Continuous, Automated, Mandibular Distraction Device

描述（由申请人提供）：Physical Sciences Inc. (PSI)与马萨诸塞州总医院口腔颌面外科的临床医生合作，建议继续开发一种用于下颌骨牵引成骨（DO）的创新装置。正在开发的概念在全埋式致动器中使用微型液压装置，能够产生线性和曲线牵引轨迹。这种新的牵引器将通过自动化运动过程来减少患者的责任，允许临床医生随着治疗的进展改变运动的牵引速率，并通过使运动几乎连续来减少牵引时间。它还将提供全埋放置的选择，没有链接或电气连接穿过皮肤。第一阶段通过台架测量和在猪尸体中植入原型的测试证明了该概念的可行性。所有提议的第一阶段目标都已完成，团队能够完成提议的第一阶段工作之外的几个开发步骤。我们在此建议在初步成功的基础上进行第二阶段计划，该计划将完善设计，生产几种原型，并在活体动物中进行测试。虽然需要进行额外的测试，但第二阶段的工作将开发生产临床有用的牵引器所需的所有基本组件。

DESCRIPTION (provided by applicant): Physical Sciences Inc. (PSI), in partnership with clinicians in the Massachusetts General Hospital Department of Oral and Maxillofacial Surgery, proposes to continue development of an innovative device for performing distraction osteogenesis (DO) of the mandible. The concept under development uses miniature hydraulics in a fully buried actuator capable of producing linear and curvilinear distraction trajectories. This new distractor will reduce patient responsibility by automating the motion process, permit clinicians to alter the distraction rate of motion as treatment progresses, and reduce distraction time by making the motion virtually continuous. It will also offer the option of fully-buried placement, with no linkages or electrical connections passing through skin. Phase I demonstrated feasibility of the concept with bench top measurements and tests with the prototype implanted in a pig cadaver. All of the proposed Phase I objectives were completed, and the team was able to complete several development steps beyond the proposed Phase I effort. We propose herein to build on the initial success with a Phase II program that will refine the design, produce several prototypes, and perform testing in live animals. Though additional testing will be required, the Phase II work will develop all of the essential components necessary to produce a clinically-useful distractor.