SBIR Phase II: Innovative Platform for Low Volume Blood Coagulation Analysis

这项小企业创新研究（SBIR）二期项目的更广泛影响/商业潜力解决了新生儿和儿科患者以及脆弱的成人患者的凝血和相关出血风险问题。现有的系统使这些患者面临更大的风险，因为它们不能在低血容量的情况下操作，而且由于需要接触检测样本，它们的可靠性较低。仅使用一滴血，提议的非接触式技术平台可以安全可靠地评估所有患者的凝血情况，并为开发凝血异常的新生儿筛查试验提供了机会。该技术可以减少新生儿和儿科患者的副作用，只需使用成人医疗保健技术所需样本量的1/100，并将重症监护提供者的诊断响应时间提高3倍以上。这项技术可以将血液凝固分析的成本降低30%以上，从而使美国患者每年节省11亿美元。这个小型企业创新研究（SBIR）二期项目开发了一种创新的非接触式血液凝固分析技术，该技术将光光学和粘弹性测量集成在一滴血中。该技术的基础是利用声辐射力将小样本悬浮在宿主流体（空气）中，并测量悬浮过程中试样在变形下的物理特性。由于其非接触特性和低样本量要求，该技术可以快速（10分钟）可靠地评估出血/血栓形成风险，并且对血液凝固和纤维蛋白溶解过程中剪切粘度和弹性的时间变化敏感。该项目的目标是开发和测试一种在无菌条件下快速、可靠、易于使用的滴血凝血分析系统。这一目标将通过满足四个目标来实现：1)开发用于从标准采血管自动部署样本的模块；2)实施环境控制和样品密封（“声波盒”）；3)组装原型设备，开发控制软件，改进工作流程和人性化界面；4)评估原型可靠性，将其标准化用于凝血测量，并进行初步临床试验。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。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project addresses the problem of blood clotting and associated bleeding risks in neonatal and pediatric patients as well as vulnerable adult patients. Existing systems put these patients at further risk because they cannot operate with low volumes of blood, and because they are less reliable owing to the requirement for test sample contact. Using only a single drop of blood, the proposed non-contact technology platform enables safe and reliable assessment of blood clotting for all patients and provides an opportunity for development of newborn screening tests for coagulation abnormalities. This technology can reduce side effects for neonatal and pediatric patients by using 1/100th the sample volume required by technologies developed for adult healthcare and improve diagnostic response time for critical care providers by more than 3x. This technology could decrease the cost of blood coagulation analysis by over 30%, thus allowing for patients in the United States to save $1.1 billion annually.This Small Business Innovation Research (SBIR) Phase II project develops an innovative technology for non-contact blood coagulation analysis that integrates photo-optical and viscoelastic measurements in a single drop of blood. The basis of the technology is to levitate a small sample in a host fluid (air) by the acoustic radiation force and measure its physical properties under deformation during levitation. Due to its non-contact feature and low sample volume requirement, this technology can rapidly (10 minutes) and reliably assess bleeding/thrombotic risks and is sensitive to temporal changes in shear viscosity and elasticity during blood clotting and fibrinolysis. The goal of this project is to develop and test a system for fast, reliable, and easy-to-use drop-of-blood coagulation analysis under sterile conditions. This goal will be achieved by meeting four objectives: 1) develop the module for automatic sample deployment from standard blood collection tubes; 2) implement environmental control and sample containment (“acoustic cartridge”); 3) assemble prototype devices and develop the control software with improved workflow and a user-friendly interface; and 4) assess prototype reliability, standardize it for coagulation measurements, and conduct initial clinical testing.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.