SBIR Phase I: Dose control of intravascular ultrasound guided and enhanced drug delivery with microbubbles

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to address the massive unmet need of peripheral arterial disease (PAD) which affects over 12 million Americans and results in over 65,000 amputations each year. This project will provide the proof of concept for a novel drug delivery technique that will improve the durability of procedures to restore blood flow in PAD patients. The result technology will help reduce the burden of disease while reducing the significant societal and health system costs caused by amputations. The proposed project will address the challenge of providing controlled drug dose to arteries of varying diameter and length. Peripheral arterial disease (PAD) patients have atherosclerotic lesions that are long and diffuse, requiring treatment to multiple sites with different vessel diameters and lengths. Existing drug delivery platforms require the use of multiple, expensive devices to treat these patients. This project will demonstrate that a single ultrasound-enhanced drug delivery catheter can provide drug delivery to different artery diameters and lengths, providing significant potential cost and time savings during endovascular procedures. In order apply the desired drug dose to arteries of varying size, real time imaging feedback will be used to adjust the treatment settings to compensate for changes in size. To achieve this goal, ex vivo swine arteries of different sizes will be treated under physiological flow conditions while varying the treatment parameters in order to determine the effect of vessel size on delivered drug dose. From this project, algorithms that can control drug dose to match varying artery diameter will be developed for future in vivo animal model studies.