SBIR Phase II: IVUS Drug Delivery for Critical Limb Ischemia

SBIR II 期：IVUS 药物输送治疗严重肢体缺血

• 批准号: 1831176
• 负责人: Joseph Kilroy
• 金额: $ 75万
• 依托单位: SoundPipe
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1831176&HistoricalAwards=false
• 关键词: SBIR; Phase; II; IVUS; Drug

This SBIR Phase II project will develop a drug delivery technology to address the unmet need of antiproliferative drug delivery below-the-knee. In the United States, there are 323,000 new critical limb ischemia (CLI) patients each year. CLI is the most severe stage of peripheral artery disease (PAD), atherosclerosis of the lower limbs. Ultimately, 40% of CLI patients will undergo lower limb amputation as a result of CLI, half of whom will then die within a year. Existing technologies have failed in these vessels, resulting in higher rates of patient amputation. This project will create a better intravascular drug delivery tool to treat PAD patients after angioplasty. This improved drug delivery will provide three key societal benefits: 1) reduced costs and greater efficiency when revascularizing the vessels of critical limb ischemia patients, 2) a reduction in healthcare costs by reducing repeat procedures, and 3) improved patient outcomes resulting from improved drug delivery achieved using image guidance. If successful, this technology may improve patient health while reducing treatment costs for millions of patients around the world. This will also improve understanding of what aspects of CLI treatment are most effective by offering the flexibility to vary different aspects of drug delivery. When completed, this project will enhance the understanding of intravascular drug delivery with ultrasound and microbubbles.This project will provide strong technical innovation through a new ultrasound drug delivery device and new methods to evaluate cardiovascular drug delivery devices. Using a combination of intravascular ultrasound and drug loaded microbubbles, this project will provide better localization of delivery with lower drug doses. This project will then evaluate the drug delivery platform using realistic models of human disease from donated tissue combined with routine techniques (histopathology) and more recent advances (microCT) to evaluate the effect of the disease on drug delivery. The core research objective of this project is to deliver paclitaxel to human diseased arteries with the new intravascular ultrasound and microbubble drug delivery platform. It is anticipated that this project will result in an improved drug uptake over the existing technologies in diseased arteries where drug uptake is poorest. The data and techniques from this project will be used to compel adoption among interventionalists and to validate the the drug delivery system as a tool to prevent amputations in CLI patients.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

SBIR二期项目将开发一种药物输送技术，以解决膝关节以下抗增殖药物输送的未满足需求。在美国，每年有323,000名新的严重肢体缺血（CLI）患者。CLI是外周动脉疾病（PAD）最严重的阶段，即下肢动脉粥样硬化。最终，40%的CLI患者将因CLI而接受下肢截肢，其中一半将在一年内死亡。现有的技术在这些血管中失败了，导致患者截肢率更高。本项目将为血管成形术后PAD患者提供更好的血管内给药工具。这种改进的药物输送将带来三个关键的社会效益：1)降低成本，提高肢体缺血危重患者血管重建的效率；2)减少重复手术，降低医疗成本；3)使用图像引导改善药物输送，改善患者预后。如果成功，这项技术可能会改善患者的健康状况，同时降低全球数百万患者的治疗成本。这也将通过提供不同给药方面的灵活性，提高对CLI治疗哪些方面最有效的理解。该项目完成后，将加深对超声和微泡血管内给药的理解。本项目将通过一种新的超声给药装置和评价心血管给药装置的新方法提供强有力的技术创新。结合血管内超声和载药微泡，该项目将以更低的药物剂量提供更好的递送定位。然后，该项目将使用来自捐赠组织的真实人类疾病模型，结合常规技术（组织病理学）和最新进展（微ct）来评估疾病对药物输送的影响，从而评估药物输送平台。本项目的核心研究目标是利用新型血管内超声微泡给药平台将紫杉醇输送到人病变动脉。预计该项目将导致在药物摄取最差的患病动脉中改善现有技术的药物摄取。该项目的数据和技术将用于促使介入医师采用，并验证药物输送系统作为防止CLI患者截肢的工具。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。