Product Development and Demonstration of Automated Mandibular Distractor

自动下颌牵开器产品开发与演示

基本信息

批准号：
7670564
负责人：
JOHN C MAGILL
金额：
$ 13.81万
依托单位：
PHYSICAL SCIENCES, INC
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-06-24 至 2009-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7670564
关键词：
Address Admission activity Animal Testing Animals Automation Bathing Benchmarking Biological Biomechanics Blood Bone Lengthening Bone Transplantation Boxing Cadaver Charge Clinical Computer software Corrosion Cost Savings Custom Deformity Development Devices Distraction Osteogenesis Elasticity Electronics Engineering Environment Failure Family suidae Fatigue Gases General Hospitals Grant Healed Histology Human Implant In Vitro Investments Lead Life Liquid substance Living Wills Mandible Manufacturer Name Marketing Massachusetts Mature Bone Measurement Measures Mechanics Medical Medical Device Methods Microprocessor Miniature Swine Modeling Molds Monitor Motion Motor Operative Surgical Procedures Oral Oral cavity Osteotomy Outcome Particulate Patients Performance Personal Digital Assistant Persons Phase Plague Positioning Attribute Preparation Procedures Process Protein Structure Initiative Protocols documentation Quality Control Request for Proposals Science Site Skin Small Business Innovation Research Grant Solutions Specific qualifier value Surgeon System Techniques Technology Testing Time Tube Ultrasonography United States National Institutes of Health Update Work base biomaterial compatibility bone bone healing craniomaxillofacial design distraction healing implant material implanted sensor improved in vivo manufacturing facility manufacturing scale-up maxillofacial meetings novel oral surgery specialty osteogenic particle patient responsibilities physical science prevent product development programs prototype public health relevance sample fixation seal sensor skeletal success technology development

项目摘要

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.

描述（由申请人提供）：牵引成骨术正在成为获得纠正先天性和后天性颅颌面畸形所需的骨骼扩张的首选方法。该手术包括在扩张部位进行截骨术，并使用机械装置以每天 1 毫米的速度将所得节段分开。自然成骨过程会产生新骨来填补不断扩大的间隙。下颌骨常扩张超过30毫米。用于分散下颌骨的机械装置有一个驱动螺钉，其末端突出穿过皮肤或进入口腔。患者或其护理人员每天需要转动螺钉 2-4 次。该过程的自动化将减少与治疗要求依从性差相关的并发症，并且众所周知，连续运动产生新骨的速度是每天两次离散调整的两倍。这些优势将改善结果并减少设备植入的时间。该提案请求 FastTrack SBIR 拨款，以完成下颌骨连续自动牵引器的开发。该设备使用液压驱动和基于微处理器的闭环位置控制来执行牵引，并且可以沿着线性和曲线轨迹精确地牵引。迄今为止，没有其他经过测试的自动干扰器具有这些功能。关键组件包括植入的执行器、患者外部佩戴的控制器以及临床医生用于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半岛小型猪（n=5）中的可行性。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，适合临床使用，并最终形成可供人体试验和产品开发的设备。第一阶段需要开发和演示一种在体内可靠运行的位置传感器。第二阶段将包括临床医生用户界面的详细设计和坚固的外部控制单元的设计，然后在尤卡坦半岛小型猪（n=15）中测试该设备。测试将包括以分立设备使用的速率演示新设备，以及以更高的速率进行测试，以量化持续分心的优势。该提案团队由Physical Sciences Inc.领导，成员包括马萨诸塞州总医院口腔/颌面外科部门的外科医生和嵌入式系统设计公司的电子工程师。该提案还包含财务分析，显示通过自动化实现的预期成本节省、预计收入和所需投资。公众健康相关性：牵引成骨是一种通过利用人体自然骨愈合功能来矫正骨畸形的技术。与骨移植相比，它具有许多优点来延长骨骼，但目前的牵引器仍然受到用户问题的困扰，这些问题使治疗变得复杂，有时甚至阻碍了治疗的成功。这里提出的自动化设备将通过消除患者的责任来改善结果，并且它将利用连续运动的生物学优势来减少设备的植入时间。