Throughmask ElectroEtching for Cost-Effective Nitinol Stent Fabrication

描述（由申请人提供）：描述法拉第技术公司。提出开发基于镍钛合金支架的脉冲电解穿透掩模蚀刻的法拉第电蚀刻工艺，用于快速支架制造，同时在中性、水性、无毒电解质中保持图案保真度。该过程将使支架制造成为可能，同时最大限度地减少与镍钛合金支架的传统激光切割和电解抛光相关的过程控制困难和高拒收率。与传统的激光切割实践相比，法拉第电蚀刻工艺不会对支架造成热损伤，因此无需清除不需要的氧化物。据信，法拉第过程将能够在不到两分钟的时间内“切割”一个支架，而与图案的复杂性无关。第一阶段工作的具体目标是证明这种创新的脉冲电解穿透掩模蚀刻工艺用于镍钛合金支架的成本有效制造的可行性，对于最小支柱宽度为50 μ m和槽宽度为37.5 μ m的支架，蚀刻速率>25 μ m/min。第一阶段项目的评价指标为：1）尺寸公差，2）蚀刻速率和3）表面光洁度。法拉第将由密西西比大学医学中心的莱尔·扎迪亚卡斯博士协助。拟议项目通过开发创新支架制造工艺满足NIH的使命，总体目标是根据行政命令“鼓励制造业创新”解决美国制造业经济中的技术创新问题。该技术将为镍钛合金支架提供快速、高产、具有成本效益的制造工艺，为更先进的支架设计和与药物洗脱支架的兼容性提供基础。支架是医疗器械市场增长最快的部分之一。从1990年推出以来，支架市场在2005年增长到50亿美元。为了实现第一阶段的目标，法拉第将完成以下任务，包括在镍钛合金管上建立支架图案，构建并使用实验室规模的加工设备，以使用法拉第电蚀刻工艺制造支架，根据所需的尺寸和表面条件分析支架，并编制制造工艺流程和经济评估。这项工作旨在过渡到第二阶段计划，其中将在中试规模设备中制造一系列支架设计。 公共卫生相关性：所提出的计划将实现可扩张血管内假体装置或支架的高产量、高精度制造。提高支架的产量和精度将降低这些设备的成本和故障率，对公众健康有直接的好处。此外，这种制造技术将使更先进的支架设计成为可能，并与药物洗脱支架兼容。

DESCRIPTION (provided by applicant): Description Faraday Technology, Inc. proposes to develop the Faradayic ElectroEtching Process, based on pulsed electrolytic through-mask etching of nitinol stents, for rapid stent fabrication while maintaining pattern fidelity in a neutral, aqueous, non-toxic electrolyte. This process will enable stent manufacturing while minimizing process control difficulties and high reject rates associated with conventional laser cutting and electropolishing of nitinol stents. Compared to conventional laser cutting practices, the Faradayic ElectroEtching Process will not impart thermal damage to the stent, eliminating the need for descaling of undesired oxides. It is believed that the Faradayic Process will be able to "cut" a stent in less than two minutes, independent of the pattern complexity. The specific aims of the Phase I effort are to demonstrate the feasibility of this innovative pulsed electrolytic through-mask etching process for cost- effective fabrication of nitinol stents, with etch rates of >25 <m/min for stents with a minimum strut width of 50 <m and slot width of 37.5 <m. The measures of merit for the Phase I project will be: 1) dimensional tolerance, 2) etch rate, and 3) surface finish. Faraday will be assisted by Dr. Lyle Zardiackas of the University of Mississippi Medical Center. The proposed project meets the NIH mission by developing an innovative 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 rapid, high yield, cost-effective manufacturing process for nitinol stents, providing the basis for more advanced stent designs and compatibility with drug eluting stents. Stents represent one of the fastest growing segments of the medical device market. From their introduction in 1990, the stent market has grown to $5 billion in 2005. To achieve the objectives of the Phase I, Faraday will complete tasks that include establishing a stent pattern on nitinol tubes, building and using a bench-scale processing apparatus to fabricate stents using the Faradayic ElectroEtching Process, analyzing the stents in terms of required dimensional and surface condition, and compiling a manufacturing process flow and economic assessment. This effort is designed to transition into a Phase II program, in which a range of stent designs would be manufactured, in pilot-scale equipment. PUBLIC HEALTH RELEVANCE: The proposed program will enable high yield, high precision manufacturing of expandable vascular endoprostheses devices, or stents. Increasing the yield and precision of the stent will lower the cost and failure rate of these devices, with immediate benefit to the public health. Furthermore, this manufacturing technology will enable more advanced stent designs and is compatible with drug eluting stents.