SBIR Phase I: A novel shear-based platelet function test (PFT) using 3D MEMS electrodes

SBIR 第一阶段：使用 3D MEMS 电极的新型剪切血小板功能测试 (PFT)

• 批准号: 1722200
• 负责人: Xin Zhao
• 金额: $ 22.5万
• 依托单位: Atantares Corp
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-01 至 2018-12-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1722200&HistoricalAwards=false
• 关键词: SBIR; Phase; novel; shear; based

The broader impact/commercial potential of this project relates to the management of clottingand bleeding which is a major clinical challenge that costs $100B healthcare system burden. Inthe United States, it affects more than ten million patients of major surgery, trauma,cardiovascular disease, stroke and cancers. The underlying biology is a complex orchestration ofprotein and cellular pathways that react in the context of blood flow. Proven diagnostic tools thatcapture this complexity, and also meet the constraints of diverse challenges do not exist. Thisproject intends to create a novel modular hemostasis test platform using proprietary microsystemmodules deployed in configurable cartridges tailored to meet clinical requirements. Initially a3D microelectrode based platelet function test module will be developed and optimized withpotential for best in class performance following multi-scale optimization of the dynamic,physical diagnostic environment.This Small Business Innovation Research (SBIR) Phase I project seeks to develop a simple, lowcost platelet function assay (PFA) with the objective of delivering best in class performance viamultiscale optimization of the local biophysical diagnostic environment. Multiplate ElectrodeAggregometry (MEA), a macroscale impedance-based device has already shown promise, yetremains cumbersome and has suboptimal classification accuracy between patient subsets. InMEA tests, as with most PFAs, the role of local fluid shear and macro/microscale physicalenvironment remains largely neglected despite their well-recognized role in platelet response.Preliminary work suggests untapped potential in controlling and modifying PFA performance.By optimizing these signals with respect to clinical end points and subpopulation differentiation,this shear-based micro-platelet function test modules stand to revolutionize platelet functiontesting for the broadest possible benefits.

该项目更广泛的影响/商业潜力与凝血和出血的管理有关，这是一项重大的临床挑战，会造成 100B 美元的医疗保健系统负担。在美国，它影响着超过一千万的大手术、创伤、心血管疾病、中风和癌症患者。其基础生物学是蛋白质和细胞通路的复杂编排，它们在血流中发生反应。能够捕捉这种复杂性并满足各种挑战的约束的经过验证的诊断工具并不存在。该项目打算使用部署在可配置卡盒中的专有微系统模块创建一个新颖的模块化止血测试平台，以满足临床需求。最初，将开发和优化基于 3D 微电极的血小板功能测试模块，在动态物理诊断环境的多尺度优化后，具有实现一流性能的潜力。这个小型企业创新研究 (SBIR) 第一阶段项目旨在开发一种简单、低成本的血小板功能测定 (PFA)，其目标是通过局部生物物理诊断环境的多尺度优化来提供一流的性能。多板电极聚集测量法 (MEA) 是一种基于阻抗的宏观设备，已经显示出应用前景，但仍然很麻烦，并且在患者子集之间的分类准确性欠佳。在 MEA 测试中，与大多数 PFA 一样，局部流体剪切和宏观/微观物理环境的作用在很大程度上仍然被忽视，尽管它们在血小板反应中的作用已得到充分认可。初步工作表明在控制和修改 PFA 性能方面尚未开发的潜力。通过根据临床终点和亚群分化优化这些信号，这种基于剪切的微血小板功能测试模块将彻底改变血小板 功能测试以获得尽可能广泛的好处。