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首页> 外文期刊>Biomaterials Science >Design, development, testing at ISO standards andin vivofeasibility study of a novel polymeric heart valve prosthesis
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Design, development, testing at ISO standards andin vivofeasibility study of a novel polymeric heart valve prosthesis

机译：设计，开发，ISO标准测试和新型聚合物心脏瓣膜假体的致命性研究

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Clinically available prosthetic heart valves are life-saving, but imperfect: mechanical valves requiring anticoagulation therapy, whilst bioprosthetic valves have limited durability. Polymer valves offer the prospect of good durability without the need for anticoagulation. We report the design and development of a polymeric heart valve, its bench-testing at ISO standards, and preliminary extra-vivo andin vivoshort-term feasibility. Prototypes were manufactured by injection moulding of styrenic block copolymers to achieve anisotropic mechanical properties. Design was by finite element stress-strain modelling, which has been reported previously, combined with feedback from bench and surgery-based testing using various combinations of materials, valve geometry and processing conditions. Bench testing was according to ISO 5840:2015 standards using anin vitrocardiovascular hydrodynamic testing system and an accelerated fatigue tester. Bench comparisons were made with a best-in-class bio-prosthesis. Preliminary clinical feasibility evaluations included extra-vivo and short-term (1-24 hours)in vivotesting in a sheep model. The optimised final prototype met the requirements of ISO standards with hydrodynamic performance equivalent to the best-in-class bioprosthesis. Bench durability of greater than 1.2 billion cycles (30 years equivalent) was achieved (still ongoing). Extra-vivo sequential testing (n= 8) allowed refinement of external diameter, 3D shape, a low profile, flexibility, suturability, and testing of compatibility to magnetic resonance imaging and clinical sterilisation.In vivoshort-term (1-24 hours) feasibility (n= 3) confirmed good suturability, no mechanical failure, no trans-valvular regurgitation, competitive trans-valvular gradients, and good biocompatibility at histopathology. We have developed and tested at ISO standards a novel prosthetic heart valve featuring competitive bench-based hydrodynamics and durability, well beyond the ISO requirements and comparable to a best-in-class bioprosthesis.In vivoshort-term feasibility testing confirmed preliminary safety, functionality and biocompatibility, supporting progression to a long-term efficacy trial.
机译：临床上可用的假肢阀门是挽救生命寿命，但不完美：需要抗凝治疗的机械阀，生物假置阀具有有限的耐用性。聚合物阀门提供良好耐用性的前景，而无需抗凝血。我们报道了聚合物心脏瓣膜的设计和开发，其在ISO标准的台阶测试，以及初步额外的体内和invivoshort期可行性。通过苯乙烯嵌段共聚物的注射成型制造原型，以实现各向异性机械性能。设计是通过有限元应力 - 应变建模，其先前已经报道，并使用各种材料，阀门几何和加工条件的基于工作台和外科的测试反馈。台式测试根据ISO 5840：2015标准使用Anin vitrocardioviovive血管流体动力学测试系统和加速疲劳测试仪。替补比较是通过级别的生物假肢进行的。初步临床可行性评估包括在绵羊模型中维持体内和短期（1-24小时）。优化的最终原型符合ISO标准的要求，其具有相当于最佳生物体系的流体动力学性能。实现了大于12亿周期（相当于30亿周期的台式耐久性（仍然正在进行）。超级序列测试（n = 8）允许改进外径，3D形状，低调，柔韧性，缝隙性和对磁共振成像和临床消毒的兼容性的测试。Vivoshort-term（1-24小时）可行性（n = 3）证实了良好的患者性，无机械故障，无反式瓣膜流动，竞争性逆瓣梯度，以及在组织病理学的良好生物相容性。我们在ISO标准开发和测试了一种新型的假肢心脏瓣膜，具有竞争性的替补的流体动力学和耐用性，远远超出了ISO要求和与最佳的生物假期相当。在Vivoshort期可行性测试证实了初步安全性，功能和功能生物相容性，支持进展到长期疗效试验。

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