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US 12,622,718 B2Granted
Intravascular lithoplasty balloon systems, devices and methods
AssigneeCardiovascular Systems, Inc.
InventorsJ. Samuel Batchelder, John R. Ballard, Michael P. Brenzel, Alexander P. Thome
Life of this patent
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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 flow and pressure waves. In some embodiments, the electrodes are spaced apart across relatively long distances to create a stronger shock. In some embodiments, the saline ionically conducting between the electrodes is confined to reduce parasitic heating. In some embodiments, the balloon is partially deflated during arc generation.
Claims32
An intravascular lithotripsy system comprising:
- an elongate member defining a lumen;
- a first set of two spaced-apart electrodes with a gap therebetween attached to the elongate member;
- a voltage pulse generator in electrical communication with the first set of two spaced-apart electrodes;
- an inflatable sleeve surrounding the at least one of the two spaced-apart electrodes and comprising a proximal end, a distal end, at least one inflated volume and at least one inflated diameter, the proximal end and the distal end of the sleeve both operatively attached to the elongate member, the inflatable sleeve being configured to be inflated with a fluid;
- an inflatable balloon that is configured to surround the inflatable sleeve, wherein the inflatable balloon is configured to be inflated with the fluid and comprising at least one inflated volume, wherein an inflated volume of the inflatable balloon comprises a volume that is at least two times greater than the at least one inflated volume of the inflatable sleeve that is surrounded by the balloon, wherein the inflatable sleeve is surrounded by the fluid within the inflatable balloon;
- and
- a fluid reservoir comprising the fluid and in fluid communication with an interior of the inflatable sleeve, wherein the interior of the inflatable sleeve is in fluid communication with the fluid within the inflated balloon and is configured to be inflated by passive or diffusive inflation with fluid from within the inflatable balloon, or by active inflation with the fluid from the fluid reservoir.
4 more elements
An intravascular lithotripsy system comprising:
- an elongate member defining a lumen;
- two spaced-apart electrodes configured to be in electrical communication with a voltage pulse generator that is configured to apply voltage to one of the two spaced-apart electrodes and generate an arc therebetween, the arc launching a shock wave with a high peak wave pressure and a low tensile wave pressure and maximize electrical energy expended when the arc is initiated;
- a first fluid fillable member surrounding the two spaced-apart electrodes, the first fluid fillable member comprising a proximal end and a distal end, wherein the proximal end and the distal end is sealed to an outer surface of the elongate member, configured such that a fluid within the first fluid fillable member in an inflated configuration is constrained to a channel surrounding the two spaced-apart electrodes;
- and
- a fluid reservoir in fluid communication with an interior of the first fluid fillable member.
2 more elements
An intravascular lithotripsy system comprising:
- an elongate member defining a lumen;
- two spaced-apart electrodes attached to the elongate member and configured to electrically communicate with a voltage pulse generator;
- wherein the voltage pulse generator is configured to apply voltage to one of the two spaced-apart electrodes and generate an arc therebetween that launches a shockwave with a high peak wave pressure and a low tensile wave pressure and maximize electrical energy expended when the arc is initiated;
- an inflatable balloon surrounding the two spaced-apart electrodes, the inflatable balloon sealed to the elongate member to form an interior;
- and
- a fluid reservoir in fluid communication with the interior of the inflatable balloon,
- wherein the inflatable balloon is deflated to a deflated configuration configured to constrain the fluid within the interior of the balloon to a narrow channel of fluid around the two spaced-apart electrodes before application of voltage to one of the two spaced-apart electrodes and maintained in the deflated configuration as the arc is generated,
- wherein the balloon's position is constrained such that the deflated configuration of the balloon is distanced from the arc generated between the spaced-apart electrodes.
5 more elements
An intravascular lithotripsy device, comprising:
- an elongate member defining a lumen;
- a pressure wave generator attached to the elongate member comprising a wire and a ring electrode, wherein the pressure wave generator is configured for electrical communication with a voltage pulse generator that is configured to apply voltage to one of the wire and the ring and generate an arc therebetween, the arc launching a shockwave with a high peak wave pressure and a low tensile wave pressure and maximize electrical energy expended when the arc is initiated;
- and
- a fluid-fillable enclosure surrounding the pressure wave generator, wherein the fluid-fillable enclosure is configured for fluid communication with a fluid reservoir,
- wherein when the fluid-fillable enclosure is in a fluid-filled configuration, the fluid-fillable enclosure is configured such that fluid within the fluid-fillable enclosure at least partially fills a gap between the wire and the ring electrode, and
- when the fluid-fillable enclosure is in the fluid-filled configuration, the fluid-fillable enclosure is at least partially disposed against an outer surface of the ring electrode.
3 more elements
Dependencies are inferred from the claim text.