SBIR Phase I: Technology development and pre-clinical testing of a novel minimally invasive catheter-based blood clot-retrieval and clot-filtering device

这个小企业创新研究（SBIR）一期项目旨在开发业界首个基于导管的中风治疗设备，该设备既可以作为血凝块回收装置，也可以作为血凝块过滤装置。中风是纳税人的主要经济负担，每年花费655亿美元。中风患者一生的平均医疗费用为140,048美元。治疗急性中风的第一步是清除血凝块，以恢复大脑的重要血液供应。然而，现有的基于导管的治疗方法在清除血块方面只显示出适度的成功，并且对不到三分之二的中风患者有效。此外，这些疗法会将碎片释放到血液中，导致进一步的中风。该项目的研究目标是对一种更有效的凝块回收装置和凝块过滤装置进行临床前测试，使现有的中风治疗更安全。这项研究的广泛影响是深远的，因为全球中风负担是惊人的。美国每年发生78万例中风，全世界每年发生近2050万例中风。这个项目预计会产生重要成果。首先，我们将验证这种凝块回收装置去除血凝块的效果。其次，这种凝块过滤装置在防止导管中风治疗过程中碎片释放方面的功效将得到证实，从而使这些手术更安全。这种公私伙伴关系预计将通过挽救生命、创造就业机会和减轻中风给纳税人带来的经济负担，对社区产生重要的积极影响。

This Small Business Innovation Research (SBIR) Phase I project aims to develop the industry's first catheter-based stroke treatment device that serves both as a blood clot-retrieval as well as a clot-filtering device. Stroke is a major economic burden on the tax payer costing $65.5 billion/year. The mean lifetime healthcare cost for a stroke patient is $140,048. The first step in the treatment of acute stroke is the removal of the blood clot to restore vital blood supply to the brain. However, existing catheter-based therapies have only shown modest success in removing clots and are effective in less than two-thirds of stroke patients. In addition, these therapies can release debris into the blood stream causing further strokes. The research objective of this project is to perform pre-clinical testing of a more effective clot-retrieval device and a clot-filtering device that can make existing stroke therapies safer.The broader impacts of this research are far-reaching as the global stroke burden is staggering. Each year 780,000 strokes occur in the US and nearly 20.5 million strokes occur worldwide. This project is projected to yield important outcomes. First, the efficacy of this clot-retrieval device in removing blood clots will be confirmed. Second, the efficacy of this clot-filtering device will be confirmed in preventing release of debris during catheter-based stroke treatments thereby making these procedures safer. This public-private partnership is expected to have an important positive impact on the community by saving lives, creating jobs, and decreasing the economic burden of stroke on the tax payer.