Product Development and Demonstration of Automated Mandibular Distractor

描述(由申请人提供)：牵引成骨正在成为获得必要的骨骼扩张以矫正先天性和获得性颅颌面部畸形的首选方法。这一过程包括在扩张部位进行截骨和机械装置，以1 mm/天的速度分离所产生的节段。自然的成骨过程会产生新的骨骼来填补不断扩大的缺口。下颌骨通常扩张超过30毫米。用来分散下颌骨的机械装置有一个驱动螺丝，螺丝的一端从皮肤或口腔中伸出。患者或他们的护理人员每天要旋转螺丝2-4次。自动化的过程将减少与治疗要求依从性较差相关的并发症，而且众所周知，连续运动可以产生新骨，牵张率是每天两次离散调整的两倍。这些优势将改善结果并减少装置必须植入的时间。这项提案要求获得FastTrack SBIR拨款，以完成下颌骨连续、自动牵张器的开发。该装置使用液压驱动和基于微处理器的闭环位置控制来执行分心，并可以沿直线和曲线轨迹精确分心。到目前为止，还没有测试过的其他自动分心装置具有这些功能。关键组件包括植入的致动器、患者外部佩戴的控制器，以及临床医生用来监控和调整治疗的用户界面。初步动物试验表明，该概念在尤卡坦小型猪(n=5)中是可行的。这里提出的工作将通过工程组件来完成技术开发，这些组件足够坚固，可以用于临床，并以准备好进行人体试验和产品开发的设备结束。第一阶段需要开发和展示一种将在体内可靠工作的位置传感器。第二阶段将包括临床医生用户界面的详细设计和坚固耐用的外部控制单元的设计，然后在尤卡坦小型猪(n=15)中测试该设备。测试将包括以分立设备的速度演示新设备，以及以更高的速度测试以量化持续分心的好处。提议团队由物理科学公司领导，其中包括马萨诸塞州综合医院口腔/颌面外科的外科医生和嵌入式系统设计公司的电子工程师。该提案还包含一份财务分析，显示了通过自动化实现的预期成本节约、预计收入和所需投资。 公共卫生相关性：牵张成骨是一种通过利用人体自然的骨愈合功能来矫正骨骼变形的技术。与骨移植相比，它在延长骨骼方面有许多优势，但目前的牵引器仍然受到使用者问题的困扰，这些问题使治疗复杂化，有时还会阻碍其成功。这里提出的自动化装置将通过消除患者的责任来改善结果，它将利用持续运动的生物益处来减少装置的植入时间。

DESCRIPTION (provided by applicant): Distraction Osteogenesis is becoming the preferred method to obtain the skeletal expansion necessary to correct congenital and acquired craniomaxillofacial deformities. The procedure consists of an osteotomy at the expansion site and a mechanical device to separate the resulting segments at 1mm/day. Natural osteogenic processes produce new bone to fill the expanding gap. The mandible is often expanded more than 30mm. The mechanical devices used for distracting the mandible have an actuation screw whose end protrudes through the skin or into the mouth. Patients or their caretakers are charged with turning the screw 2-4 times daily. Automating the process will reduce complications associated with poor compliance with the treatment requirements, and continuous motion is known to produce new bone at twice the distraction rate as twice-daily discrete adjustments. These advantages will improve outcomes and reduce the time a device must be implanted. This proposal requests a FastTrack SBIR grant to complete development of a continuous, automated distractor for the mandible. The device uses hydraulic actuation and microprocessor-based closed-loop position control to perform the distraction and can accurately distract along both linear and curvilinear trajectories. No other automated distracters tested to date have these features. Key components include the implanted actuator, a controller that the patient wears externally, and a user interface used by the clinician to monitor and adjust the treatment. Preliminary animal trials showed feasibility of the concept in Yucatan minipigs (n=5). The work proposed here will complete technology development by engineering components that are sufficiently rugged for clinical use and end with a device ready for human trials and product development. Phase I entails developing and demonstrating a position sensor that will function reliably in vivo. Phase II will consist of detailed engineering of the clinician's user interface and engineering a rugged external control unit, and then testing the device in Yucatan minipigs (n=15). The tests will include demonstration of the new device at the rates used with discrete devices, as well as tests at a higher rate to quantify the advantages of continuous distraction. The proposing team is led by Physical Sciences Inc., and includes surgeons in the Department of Oral/Maxillofacial Surgery at the Massachusetts General Hospital and electronic engineers at Embedded Systems Design. The proposal also contains a financial analysis showing expected cost savings achieved through automation, projected revenues, and required investments. PUBLIC HEALTH RELEVANCE: Distraction Osteogenesis is a technique for correcting bone deformities by tapping the body's natural bone- healing functions. It has many advantages over bone grafting to lengthen bone, but current distractors are still plagued by user problems that complicate treatment and sometimes hinder its success. The automated device proposed here will improve outcomes by eliminating patient responsibility, and it will use the biological benefits of continuous motion to reduce the time a device is implanted.