I-Corps: Ultrasound-Activated Shape Memory Lengthening Device for Orthopedic Applications

I-Corps项目的更广泛影响/商业潜力是开发一种医疗设备，用于治疗骨骼不成熟的儿科患者的骨折和畸形。儿童人群中15%到30%的骨折发生在骨骺或生长板附近。这些儿童患者报告了并发症，如骨骼生长不均匀的发生，以及随着骨骼成熟需要进行后续手术来重新调整设备。所提出的技术是一种生长友好的手术治疗，在儿童生长过程中允许骨愈合和随后的延长。所提出的技术旨在为变形骨部分的初始稳定提供足够的力，以及适应骨骼延长的自然趋势所需的适应性力。所提出的技术可以扩展到骨质疏松和骨质减少的骨折固定，其中随着时间的推移，骨骼的孔隙度、密度和强度发生了显著变化。该技术的应用可以减少骨畸形治疗的恢复时间和医疗费用。这个I-Corps项目是基于一种超声激活的形状记忆延长装置的开发，用于治疗骨骼不成熟的儿童患者的骨折和畸形。提出的技术使用超声波加热来激活生物相容性材料镍钛诺的形状变化，在非侵入性骨科手术装置中。该技术的初步结果表明，超声波产生的每一次温度升高都会引起镍钛诺装置形状的轻微变化，这可能会使骨骼在没有外力的情况下自然延长（用于生长板骨折），或者在手术的初始阶段迫使骨骼延长（用于脊柱侧凸治疗）。超声波加热在几度的范围内——在激活形状变化的范围内，并且仍然被体内植入物附近的组织所适应。与温度相关的形状变化和延长可以根据不同的骨形态或患者的要求进行定制。此外，该装置可减少或消除重新调整的手术，并可将并发症减少15-50%。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 I-Corps project is the development of a medical device for the treatment of bone fractures and deformities in pediatric patients with immature skeletons. Fifteen to thirty percent of all fractures in the pediatric population occur close to the physeal or growth plate. These pediatric patients have reported complications such as the occurrence of uneven bone growth and the need for follow-up surgeries to readjust devices as bones mature. The proposed technology is a growth-friendly surgical treatment that allows bone union and subsequent lengthening during child growth. The proposed technology is designed to provide adequate forces for the initial stabilization of deformed bone parts, as well as adaptable forces that are required to accommodate the natural tendency for bones to lengthen. The proposed technology may be extended to fracture fixation in osteoporotic and osteopenic bones where there are significant changes in the porosity, density, and strength of bones over time. Applications of the proposed technology may decrease recovery time and reduce health care costs for the treatment of bone deformities.This I-Corps project is based on the development of an ultrasound-activated shape memory lengthening device for the treatment of bone fractures and deformities in pediatric patients with immature skeletons. The proposed technology uses ultrasound heating to activate a shape change in the biocompatible material, nitinol, in a non-invasive orthopedic surgical device. Initial results with the proposed technology have demonstrated that each increase in temperature from ultrasound causes a slight change in the shape of a nitinol device, which may allow a bone to naturally lengthen without force (for growth plate fractures) or force the bones to lengthen (for scoliosis treatments) after the initial stages of the surgery. The ultrasound heating is on the order of a few degrees – well within the range for activating the shape change and still be accommodated by the tissues adjacent to the implant in the body. The temperature-associated shape change and lengthening may be tailored to suit different bone morphologies or patient requirements. In addition, the proposed device may minimize or eliminate surgeries for readjustment and may reduce complications by 15-50%.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.