917194 · Mar 9, 2018
Continuation 15819726 · Nov 21, 2017
Continuation 14400455
Provisional Application 61681552 · Aug 9, 2012
Related Publication 20210031020A1 · Feb 4, 2021