Cardiovascular Systems, Inc.

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.

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.

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.

An intravascular lithotripsy device, comprising: (i) a first wire conductor operatively connectable to a voltage pulse generator, wherein the first wire conductor comprises a first exposed wire portion comprising that forms a first electrode for at least one pair of spaced-apart electrodes; and (ii) a support member, comprising a body comprising conductive material that is partially covered by insulating material, wherein the body defines a first cutout and a first channel in communication with the first cutout, wherein the first cutout defines a second electrode for the at least one pair of spaced-apart electrodes, wherein the first wire conductor is received and secured by the first channel such that the first wire conductor extends along the support member and the first cutout and such that the first electrode is spaced apart from the second electrode to form an arc generating region between the first electrode and the second electrode.

A catheter and segmented balloon system for a lithotripsy system having improved accommodation for curved configurations, which minimizes or prevents damage to the balloon during generation of the lithotripsy shock wave (e.g., resulting from electrical arcing of electrode pairs or use of a laser). Embodiments of the catheter include an elongate member with alternating flexibility regions wherein stiffer regions are configured to support at least one lithotripsy emitter, and wherein more flexible regions are disposed on either side of each stiffer region. This configuration minimizes risk that the section with the lithotripsy emitter(s), will tend to bend in a manner that positions the emitter close to the balloon wall. Embodiments of the segmented balloon system include balloon segments with interposed sections between each of the segmented balloons wherein the outer diameter of an inflated balloon segment is larger than the outer diameter of the interposed section.

Embodiments of the disclosed microcatheters comprise an inner tube that extends from a distal tip to a proximal hub. One embodiment of a microcatheter comprises a first inner coil wound around a length of the inner tube, a second middle coil wound around the first coil and in a different winding direction or lay than the winding direction or lay of the first coil, and a third outer coil wound around a proximal portion of the second coil and in a different winding direction or lay than the winding direction or lay of the second coil. In one disclosed embodiment, the first, second and third coils include distal ends that terminate distally together at a common location that is spaced proximally from the distal tip. Gaps in one or more of the first, second or third coils may be provided between groups or sections of wire filars forming the coils to improve flexibility while maintaining sufficient axial force transmission and torque capabilities.