SBIR Phase I: Dynamic Night Splint

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是改善脚底筋膜炎(PF)的护理，这是一种沿着脚底连接脚后跟和脚趾的纤维组织(足底筋膜)的炎症。这种进行性退行性疾病会导致刺痛，有时还会导致虚弱的疼痛。足底筋膜炎在运动员中最常见，但也发生在久坐的人，特别是超重的人，是成年人脚跟疼痛的最常见原因，估计终身风险为10%。在美国，每年大约有200-300万名PF患者接受治疗，这是去看足科医生的主要原因。PF的保守治疗是适度成功的，但20%至30%的患者进展为慢性疾病，可持续数年，难以治疗。与传统夹板技术相比，拟议的动态夜间夹板旨在加速愈合，并改善患者的依从性和预后。这可能会被用于其他可控运动比静态约束更好的医疗条件。这个小型企业创新研究(SBIR)第一阶段项目集成了微型机电组件、“物联网”技术和以患者为中心的医疗器械设计方法，以实现重新想象的夜间夹板。这一概念使得从对受伤组织的刚性约束转变为主动操纵组织以加速恢复。为了实现临床上可行的解决方案，这将满足相互竞争的要求，包括整合动态组件、控制和电源系统、直观的用户界面和可靠的安全功能，同时将外形系数降至最低，并使患者舒适度最大化。这一阶段的项目设计和制造的夜间夹板与必要的元素(腿接合灵活的“靴子”结构，机电驱动系统，和移动应用程序用户界面)，以验证设计通过台架测试和用户评估。该奖项反映了国家科学基金会的法定使命，并已被认为值得支持，通过使用基金会的智力价值和更广泛的影响审查标准进行评估。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is improved care for plantar fasciitis (PF), an inflammation of the fibrous tissue (plantar fascia) along the bottom of the foot connecting the heel bone to the toes. This progressive degenerative condition results in stabbing, sometimes debilitating, pain. Plantar fasciitis is most common in athletes, but it also occurs in sedentary people, particularly overweight individuals, and is the most common cause of heel pain in adults, with an estimated lifetime risk of 10%. In the US, approximately 2-3 million patients are treated for PF every year and it is the leading reason to visit a podiatrist. Conservative treatments of PF are moderately successful, but 20% to 30% of patients progress to a chronic condition that can last years and is difficult to treat. The proposed dynamic night splint is intended to accelerate healing relative to conventional splinting technologies and to improve patient compliance and prognosis. This can potentially be used for other medical conditions where controlled motion is better than a static constraint.This Small Business Innovation Research (SBIR) Phase I project integrates miniature electromechanical components, “internet-of-things” technology, and a patient-centric approach to medical device design to achieve a re-imagined night splint. The concept enables a shift from rigid constraint of the injured tissue to actively manipulating the tissue to accelerate recovery. To achieve a clinically viable solution this will address competing requirements, including incorporation of dynamic components, a control and power system, an intuitive user interface, and reliable safety features, while minimizing the form factor and maximizing patient comfort. This Phase 1 project designs and fabricates the night splint with the necessary elements (a leg engaging flexible “boot” structure, an electromechanical drive system, and a mobile app user interface) to validate the design through bench testing and user assessments.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.