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
• 负责人: MARIA E INMAN
• 金额: $ 49.35万
• 依托单位: FARADAY TECHNOLOGY, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-01 至 2014-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8314243
• 关键词: 3-Dimensional; Acids; Address; Alloys; Biocompatible Materials; Blood Vessels; Boston; Corrosion; Data; Development; Development Plans; Devices; Dimensions; Documentation; Economics; Electrolytes; Failure; Fluorides; Hydrofluoric Acid; Implant; Industry; Intellectual Property; Lasers; Legal patent; Libraries; Manufactured Supplies; Marketing; Masks; Measures; Medical; Medical Device; Medical center; Methods; Mission; Mississippi; Pattern; Perchloric Acids; Phase; Phosphoric Acids; Physiologic pulse; Polishes; Procedures; Process; Public Health; Regulation; Resistance; Salts; Sampling; Sodium Chloride; Stents; Sulfuric Acids; Surface; Technology; Testing; Time; Tube; Tubular formation; United States National Institutes of Health; Universities; Variant; Width; Work; aqueous; base; commercialization; cooking; cost; cost effective; design; design and construction; improved; industry partner; innovation; interest; manufacturing process; meetings; nitinol; programs; technological innovation

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. 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 is compatible with [stents and other implants manufactured from a wide range of biocompatible materials].

描述（由申请人提供）：法拉第技术公司提议在简单的水性电解液中开发FARADAYIC [电解抛光工艺，基于支架的脉冲反向电解抛光，由镍钛诺和其他行业感兴趣的材料制成，用于快速、具有成本效益的表面精加工]。该过程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）对支架进行传统电解抛光相关的过程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提出了严重的问题。此外，当前电解抛光工艺的稳健性的缺乏导致高支架拒收率，接近40- 50%。]与传统的电解抛光相比，FARADAYIC电解抛光将使用简单的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[电解抛光工艺]，过渡到半规模的试验制造设备，并与我们的工业合作伙伴合作，为全面的工业实施做好准备。第二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，3）尺寸公差，和）耐腐蚀性]。法拉第将由密西西比大学医学中心的莱尔·扎迪亚卡斯博士和迈克尔·罗奇博士协助。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，[并将与由各种材料制成的支架和其他医疗器械兼容。支架是医疗器械市场增长最快的部分之一。自1990年推出以来，支架市场已增长至2011年的50多亿美元。为了实现第二阶段的目标，法拉第将完成的任务包括优化法拉第（电抛光工艺），过渡到管状支架，评估行业感兴趣的其他材料的法拉第工艺，设计和建造一个新的支架。- 规模的中试制造装置，用于演示镍钛合金支架管的连续、工业规模的加工，并完成制造工艺流程、经济评估，质量计划，并制定符合FDA法规的文件、流程和程序。这项工作旨在进入第三阶段计划，在该阶段，该技术将过渡到我们的工业合作伙伴。 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，该制造技术与[由各种生物相容性材料制成的支架和其他植入物]兼容。