Design, Development and Validation of a Preproduction Prototype Rig for Clinical evaluation of biodegradable stents

越来越多的证据表明，下一代可生物降解冠状动脉支架优于传统的永久植入药物洗脱支架。只有两种生物降解支架被批准在欧盟销售，还有几种正在开发中。聚合物支架的制造带来了重大挑战。可生物降解的聚合物支架不具有必要的材料特性，无法促进球囊导管的卷曲、膨胀，也无法为目标血管提供径向支撑。已经开发了不同的方法来改善材料的性能，包括吹塑，退火和微编织。Arterius和Bradford大学开发了专有的模拉技术来改善机械性能。在Innovate UK-SMART奖的财政支持下，获得了卓越的成果，用于概念研究和开发的证明，包括临床前评估。到目前为止，已经使用了一个小规模的研发模具拉伸系统。虽然这已被证明足以用于临床前试验，但现在需要一种专用的新型预生产原型模制系统，能够以可重复的方式生产高质量的管，用于临床批准的冠状动脉、外周、泌尿科和胆道支架的制造。医疗器械生产的监管要求要求严格的质量标准，生产系统的开发将旨在满足这些标准。生产前的拉深设备的关键要求是能够生产出高表面质量和沿长度方向尺寸一致的拉深管。生产过程将简化，并允许精确控制管的尺寸。最后，该系统应与洁净室兼容-产生最小的颗粒，并易于清洁。该系统也将在临床上适用于所有类型的可生物降解支架应用。

Increasing evidence is demonstrating that next generation biodegradable coronary stents areoutperforming traditional permanently implanted drug eluting stents. Only two biodegradablestents are approved for sale within the EU, with several more in development.Manufacturing of polymer stents introduces significant challenges. Biodegradable polymericstents do not have the necessary material properties to facilitate crimping onto ballooncatheter, expansion, and to provide radial support to the target vessel. Different approacheshave been developed to improve the material properties, including blow moulding, annealingand micro braiding.Arterius and Bradford University have developed the proprietary technique of Die-Drawing toimprove the mechanical properties. Excellent results have been obtained with financialsupport from Innovate UK-SMART Awards for proof of concept research and development,including preclinical assessment.To date, a small-scale R&D die drawing system has been used. Whilst this proved sufficientfor preclinical trials, there is now the need for a dedicated novel pre-production prototype diedrawing system capable of producing high quality tubing in a reproducible manner for themanufacture of clinically approved coronary, peripheral, urology and biliary stents.The regulatory requirements for medical device manufacture demand rigorous qualitystandards, which development of the production system would aim to meet. Key requirementsof the pre-production die drawing rig are to be capable of producing die drawn tubes of highsurface quality and consistent dimensions along the length. The production process will besimple and allow for accurate control of tube dimensions. Finally, the system should be cleanroom compatible - to produce minimal particles and be easily cleanable.The proposed system will also be clinically applicable to all types of biodegradable stentapplications.