Actuator for Bone Lengthening/Transport System:Phase II

描述（由申请人提供）：肢体缩短畸形和骨节段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于横向针或钢丝，这容易引起疼痛、疤痕、收缩和感染风险。第一阶段的研究证明了一种基于牵张成骨的骨延长/运输新方法的可行性，该方法使用髓内棒固定和单个纵向牵引电缆执行器。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，从而消除所有经皮导线穿透，最大限度地减少患者干预，并且不太可能需要换棒。在第一阶段，设计、制造了6个工程原型执行器，并成功地在1200 n的不同牵引力下进行了实验测试。在第二阶段，最终形式的牵引力执行器——高性能、独立和远程控制——将被开发、测试，并与大部分现有的髓内钉套件和相关植入物硬件相结合。第二阶段成功开发了一种功能强大、成本效益高的驱动器，体积为160cc或更小，重量为200g或更小，将为第三阶段的完全植入式骨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.