Actuator for Bone Lengthening/Transport System:Phase II

描述(申请人提供)：肢体缩短畸形和骨节段性缺陷仍然是患者和骨科医生面临的最困难的挑战之一。纠正这些问题的传统技术主要依赖横向销或线，它们容易疼痛、疤痕、宫缩和感染的风险。第一阶段的研究证明了一种新的骨延长/运输方法的可行性，该方法基于牵张成骨，使用髓内棒固定和单个纵向牵引电缆致动器。这项工作的具体目标是开发一种完全可植入的致动器来驱动电缆运动，从而消除电线的所有经皮穿透，最大限度地减少患者干预，并使棒不太可能更换。在第一阶段，设计、制造了六个工程原型执行器，并成功地进行了台架测试，牵张力从1200 N到1200 N不等。在第二阶段，将开发、测试最终形成的高功率、独立和远程控制的牵引力执行器，并将其与主要现有的髓内钉和相关的植入硬件组合在一起。第二阶段成功开发出一种能力强大、成本效益高、体积为160毫升或更小、重量为200克或更小的执行器，这将为第三阶段完全可植入的骨骼延长和运输系统的商业开发奠定基础。

DESCRIPTION (provided by applicant): Limb-shortening deformities and bone segmental defects remain among the most difficult challenges faced by patients and orthopaedists. Traditional techniques to correct these problems rely primarily on transverse pins or wires, which are subject to pain, scars, contractions, and risk of infection. The Phase I research demonstrated the feasibility of a new method for bone lengthening/transport, based on distraction osteogenesis, and using intramedullary rod fixation and a single, longitudinal traction cable actuator. The specific aim of the work is develop a completely implantable actuator to drive cable motion, thus eliminating all percutaneous penetration of wires, minimizing patient intervention, and making the need for rod exchange unlikely. In Phase I, six engineering prototype actuators were designed, built and successfully bench-tested with varying distraction forces to 1,200 N. In Phase II, the final-form distraction actuator -high-powered, self-contained and remotely controlled - will be developed, tested and combined with a largely existing suite of intramedullary nails and associated implant hardware. The successful Phase II development of a capable, cost-effective actuator, occupying a volume of 160 cc or less and weighing 200 g or less, will set the stage for the Phase III commercial development of a fully implantable bone lengthening and transport system.