SBIR Phase II: Development of a pad and sensor system for a dynamic scoliosis brace

这项小型企业创新研究（SBIR）II期项目的更广泛影响/商业潜力是改善脊柱侧凸患者的临床护理。 脊柱侧凸是脊柱的侧向弯曲，影响美国600 - 900万人，占人口的2-3%，估计到2028年医疗费用为35亿美元。脊柱侧凸的当前治疗包括支具和/或脊柱手术。患者通常使用刚性胸椎脊柱侧凸支具进行治疗，该支具通常不提供弯曲矫正。佩戴支具的依从性可能具有挑战性。所提出的技术是一种智能的主动支架，通过动态的可调节平台向脊柱施加矫正力，并通过其传感器报告顺应性。这种个性化系统可以以降低的成本改善临床结果。这个小企业创新研究第二阶段项目旨在推动创新脊柱侧弯支具的开发。所提出的系统设计为舒适的，以增加患者的佩戴依从性。 该支架有一个动态机制，可以调整，以提供持续的压力，并将有蓝牙连接的传感器，使家长和医生，以确保治疗质量。 这项新技术将适应患者的生长和曲线矫正，同时保持精确的配合，并可能减少佩戴支具的社会耻辱。在该第二阶段提案中，将验证智能垫和传感器系统在临床环境中的功能和耐用性，将收集移动的应用程序和医生仪表板上的（矫形师、脊柱专家、患者和家属）信息，该奖项反映了NSF的法定使命，并被认为值得通过使用基金会的学术价值和更广泛的影响评审标准。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to improve clinical care for scoliosis patients. Scoliosis, a sideways curvature of the spine, affects 6-9 million individuals in the US, or 2-3% of the population, and has estimated healthcare costs of $3.5 billion by 2028. Current treatments for scoliosis include bracing and/or spinal surgery. Patients are often treated with a rigid thoracic scoliosis brace that does not typically provide curve correction. Compliance with wearing the brace can be challenging. The proposed technology is an intelligent, active brace that applies corrective forces to the spine via a dynamic, adjustable platform and reports compliance through its sensors. This personalized system may improve clinical outcomes at reduced cost. This Small Business Innovation Research Phase II project seeks to advance the development of an innovative scoliosis brace. The proposed system is designed to be comfortable to increase wear compliance by patients. The brace has a dynamic mechanism that can be adjusted to provide continuous pressure, and will have Bluetooth-connected sensors allowing parents and physicians to ensure treatment quality. The new technology will accommodate patient growth and curve correction while maintaining a precise fit, and may lessen the social stigma of wearing a brace. In this Phase II proposal, functionality and durability of the smart pad and sensor system in a clinical setting will be verified, feedback from end users (orthotists, spine specialists, patients and families) on the mobile application and physician dashboard will be collected, and the system economics and fabrication will be optimized.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.