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

这个小型企业技术转移（STTR）第一阶段项目的更广泛影响/商业潜力是开发一种早期远程监测解决方案，通知医疗保健提供者危险的血压趋势，实现具有成本效益的干预措施，并在以后预防代价高昂的心脏事件或器官损伤。临床模式从不频繁的时间点和手动血压测量转变为连续和自动监测和报告，可能会增加对昼夜血压趋势和变异性的理解，这可能会节省5亿多美元的医疗保健费用，并促进美国公众的健康。在美国，估计有1.16亿人患有高血压，每年造成1310亿美元的经济损失，并导致中风、心脏病、肾病和死亡。一个不需要病人操作的连续和自动的长期监测器为近300万在家监测血压和服用多种药物治疗高血压的人提供了安心；但他们的血压没有控制在健康范围内。技术的成功开发和整合可能为未来主要慢性疾病的植入式闭环解决方案提供重大机会。这个小企业技术转移第一阶段项目将评估植入式血压监测仪的能力，以解决当前众所周知的挑战，如由于组织成熟和封装效应导致的传感器漂移和传感器故障、传感器运动和迁移、身体运动和活动。该项目将模拟、设计和开发超声波传感器，该传感器具有提供准确、长期、连续的血压测量的技术能力，当密封包装在生物相容性材料中用于慢性皮下植入时。三个超声波传感器将被建模、设计、制造，并通过生理台模拟在一系列临床场景中与血压测量的相关性进行测试。超声波传感器的小型化外形将被密封，并在模拟封装生物过程的加速测试中进一步测试功耗、生物相容性和传感器性能。目标是设计和开发一种超声波传感器，该传感器具有在动态植入环境中持续监测血压至少一年的功能。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 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.