Granted Patent B2

US 12,661,136 · App. 17/454,667 · Granted Jun 23, 2026

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: Cardiovascular Systems, Inc.

A61B17/22022A61M25/104A61B2017/22001A61B2017/22005A61B2017/22025A61B2017/22051A61M2025/109A61M2205/0233

Abstract

Claims (23)

1 . A method for monitoring progress of an intravascular balloon lithotripsy procedure that directs energy toward a lesion comprising at least one calcified region and located within a blood vessel, the method comprising:

providing an elongate member, a fluid inflatable balloon surrounding a portion of the elongate member, and at least one pair of spaced-apart electrodes located along the elongate member and within an interior of the fluid inflatable balloon, the at least one pair of spaced-apart electrodes defining at least one spark gap;

providing a voltage pulse generator operatively connected with the at least one spaced-apart electrode pair;

providing a controller in operative communication with the voltage pulse generator and comprising a processor and a memory, the processor configured to execute programmed instructions;

initiating a plurality of voltage pulses with the voltage pulse generator;

positioning the fluid inflatable balloon proximate the lesion and inflating the fluid inflatable balloon with fluid to a predetermined pressure, wherein the fluid comprises a resistance and/or an impedance;

applying an initiated voltage pulse of the plurality of voltage pulses to each one of the at least one spaced-apart electrode pairs;

generating a plurality of electrical arcs between the electrodes of each one of the at least one pair of spaced-apart electrodes;

monitoring the resistance and/or impedance of the fluid within the fluid inflatable balloon and measuring a change in the resistance and/or impedance of the fluid before the generating of the plurality of electrical arcs; and

measuring the change in resistance and/or impedance of the fluid during the generating of the plurality of electrical arcs,

wherein the measured change in resistance and/or impedance of the fluid corresponds with an expansion of the fluid inflatable balloon.

2 . The method of claim 1 , further comprising monitoring the resistance and/or impedance in the fluid proximate at least one of the plurality of pairs of spaced-apart electrodes.

3 . The method of claim 1 , further comprising measuring a decrease in the resistance and/or impedance of the fluid during the expansion.

4 . The method of claim 3 , wherein a decrease in the resistance and/or impedance of the fluid corresponds with the expansion of the fluid inflatable balloon.

5 . The method of claim 4 , wherein the expansion of the fluid inflatable balloon corresponds with progress of the lithotripsy procedure in cracking one or more calcified regions of the lesion.

6 . The method of claim 5 , further comprising providing an alert for the progress of the lithotripsy procedure.

7 . The method of claim 6 , further comprising determining when the lithotripsy procedure is sufficiently complete based on the measured resistance and/or impedance of the fluid during the generating of the plurality of electrical arcs.

8 . The method of claim 7 , further comprising providing an alert that the lithotripsy procedure is sufficiently complete.

9 . The method of claim 7 , further comprising:

comparing the resistance and/or impedance of the fluid before generating the plurality of electrical arcs with the measured resistance and/or impedance of the fluid during the generating of the plurality of arcs;

monitoring the progress of the lithotripsy procedure based on the comparison;

determining when the lithotripsy procedure is sufficiently complete based on the comparison; and

providing an alert that the lithotripsy procedure is sufficiently complete.

Assignments (2)

Continuity (3)

References Cited (400)