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

小型企业创新研究(SBIR)第一阶段项目的更广泛影响/商业潜力是一种新型设备，使骨盆治疗师能够在负责盆底症状的活动期间评估、诊断和治疗患者。在美国，每四名女性中就有一人患有盆底疾病，这种疾病导致每年200亿美元的成本和反复出现的负面患者体验。盆腔物理治疗是推荐的一线治疗方法，但需要定期治疗，每次就诊都会给患者和临床资源带来负担。目前的系统仅限于具有特定情景肌肉情况的静态患者情况。这种新型的盆底监测设备旨在当相当比例的盆底事件发生时，在慢性非卧床条件下提供优化的盆底肌肉反馈。这项小型企业创新研究(SBIR)第一阶段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。一种可穿戴的盆底监测设备将为慢性非卧床状况提供动态评估和治疗。该项目旨在设计和制作用于锻炼的骨盆底力传感器的部件和系统原型。该设备将集成到一个舒适的、符合人体工程学的硅胶外壳中，该外壳带有可更换的套筒，以适应不同患者的解剖结构，以及一个无线生物反馈软件，用于从该设备向患者和治疗师传达数据。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强大的性能。人体工程学的形状将在有限的患者飞行员身上进行舒适性和阴道保留的测试。该项目的成功完成将证明一种用于患者的新型可移动盆底监测和反馈设备的技术和商业可行性。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 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.