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

SBIR第一阶段项目的广泛/商业影响将推动嵌入式传感器的开发，以支持最常见的脊柱畸形形式，青少年特发性脊柱侧凸（AIS）的治疗。 在美国，AIS并发症每年导致超过440，000次办公室就诊，130，000次医院就诊和17，000次急诊室就诊。这种疾病通过被动支具治疗减少脊柱弯曲进展来解决，这对使用者来说是痛苦的，并且不能纠正畸形，最终，超过三分之一的支具使用者停止佩戴支具。为了改善支具在停止曲线进展时的使用、舒适性和有效性，该项目将开发一种支具，该支具可向脊柱施加矫正压力以治疗AIS，并集成传感器来测量支具使用的持续时间和施加到脊柱的矫正力。真实的时间。该传感器将允许父母、患者和临床医生监测依从性;更重要的是，当矫正力低于阈值时，它将触发警报，以便临床医生可以及时安排调整。这个小型企业创新研究（SBIR）第一阶段项目将能够开发一种精确的方法来测量脊柱侧凸动态支具传感器中的矫正力。本提案中将解决的技术障碍是开发用于精确测量矫正力的嵌入式支具方法，因为支具的传感器系统必须能够可靠地检测传递到患者躯干的矫正力的方向或大小的变化。这将需要开发一个传感器系统，可以准确地解决这些力量。第一个技术目标将是优化每个垫上的力传感器的数量和模式。第二个技术目标是开发一种识别和获取有意义的力测量值的方法。这些目标将开发一种新型的动态脊柱侧凸支具，通过在原型中添加传感器并在第二阶段用于人类受试者来进一步增强。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/commercial impact of this SBIR Phase I project will advance the development of embedded sensors to support treatment for the most prevalent form of spinal deformity, adolescent idiopathic scoliosis (AIS). AIS complications cause more than 440,000 office visits, 130,000 hospital visits, and 17,000 emergency room visits each year in the United States. This disorder is addressed by reducing spine curve progression through passive brace treatment, which is painful for users and does not correct the deformity, and eventually, over one-third of brace users stop wearing the brace. To improve use, comfort, and effectiveness of braces at halting curve progression, this project will develop a brace that applies corrective pressure to the spine to treat AIS with integrated sensors measuring the duration of brace use and the corrective forces applied to the spine in real time. This sensor will allow parents, patients, and clinicians to monitor compliance; more importantly it will trigger an alert when corrective forces fall below a threshold so that clinicians can schedule adjustments in a timely manner. This Small Business Innovation Research (SBIR) Phase I project will enable the development of an accurate method to measure corrective forces in a sensor for a scoliosis dynamic brace. The technical hurdles that will be addressed in this proposal are the development of an embedded brace methodology for accurate measurements of corrective forces, as the sensor system of the brace must be able to reliably detect a change in the direction or magnitude of corrective force delivered to the patient's torso. This will require the development of a system of sensors that can accurately resolve these forces. The first technical objective will be to optimize the number and pattern of force sensors on each pad. The second technical objective will develop a method for identifying and acquiring meaningful force measurements. These aims will develop a novel dynamic scoliosis brace for further enhancement through addition of a sensor in the prototype and use in human subjects in Phase II.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.