SHOCKWAVE MEDICAL, INC.

The present disclosure provides a catheter for treating lesions in a body lumen, such as calcified lesions and occlusions in vasculature. The catheter can include a dual-layer electrode assembly having a first conductive sheath and a second conductive sheath arranged circumferentially therearound. In some implementations, a first conductive sheath can be a flat coil. When a voltage is applied across the conductive sheaths, current flows across an arcing region, for example, from the distal side edge of the first sheath to the distal side edge of the second sheath to produce shock waves and/or cavitation bubbles. As a treatment continues, the sheaths slowly erode at the arcing region where current flows between the sheaths. To increase the lifespan of the electrode assembly, the distal side edges of the sheaths may be shaped to promote erosion of the sheaths in a predetermined or semi-controlled pattern.

Disclosed herein are systems and methods for applying voltage(s) across electrodes of a shock wave catheter system. The electrodes in the shock wave catheter may be activated by using at least one packet comprising a plurality of sub-pulses. The plurality of sub-pulses within a packet may be delivered in rapid succession (e.g., with a frequency of 100 Hz-10 kHz, pulse width duration of 1 μs or shorter, and/or peak power of 250 kW or higher). The packets may be delivered in bursts with, e.g., a frequency of 1-4 Hz). The time between adjacent sub-pulses may be less than the time between adjacent packets. The sub-pulses may be delivered with a higher peak power (lower energy) compared to non-burst pulses. The voltages of the sub-pulses may be applied using a single- or multi-stage generator circuit. The shock wave catheter may be operated in burst mode operation and/or non-burst mode operation.

Shock wave catheters and methods of use thereof are disclosed herein for intravascular lithotripsy (IVL) and intravascular imaging of a body lumen. The shock wave catheter can include an elongate tube; a shock wave emitter mounted to a distal portion of the elongate tube, the shock wave emitter configured to emit shock waves for treating a lesion in a body lumen; a sensor for imaging the body lumen, the sensor mounted to the distal portion of the elongate tube distally of the shock wave emitter; and an enclosure sealed to the elongate tube and enclosing the shock wave emitter. The at least one sensor may be an ultrasound transducer for intravascular ultrasound (IVUS) imaging of the body lumen. Alternatively, the at least one sensor may be an optical coherence tomography (OCT) sensor for OCT imaging of the body lumen.

The present invention provides a catheter for treating an occlusion in a body lumen. The catheter includes an elongated tube, a first electrode pair and a second electrode pair each configured to generate shock waves. The catheter also includes a flexible polymer enclosure that is fillable with conductive fluid and wrapped circumferentially around at least a portion of the elongated tube such that it surrounds the first and second electrode pairs. The first and second electrode pairs can be arranged relative to one another to promote interference between shock waves generated at the electrode pairs when voltage is delivered across the electrodes of each pair. Electrode pairs can be longitudinally adjacent (spaced a relatively small longitudinal distance apart), longitudinally aligned (at the same longitudinal location), circumferentially offset (offset about the circumference of the catheter), circumferentially aligned (at the same circumferential location), or any combination of any of the above.

Provided herein are methods and systems for treating a target area of a body lumen using an intravascular lithotripsy catheter, the method comprising: receiving, at a computing system, patient-specific information for a patient that has the at least partially occluded body lumen; determining, by the computing system, at least one parameter of a treatment of the at least partially occluded body lumen with the intravascular lithotripsy catheter, wherein the at least one parameter is determined by processing the patient-specific information with at least one machine learning model; and displaying, by the computing system, guidance for treating the at least partially occluded body lumen with the intravascular lithotripsy catheter based on the at least one parameter, wherein treating the at least partially occluded body lumen with the intravascular lithotripsy catheter comprises the intravascular lithotripsy catheter generating at least one shock wave.

A catheter includes a catheter body; at least one shock wave emitter disposed on the catheter body; and a moveable shield extending at least partially around the catheter body and configured for translating along the catheter body. Exemplary catheters are configured to modify lesions, including fibrotic and calcified tissue buildup within the body.

A catheter for generating shock waves includes a first elongate member; at least one shock wave emitter carried by the first elongate member; and an expandable member configured to move the at least one shock wave emitter laterally toward a lesion.

A method of facilitating pacemaker lead removal using a shock wave catheter includes: advancing a catheter over a pacemaker lead, the catheter comprising a nozzle comprising an outlet sized to receive the pacemaker lead, and at least one shock wave emitter positioned proximally of the nozzle outlet; positioning the nozzle outlet adjacent to a treatment site comprising a lesion located at least partially distal to the nozzle outlet; generating one or more shock waves that propagate distally within the nozzle and are concentrated by the nozzle to disrupt the lesion to facilitate removal of the pacemaker lead.

An apparatus includes a balloon adapted to be placed adjacent a calcified region of a body. The balloon is inflatable with a liquid. The apparatus further includes a shock wave generator within the balloon that produces shock waves that propagate through the liquid for impinging upon the calcified region adjacent the balloon. The shock wave generator includes a plurality of shock wave sources distributed within the balloon.

A shock wave catheter includes an elongate member and a shock wave emitter assembly located at a distal region of the elongate member. The shock wave emitter assembly includes a shock absorber made of a low durometer material. A shock wave catheter system includes a shock wave catheter with a shock absorber and a high voltage power supply configured to generate high voltage pulses. A method for treating a lesion in a body lumen includes generating shock waves with a shock wave catheter system that includes a shock wave catheter with a shock absorber.