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

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是专注于为手术和重症监护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血压监测，因为这种监测需要专门的技能来实施侵入性手术，并且还可能引入潜在的并发症。其余患者使用无创血压袖带间歇性监测，导致读数之间的信息间隔和潜在的延迟反应时间。快速血压下降与患者预后不良相关，如器官损伤/衰竭、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监护患者的数量，提高护理质量和患者预后，而且还可能在其他应用中实现持续血压监测，例如产科的先兆子痫患者。这个项目也有商业潜力。美国每年进行的手术超过5000万例，可服务的潜在市场每年达到25亿美元。扩大到全球市场，每年进行超过2.3亿次手术，总潜在市场超过110亿美元。这个小企业创新研究（SBIR）二期项目开发了一种无线、连续、无创血压监测设备，可以以高时间分辨率捕捉血压的快速波动。目前为满足非侵入性连续血压监测需求而开发的技术在准确性、成本和易用性方面受到限制。将该项目推进到商业和临床准备阶段的研究目标是：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外形因素，以及开发用于提高可用性的智能校准系统。通过在临床环境中反复设计和测试设备，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。二期项目成果是一种可穿戴、无创、连续血压监测设备，将用于手术室和重症监护病房。该设备不仅有可能使临床医生更深入地了解患者状况，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、治疗效果和人口统计学中患者分层的理解。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 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.