VISTASEAL

维斯塔
  • 文章类型: Journal Article
    目的:纤维蛋白封闭剂通常用于软骨碎片和植入物的关节内手术固定。然而,纤维蛋白封闭剂在软骨修复方面的机械性能尚不清楚。这项研究的目的是使用离体模型表征纤维蛋白密封剂的粘合和摩擦特性。
    方法:用一次Tisseel或Vistaseal组装天然牛软骨-骨复合材料。在拉伸和搭接剪切下测试复合材料。此外,摩擦系数(COF)在单独的天然软骨环模型和软骨切碎的模型中进行测量。最后,评估了双重应用纤维蛋白密封剂的效果。
    结果:拉伸模量没有显着差异,极限抗拉强度(UTS),剪切模量,或极限剪切强度(USS)之间的2纤维蛋白密封剂。两种纤维蛋白密封剂均显示UTS和USS<8和<30kPa,分别。当单独或与切碎的软骨一起测试时,密封剂之间的COF没有差异。与单次施用纤维蛋白密封剂相比,两次施用纤维蛋白密封剂不会改变机械性能。
    结论:纤维蛋白密封剂粘合性能不受所研究的密封剂类型或在牛软骨-骨模型中的应用数量的影响。纤维蛋白密封剂的摩擦学特性不受密封剂类型或添加切碎的软骨的影响。Tisseel和Vistaseal的粘合性能低于软骨修复植入物体内固定所需的粘合性能。这些发现激发了用于软骨修复应用的改进的软骨特异性粘合剂的开发。
    OBJECTIVE: Fibrin sealants are routinely used for intra-articular surgical fixation of cartilage fragments and implants. However, the mechanical properties of fibrin sealants in the context of cartilage repair are unknown. The purpose of this study was to characterize the adhesive and frictional properties of fibrin sealants using an ex vivo model.
    METHODS: Native bovine cartilage-bone composites were assembled with a single application of Tisseel or Vistaseal. Composites were tested in tension and lap shear. In addition, the coefficient of friction (COF) was measured in a native cartilage annulus model alone and with minced cartilage. Finally, the effect of a double application of fibrin sealant was evaluated.
    RESULTS: There were no significant differences in tensile modulus, ultimate tensile strength (UTS), shear modulus, or ultimate shear strength (USS) between the 2 fibrin sealants. Both fibrin sealants demonstrated a UTS and USS of <8 and <30 kPa, respectively. There were no differences in COF between the sealants when tested alone or with minced cartilage. A double application of fibrin sealant did not alter the mechanical properties compared with a single application of fibrin sealant.
    CONCLUSIONS: Fibrin sealant adhesive properties are not affected by the sealant type studied or the number of applications in a bovine cartilage-bone model. Fibrin sealant tribological properties are not affected by sealant type or the addition of minced cartilage. The adhesive properties of Tisseel and Vistaseal were less than those desired for the in vivo fixation of cartilage repair implants. These findings motivate the development of an improved cartilage-specific adhesive for cartilage repair applications.
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  • 文章类型: Journal Article
    纤维蛋白密封剂是外科工具箱中公认的组成部分,尤其是在围手术期出血风险较高的手术中。它们广泛用作止血剂,在各种手术环境中的密封剂或组织粘合剂表明,选择合适的密封剂系统会影响临床结果。虽然许多研究已经比较了纤维蛋白封闭剂与其他天然或合成封闭剂的止血效率,关于纤维蛋白密封剂配方的细微差异与它们的生物学性能之间的关系,仍然存在有限的数据。这里,我们对美国和欧洲两种最常用的纤维蛋白封闭剂进行了深入的物理化学和生物学鉴定:TISSEEL™("FS")和VISTASEAL™/VERASEAL™("FS+Osm").我们的化学分析证明了两种密封剂之间的差异,在FS+Osm制剂中具有较低的纤维蛋白原浓度和超生理渗透压。流变学测试显示FS凝块具有更大的凝块刚度,与网络密度密切相关。通过扫描电子显微镜的超微结构分析显示FS和FS+Osm纤维蛋白网络之间的差异,后者的特征在于与FS的生理纤维状网络相反的大部分无定形的水凝胶结构。在FS和FS+Osm纤维蛋白网络上接种人成纤维细胞的细胞相容性实验,或在密封剂提取物存在下培养,揭示FS+Osm诱导细胞凋亡,这在FS中未观察到。虽然不同的密封剂渗透压和纤维蛋白原的量,以及因子XIII或添加剂如抗纤维蛋白溶解剂的存在,可以解释两种纤维蛋白密封剂之间观察到的机械和结构差异,已知这些物质中没有一种在密封剂制剂中的各自浓度下引起细胞凋亡。因此,我们得出结论,FS+Osm制剂中的高渗透压是细胞凋亡的主要触发因素-应该更详细地评估这种机制。因为它可能会影响细胞伤口原位愈合反应。
    Fibrin sealants are well-established components of the surgical toolbox, especially in procedures that harbor a high risk of perioperative bleeding. Their widespread use as hemostats, sealants or tissue-adhesives in various surgical settings has shown that the choice of the appropriate sealant system affects the clinical outcome. While many studies have compared the hemostatic efficiency of fibrin sealants to that of other natural or synthetic sealants, there is still limited data on how subtle differences in fibrin sealant formulations relate to their biological performance. Here, we performed an in-depth physicochemical and biological characterization of the two most commonly used fibrin sealants in the US and Europe: TISSEEL™ (\"FS\") and VISTASEAL™/VERASEAL™ (\"FS+Osm\"). Our chemical analyses demonstrated differences between the two sealants, with lower fibrinogen concentrations and supraphysiological osmolality in the FS+Osm formulation. Rheological testing revealed FS clots have greater clot stiffness, which strongly correlated with network density. Ultrastructural analysis by scanning electron microscopy revealed differences between FS and FS+Osm fibrin networks, the latter characterized by a largely amorphous hydrogel structure in contrast to the physiological fibrillar network of FS. Cytocompatibility experiments with human fibroblasts seeded on FS and FS+Osm fibrin networks, or cultured in presence of sealant extracts, revealed that FS+Osm induced apoptosis, which was not observed with FS. Although differential sealant osmolality and amounts of fibrinogen, as well as the presence of Factor XIII or additives such as antifibrinolytics, may explain the mechanical and structural differences observed between the two fibrin sealants, none of these substances are known to cause apoptosis at the respective concentrations in the sealant formulation. We thus conclude that hyper osmolality in the FS+Osm formulation is the primary trigger of apoptosis-a mechanism that should be evaluated in more detail, as it may affect the cellular wound healing response in situ.
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