ElectroPolishing for Cost Effective, High Yield Nitinol Stent Fabrication

描述(由申请人提供)：Faraday Technology建议在简单的水电解液中开发FARADAYIC[基于支架的脉冲反向电解抛光工艺，由镍醇和其他行业感兴趣的材料制成，用于快速、经济高效的表面抛光]。该工艺将最大限度地降低[使用混合高浓度酸性电解液(包括硫酸、磷酸、氢氟酸和高氯酸)对支架进行常规电抛光所带来的工艺控制困难和高废品率。强酸的存在在表面污染和工人暴露方面是一个严重的问题。此外，目前的电抛光工艺缺乏稳定性，导致支架废弃率很高，接近40%-50%。]与传统的电抛光相比，FARADAYIC电抛光将使用简单的17wt%硫酸电解液提供均匀光滑的表面。第二阶段工作的具体目标是优化[电抛光工艺]，过渡到规模的中试制造设备，并与我们的行业合作伙伴合作，为这项技术的全面工业实施做好准备。第二阶段项目的衡量标准将包括：[1)地表 根据工业支架规格，2)抛光速度、3)尺寸公差和)耐腐蚀性]。法拉第将得到密西西比大学医学中心的莱尔·扎迪亚卡斯博士和迈克尔·罗奇博士的协助。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、成本效益高的镍钛支架制造工艺[并将与支架和由多种材料制造的其他医疗器械兼容。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，支架市场已在2011年增长到超过50亿美元。]为了实现第二阶段的目标，Faraday将完成任务，包括优化FARADAYIC[电抛光工艺]，过渡到管状支架，评估FARADAYIC工艺用于其他行业感兴趣的材料，设计和建造用于演示镍钛支架管的连续、工业规模加工的？规模中试制造设备，并完成制造工艺流程、经济评估、质量计划，以及制定符合FDA法规的文件、工艺和程序。这一努力旨在进入第三阶段计划，在该计划中，技术将过渡到我们的行业合作伙伴。

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.