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

该I-Corps项目更广泛的影响/商业潜力是开发一种用于治疗骨骼不成熟的儿科患者骨折和畸形的医疗器械。 在儿科人群中，15%至30%的骨折发生在骨骺板或生长板附近。这些儿科患者报告了并发症，如骨生长不均匀，以及随着骨成熟需要进行随访手术以重新调整器械。该技术是一种生长友好的手术治疗，允许骨愈合和随后的儿童生长期间延长。所提出的技术旨在提供足够的力来初始稳定变形的骨部分，以及适应骨延长的自然趋势所需的适应力。所提出的技术可扩展到骨质疏松和骨质减少骨的骨折固定，其中骨的孔隙率、密度和强度随时间发生显著变化。应用所提出的技术可能会减少恢复时间和降低医疗保健成本的治疗骨deformations.This I-Corps项目是基于超声激活的形状记忆延长装置的发展，用于治疗骨折和畸形的儿科患者与未成熟的骨骼。 所提出的技术使用超声加热来激活非侵入性整形外科器械中生物相容性材料镍钛诺的形状变化。所提出的技术的初步结果已经证明，超声引起的每次温度升高都会导致镍钛合金器械形状的轻微变化，这可能会使骨骼在不用力的情况下自然伸长（对于生长板骨折）或在手术的初始阶段后迫使骨骼伸长（对于脊柱侧凸治疗）。超声加热大约为几度-完全在用于激活形状变化的范围内，并且仍然由体内植入物附近的组织适应。与温度相关的形状变化和延长可以被定制以适合不同的骨形态或患者要求。 此外，该设备可以最大限度地减少或消除重新调整的手术，并可减少15- 50%的并发症。该奖项反映了NSF的法定使命，并已被认为值得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的支持。

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.