SBIR Phase II: A Beat-to-Beat Blood Pressure Monitor Using Micro-Nanoscale Wrinkled Functional Materials

这个小型企业创新研究(SBIR)第二阶段项目的更广泛影响/商业潜力专注于为手术和重症护理中的患者提供实时和持续的血压监测。目前，只有10%-15%的手术患者接受持续的血压监测，因为这种监测需要专门的技能来管理有创手术，而且可能会带来潜在的并发症。其余患者使用无创血压袖带进行间歇性监测，导致读数之间的信息差距和潜在的反应时间延迟。血压的快速下降与不良的患者结局有关，如器官损伤/衰竭、手术后并发症和死亡。该项目的成功不仅有可能增加接受持续监测的外科和重症护理患者的数量，改善护理质量和患者结局，而且还可以在其他应用中实现连续血压监测，例如在产科的先兆子痫患者中。这个项目也有商业潜力。美国每年进行的手术超过5000万例，可服务、可定位的市场为每年25亿美元。扩展到每年超过2.3亿例手术的全球市场，总目标市场超过110亿美元。这个小型企业创新研究(SBIR)第二阶段项目开发了一种无线、连续和无创的血压监测设备，可以捕捉高时间分辨率的血压快速波动。目前开发的用于满足对非侵入性、持续血压监测的需求的技术在准确性、成本和易用性方面都受到限制。将该项目推向商业和临床就绪的研究目标是：通过传感器改进和算法开发来优化设备，开发用于机械和电气稳定性的形状因数，以及开发用于提高可用性的智能校准系统。通过迭代的设备设计和临床环境中的测试，该项目旨在解决持续血压监测的长期挑战，即运动、校准和信号漂移。第二阶段的项目成果是一种可穿戴的、非侵入性的、连续的血压监测设备，用于手术室和重症监护病房。这一设备不仅有可能使临床医生更深入地了解患者的情况，在临床环境中实现快速反应和改善护理，而且还可以用于提高对疾病进展、治疗有效性和跨人口统计学的患者分层的了解。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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 is focused on providing real-time and continuous monitoring of blood pressure for patients in surgery and critical care. Currently, only 10-15% of patients undergoing surgery receive continuous blood pressure monitoring because such monitoring requires specialized skill to administer the invasive procedure and can also introduce potential complications. The remaining patients are monitored intermittently with a non-invasive blood pressure cuff, resulting in gaps in information between readings and potentially delayed response times. Rapid blood pressure drops are associated with poor patient outcomes such as organ damage/failure, post-surgical complications, and death. The success of this project has the potential to not only increase the number of surgical and critical care patients who receive continuous monitoring, improving quality of care and patient outcomes, but also to enable continuous blood pressure monitoring in other applications, such as in pre-eclampsia patients in obstetrics. This project also has commercial potential. With over 50 million surgeries performed in the US each year, the serviceable, addressable market is $2.5 billion per year. Expanded to the global market where over 230 million surgeries are performed annually, the total addressable market is over $11 billion.This Small Business Innovation Research (SBIR) Phase II project develops a wireless, continuous, and non-invasive blood pressure monitoring device that can capture rapid fluctuations in blood pressure with high temporal resolution. Current technologies developed to address the unmet need for non-invasive, continuous blood pressure monitoring have been limited in their accuracy, cost, and ease-of-use. The research objectives to advance this project to commercial and clinical readiness are: device optimization through sensor improvement and algorithm development, form factor development for mechanical and electrical stability, and development of a smart calibration system for improved usability. Through iterative device design and testing in clinical environments, this project aims to tackle the long-standing challenges of continuous blood pressure monitoring, namely motion, calibration, and signal drift. The Phase II project outcome is a wearable, non-invasive, and continuous blood pressure monitoring device to be used in the operating room and intensive care unit. This device has the potential to not only empower clinicians with greater insight into patient condition, enabling rapid response and improved care in the clinical setting, but it can also be used to improve understanding of disease progression, treatment effectiveness, and patient stratification across demographics.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.