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

I-Corps项目更广泛的影响/商业潜力是开发一种医疗设备，用于治疗骨骼未成熟的儿科患者的骨折和畸形。在儿科人群中，15%至30%的骨折发生在生长板或生长板附近。这些儿科患者报告了并发症，如骨骼生长不均匀的发生，以及随着骨骼成熟需要后续手术重新调整设备。这项拟议的技术是一种对生长有利的外科治疗方法，可以在儿童生长过程中进行骨愈合和随后的延长。拟议的技术旨在为变形的骨骼部分的初始稳定提供足够的力，以及适应骨骼自然延长的趋势所需的适应性力。建议的技术可以扩展到骨质疏松和骨质疏松骨骼的骨折固定，这些骨骼的孔隙度、密度和强度随着时间的推移有显著变化。应用这项拟议的技术可以缩短骨变形治疗的恢复时间并降低医疗成本。这项I-Corps项目是基于开发一种超声激活的形状记忆延长器，用于治疗具有未成熟骨骼的儿童骨折和畸形。这项拟议的技术使用超声波加热来激活非侵入性整形外科设备中生物兼容材料镍钛醇的形状变化。这项拟议技术的初步结果表明，超声波产生的温度每升高一次，镍钛合金装置的形状就会发生轻微变化，这可能会使骨骼自然延长(对于生长板骨折)，或者在手术初始阶段后迫使骨骼延长(用于脊柱侧弯治疗)。超声波加热在几度量级--完全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容纳。温度相关的形状变化和延长可以定制以适应不同的骨形态或患者的要求。此外，建议的设备可以最大限度地减少或消除重新调整的手术，并可以减少15%-50%的并发症。这一奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.