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Textile Heart Valve: Novel Shaping Process and Material Performances

机译:纺织心脏瓣膜:新颖的成型工艺和材料性能

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摘要

Percutaneous aortic valve implantation has become an alternative technique to surgical valve replacement in patients with high risk for open chest surgery. Biological valve tissue associated with metallic stents is, however, fragile and risks being degraded when the valve leaflet is folded within the stent. Textile polyester is a less fragile material, which could be an alternative solution to replace valve leaflets. However, a textile membrane must be shape set to create a valve with a low profile and efficient sealing in the closed position. The purpose of the present work is to present a controlled shaping process for textile material that is non traumatic for the fabric surface, based on suction principle. The manufacturing process is detailed, and the performances of the shaped material as a valve are tested in vitro and in vivo (sheep model) and reported. Results show that the shaping process allows precise dimension setting for the textile material. The in vitro performances obtained for the valve prototype validate the efficiency of the shaped material, which provides sealed closing to the prosthesis. Early in vivo tests confirm the efficacy of the prototype.
机译:经皮主动脉瓣植入术已成为开胸手术高风险患者手术瓣膜置换的替代技术。然而,与金属支架相关的生物瓣膜组织是脆弱的,并且当瓣膜小叶在支架内折叠时有退化的风险。纺织聚酯是一种较不易碎的材料,可以替代瓣膜小叶。但是,必须将纺织膜的形状设定为能够在关闭位置形成低轮廓且有效密封的阀门。本发明的目的是提出一种基于抽吸原理的,对织物表面无损伤的纺织材料的受控成形方法。详细的制造过程,并在体外和体内(绵羊模型)测试并报告了成型材料作为阀门的性能。结果表明,成形过程可以为纺织材料精确设定尺寸。瓣膜原型获得的体外性能验证了成型材料的效率,从而为假体提供了密封的封闭。早期的体内测试证实了原型的功效。

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