Throughmask ElectroEtching for Cost-Effective Nitinol Stent Fabrication

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 gt25 lt m/min for stents with a minimum strut width of 50 lt m and slot width of 37.5 lt 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.