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

SBIR 第一阶段：血管内超声引导的剂量控制和微泡增强药物输送

• 批准号: 1621681
• 负责人: Joseph Kilroy
• 金额: $ 22.5万
• 依托单位: SoundPipe
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2019-09-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1621681&HistoricalAwards=false
• 关键词: SBIR; Phase; Dose; control; intravascular

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.

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是解决大量未满足的外周动脉疾病（PAD）需求，该疾病每年影响超过1200万美国人，导致超过65,000例截肢。该项目将为一种新的药物输送技术提供概念证明，该技术将提高PAD患者恢复血流过程的耐久性。结果技术将有助于减轻疾病负担，同时减少由截肢引起的重大社会和卫生系统成本。拟议的项目将解决为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）患者具有长而弥漫性的动脉粥样硬化病变，需要在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将药物输送到不同的动脉直径和长度，从而在血管内手术中节省大量潜在的成本和时间。为了将所需的药物剂量应用于不同大小的动脉，实时成像反馈将用于调整治疗设置以补偿大小的变化。为了实现这一目标，我们将在生理流动条件下处理不同大小的离体猪动脉，同时改变处理参数，以确定血管大小对给药剂量的影响。通过这个项目，可以控制药物剂量以匹配不同动脉直径的算法将为未来的体内动物模型研究开发。