NITINOL POWERED IMPLANTABLE BONE DISTRACTOR

镍钛合金动力植入式骨牵引器

• 批准号: 2856151
• 负责人: GERALD G CANO
• 金额: $ 37.85万
• 依托单位: METAMORPHIC SURGICAL DEVICES
• 依托单位国家: 美国
• 财政年份: 1996
• 资助国家: 美国
• 起止时间: 1996-08-01 至 2000-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2856151
• 关键词: biomaterial compatibility; biomedical device power system; biomedical equipment development; craniofacial; dogs; histopathology; implant; laboratory rabbit; medical implant science; nickel; nonhuman therapy evaluation; orthopedics; osteogenesis; skeletal prosthesis; titanium

The 1995 meeting of the International Association of Plastic and Reconstructive Surgeons affirmed that, during the next decade, bone distraction has the potential to replace many complex craniofacial surgical procedures currently in use or allow procedures to be performed that were not technically feasible in the past. MSD's product objective, a completely buried bone distraction system suitable for craniomaxillofacial applications powered by an electronically controlled Nitinol actuator, will distract both osteotomy sites and patent craniofacial sutures automatically with small, precise, and frequent incrementation to mimics continuous growth and thus improve osteogenesis. The buried system includes: i) a small encapsulated distractor unit that incorporates an integral Nitinol actuator to mechanically power the unit; ii) buried electronic control circuitry that both monitors the system and also times the application of electric current to the Nitinol actuator to produce incremental distraction; and, iii) an implantable battery to power the system for up to 30 days operation. Required implantable battery and micro-controller technologies are well within "state-of-the-art." Under this Phase II proposal, the distractor system will be i) completely designed and prototyped, ii) tested both on the bench and in appropriate animal models, and, lastly, iii) undergo biocompatibility testing by an accredited laboratory in preparation for an FDA submission and human trials. PROPOSED COMMERCIAL APPLICATION In the United States, 134 centers perform approximately 7,000 intracranial, craniofacial and orthognathic procedures annually. However, 11 centers in four states currently perform over 41 percent of the total procedures, averaging over 250 procedures per year. Such a high concentration of surgical activity provides a substantial opportunity for MSD's distractor to gain substantial and rapid market acceptance. It is estimated that currently 30 percent-40 percent of the total 7,000 surgical procedures performed in these specialized centers could immediately benefit from a clinically suitable distractor. MSD also expects that its distractor will be used to replace approximately one-half of the craniofacial bone grafting procedures within three years due to the significant cost savings that MSD's distractor provides.

1995年国际塑料与塑料协会会议 重建外科医生确认，在接下来的十年中，骨 分散注意力有可能取代许多复杂的颅面手术 当前正在使用的外科手术或允许执行的手术 这在过去技术上是不可行的。 默沙东的产品 目标，完全埋入骨牵引系统，适用于 由电子控制的颅颌面应用 镍钛合金致动器，会分散截骨部位和专利 颅面自动缝合，小、精确、频繁 增量模仿持续增长，从而提高 成骨。 埋地系统包括： i) 小型封装 牵引装置包含一个集成的镍钛诺执行器 为装置提供机械动力； ii) 埋地电子控制电路 既可以监控系统，也可以对电力的应用进行计时 向镍钛诺执行器提供电流以产生增量分散；和， iii) 植入式电池可为系统供电长达 30 天 手术。 所需的植入式电池和微控制器 技术完全属于“最先进的”。在本第二阶段 建议，牵引系统将 i) 完全设计和 原型化，ii) 在工作台上和适当的动物身上进行了测试 模型，最后，iii) 接受生物相容性测试 认可实验室正在准备 FDA 提交和人类 试验。 拟议的商业应用 在美国，134 个中心执行大约 7,000 每年进行颅内、颅面和正颌手术。 然而，目前，四个州的 11 个中心的执行率超过 41%。 手术总数，平均每年超过 250 例。 这样一个 高集中度的手术活动提供了大量的 默沙东分心器获得大量快速市场的机会 验收。 据估计，目前有30%-40% 这些专业中心总共进行了 7,000 例外科手术 可以立即受益于临床上合适的牵引器。 默沙东 还预计其干扰器将被用来替代大约 三年内完成二分之一的颅面骨移植手术 由于 MSD 的牵引器可显着节省成本。