Abstract

In the past decade, balloon-expandable percutaneous pulmonary valves have been developed and applied in clinical practice. However, all the existing products of pulmonary artery interventional valves in the market have a straight structure design, and they require a preset support frame and balloon expansion. This shape design of the valve limits the application range. In addition, the age of the population with pulmonary artery disease is generally low, and the existing products cannot meet the needs of anti-calcification properties and valve material durability. In this study, through optimization of the support frame and leaflet design, a self-expanding pulmonary valve product with a double bell-shaped frame was designed to improve the match of the valve and the implantation site. A loading and deployment study showed that the biomaterial of the valve was not damaged after being compressed. Pulsatile flow and fatigue in vitro tests showed that the fabricated pulmonary valve met the hydrodynamic requirements after 2 × 10⁸ accelerated fatigue cycles. The safety and efficacy of the pulmonary valve product were demonstrated in studies of pulmonary valve implantation in 11 pigs. Angiography and echocardiography showed that the pulmonary valves were implanted in a good position, and they had normal closure and acceptable valvular regurgitation. The 180 days’ implantation results showed that the calcium content was 0.31–1.39 mg/g in the anti-calcification treatment group, which was significantly lower than that in the control valve without anti-calcification treatment (16.69 mg/g). Our new interventional pulmonary valve product was ready for clinical trials and product registration.

中文翻译：

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自膨胀式肺动脉瓣治疗肺动脉瓣疾病的临床前研究

摘要

在过去的十年中，已开发出球囊可扩张的经皮肺动脉瓣并将其应用于临床实践。然而，市场上所有现有的肺动脉介入瓣膜产品均具有直的结构设计，并且它们需要预设的支撑框架和球囊膨胀。阀门的这种形状设计限制了其应用范围。另外，患有肺动脉疾病的人群的年龄通常较低，并且现有产品不能满足抗钙化特性和瓣膜材料耐久性的需求。在这项研究中，通过优化支撑框架和瓣叶设计，设计了带有双钟形框架的自膨胀式肺动脉瓣产品，以改善瓣膜和植入部位的匹配性。负载和展开研究表明，瓣膜的生物材料在压缩后没有受到破坏。搏动和疲劳体外试验表明，经制造的肺动脉瓣在2×10 ^8个加速疲劳循环后符合流体力学要求。在11只猪的肺动脉瓣植入研究中证明了肺动脉瓣产品的安全性和有效性。血管造影和超声心动图检查显示，肺动脉瓣植入位置良好，并具有正常的闭合性和可接受的瓣膜返流。180天的植入结果表明，抗钙化治疗组的钙含量为0.31-1.39 mg / g，这明显低于未经抗钙化处理的对照瓣膜中的钙含量（16.69 mg / g）。我们的新型介入性肺动脉瓣产品已准备好进行临床试验和产品注册。