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

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，花费了1000亿美元的医疗保健系统负担。在美国，它影响了超过一千万的大手术，创伤，心血管疾病，中风和癌症患者。潜在的生物学是一个复杂的蛋白质和细胞通路的协调，在血液流动的背景下反应。目前还不存在既能捕捉这种复杂性，又能满足各种挑战的约束条件的故障诊断工具。本项目旨在创建一种新型的模块化止血测试平台，该平台使用专有的微系统模块，这些模块部署在定制的可配置盒中，以满足临床要求。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之后，具有同类最佳性能的潜力。这个小企业创新研究（SBIR）第一阶段项目旨在开发一个简单，低成本血小板功能测定其目的是通过局部生物物理诊断环境的多尺度优化来提供同类最佳性能。多板电极聚集测定法（MEA）是一种基于宏观阻抗的设备，已经显示出希望，但仍然很麻烦，并且在患者子集之间的分类准确性不佳。在MEA试验中，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是公认的。初步工作表明，在控制和修改PFA性能方面尚未开发的潜力。通过优化这些信号与临床终点和亚群分化，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益处。

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.