Stacchino C, Bona G, Rinaldi S, Vallana F
Sorin Biomedica S.p.A., Saluggia (VC), Italy.
J Heart Valve Dis. 1995 Jul;4 Suppl 1:S102-5.
The Pericarbon Stentless valve (PS) in an unstented bioprosthesis made of glutaraldehyde tanned bovine pericardium. Its design concept and chemical fixation process are based on those developed for the stented Pericarbon valve, which has been in clinical use for eight years. The two-sheet design and the special suture pattern with which the two pieces of pericardium are attached aim at avoiding stress concentration during function. The resulting cylindrical structure is a relatively low-profile valve conduit, which can be further trimmed by the implanting surgeon to the individual patient's specific anatomical requirements. The main advantage of the stentless concept is optimum hemodynamic characteristics, inherent in the high external/internal diameter ratio. The unique design and material selection of the PS valve offer the following advantages: Free-hand insertion similar to that with homograft aortic valves. Absence of any fabric cover or reinforcement providing a maximum effective orifice area and reduced risk of infection. Wide range of available sizes from 15 mm to 29 mm. Special methods have been developed for laboratory testing of the PS. These, and the in vitro results are presented in detail, with particular emphasis on the hydrodynamic performances under different flow conditions. Clinical implantation of the Pericarbon Stentless valve has already been started, and early results in the aortic position show good hemodynamic function and a low rate of complications.
Pericarbon无支架瓣膜（PS）是一种由戊二醛鞣制的牛心包制成的无支架生物假体。其设计理念和化学固定工艺基于已临床应用八年的有支架Pericarbon瓣膜。两片式设计以及连接两片心包的特殊缝合方式旨在避免功能过程中的应力集中。由此产生的圆柱形结构是一种外形相对较低的瓣膜管道，植入外科医生可根据个体患者的具体解剖要求进一步修剪。无支架理念的主要优点是具有最佳的血流动力学特性，这源于高的外径/内径比。PS瓣膜独特的设计和材料选择具有以下优点：类似于同种异体主动脉瓣的徒手植入。没有任何织物覆盖或加固，提供最大有效开口面积并降低感染风险。有15毫米至29毫米的多种可用尺寸。已开发出用于PS实验室测试的特殊方法。详细介绍了这些方法以及体外测试结果，特别强调了不同流动条件下的流体动力学性能。Pericarbon无支架瓣膜的临床植入已经开始，主动脉位置的早期结果显示出良好的血流动力学功能和较低的并发症发生率。
