SBIR Phase II: In-vivo validation of a volume-manufacturable and factory-calibrated wearable NT-proBNP monitoring system for heart failure treatment

这个小型企业创新研究（SBIR）第二阶段项目的更广泛的影响/商业潜力将直接解决心血管疾病日益增长的国家经济和个人负担，因为它成为超过一半的美国人进入60岁的现实。心力衰竭是一种心血管疾病，特别具有挑战性，因为许多患者在首次住院后几个月就再次入院。大大改善患者的预后已经是可能的，使患者不再返回医院，但前提是患者的治疗可以迅速优化为心力衰竭处方的药物。这种快速优化需要多次返回医生进行血液检查，以指导治疗计划，相应地调整患者的药物水平。因此，心脏病专家一直在寻求新技术来帮助他们护理心力衰竭患者，越来越多的人呼吁使用远程监测技术。这个小型企业创新研究（SBIR）第二阶段项目将创建有史以来第一个可穿戴的心力衰竭监测器，用于心脏挣扎时心脏释放的肽分子，从而提供直接和连续的心力衰竭治疗进展情况的测量。具体来说，适体是一种寡核苷酸，它将被用来在一个微小的电线传感器上捕获心力衰竭肽分子，该传感器无痛地嵌入皮肤表面下几毫米。当这些适体捕获肽时，它们以电信号的形式提供肽浓度的连续测量。该项目将创建一个工作原型，就像可穿戴式连续葡萄糖监测仪的成功证明一样，利用数十年来对葡萄糖监测仪的投资以及医生和患者对葡萄糖监测仪的信任。在第二阶段项目中，可穿戴式心力衰竭监测仪原型将在动物模型中进行一周以上的运行验证，这是一个关键的证明点，将使开发可穿戴式心力衰竭监测仪的进一步商业投资用于人类使用。该奖项反映了NSF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 II project will directly address the growing national economic and individual burden of cardiovascular disease as it becomes a reality for more than half of all Americans entering their sixties. Heart-failure is a cardiovascular disease that is particularly challenging given that many patients end up readmitted to the hospital just months after initial hospitalization. Greatly improved outcomes for patients are already possible, keeping patients from returning to the hospital, but only if the patient treatment can be rapidly optimized for the medications prescribed for heart failure. This rapid optimization requires multiple trips back to the doctor for blood tests to guide the treatment plan, adjusting patient medication levels accordingly. Cardiologists have therefore been asking for new technologies to aid their ability to care for heart-failure patients, with an increasing call for remote monitoring technology. This Small Business Innovation Research (SBIR) Phase II project will create the first-ever wearable, heart-failure monitor for a peptide molecule released by the heart when the heart is struggling, therefore providing a direct and continuous measurement of how well heart-failure treatment is progressing. Specifically, aptamers, which are oligonucleotides, will be used to capture heart-failure peptide molecules on a tiny electrical wire sensor embedded painlessly a few millimeters beneath the skin surface. As these aptamers capture the peptides, they provide a continuous measurement of the peptide concentrations in the form of an electrical signal. The project will create a working prototype that is like the proven success of wearable continuous glucose monitors, leveraging decades of investment in glucose monitors and significant doctor and patient trust in glucose monitors. Under the Phase II project, the wearable heart-failure monitor prototype will be validated for more than one week of operation in an animal model, a key proof point that will enable further commercial investment in developing the wearable heart-failure monitor for human use.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.