I-Corps: A novel vaginal dynamometer for evaluating pelvic floor health in women

I-Corps项目更广泛的影响/商业潜力是开发一种新设备，以准确测量盆底强度，为医生提供可靠和可重复的盆底健康评估。在美国，每四个女性中就有一个在她们的一生中会经历盆底疾病。医生仍然依靠指诊，一种手指挤压试验，来评估骨盆底，其临床可靠性很低。该装置可以检测盆底力量的微小变化，帮助医生在症状出现之前诊断盆底疾病。该项目不仅将专注于这种诊断设备的开发，还将开始评估其他盆底护理和康复产品的需求和商业机会。骨盆健康是一个很大程度上服务不足的市场，直到最近才通过几个流动卫生培训辅助设备的商业化获得关注。这个I-Corps项目是探索阴道测力仪的发展，基于一个可重复使用的窥镜和一个可移动的传感器来评估骨盆底的强度。该装置的结果表明，可移动传感器设计提供了准确的结果，同时将每次使用的成本降低到常规使用的可接受水平。目前盆底评估技术的主要限制因素是使用成本。会阴计、超声波和核磁共振成像在常规妇科检查中是非常昂贵的。可移动传感器设计允许设备的患者接触部分进行标准的再处理协议，如高压灭菌器，而易碎的传感器和电子设备被移除并重复使用。我们相信这样的设计将可用于常规妇科应用，并可能成为盆腔健康的重要标志，就像血压是心血管健康的重要标志一样。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 I-Corps project is the development of a new device to take accurate measures of pelvic floor strength to provide with physicians with a reliable and repeatable assessment of pelvic floor health. One in every four women in the US will experience a pelvic floor disorder in their lifetime. Physicians still rely on digital palpation, a finger-squeeze test, to assess the pelvic floor, which has marginal clinical reliability. This device can detect small changes in pelvic floor strength and help physicians diagnose a pelvic floor disorder before symptoms arise. This project will not only focus on the development of this diagnostic device, but also begin assessing the need and commercial opportunity for other products focused on pelvic floor care and rehabilitation. Pelvic health is a largely underserved market and has only recently gained attention through the commercialization of several mobile health training aids. This I-Corps project is to explore the development of a vaginal dynamometer, based on a reusable speculum coupled with a removable sensor to assess pelvic floor strength. The results from this device showed that a removable sensor design provides accurate results while reducing the cost-per-use to an acceptable level for routine use. The major limiting factor of current pelvic floor assessment technologies is the cost of use. Perineometers, ultrasound, and MRI are prohibitively costly for routine use in regular gynecologic checkups. The removable sensor design allows the patient-contacting portion of the device to undergo standard reprocessing protocols, such as autoclave, while the fragile sensor and electronics are removed and reused. We believe that such a design would become accessible for routine gynecologic use and could become a vital sign of pelvic health, much like blood pressure is for cardiovascular health.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.