SBIR Phase I: An ambulatory pelvic floor monitoring and feedback device for use in physical therapy

这项小企业创新研究（SBIR）一期项目的更广泛影响/商业潜力是一种新型设备，使盆腔治疗师能够在引起盆底症状的活动期间评估、诊断和治疗患者。在美国，四分之一的女性患有盆底疾病，这种疾病每年造成200亿美元的损失和反复出现的负面患者经历。盆腔物理治疗是推荐的一线治疗方法，但需要定期管理，每次就诊都给患者和临床资源带来负担。目前的系统仅限于静态的病人条件与特定的情境肌肉条件。这种新颖的盆底监测装置旨在提供优化的盆底肌肉反馈在慢性动态条件下，当一个显著百分比的盆底事件发生。这个小企业创新研究（SBIR）一期项目是一种以患者自我管理的方式减轻盆底疾病负担的新型设备。一种可穿戴的骨盆底监测设备将提供动态评估和治疗慢性流动条件。本项目旨在设计和制作运动时使用的骨盆底力传感器的组件和系统的原型。该设备将被集成到一个舒适且符合人体工程学的硅胶外壳中，该外壳具有可互换的袖子，以适应不同患者的解剖结构，以及一个无线生物反馈软件，用于从设备向患者和治疗师传输数据。该系统将进行台式测试，以确保传感器和数据传输的准确和稳健性能。人体工程学的形状将在有限的病人试点测试舒适性和阴道保留。该项目的成功完成将证明一种新型动态盆底监测和反馈设备在技术和商业上的可行性。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 Innovation Research (SBIR) Phase I project is a novel device that enables pelvic therapists to evaluate, diagnose, and treat patients during activities responsible for pelvic floor symptoms. One in four women in the US has a pelvic floor disorder and this disorder results in $20 billion in annual costs and negative recurring patient experiences. Pelvic physical therapy is the recommended first-line treatment but requires regular management, burdening the patient and clinical resources with each visit. Current systems are limited to static patient conditions with specific situational muscle conditions. This novel pelvic floor monitoring device aims to provide optimized pelvic floor muscle feedback during chronic ambulatory conditions when a significant percent of pelvic floor events occur.This Small Business Innovation Research (SBIR) Phase I project is a novel device to reduce the burden of pelvic floor disorders in a patient self-managed manner. A wearable pelvic floor monitoring device will provide dynamic evaluation and treatment for chronic ambulatory conditions. This project aims to design and prototype the components and system of a pelvic floor force sensor for use during exercise. The device will be integrated into a comfortable and ergonomically fitted silicone shell with interchangeable sleeves to fit different patients’ anatomies, and a wireless biofeedback software for communicating data from the device to the patient and therapist. The system will be benchtop tested to ensure accurate and robust performance of the sensors and data transmission. The ergonomic shape will be tested in a limited patient pilot for comfort and vaginal retention. Successful completion of this project will demonstrate the technical and commercial feasibility of a novel ambulatory pelvic floor monitoring and feedback device for patients.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.