Intravascular Lithoplasty System With Improved Durability, Efficiency and Pressure Output Variability

An intravascular lithotripsy (IVL) catheter comprising:

• an elongate member comprising an outer surface and a distal end;
• a fluid-inflatable balloon disposed at or near the distal end of the elongate member, the fluid-inflatable balloon comprising:
• a proximal section,
• a distal section, and
• an inflatable section disposed between the proximal section and the distal section, the inflatable section comprising an inflated state and a deflated state;
• and
• at least one lithotripsy emitter disposed within the fluid-inflatable balloon, wherein the at least one lithotripsy emitter is configured to emit a pressure wave,
• wherein the distal section of the fluid-inflatable balloon comprises a lumen configured to receive a guidewire,
• wherein the distal section of the fluid-inflatable balloon extends beyond a distal end of the elongate member to form a tip, and
• wherein the tip is a flexible and atraumatic tip to facilitate advancement through a vasculature.

A method of treating a calcified lesion by advancing an intravascular lithotripsy (IVL) catheter over a guidewire, the IVL catheter comprising an elongate member and a fluid-inflatable balloon disposed at or near a distal end of the elongate member, the balloon having a distal section with a distal region extending beyond a distal end of the elongate member to form a flexible tip, the method comprising:

• introducing the guidewire into a lumen defined by the flexible tip of the balloon;
• advancing the IVL catheter distally along the guidewire, wherein the guidewire extends to the calcified lesion;
• advancing the IVL catheter along the guidewire such that the flexible tip translates through a vasculature and towards the calcified lesion;
• inflating the fluid-inflatable balloon with a fluid;
• and
• actuating a lithotripsy emitter within the balloon to generate a pressure wave within the fluid-inflatable balloon to treat the calcified lesion.