STTR Phase I: Innovative Platform for Low Volume Blood Coagulation Analysis

SBIR一期项目旨在评估新生儿和儿科患者的凝血及相关出血和血栓形成风险。现有的凝血分析仪使这些患者面临更大的风险，因为它们不能在低血容量下操作，而且由于需要接触测试样本，它们的可靠性较低。该项目将为这些患者开发声学镊子Thomboelastometry （ATT）。这种非接触式技术平台仅使用一滴血，可以安全可靠地评估幼儿的凝血情况，并为开发凝血异常的新生儿筛查试验提供了机会。这项技术是美国国家科学基金会资助的成果，该基金支持了几名生物医学和机械工程方面的博士生的培训。通过使用成人医疗保健技术所需的1/100样本量，ATT可以减少新生儿和儿科患者的副作用，并将重症监护提供者的诊断响应时间提高350%。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20亿美元。SBIR一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单滴血（6uL体积）中。ATT技术的实质是利用声辐射力将小样本悬浮在宿主流体（如空气）中，并测量其在悬浮过程中变形下的物理性质。ATT解决了由于血液样本与人造表面接触而导致的现有凝血分析仪的高可变性和低标准化问题。由于其非接触特性和低样本量要求，ATT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。此外，ATT可测定血小板功能，评估纤维蛋白原及其他凝血因子的功能水平。该项目的目标是为儿童凝血分析仪市场开发一种用户友好的最小可销售产品。这一目标将通过满足以下三个目标来实现：1)构建用户友好的原型；2)开发设备控制、数据采集和数据分析集成软件；3)对样机进行校准并使其标准化，以便进行凝血测量。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。

This SBIR Phase I project addresses the problem of assessing blood clotting and associated bleeding and thrombosis risks in neonatal and pediatric patients. Existing coagulation analyzers 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. This project will develop Acoustic Tweezing Thomboelastometry (ATT) for these patients. Using only a single acoustically-levitated drop of blood, this non-contact technology platform enables safe and reliable assessment of blood clotting in small children and provides an opportunity for development of newborn screening tests for coagulation abnormalities. This technology is the outcome of NSF funding which has supported the training of several PhD students in biomedical and mechanical engineering. ATT 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 up to 350%. This technology could decrease the cost of blood coagulation analysis by over 30%, thus allowing for patients in the United States to save $2.0 billion annually.This SBIR Phase I project develops an innovative technology for non-contact blood coagulation analysis that integrates photo-optical and viscoelastic measurements in a single drop of blood (6uL in volume). The essence of the ATT technology is to levitate a small sample in a host fluid (e.g., air) by the acoustic radiation force and measure its physical properties under deformation during levitation. ATT addresses the issue of high variability and poor standardization of existing coagulation analyzers caused by blood sample contact with artificial surfaces. Due to its noncontact feature and low sample volume requirement, ATT 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. In addition, ATT can measure platelet function and assess the functional levels of fibrinogen and other coagulation factors. The goal of this project is to develop a user-friendly minimal marketable product for the market of pediatric coagulation analyzers. This goal will be achieved by meeting the following three objectives: 1) build the user-friendly prototype; 2) develop integrated software for device control, data acquisition, and data analysis; and 3) calibrate the prototype and standardize it for coagulation measurements.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.