Delaware Patent of the Month – April 2024
In the realm of medical advancements, FastWave Medical has secured a patent for an innovative solution for treating calcified-plaque lesions within a patient’s vasculature. The patent outlines a groundbreaking medical device designed to revolutionize intravascular lithotripsy (IVL) procedures.
This cutting-edge medical device features an elongated body with a central longitudinal axis, accompanied by a distal elongated body portion housing a balloon. The balloon, equipped with an interior and exterior surface, inflates upon fluid infusion, allowing the exterior surface to make contact with the calcified lesion in the vasculature. Positioned within the elongated body is a pressure wave emitter, comprising an optical fiber that transmits laser energy to generate cavitation bubbles in the fluid. These bubbles, upon collapse, produce shock waves that effectively fragment the calcified lesion.
To ensure optimal performance and patient safety, the device incorporates various advanced features. A fiber positioner surrounds the optical fiber, maintaining its position within the balloon. The fiber terminates near the distal end of the elongated body portion, allowing precise energy delivery. Additionally, a shroud prevents direct contact between the optical fiber and the balloon, enhancing durability and safety during the procedure.
In terms of functionality, the device offers versatility and customization. A laser energy generator selectively pulses the laser energy, enabling the creation of a Moses Effect for enhanced efficiency. The laser energy parameters, including wavelength, energy, pulse width, and repetition rate, are adjustable to suit specific treatment requirements.
The device incorporates safety mechanisms to mitigate potential risks. A pressure sensor detects balloon ruptures, halting the laser energy to prevent adverse effects. A fiber interrogation mechanism monitors fiber breakage, ensuring uninterrupted energy transmission.
The device’s design prioritizes patient comfort and procedural efficacy. The elongated body includes a central lumen for fluid transmission, facilitating blood displacement during treatment. Additionally, the balloon’s interior surface features a metalized coating to enhance durability.
FastWave Medical’s medical device represents a significant advancement in IVL procedures. With its innovative design, customizable features, and emphasis on safety and efficacy, this device holds immense promise for improving patient outcomes in the treatment of calcified-plaque lesions.
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