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

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是一种新型器械，使盆腔治疗师能够在活动期间评估、诊断和治疗患者的骨盆底症状。在美国，四分之一的女性患有骨盆底疾病，这种疾病导致每年200亿美元的费用和负面的反复出现的患者经历。盆腔物理治疗是推荐的一线治疗，但需要定期管理，每次就诊都会增加患者和临床资源的负担。当前系统限于具有特定情境肌肉状况的静态患者状况。这种新型的骨盆底监测设备旨在提供优化的骨盆底肌肉反馈，在慢性非卧床条件下，当一个显着的百分比发生的骨盆底事件。这个小企业创新研究（SBIR）的第一阶段项目是一种新型的设备，以减轻患者自我管理的方式骨盆底疾病的负担。可穿戴骨盆底监测设备将为慢性非卧床状况提供动态评估和治疗。本项目旨在设计和原型的组件和系统的骨盆底力传感器在运动过程中使用。 该设备将被集成到一个舒适和符合人体工程学的硅胶外壳中，外壳具有可互换的套管，以适应不同患者的解剖结构，以及一个无线生物反馈软件，用于将数据从设备传输到患者和治疗师。该系统将进行台架测试，以确保传感器和数据传输的准确和稳健性能。 人体工程学形状将在有限的患者试点中测试舒适度和阴道保留。该项目的成功完成将证明一种新型的非卧床骨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.