IP Library Granted Patent US 11,896,248
Granted Patent B2
US 11,896,248 · App. 17/454,587 · Granted Feb 13, 2024

Systems, devices and methods for generating subsonic pressure waves in intravascular lithotripsy

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
A61B17/22A61M25/104A61B2017/22001A61B2017/22051A61M2025/109A61M2205/0233
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Quick Facts
Patent No.
US 11,896,248
App. No.
17/454,587
Granted
Feb 13, 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 (52)

1. A balloon catheter comprising:

an elongated carrier;

an angioplasty balloon comprising a material and disposed near a distal end of the elongated carrier, wherein a distal end of the angioplasty balloon is sealed against the elongated carrier, 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 a conductive fluid;

a pressure wave generator configured to generate subsonic pressure waves disposed along the elongated carrier and within the interior region of the balloon and comprising a proximal ring electrode and a distal ring electrode spaced an axial distance from the proximal ring electrode, the axial distance therebetween comprising a spark gap; and

a pulse generator in electrical communication with the proximal ring electrode,

wherein application of a voltage pulse from the pulse generator to the proximal ring electrode is configured to generate at least one electrical arc between the proximal ring electrode and the distal ring electrode across the spark gap and through the conductive fluid, and generation of subsonic pressure waves that pass through the conductive fluid and balloon material at subsonic speed,

wherein the proximal ring electrode comprises

a front surface and a rear surface, wherein the front surface comprises a plurality of spaced-apart extensions extending away from the front surface and toward the distal ring electrode,

wherein the plurality of spaced-apart extensions are arranged circumferentially spaced-apart around at least part of the front surface of the proximal ring electrode,

wherein the plurality of spaced-apart extensions are configured to preferentially select one spaced-apart extension to generate the at least one electrical arc across the spark gap wherein the preferentially selected spaced-apart extension comprises a length that is longer than the length of any one of the remaining plurality of spaced-apart extensions.

2. The balloon catheter of claim 1 , wherein the preferentially selected spaced-apart extension of the proximal ring electrode is configured to initiate generation of the at least one electrical arc across the spark gap.

3. The balloon catheter of claim 1 , wherein the preferentially selected spaced-apart extension of the proximal ring electrode is configured to receive the at least one electrical arc, wherein the at least one electrical arc is initiated from the distal ring electrode.

4. A balloon catheter comprising:

an elongated carrier;

an angioplasty balloon comprising a material and disposed near a distal end of the elongated carrier, wherein a distal end of the angioplasty balloon is sealed against the elongated carrier, 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 a conductive fluid;

a proximal ring electrode and a distal ring electrode spaced an axial distance from the proximal ring electrode, the axial distance therebetween comprising a spark gap; and

a pulse generator in electrical communication with the proximal ring electrode,

wherein application of a voltage pulse from the pulse generator to the proximal ring electrode is configured to generate at least one electrical arc between the proximal ring electrode and the distal ring electrode across the spark gap and through the conductive fluid, and generation of subsonic pressure waves that pass through the conductive fluid and balloon material at subsonic speed,

wherein the distal ring electrode comprises

a front surface and a rear surface, wherein the front surface comprises a plurality of spaced-apart extensions extending away from the front surface and toward the proximal ring electrode,

wherein the plurality of spaced-apart extensions are arranged circumferentially spaced-apart around at least part of the front surface of the distal ring electrode,

wherein the plurality of spaced-apart extensions are configured to preferentially select one spaced-apart extension in the plurality of spaced-apart extensions to generate the at least one electrical arc between the proximal ring electrode and the distal ring electrode, wherein the preferentially selected spaced-apart extension of the distal ring electrode comprises a length that is longer than the length of any one of the remaining plurality of spaced-apart extensions of the distal ring electrode.

5. The balloon catheter of claim 4 , wherein the preferentially selected spaced-apart extension of the distal ring electrode is configured to initiate generation of the at least one electrical arc across the spark gap, wherein the proximal ring electrode is configured to receive the at least one electrical arc.

6. The balloon catheter of claim 4 , wherein the preferentially selected spaced-apart extension of the distal ring electrode is configured to receive the at least one generated electrical arc, wherein the at least one electrical arc is initiated by the proximal ring electrode.

