ElectroPolishing for Cost Effective, High Yield Nitinol Stent Fabrication

描述（由申请人提供）：法拉第技术提出在简单的水电解质中开发FARADAYIC[电抛光工艺，基于脉冲反向电解抛光支架，由镍钛诺和其他工业感兴趣的材料制成，用于快速，经济有效的表面处理]。该工艺将最大限度地减少使用混合高浓度酸性电解质（包括硫酸、磷酸、氢氟酸和高氯酸）对支架进行传统电抛光的过程控制困难和高废品率。就表面污染和工人暴露而言，强酸的存在是一个严重的问题。此外，目前的电抛光工艺缺乏稳健性，导致支架废品率高，接近40- 50%。与传统的电抛光相比，FARADAYIC电抛光将提供均匀光滑的表面，使用简单的17 wt%硫酸电解质。第二阶段的具体目标是优化[电抛光工艺]，过渡到一个规模的试点制造设备，并与我们的工业合作者合作，为全面的工业实施准备这项技术。二期工程的优点衡量标准将包括：[1]表面

DESCRIPTION (provided by applicant): 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 surfce finishing] in a simple aqueous electrolyte. This process will minimize the process control difficulties and high reject rates associated with [conventional electropolishing of stents using mixed high concentration acid electrolytes, including sulfuric, phosphoric, hydrofluoric and perchloric acids. The presence of strong acids presents a serious issue in terms of surface contamination and worker exposure. Furthermore, the lack of robustness of the current electropolishing process results in high stent reject rates, approaching 40- 50%.] Compared to conventional electropolishing, FARADAYIC ElectroPolishing will provide a uniformly smooth surface using a simple 17 wt% sulfuric acid electrolyte. The specific aims of the Phase II effort are to optimize the [ElectroPolishing process], transition to an ¿-scale pilot manufacturing apparatus, and work with our industrial collaborators to prepare this technology for full-scale industrial implementation. The measures of merit for the Phase II project will include: [1) surface finish, based on industrial stent specifications, 2) polishing rate, 3) dimensional tolerance, and ) corrosion resistance]. Faraday will be assisted by Dr. Lyle Zardiackas and Dr. Michael Roach 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, [and will be compatible with stents and other medical 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 has grown to over $5 billion in 2011.] To achieve the objectives of the Phase II, Faraday will complete tasks that include optimizing the FARADAYIC [ElectroPolishing process], transitioning to tubular stents, evaluating the FARADAYIC Processes for other materials of interest to industry, designing and building an ¿-scale pilot manufacturing apparatus for demonstration of continuous, industrial-scale processing of Nitinol stent tubes, and completing 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 a Phase III program, in which the technology would be transitioned to our industrial collaborators.