Cardiovascular Systems, Inc.

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.

A pressure wave generating catheter system includes a catheter and a plurality of electrodes disposed within in the catheter. A fluid-fillable balloon encloses the plurality of electrodes. A pulse generator is coupled in electrical communication with the plurality of electrodes in the catheter. The pulse generator is configured to for a given cycle, cause a first voltage pulse to be applied to at least a portion of the plurality of electrodes in the catheter, after which a second voltage pulse is applied to at least a portion of the plurality of electrodes in the catheter, the first voltage pulse causing an initial pressure wave, and wherein the second voltage pulse occurs prior to the initial pressure wave resulting from the first voltage pulse dissipating.

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.

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.

A catheter system for treating calcific lesions in a patient is disclosed. The system includes an elongated carrier defining a guidewire passageway and an expandable balloon disposed at a distal region of the carrier. The balloon is configured to receive an inflation fluid and encloses a plurality of electrodes arranged to define at least ten electrode gaps capable of electrical arcing. One or more pulse generators are configured to deliver voltage pulses to the electrodes to generate electrical arcs across multiple electrode gaps, thereby producing pressure waves within the fluid. The pressure waves propagate through the balloon and interact with a calcific lesion. The timing of the voltage pulses and the spacing of the electrodes are selected to cause interference between at least two of the pressure waves, enhancing interaction with the lesion.

An intravascular lithotripsy (IVL) console is disclosed, comprising a power plug configured to couple to a mains power source, with the power plug extending outside an enclosure housing internal console circuitry. The console includes conductors coupled to the power plug and a first isolation barrier that electrically isolates power from the mains power source. The internal console circuitry includes low-voltage control circuitry and high-voltage power circuitry, which generates high-voltage pulses for emitters in a catheter. A second isolation barrier couples a first processor in the low-voltage control circuitry to a second processor in the high-voltage power circuitry. The second processor receives commands from the first processor and causes the high-voltage power circuitry to deliver high-voltage pulses to the emitters. The isolation barriers allow the power plug to supply power while the high-voltage power circuitry delivers pulses to the emitters.

A device for creating a pilot hole through lesions in body passageways including an elongated flexible drive shaft advanceable over a guide wire, the drive shaft having a proximal end and a distal end, and a piloting head fixedly attached to at least a portion of the distal end of the driveshaft, wherein the piloting head comprises a distal end having a first diameter, a proximal end having a second diameter that is larger than the first diameter, and an intermediate shoulder area comprising a third diameter that is larger than the first and second diameters, wherein the intermediate shoulder area comprises a radiused crest having a backside area having an abrasive coating, and wherein the diameter of the piloting head tapers down at a generally constant angle from the intermediate shoulder area to the proximal end of the piloting head.

Various embodiments of the systems, methods, and devices are provided for controlled operation of an intravascular lithotripsy system for breaking up calcified lesions in an anatomical conduit. More specifically, control arrangements are disclosed concerning managing and/or providing electrical energy to generate an electrical arc between a set of spaced-apart electrodes disposed within a fluid-filled member configured to contain a conductive fluid.

Various embodiments of the systems, methods and devices are provided comprising angioplasty to break up calcification or other tissue in occlusive areas within a blood vessel. The various embodiments disclosed comprise pressure pulse periods designed to break up calcified occlusive material through a cyclically stretching of the vessel walls without damaging the vessel wall tissue.

A device may include an elongate member; a fluid-fillable enclosure formed of a material and surrounding a distal region of the elongate member; at least one pair of spaced-apart electrodes operatively associated with the elongate member and within the fluid-fillable enclosure. Each pair of the at least one pair of spaced-apart electrodes form a spark gap. A voltage pulse generator is in operative electrical communication and association with the at least one pair of spaced-apart electrodes. A controller in operative association with the voltage pulse generator and configured to control the voltage pulse generator. The device is configured to produce a plurality of electrical arcs across the at least one pair of spaced-apart electrodes, each of the plurality of electrical arcs being produced in response to a voltage pulse provided by the voltage pulse generator. The device is further configured to generate at least one non-arcing voltage pulse.