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用于生物可吸收性胆道内支架置入术的新型丝素蛋白基双层支架

Novel Silk Fibroin Based Bilayer Scaffolds for Bioabsorbable Internal Biliary Stenting.

作者信息

Isella Benedetta, Hassan Nourhan, Drinic Aleksander, Eickhoff Roman M, Kröger Nadja, Vaughan Ted J, Kopp Alexander

机构信息

Biomechanics Research Centre (BioMEC), School of Engineering, College of Science and Engineering, Institute for Health Discovery and Innovation, University of Galway, Galway, Ireland.

Fibrothelium GmbH, Aachen, Germany.

出版信息

J Biomed Mater Res B Appl Biomater. 2025 Feb;113(2):e35499. doi: 10.1002/jbm.b.35499.

Abstract

Biliary duct reconstruction is one of the most challenging parts of liver transplantation and accounts for 40%-60% of complications. While current stent-based devices on the market show promising results in reducing complications, they are manufactured from permanent synthetic materials and require a second reintervention for their removal. This exposes the patients to other potential complications and increases healthcare costs. This study develops a fabrication technique to produce a bioabsorbable biliary stent based on silk fibroin. The process used a dip-coating procedure for silk fibroin that produced highly smooth monolayer tubular specimens without the use of any additional surfactants during removal. This process was combined with an electrospinning step to produce bilayer structures through the deposition of electrospun silk fibroin on the outer surface. The structures proved to have promising mechanical, morphological, and cytocompatibility properties for use in the field of biliary stenting. Furthermore, the technique investigated proved to be reproducible, achieving an important requirement for large-scale use even in the presence of a biomaterial derived from a natural source. These results show the possibility of obtaining a completely bioabsorbable internal biliary stent that does not require any second reintervention. This study can be the starting point for further investigations both in vitro and in vivo to assess the suitability of silk fibroin biliary stents for clinical applications.

摘要

胆管重建是肝移植中最具挑战性的部分之一,并发症发生率占40%-60%。虽然目前市场上基于支架的装置在减少并发症方面显示出有前景的结果,但它们由永久性合成材料制造,并且需要二次介入来取出。这使患者面临其他潜在并发症,并增加了医疗成本。本研究开发了一种制造技术,以生产基于丝素蛋白的可生物吸收胆管支架。该工艺对丝素蛋白采用浸涂程序,在去除过程中不使用任何额外的表面活性剂,从而生产出高度光滑的单层管状标本。该工艺与静电纺丝步骤相结合,通过在其外表面沉积静电纺丝的丝素蛋白来生产双层结构。这些结构在胆管支架领域具有良好的机械、形态和细胞相容性特性。此外,所研究的技术被证明具有可重复性,即使在存在天然来源生物材料的情况下,也满足大规模使用的一项重要要求。这些结果表明,有可能获得一种完全可生物吸收的内部胆管支架,而无需任何二次介入。本研究可以作为进一步体外和体内研究的起点,以评估丝素蛋白胆管支架在临床应用中的适用性。

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