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

SBIR II 期：使用微纳米皱纹功能材料的逐搏血压监测仪

• 批准号: 2213169
• 负责人: Joshua Kim
• 金额: $ 100万
• 依托单位: VENA VITALS, INC.
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-15 至 2025-02-28
• 项目状态: 未结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2213169&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Beat; Blood

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.

这项小型企业创新研究（SBIR）II期项目的更广泛的影响/商业潜力集中在为手术和重症监护中患者的血压提供实时和持续监测。目前，只有10-15％的接受手术的患者接受连续的血压监测，因为这种监测需要专门的技能来管理侵入性手术，还可以引入潜在的并发症。用非侵入性血压袖带间歇性地监测其余患者，从而导致读数和潜在延迟的反应时间之间的信息差距。快速血压下降与患者差的差有关，例如器官损伤/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，改善护理质量和患者预后的手术和重症监护患者的数量，而且还可以在其他应用中进行连续的血压监测，例如在妇产科前患者中的持续血压监测。该项目还具有商业潜力。每年在美国进行超过5000万次手术，可提供的可寻址市场每年为25亿美元。扩展到全球市场，每年进行超过2.3亿次手术，总可寻址市场超过110亿美元。这项小型企业创新研究（SBIR）II期项目开发了一种无线，连续和非侵入性血压监测设备，可以捕获血压快速以高临时分辨率捕获血压快速波动。目前开发的技术是为了满足对非侵入性，连续血压监测的未满足需求的限制，其准确性，成本和易用性。将该项目推向商业和临床准备就绪的研究目标是：通过传感器改进和算法开发设备优化，机械和电气稳定性的外形因素开发以及开发智能校准系统以提高可用性。通过在临床环境中的迭代设备设计和测试，该项目旨在应对连续血压监测，即运动，校准和信号漂移的长期挑战。 II期项目的结果是可穿戴，无创和连续的血压监测装置，可在手术室和重症监护室中使用。该设备不仅有可能使临床医生能够更深入地了解患者状况，从而在临床环境中迅速反应和改善护理，而且还可以用来提高人们对跨人口统计学的疾病进展，治疗有效性和患者分层的了解。该奖项反映了NSF的法定任务，并通过对基础的智力进行了评估，并通过评估了基础的智力效果，并具有评估。