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

这项小型企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是解决外周动脉疾病（PAD）的巨大未满足需求，该疾病影响了1200多万美国人，每年导致65，000多例截肢。该项目将为一种新型药物输送技术提供概念验证，该技术将提高PAD患者恢复血流的程序的耐久性。所产生的技术将有助于减轻疾病负担，同时减少截肢造成的重大社会和卫生系统成本。拟议的项目将解决向不同直径和长度的动脉提供受控药物剂量的挑战。外周动脉疾病（PAD）患者的动脉粥样硬化病变较长且弥漫，需要对不同血管直径和长度的多个部位进行治疗。现有的药物输送平台需要使用多种昂贵的设备来治疗这些患者。该项目将证明，单个超声增强药物输送导管可以为不同直径和长度的动脉提供药物输送，从而在血管内手术期间节省大量潜在成本和时间。为了将期望的药物剂量应用于不同尺寸的动脉，将使用真实的时间成像反馈来调整治疗设置以补偿尺寸的变化。为了实现这一目标，将在生理流动条件下处理不同尺寸的离体猪动脉，同时改变处理参数，以确定血管尺寸对递送药物剂量的影响。通过该项目，将开发能够控制药物剂量以匹配不同动脉直径的算法，用于未来的体内动物模型研究。

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.