In vivo assessment of a novel biodegradable ureteral stent
In vivo assessment of a novel biodegradable ureteral stent
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DOI：
10.1007/s00345-017-2124-3
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发表时间：
2018-02-01
影响因子：
3.4
通讯作者：
Lima, Estevao
中科院分区：
文献类型：
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作者：
Barros, Alexandre A.;Oliveira, Carlos;Lima, Estevao
对一种新开发的生物可降解输尿管支架（BUS）进行体内评估，该支架采用天然聚合物生产。BUS基于一项专利技术，将注射工艺与超临界流体技术相结合。研究在ICVS-米尼奥大学（葡萄牙布拉加）进行，共使用10头家猪。在7只动物中，插入实验BUS支架，而在其余动物中使用市售支架（6-Fr Biosoft（A（R））duo支架，Porges Coloplast，丹麦）。术后行静脉肾盂造影检查，评价肾积水程度。测量体内支架降解作为重量损失的函数。此外，在体内降解过程中测试了BUS的拉伸性能。最多10天后，处死动物并进行尸检。比较了支架组之间以及每组中未植入支架的对侧输尿管和植入支架的输尿管之间的组织。通过组织病理学分级评估生物相容性。在所有情况下，BUS仅在X射线上的前24小时内可见，并且在所有情况下，BUS在10天后在尿液中完全降解，如尸检所证实的。在降解过程中，BUS的机械性能下降，而商业输尿管支架保持不变。在支架植入后的所有时间点，肾积水的水平都很低。总体而言，与对照组相比，植入BUS支架的动物的平均肾积水等级较低。与商业支架相比，BUS显示出更好的病理条件，因此具有更好的生物相容性，尽管本研究存在局限性，但我们的新型天然来源聚合物基BUS的体内测试表明，该装置具有均匀降解，良好的尿液引流和高生物相容性。下一步将是增加其稳定性，并在不影响其降解的情况下提高不透射线性。最终，将需要临床研究来确定其在人类中使用的安全性和可行性。
To perform an in vivo assessment of a newly developed biodegradable ureteral stent (BUS) produced with natural-based polymers.The BUS is based on a patented technology combining the injection process with the use of supercritical fluid technology. Study was conducted at ICVS-University of Minho (Braga, Portugal) and a total of ten domestic pigs were used. In seven animals, the experimental BUS stent was inserted, whereas in the remaining a commercially available stent was used (6-Fr Biosoft(A (R)) duo stents, Porges Coloplast, Denmark). Post-stenting intravenous pyelogram was used to evaluate the degree of hydronephrosis. The in vivo stent degradation was measured as function of the weight loss. Moreover, the tensile properties of the BUS were tested during in vivo degradation. After maximum 10 days, animals were killed and necropsy was performed. Tissues were compared between the stented groups as well as between the non-stented contralateral ureters and stented ureters in each group. Biocompatibility was assessed by histopathological grading.In all cases, the BUS was only visible during the first 24 h on X-ray, and in all cases the BUS was completely degraded in urine after 10 days, as confirmed on necropsy. During the degradation process, the mechanical properties of the BUS decreased, while the commercial ureteral stents remained constant. At all time-points after stent insertion, the level of hydronephrosis was minimal. Overall, animals stented with BUS had an average grade of hydronephrosis which was lower compared to the controls. The BUS showed better pathological conditions, and hence better biocompatibility when compared with commercial stents.Notwithstanding the limitations of the present study, the in vivo testing of our novel natural origin polymer-based BUS suggests this device to feature homogeneous degradation, good urine drainage, and high biocompatibility. Next steps will be to increase its stability, and to improve the radiopacity without compromising its degradation. Ultimately, clinical studies will be required to determine the safety and feasibility of its use in humans.