Durisin M, Seitz J M, Reifenrath J, Weber C M, Eifler R, Maier H J, Lenarz T, Klose C
Department of Otorhinolaryngology, Hannover Medical School, Carl-Neuberg-Strasse 1, 30625, Hannover, Germany.
Institut für Werkstoffkunde (Materials Science), Leibniz Universität Hannover, An der Universität 2, 30823, Hannover, Germany.
Eur Arch Otorhinolaryngol. 2016 Jun;273(6):1455-67. doi: 10.1007/s00405-015-3774-7. Epub 2015 Sep 4.
The frontal sinus recess consists of anatomically narrow passages that are prone to stenosis in endonasal frontal sinus surgery for chronic sinus disease. Over the past 100 years, diverse frontal sinus stents have been developed and evaluated in clinical and animal studies. However, superinfection, formation of granulations tissue, stent dislocation and late stenosis of the duct have remained challenges and subject of debate in the literature. Currently developed biodegradable materials, including rare earth-containing magnesium alloys are promising candidates for application as temporary implant materials. The Mg 2 % wt Nd alloy (MgNd2) was used to design a nasal stent that fit the porcine anatomy. In the current study, we evaluate biocompatibility, biodegradation and functionality of a frontal sinus stent in 16 minipigs over 6 months. Intraoperative endoscopy revealed free stent lumen in all cases. Blood examination and clinical examinations indicated no systematic or local inflammation signs. The histopathology and elements analysis showed a very good biocompatibility. The μ-computed tomography-based volumetric analysis showed substantial stent degradation within 6 months. Our MgNd2 based stent appears to be a promising, solid basis for the development of a frontal sinus stent for clinical use.
额窦隐窝由解剖学上狭窄的通道组成,在慢性鼻窦疾病的鼻内镜额窦手术中容易发生狭窄。在过去100年里,人们开发了多种额窦支架,并在临床和动物研究中进行了评估。然而,支架感染、肉芽组织形成、支架移位和导管后期狭窄仍然是文献中争论的挑战和主题。目前开发的可生物降解材料,包括含稀土的镁合金,有望作为临时植入材料应用。采用2%重量百分比钕的镁合金(MgNd2)设计了一种适合猪解剖结构的鼻支架。在本研究中,我们在16只小型猪身上对额窦支架进行了6个月的生物相容性、生物降解性和功能性评估。术中内镜检查显示所有病例支架管腔通畅。血液检查和临床检查均未发现全身或局部炎症迹象。组织病理学和元素分析显示生物相容性良好。基于μ计算机断层扫描的体积分析显示,6个月内支架有明显降解。我们基于MgNd2的支架似乎是开发临床用额窦支架的一个有前景的坚实基础。