Actuator for Bone Lengthening/Transport System:Phase II

描述（由申请人提供）：肢体短缩畸形和骨节段性缺损仍然是患者和骨科医生面临的最困难的挑战。纠正这些问题的传统技术主要依赖于横向针或线，这会导致疼痛、疤痕、收缩和感染的风险。I期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，并使用髓内棒固定和单个纵向牵引缆线致动器。该工作的具体目标是开发一种完全植入式致动器，以驱动电缆运动，从而消除所有经皮导丝穿透，最大限度地减少患者干预，并使更换棒的需求变得不太可能。在第一阶段，设计、制造了六个工程原型致动器，并成功地进行了台架测试，牵引力可达1,200 N。在第二阶段，最终形式的牵引致动器-高功率，独立和远程控制-将被开发，测试和结合现有的髓内钉和相关的植入硬件套件。第二阶段的成功开发，一个有能力的，具有成本效益的驱动器，占用体积为160毫升或更少，重量为200克或更少，将设置阶段三商业开发的完全植入式骨延长和运输系统。

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.