SBIR Phase I: A novel multianalyte microsensor platform for continuous wireless monitoring applications

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力是开发一种创新的、用户友好的连续无线传感平台，用于同时监测多种分析物和生理参数。无线传感器市场价值130亿美元，并以每年10%的速度增长。与目前使用的离散采样技术相比，由于对易于使用的传感平台的需求未得到满足，该平台可以为用户提供有关其研究的实时定量和连续数据，因此市场渗透率不足。这是因为目前的连续传感器要么是有线的，要么是笨重的（离散的无线），对研究造成干扰，需要特殊的插入程序（例如，动物研究的复杂手术），并且不容易与实验工作流程集成。鉴于我们在糖尿病无线传感器开发方面的经验，许多研究人员要求我们开发生化传感平台技术，以支持材料科学，制药，体外诊断，蛋白质工程和疾病途径的研究。这样一个平台可以给生物医学研究人员带来革命性的变化，它可以用来研究新药、细胞培养、人工培养器官、生物灵感材料。该小型企业创新研究第一阶段项目旨在开发一种独特的单片半导体平台，能够在低于mm3的足迹下同时无线监测多种生化和生理标志物。这使得该设备可用于传统大型传感器无法使用的各种应用，包括试管、多孔板和细胞培养。此外，该平台可以使用基于针头的插入装置注射到皮肤下，从而消除了目前使用的复杂外科手术。无线微型设计的结果是一个稳定的传感器环境接口，而不是目前的有线和笨重的无线设备，由于不断的接口刺激而遭受响应的不断变化。此外，它的极小尺寸最大限度地减少了与设备尺寸成正比的异物反应和植入损伤，从而最大限度地减少了校准频率。微/纳米设计用于在互补金属氧化物半导体（CMOS）专用集成电路（ASIC）的顶层制造图案电极，以形成完全集成的系统，而无需在当前产品中使用离散封装。这提高了可制造性，降低了批量生产的单位成本。在第一阶段成功可行性后，我们将优化系统并制定制造计划，以便在第二阶段将其商业化。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。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is the development of an innovative and user-friendly continuous wireless sensing platform for simultaneously monitoring multiple analytes and physiological parameters. The wireless sensor market is worth $13 Billion and is growing 10% annually. There is an under-penetration in the market due to the unmet need of an easy-to-use sensing platform that can provide users with quantitative and continuous data about their studies in real-time as compared to discrete sampling techniques used currently. This is because the current continuous sensors are either wired or bulky (discrete wireless), are disruptive to the studies, require special insertion procedures (e.g., complex surgeries for animal research), and do not easily integrate with the experimental workflow. Given our experience in wireless sensor development for diabetes, many researchers have asked us to develop a platform technology for biochemical sensing to enable research in materials science, pharmaceutical, in vitro diagnostics, protein engineering, and disease pathways. Such a platform can revolutionize biomedical researchers with a tool to study new drugs, cell cultures, artificially grown organs, bioinspired materials. This Small Business Innovation Research Phase I project is intended to develop a unique monolithic semiconductor platform capable of wirelessly monitoring multiple biochemical and physiological markers simultaneously at a sub-mm3 footprint. This enables the device to be used in a variety of applications where conventional larger sensors can’t be used, including test tubes, multi-well plates, and cell cultures. Moreover, the platform can be injected under the skin using a needle-based insertion device, eliminating complicated surgical procedures currently used. The wireless miniature design results in a stable sensor-environment interface as opposed to the current wired and the bulky wireless devices that suffer from constant variation in response due to constant interface irritation. Furthermore, it’s extremely small size minimizes foreign body response, which is proportional to device size, and implantation injury, and hence minimizes calibration frequency. Micro/nano design is used to fabricate patterned electrodes on the top layer of a Complementary Metal Oxide Semiconductor (CMOS) Application Specific Integrated Circuit (ASIC) to form a fully integrated system without the need for discrete packaging used in current products. This enhances manufacturability and reduces unit cost in volume production. After successful feasibility in this Phase-I, we will optimize the system and develop a manufacturing plan to commercialize it in Phase-II.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.