Electropolishing of Nitinol Stents in Aqueous, Acid Free Solutions

在无酸水溶液中电解抛光镍钛合金支架

基本信息

  • 批准号:
    8452752
  • 负责人:
  • 金额:
    $ 15万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2013
  • 资助国家:
    美国
  • 起止时间:
    2013-09-01 至 2014-08-31
  • 项目状态:
    已结题

项目摘要

Project Summary/Abstract Faraday Technology proposes to develop the FARADAYIC ElectroPolishing Process, based on pulse reverse electrolytic polishing of stents, fabricated from nitinol and other materials of interest to industry, for rapid, cost-effective surface finishing in a simple aqueous acid-free electrolyte. This process will eliminate the worker safety hazards associated with conventional electropolishing, that uses mixed high concentration acid electrolytes, including sulfuric, phosphoric, hydrofluoric and perchloric acids. As an additional benefit, this process will also minimize the current process control difficulties and high reject rates associated with conventional electropolishing of stents in strong acid electrolytes. Specifically, the lack of robustness of conventional electropolishing results in stent reject rates approaching 40-50%, which greatly increases device cost. Compared to conventional electropolishing, FARADAYIC ElectroPolishing will provide a uniformly smooth surface using a simple salt solution, such as sodium chloride or sodium nitrate. The specific aims of the Phase I are to optimize the ElectroPolishing process using simple salt solutions on industry supplied stents fabricated from Nitinol, design to an ¿-scale manufacturing apparatus that would be built and tested in Phase II, and work with our collaborators to prepare a transition strategy for this technology for industrial implementation. The measures of merit for the Phase I project will include: 1) surface finish, based on industrial stent specifications, 2) polishing rate, and 3) dimensional tolerance. The proposed project meets the NIH mission by developing an innovative, non-toxic stent manufacturing process with the overall aim of addressing technological innovation in the U.S. manufacturing economy consistent with Executive Order "Encouraging Innovation in Manufacturing". This technology will enable a safe, high yield, cost-effective manufacturing process for nitinol stents, and will be compatible with stents and other devices fabricated from a wide variety of materials. Stents represent one of the fastest growing segments of the medical device market. From their introduction in 1990, the stent market grew to over $5 billion in 2011. To achieve the Phase I aims, Faraday will optimize the FARADAYIC ElectroPolishing process on tubular stents, evaluate the FARADAYIC Processes for other materials of interest to industry, design an ¿-scale pilot manufacturing apparatus for demonstration of continuous, industrial-scale processing of Nitinol stent tubes, and complete a manufacturing process flow, economic assessment, quality plan, and development of documentation, processes and procedures for compliance with FDA regulations. This effort is designed to move into Phase II and III, in which the technology would be transitioned to our industrial collaborators.
项目总结/摘要 法拉第技术公司提出开发基于脉冲反向的法拉第电抛光工艺 电解抛光由镍钛诺和工业上感兴趣的其它材料制成的支架,用于快速, 在简单的含水无酸电解液中进行成本效益高的表面处理。这一过程将消除工人 与使用混合高浓度酸的传统电解抛光相关的安全隐患 电解质,包括硫酸、磷酸、氢氟酸和高氯酸。作为额外的好处,这 过程还将最大限度地减少目前的过程控制困难和高废品率相关的 在强酸性电解质中对支架进行常规电抛光。具体而言,缺乏鲁棒性 传统的电抛光导致支架废品率接近40- 50%,这大大增加了设备 成本与传统的电解抛光相比,法拉帝电解抛光将提供均匀的 使用简单的盐溶液,如氯化钠或硝酸钠,使表面光滑。的具体目标 第一阶段是在行业供应的支架上使用简单的盐溶液优化电解抛光工艺 由镍钛合金制成,设计为半规模制造装置,将在第三阶段构建和测试 II,并与我们的合作者一起为这项技术的工业发展制定过渡战略。 实施.第一阶段项目的优点措施将包括:1)表面光洁度,基于 工业支架规格,2)抛光速率,和3)尺寸公差。 拟议的项目符合美国国立卫生研究院的使命,通过开发一种创新的,无毒的支架制造 这一进程的总体目标是解决美国制造业经济中的技术创新问题 与行政命令“鼓励制造业创新”相一致。这项技术将使 安全、高产率、具有成本效益的镍钛合金支架制造工艺,并将与支架兼容, 由多种材料制成的其它装置。支架是增长最快的领域之一 医疗器械市场。从1990年推出以来,支架市场在2011年增长到超过50亿美元。 为了实现第一阶段的目标,法拉第将优化管状支架上的法拉第电抛光工艺, 评估工业界感兴趣的其他材料的法拉达伊工艺,设计一个大规模的试验 用于演示镍钛合金支架管的连续、工业规模加工的制造设备, 并完成制造工艺流程、经济评估、质量计划和开发 符合FDA法规的文件、流程和程序。这一努力旨在推动 进入第二阶段和第三阶段,在这两个阶段,技术将过渡到我们的工业合作者。

项目成果

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MARIA E INMAN其他文献

MARIA E INMAN的其他文献

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{{ truncateString('MARIA E INMAN', 18)}}的其他基金

ElectroPolishing for Cost Effective, High Yield Nitinol Stent Fabrication
电解抛光可实现成本效益高、产量高的镍钛诺支架制造
  • 批准号:
    8532957
  • 财政年份:
    2010
  • 资助金额:
    $ 15万
  • 项目类别:
ElectroPolishing for Cost Effective, High Yield Nitinol Stent Fabrication
电解抛光可实现成本效益高、产量高的镍钛诺支架制造
  • 批准号:
    8314243
  • 财政年份:
    2010
  • 资助金额:
    $ 15万
  • 项目类别:

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