Method for cost-effective trans aortic valve replacement device prototyping

Abstract

<p><span>Trans Aortic Valve Replacement (TAVR) has offered the cardiology sector of health a new alternative to open heart surgeries which treat aortic stenosis. The technologies used by TAVR manufacturers are kept private. Our research goal was to develop a process that allows college level laboratories to fabricate their own TAVR stents in order to research new designs and methods of fabrication which may improve current TAVR practices. By creating a solid model of a stent cell design in SolidWorks, we were able to export a cutting pattern we used with a waterjet. The stent frame was then hand polished to prepare for fabric skirting and leaflet attachment. Synthetic ripstop fabric was cut using a commercial fabric cutting machine and attached to the frame using a waterproof glue. Future research entails welding techniques, improved polishing methods, and implantation into a mechanical system. This prototype could be used for TAVR related research and surgical training simulations.</span></p>

Transcatheter Heart Valves: A Biomaterials Perspective

“…The Xeltis valves are assembled by mounting the electrospun leaflets on a self‐expandable nitinol frame. [ 83b,146,18 7]…”

“…However, balloon‐expandable and self‐expandable THVs have been constructed for academic testing and design where the manufacturing details are available. [ 48,188 ] In general, the process of manufacturing stents for THVs consists of precise laser cutting from a cylinder into the metallic frame followed by a polishing and shape setting if the stent is made with nitinol. Shape setting nitinol involves deforming the cylindrical cut stent into its final shape and preventing it from returning while it is heated to a high temperature; the stent is then quenched, which permanently sets its memory shape.…”