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

Vena Vitals, Inc., Irvine CA

Investigators

Abstract

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.