Throughmask ElectroEtching for Cost-Effective Nitinol Stent Fabrication

描述(申请人提供)描述：Faraday Technology，Inc.计划开发基于Niinol支架的脉冲电解穿透掩膜蚀刻的Faradayic电蚀刻工艺，用于快速制造支架，同时在中性、含水、无毒的电解液中保持图案保真度。该工艺将使支架制造成为可能，同时最大限度地减少与传统激光切割和镍钛合金支架电抛光相关的工艺控制困难和高废品率。与传统的激光切割方法相比，Faradayic电蚀工艺不会对支架造成热损伤，不需要去除不需要的氧化物。人们相信，法拉达伊克过程将能够在不到两分钟的时间内“切割”一个支架，而不受图案复杂程度的影响。第一阶段工作的具体目标是证明这种创新的脉冲电解掩膜蚀刻工艺的可行性，以经济高效地制造镍钛合金支架，支架的蚀刻速率为25&lt；m/min，支架的最小支柱宽度为50&lt；m；m，槽宽为37.5&lt；m。第一阶段项目的优点衡量标准将是：1)尺寸公差，2)蚀刻速率，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。该项目符合美国国立卫生研究院的使命，开发了一种创新的支架制造流程，总体目标是解决美国制造业经济中的技术创新问题，符合“鼓励制造业创新”的行政命令。这项技术将实现快速、高产量、低成本的镍钛合金支架制造工艺，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中增长最快的细分市场之一。自1990年推出以来，支架市场已发展到2005年的50亿美元。为了实现第一阶段的目标，Faraday将完成一些任务，包括在镍镍管上建立支架模式，使用Faradayic电蚀工艺建造和使用实验室规模的加工设备来制造支架，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。这一努力旨在过渡到第二阶段计划，在该计划中，将在中试设备中制造一系列支架设计。 与公共健康相关：拟议的计划将使可膨胀血管内假体装置或支架的高产量、高精度制造成为可能。提高支架的成品率和精度将降低这些装置的成本和故障率，直接造福于公众健康。此外，这种制造技术将实现更先进的支架设计，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.