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

该项目更广泛的影响/商业潜力涉及到凝血和出血的管理，这是一个重大的临床挑战，花费了1000亿美元的医疗保健系统负担。在美国，它影响着超过1000万的大手术、创伤、心血管疾病、中风和癌症患者。潜在的生物学是在血液流动的背景下反应的蛋白质和细胞途径的复杂编排。目前还没有成熟的诊断工具能够捕捉到这种复杂性，并满足各种挑战的限制。该项目旨在创建一种新型模块化止血测试平台，使用专有的微系统模块部署在可配置的墨盒中，以满足临床需求。最初，一个基于微电极的3d血小板功能测试模块将被开发和优化，在动态物理诊断环境的多尺度优化后，具有同类最佳性能的潜力。这项小型企业创新研究（SBIR）一期项目旨在开发一种简单、低成本的血小板功能测定（PFA），目的是通过对当地生物物理诊断环境的多尺度优化，提供一流的性能。基于宏观阻抗的多板电聚仪（MEA）已经显示出前景，但仍然很麻烦，并且在患者亚群之间的分类准确性不理想。在mea测试中，与大多数PFAs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被忽视，尽管它们在血小板反应中发挥着众所周知的作用。初步工作表明，在控制和修改PFA性能方面尚未开发潜力。通过优化这些关于临床终点和亚群分化的信号，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，以获得最广泛的益处。

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.