IP Library Granted Patent US 12,702,433
Granted Patent B2
US 12,702,433 · App. 18/588,809 · Granted Aug 11, 2026

Intravascular lithotripsy systems, devices and methods

Inventors: J. Samuel Batchelder (Somers, NY); John R. Ballard (Waconia, MN); Robert D'Agostino (Minneapolis, MN); Michael P. Brenzel (St. Paul, MN); Jacob W. Staab (Apple Valley, MN)
Assignee: Cardiovascular Systems, Inc.
A61B17/225A61B2017/22001A61B2017/22051
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Quick Facts
Patent No.
US 12,702,433
App. No.
18/588,809
Filed
Feb 27, 2024
Granted
Aug 11, 2026
Kind
B2
Art Unit
3771
USPC
606/128
Abstract

Various embodiments of the systems, methods and devices are provided for breaking up calcified lesions in an anatomical conduit. More specifically, an electrical arc is generated between two spaced-apart electrodes disposed within a fluid-filled balloon, creating a subsonic pressure wave. In some embodiments, the electrodes comprise a plurality of points or extensions that allow the electrical arc to form at any one of the plurality of points to, among other things, extend the electrode life.

Claims (33)

1 . A method for delivering pressure waves to a calcified lesion comprising: advancing a catheter to a calcified lesion, wherein the catheter is in operative and electrical communication and connection with a voltage pulse generator, the method comprising:

providing an elongated carrier;

providing an inflatable balloon disposed near a distal end of the elongated carrier, and configured to be inflated with a fluid;

providing a pair of spaced-apart of electrodes operatively associated with the elongated carrier and within the inflatable balloon, wherein a distance between the spaced-apart pair of electrodes comprises a spark gap;

providing a processor operatively connected to the voltage pulse generator and comprising programmed instructions configured to control and operate the voltage pulse generator, the processor in operative communication with a voltage monitor and a current monitor;

actuating the voltage pulse generator to apply at least one voltage pulse with a voltage magnitude to the pair of spaced-apart electrodes to cause current to flow across the spark gap;

monitoring a voltage applied by the voltage pulse generator for each of the at least one voltage pulses; and

determining the voltage magnitude to be applied to the pair of spaced-apart electrodes for a subsequent voltage pulse based on the monitored voltage.

2 . The method of claim 1 , further comprising:

executing the programmed instructions of the processor to determine the voltage magnitude to be applied to the pair of spaced-apart electrodes for the subsequent voltage pulse based on the monitored voltage; and

generating the subsequent voltage pulse at the determined voltage magnitude.

3 . The method of claim 2 , further comprising terminating an electrical arc generated across the spark gap on a pulse-by-pulse basis.

4 . The method of claim 1 , further comprising terminating an electrical arc generated across the spark gap.

5 . The method of claim 1 , further comprising terminating the voltage applied by the voltage pulse generator.

6 . The method of claim 5 , further comprising terminating the voltage applied by the voltage pulse generator on a pulse-by-pulse basis.

7 . The method of claim 1 , further comprising generating a pressure wave that impacts at least part of the calcified lesion at subsonic speed.

8 . A method for delivering pressure waves to a calcified lesion comprising:

advancing a catheter to a calcified lesion, wherein the catheter is in operative and electrical communication and connection with a voltage pulse generator;

providing the catheter with an elongated carrier;

providing the catheter with an inflatable balloon disposed near a distal end of the elongated catheter, and configured to be inflated with a fluid;

providing a pair of spaced-apart of electrodes operatively connected with the elongate carrier and within the inflatable balloon, wherein a distance between the spaced-apart pair of electrodes comprises a spark gap;

providing a processor operatively connected to the voltage pulse generator and comprising programmed instructions configured to control and operate the voltage pulse generator, the processor in operative communication with a voltage monitor and a current monitor;

actuating the voltage pulse generator to apply at least one voltage pulse with a voltage magnitude to the pair of spaced-apart electrodes to cause a current to flow across the spark gap;

monitoring the current flowing between the pair of spaced apart electrodes for each of the at least one voltage pulses; and

determining the voltage magnitude to be applied to the pair of spaced-apart electrodes for a subsequent voltage pulse based on the monitored current.

9 . The method of claim 8 , further comprising:

executing the programmed instructions of the processor to determine the voltage magnitude to be applied to the pair of spaced-apart electrodes for the subsequent voltage pulse based on the monitored current; and

generating the subsequent voltage pulse at the determined voltage magnitude.

10 . The method of claim 9 , further comprising terminating an electrical arc generated across the spark gap on a pulse-by-pulse basis.

11 . The method of claim 8 , further comprising terminating an electrical arc generated across the spark gap.

12 . The method of claim 8 , further comprising terminating a voltage applied by the voltage pulse generator.

13 . The method of claim 12 , further comprising terminating a voltage applied by the voltage pulse generator on a pulse-by-pulse basis.

14 . The method of claim 8 , further comprising generating a pressure wave that impacts at least part of the calcified lesion at subsonic speed.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 10, 2024
From: NEXTERN INNOVATION, LLC
To: CARDIOVASCULAR SYSTEMS, INC.
Reel/Frame 069145/0202 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 23, 2024
From: BATCHELDER, SAM; BALLARD, JOHN R.; D'AGOSTINO, ROBERT; BRENZEL, MICHAEL P.; STAAB, JASON W.
To: NEXTERN INNOVATION, LLC
Reel/Frame 068661/0495 →
Continuity (4)
Continuation 17454668 · Nov 12, 2021
Continuation 17449883 · Oct 4, 2021
Provisional Application 63229737 · Aug 5, 2021
Related Publication 20240197350A1 · Jun 20, 2024
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