IP Library Granted Patent US 11,957,369
Granted Patent B2
US 11,957,369 · App. 17/454,668 · Granted Apr 16, 2024

Intravascular lithotripsy systems and methods

Inventors: Sam Batchelder (Somers, NY); John R. Ballard (Waconia, MN); Robert D'Agostino (Minneapolis, MN); Michael P. Brenzel (St. Paul, MN); Jacon W. Staab (Apple Valley, MN)
Assignee: Nextern Innovation, LLC
A61B17/225A61B2017/22001A61B2017/22051
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Quick Facts
Patent No.
US 11,957,369
App. No.
17/454,668
Granted
Apr 16, 2024
Kind
B2
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 (26)

1. A method for disrupting occlusions within a blood vessel and cracking or disrupting calcifications within a wall of the blood vessel, comprising:

providing:

an elongated carrier;

an angioplasty balloon comprising a material and disposed near a distal end of the elongated catheter, wherein a distal end of the angioplasty balloon is sealed against the elongated catheter, the angioplasty balloon defining an interior region;

a fluid channel in fluid communication with the interior region of the angioplasty balloon and a conductive fluid reservoir, configured to inflate the balloon with the conductive fluid;

a first electrode pair comprising a first proximal electrode disposed along the elongated carrier within the interior region of the angioplasty balloon and a first distal electrode disposed along the elongated carrier within the interior region of the angioplasty balloon, the first distal electrode spaced axially from the first proximal electrode, wherein the axial spacing between the first proximal and first distal electrodes comprises a first spark gap;

a second electrode pair comprising a second proximal electrode disposed along the elongated carrier within the interior region of the angioplasty balloon and a second distal electrode disposed along the elongated carrier within the interior region of the angioplasty balloon, the second distal electrode spaced axially from the second proximal electrode disposed along the elongated carrier, within the interior region of the angioplasty balloon, wherein the axial spacing between the second proximal and second distal electrodes comprises a second spark gap;

ensuring that the first distal electrode is in operative electrical communication with the second proximal electrode,

providing a pulse generator in operative electrical communication with one of the first proximal electrode and the first distal electrode, the pulse generator configured to generate a plurality of voltage pulses to the first electrode pair;

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

applying a first voltage pulse from the pulse generator to one of the first proximal electrode and first distal electrode;

causing current to flow between the first proximal electrode and the first distal electrode;

generating a first electrical arc across the first spark gap through the conductive fluid;

causing current to flow between the first distal electrode and the second proximal electrode;

causing current to flow between the second proximal electrode and the second distal electrode; and

generating an second electrical arc across the second spark gap through the conductive fluid,

wherein the voltage monitor is configured to monitor the magnitude of a first voltage pulse applied to one of the first proximal electrode and the first distal electrode,

wherein the current monitor is configured to monitor the magnitude of current flowing between the first proximal electrode and the first distal electrode resulting from the first applied voltage pulse, and

wherein the processor is configured to determine the magnitude of voltage to be applied to one of the first proximal electrode and the first distal electrode for a second applied voltage pulse based on one or both of the magnitude of the monitored voltage and the magnitude of the monitored current of the first voltage pulse.

2. The method of claim 1 , further comprising:

connecting the first electrode pair and the second electrode pair in series.

3. The method of claim 1 , wherein the first spark gap is axially spaced from the second spark gap.

4. The method of claim 1 , further comprising providing the first spark gap with a length and providing the second spark gap with a length, wherein the first spark gap length and the second spark gap length are substantially equal to each other.

5. The method of claim 1 , further comprising providing the first spark gap with a length and providing the second spark gap with a length, wherein the length of one of the first spark gap and the second spark gap is greater than the length of the remaining spark gap.

6. The method of claim 1 , further comprising:

connecting the first electrode pair and the second electrode pair in parallel.

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 Aug 4, 2023
From: BATCHELDER, SAM; BALLARD, JOHN R.; D'AGOSTINO, ROBERT; BRENZEL, MICHAEL P.; STAAB, JASON W.
To: NEXTERN INNOVATION, LLC
Reel/Frame 064496/0879 →
Continuity (3)
Continuation 17449883 · Oct 4, 2021
Provisional Application 63229737 · Aug 5, 2021
Related Publication 20230038308A1 · Feb 9, 2023
Cited By (2)
US 12,714,449 US 12,714,450