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）：牵张成骨术正成为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，并用机械装置以每天1mm的速度分离所产生的节段。自然成骨过程产生新骨来填补不断扩大的骨隙。下颌骨通常扩张超过30mm。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。患者或其看护人员负责每天拧螺丝2-4次。自动化过程将减少与治疗要求依从性差相关的并发症，并且已知连续运动产生新骨的速度是每天两次离散调整的两倍。这些优点将改善治疗效果，缩短植入设备的时间。该提案要求获得快速跟踪SBIR拨款，以完成下颌骨连续、自动牵开器的开发。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散，并且可以沿着线性和曲线轨迹精确分散。迄今为止，测试过的其他自动干扰器都没有这些功能。关键部件包括植入的致动器，患者外部佩戴的控制器，以及临床医生用于监测和调整治疗的用户界面。初步动物试验表明，该概念在尤卡坦迷你猪（n=5）中是可行的。这里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，并以准备用于人体试验和产品开发的设备结束。第一阶段需要开发和演示一种能够在体内可靠工作的位置传感器。第二阶段将包括对临床医生的用户界面进行详细的工程设计，并设计一个坚固的外部控制单元，然后在尤卡坦迷你猪（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，以及以更高速率进行的测试，以量化持续分心的优势。提议的团队由物理科学公司领导，包括麻省总医院口腔/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。