7. A balloon catheter comprising:

an elongated carrier;

an angioplasty balloon comprising a material and disposed near a distal end of the elongated carrier, wherein a distal end of the angioplasty balloon is sealed against the elongated carrier, 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 a conductive fluid;

a proximal ring electrode and a distal ring electrode spaced an axial distance from the proximal ring electrode, the axial distance therebetween comprising a spark gap; and

a pulse generator in electrical communication with the proximal ring electrode,

wherein application of a voltage pulse from the pulse generator to the proximal ring electrode is configured to generate at least one electrical arc between the proximal ring electrode and the distal ring electrode across the spark gap and through the conductive fluid, and generation of subsonic pressure waves that pass through the conductive fluid and balloon material at subsonic speed,

wherein the distal ring electrode and the proximal ring electrode each comprise

a front surface and a rear surface, wherein the front surfaces of the distal ring electrode and the proximal ring electrode each comprise a plurality of spaced-apart extensions extending away from the front surface and toward the spark gap,

wherein the plurality of spaced-apart extensions are arranged circumferentially spaced-apart around at least part of the front surface of the proximal ring electrode and the distal ring electrode,

wherein the plurality of spaced-apart extensions of the proximal ring electrode are configured to preferentially select one spaced-apart extension in the plurality of spaced-apart extensions of the proximal ring electrode to generate the at least one electrical arc, wherein the preferentially selected spaced-apart extension comprises a length that is longer than the length of any one of the remaining plurality of spaced-apart extensions of the proximal ring electrode.

8. The balloon catheter of claim 7 , wherein the preferentially selected spaced-apart extension of the proximal ring electrode is configured to initiate the at least one electrical electrical arc, wherein the at least one generated arc is received by the distal ring electrode.

9. The balloon catheter of claim 7 , wherein the preferentially selected spaced-apart extension of the proximal ring electrode is configured to receive the at least one electrical electrical arc, wherein the at least one generated electrical arc is initiated at the distal ring electrode.

10. A balloon catheter comprising:

an elongated carrier;

an angioplasty balloon comprising a material and disposed near a distal end of the elongated carrier, wherein a distal end of the angioplasty balloon is sealed against the elongated carrier, 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 a conductive fluid;

a pressure wave generator configured to generate subsonic pressure waves and disposed along the elongated carrier and within the interior region of the balloon and comprising a proximal ring electrode and a distal ring electrode spaced an axial distance from the proximal ring electrode, the axial distance therebetween comprising a spark gap; and

a pulse generator in electrical communication with the proximal ring electrode,

wherein application of a voltage pulse from the pulse generator to the proximal ring electrode is configured to generate at least one electrical arc between the proximal ring electrode and the distal ring electrode across the spark gap and through the conductive fluid, and generation of subsonic pressure waves that pass through the conductive fluid and balloon material at subsonic speed,

wherein the distal ring electrode and the proximal ring electrode each comprise

a front surface and a rear surface, wherein the front surface comprises a plurality of spaced-apart extensions extending away from the front surface and toward the spark gap,

wherein the plurality of spaced-apart extensions are arranged circumferentially spaced-apart around at least part of the front surface of the proximal ring electrode and the distal ring electrode,

wherein the plurality of spaced-apart extensions of the distal ring electrode are configured to preferentially select one spaced-apart extension in the plurality of spaced-apart extensions of the distal ring electrode to generate the at least one electrical arc, wherein the preferentially selected spaced-apart extension of the distal ring electrode comprises a length that is longer than the length of any one of the remaining plurality of spaced-apart extensions of the distal ring electrode.

11. The balloon catheter of claim 10 , wherein the preferentially selected spaced-apart extension of the distal ring electrode is configured to initiate the at least one electrical arc, wherein the at least one generated electrical arc is received by the proximal ring electrode.

12. The balloon catheter of claim 10 , wherein the preferentially selected spaced-apart extension of the distal ring electrode is configured to receive the at least one electrical arc, wherein the at least one generated electrical arc is initiated by the proximal ring electrode.

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 Oct 2, 2024
From: BATCHELDER, SAM; BALLARD, JOHN R.; D'AGOSTINO, ROBERT; BRENZEL, MICHAEL P.; STAAB, JASON W.
To: NEXTERN INNOVATION, LLC
Reel/Frame 068775/0011 →
Continuity (3)
Continuation 17449883 · Oct 4, 2021
Provisional Application 63229737 · Aug 5, 2021
Related Publication 20230037716A1 · Feb 9, 2023