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

STTR 第一阶段：低容量凝血分析的创新平台

• 批准号: 1843479
• 负责人: Phillip Anderson
• 金额: $ 22.5万
• 依托单位: Levisonics Inc.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-02-01 至 2021-01-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1843479&HistoricalAwards=false
• 关键词: STTR; Phase; Innovative; Platform; Low

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.

该SBIR I期项目解决了评估新生儿和儿科患者凝血和相关出血和血栓形成风险的问题。现有的凝血分析仪使这些患者处于进一步的风险中，因为它们不能在低体积的血液下操作，并且因为它们由于测试样品接触的要求而不太可靠。本计画将针对这些病患发展声推法（ATT）。 这种非接触式技术平台仅使用一滴声悬浮血液，就可以安全可靠地评估幼儿的血液凝固情况，并为开发新生儿凝血异常筛查测试提供了机会。这项技术是NSF资助的结果，该资助支持了几名生物医学和机械工程博士生的培训。 ATT可以通过使用成人医疗保健技术所需的1/100的样本量来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缩短高达350%。这项技术可以将凝血分析的成本降低30%以上，从而使美国的患者每年节省20亿美元。SBIR第一阶段项目开发了一种用于非接触式凝血分析的创新技术，该技术在单滴血液（体积为6 uL）中集成了光-光学和粘弹性测量。 ATT技术的本质是将小样品悬浮在宿主流体（例如，空气）的声辐射力，并测量其物理特性下的悬浮过程中的变形。 ATT解决了现有凝血分析仪因血液样本与人造表面接触而导致的高变异性和标准化差的问题。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可以测量血小板功能，并评估纤维蛋白原和其他凝血因子的功能水平。本项目的目标是为儿科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）建立用户友好的原型; 2）开发用于设备控制、数据采集和数据分析的集成软件;和3）的方法该奖项反映了NSF的法定使命，并被认为值得通过使用基金会的知识价值和更广泛的影响审查进行评估来支持的搜索.