Product Development and Demonstration of Automated Mandibular Distractor

自动下颌牵开器产品开发与演示

• 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
• 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

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）：牵引成骨正在成为获得矫正先天性和获得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1 mm/天的速度分离所得节段。自然的成骨过程产生新的骨来填充不断扩大的间隙。下颌骨经常扩张超过30 mm。用于牵引下颌骨的机械装置具有致动螺钉，该致动螺钉的端部突出穿过皮肤或进入口中。患者或其看护人每天转动螺钉2-4次。自动化该过程将减少与治疗要求依从性差相关的并发症，并且已知连续运动以两倍于每日两次离散调整的牵引速率产生新骨。这些优点将改善结果并减少必须植入器械的时间。该提案要求获得FastTrack SBIR资助，以完成下颌骨连续自动牵引器的开发。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牵引，并且可以沿着线性和曲线轨迹精确地进行牵引。到目前为止，没有其他测试过的自动分心器具有这些功能。关键组件包括植入式致动器、患者佩戴在外部的控制器以及临床医生用于监测和调整治疗的用户界面。初步的动物试验表明，在尤卡坦小型猪（n=5）的概念的可行性。本文提出的工作将通过工程组件完成技术开发，这些组件足够坚固，可用于临床使用，并最终完成可用于人体试验和产品开发的设备。第一阶段需要开发和展示一种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工程设计和坚固的外部控制单元的工程设计，然后在尤卡坦小型猪（n=15）中测试该设备。测试将包括在与离散器械一起使用的速率下演示新器械，以及在更高速率下的测试，以量化持续牵引的优势。提案小组由物理科学公司领导，包括马萨诸塞州总医院口腔颌面外科的外科医生和嵌入式系统设计的电子工程师。该提案还包含一份财务分析，显示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：牵引成骨是一种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，它在延长骨方面具有许多优点，但目前的牵引器仍然受到用户问题的困扰，这些问题使治疗复杂化，有时会阻碍其成功。这里提出的自动化设备将通过消除患者责任来改善结果，并且它将利用连续运动的生物学益处来减少设备植入的时间。