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: 8010659
• 负责人: JOHN C MAGILL
• 金额: $ 38万
• 依托单位: PHYSICAL SCIENCES, INC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-01 至 2012-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8010659
• 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; Mandible; Manufacturer Name; Marketing; Massachusetts; Mature Bone; Measurement; Measures; Mechanics; Medical; Medical Device; Methods; Microprocessor; Miniature Swine; Modeling; Molds; Monitor; Motion; Motor; 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; operation; 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）：分散骨化已成为获得纠正先天性和颅骨骨化畸形所需的骨骼扩张的首选方法。该过程由膨胀部位的截骨术和一种机械装置组成，以每天为1mm/天分离所得段。天然成骨过程产生新的骨头以填补扩大的空白。下颌骨通常会扩展超过30mm。用于分散下颌骨的机械设备具有驱动螺钉，其末端通过皮肤或口腔突出。患者或他们的看护人每天将螺丝转2-4次。自动化这一过程将减少与治疗要求不佳相关的并发症，并且已知连续运动以每日离散调整的两次分散率产生新的骨骼。这些优势将改善结果，并减少必须植入设备的时间。该提案要求FastTrack SBIR拨款完成下颌骨连续的，自动化的干扰器的开发。该设备使用液压致动和基于微处理器的闭环位置控制来执行干扰，并可以准确地沿线性和曲线轨迹分散注意力。迄今为止，没有其他自动化分散剂具有这些功能。关键组件包括植入的执行器，患者佩戴的控制器以及临床医生使用的用户界面来监测和调整治疗。初步动物试验显示了该概念在Yucatan Minipigs中的可行性（n = 5）。这里提出的工作将通过工程组件来完成技术开发，这些组件足够坚固耐用，可以供临床使用，并以准备人为试验和产品开发的设备结束。第一阶段需要开发和演示一个位置传感器，该位置传感器将在体内可靠地发挥作用。第二阶段将包括临床医生用户界面的详细工程和工程崎and的外部控制单元，然后在Yucatan Minipigs中测试设备（n = 15）。测试将包括以离散设备使用的速率来演示新设备，以及以较高速率进行测试，以量化连续干扰的优势。提议团队由物理科学公司领导，包括马萨诸塞州综合医院的口腔/颌面外科外科医生和嵌入式系统设计的电子工程师。该提案还包含一项财务分析，显示通过自动化实现的预期成本节省，预计收入和所需的投资。 公共卫生相关性：分散骨化是一种通过攻击人体自然骨骼愈合功能来纠正骨骼畸形的技术。它比骨头嫁接具有许多优势以延长骨骼，但是当前的干扰因素仍然受到用户问题的困扰，这些问题使治疗复杂并有时会阻碍其成功。此处提出的自动化设备将通过消除患者的责任来改善预后，它将使用连续运动的生物学益处来减少设备的植入时间。