IP Library Granted Patent US 11,877,761
Granted Patent B2
US 11,877,761 · App. 17/454,721 · Granted Jan 23, 2024

Systems, devices and methods for monitoring voltage and current and controlling voltage of voltage pulse generators

Inventors: Sam Batchelder (Somers, NY); John R. Ballard (Waconia, MN); Robert D'Agostino (Minneapolis, MN); Michael P. Brenzel (St. Paul, MN); Jason W. Staab (Apple Valley, MN)
Assignee: Nextern Innovation, LLC
A61B17/22022A61B2017/22001A61B2017/22025A61B2017/22062
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Quick Facts
Patent No.
US 11,877,761
App. No.
17/454,721
Granted
Jan 23, 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 that allow the electrical arc to form at any one of the plurality of points to, among other things, extend the electrode life.

Claims (38)

1. A balloon catheter comprising:

an elongated carrier;

a flexible balloon 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 proximal electrode disposed along the elongated carrier and a distal electrode disposed along the elongated carrier and spaced an axial distance from the proximal electrode, the axial distance therebetween comprising a spark gap;

a pulse generator in electrical communication with the proximal electrode and the distal electrode; and

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,

wherein application of voltage pulse with an applied voltage magnitude from the pulse generator to one of the proximal electrode and the distal electrode is configured to generate current flow and an electrical arc through the conductive fluid across the spark gap,

wherein the voltage monitor is configured to monitor the voltage applied to one of the proximal electrode and distal electrode,

wherein the current monitor is configured to monitor the current flowing across the spark gap, and

wherein the processor is configured to determine the magnitude of voltage to be applied as the next voltage pulse based on the monitored voltage and the monitored current.

2. The balloon catheter of claim 1 , wherein the processor is configured to terminate the voltage applied by the pulse generator.

3. The balloon catheter of claim 2 , wherein the processor is configured to terminate the voltage applied by the pulse generator on a pulse-by-pulse basis.

4. The balloon catheter of claim 1 , wherein the processor is configured to terminate the generated electrical arc.

5. The balloon catheter of claim 4 , wherein the processor is configured to terminate the generated electrical arc on a pulse-by-pulse basis.

6. The balloon catheter of claim 1 , wherein the electrical arc generates a pressure wave that travels through the conductive fluid at subsonic speed.

7. The balloon catheter of claim 6 , wherein the pressure wave travels through the balloon at subsonic speed.

8. A method for delivering subsonic pressure waves to a calcified lesion comprising: advancing a balloon catheter to a calcified lesion, wherein the balloon catheter comprises:

an elongated carrier;

a flexible balloon disposed near a distal end of the elongated catheter, wherein a distal end of the angioplasty balloon is sealed against the elongated catheter,

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

a proximal electrode disposed along the elongated carrier and a distal electrode disposed along the elongated carrier and spaced an axial distance from the proximal electrode, the axial distance therebetween comprising a spark gap;

a pulse generator in electrical communication with the proximal electrode and the distal electrode; and

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;

actuating the pulse generator to apply at least one voltage pulse with a voltage magnitude to the proximal electrode or the distal electrode to cause current to flow between the proximal electrode and the distal electrode;

generating a pressure wave within the conductive fluid;

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

monitoring the current flowing between the proximal electrode and the distal electrode for each of the at least one voltage pulses; and

determining the voltage magnitude to be applied for the next voltage pulse based on the monitored voltage and 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 for the next voltage pulse based on the monitored voltage and monitored current.

10. The balloon catheter of claim 9 , further comprising terminating the generated electrical arc on a pulse-by-pulse basis.

11. The method of claim 8 , further comprising terminating a generated electrical arc.

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

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

14. The method of claim 8 , further comprising generating a pressure wave that travels through the conductive fluid at subsonic speed.

15. The method of claim 8 , further comprising generating a pressure wave that travels through the balloon at subsonic speed.

16. The method of claim 15 , further comprising generating a pressure wave that travels toward the calcified lesion at subsonic speed.

17. The method of claim 16 , further comprising generating a pressure wave that impacts 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 Aug 7, 2023
From: BATCHELDER, SAM; BALLARD, JOHN R.; D'AGOSTINO, ROBERT; BRENZEL, MICHAEL P.; STAAB, JASON W.
To: NEXTERN INNOVATION, LLC
Reel/Frame 064508/0731 →
Continuity (3)
Continuation 17449883 · Oct 4, 2021
Provisional Application 63229737 · Aug 5, 2021
Related Publication 20230041407A1 · Feb 9, 2023