STTR Phase I: Highly Responsive Implantable Ultrasonic Sensor for Long-Term Hemodynamic Monitoring

Coravie Medical, Inc., Minneapolis MN

Investigators

Abstract

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is to develop an early remote monitoring solution that notifies healthcare providers of risky blood pressure trends, enabling cost-effective interventions and preempting costly heart events or organ damage later. The clinical paradigm shift from infrequent point-in-time and manual blood pressure measurements to continuous and automatic monitoring and reporting may increase the understanding of circadian blood pressure trends and variability that could lead to more than $500 million in healthcare savings and promote the health of the American public. In the United States, there are 116 million people estimated to have high blood pressure, costing the economy $131 billion each year, and leading to stroke, heart disease, kidney disease, and death. A continuous and automatic long-term monitor that requires no patient action offers peace of mind for the nearly 3 million who struggle with monitoring blood pressure from home and who are taking multiple medications for high blood pressure; yet have not managed their blood pressure to a healthy range. The successful development and integration of technologies may offer significant opportunities for future implantable, closed-loop solutions for major chronic health conditions. This Small Business Technology Transfer Phase I project will evaluate the ability of an implanted blood pressure monitor to address current, well-known challenges such as sensor drift and sensor failure due to tissue maturation and the encapsulation effect, sensor movement and migration, body movement and activity. This project will model, design, and develop ultrasonic sensors that have the technical capability to deliver accurate, long-term, continuous blood pressure measurement when hermetically packaged in biocompatible material for chronic subcutaneous implant. Three ultrasonic sensors will be modelled, designed, fabricated, and tested through a physiologic bench simulation for correlation to blood pressure meausrement over a range of clinical scenarios. The ultrasonic sensor’s miniaturized form factor will then be hermetically enclosed and further tested for power consumption, biocompatibility, and sensor performance during an accelerated test that simulates the biological process of encapsulation. The goal is to design and develop an ultrasonic sensor that possesses the functionality to continuously monitor blood pressure in a dynamic implant environment over a duration of at least one year. 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.