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

这个小企业创新研究（SBIR）二期项目的更广泛的影响/商业潜力是改善脊柱侧弯患者的临床护理。脊柱侧弯是一种脊柱侧弯，在美国有600万至900万人患有此病，占美国人口的2-3%，预计到2028年，该疾病的医疗成本将达到35亿美元。目前治疗脊柱侧凸的方法包括支具和/或脊柱手术。患者通常使用刚性胸侧凸支架治疗，通常不提供弯曲矫正。佩戴支架的依从性可能具有挑战性。所提出的技术是一种智能的、主动的支架，通过一个动态的、可调节的平台对脊柱施加矫正力，并通过传感器报告依从性。这种个性化的系统可以以较低的成本改善临床结果。这个小企业创新研究二期项目旨在推进一种创新的脊柱侧凸支架的发展。所提出的系统被设计为舒适，以增加患者的佩戴依从性。这种支架有一个动态的机制，可以调节以提供持续的压力，并将有蓝牙连接的传感器，让父母和医生确保治疗质量。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，并可能减少佩戴支架的社会耻辱。在这个第二阶段的提案中，将验证智能pad和传感器系统在临床环境中的功能和耐用性，收集终端用户（矫形师、脊柱专家、患者和家属）在移动应用程序和医生仪表板上的反馈，并优化系统的经济性和制造。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 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.