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

I-Corps项目更广泛的影响/商业潜力在于开发了一种新设备，可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，每四名女性中就有一名在有生之年会经历盆底疾病。医生仍然依赖手指触诊来评估盆底，这种方法在临床上几乎没有可靠性。这种设备可以检测到盆底力量的微小变化，并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，还将开始评估其他专注于盆底护理和康复的产品的需求和商业机会。骨盆健康在很大程度上是一个服务不足的市场，直到最近才通过几种流动健康训练辅助工具的商业化获得了关注。这个i-Corps项目是为了探索一种阴道测力计的开发，它基于一个可重复使用的窥镜和一个可拆卸的传感器来评估骨盆底部的力量。该装置的结果表明，可拆卸的传感器设计可提供准确的结果，同时将每次使用成本降低到常规使用可接受的水平。目前盆底评估技术的主要限制因素是使用成本。在常规妇科检查中，周围计、超声波和核磁共振的费用高得令人望而却步。可拆卸的传感器设计允许设备的患者接触部分经过标准的再处理协议，如高压灭菌器，而易碎的传感器和电子设备被拆卸和重复使用。我们相信，这样的设计将可以用于妇科的常规用途，并可能成为骨盆健康的重要标志，就像血压对于心血管健康的影响一样。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.