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材料重要吗?对尿道下裂修复用尿道支架的文献回顾和材料性能分析。

Do the materials matter? A review of the literature and analysis of the materials properties of urethral stents for hypospadias repair.

机构信息

Division of Pediatric Urology, Connecticut Children's, Hartford, CT, USA.

Biomedical Engineering, University of Connecticut, Storrs, CT, USA.

出版信息

J Pediatr Urol. 2022 Apr;18(2):160-167. doi: 10.1016/j.jpurol.2022.01.003. Epub 2022 Jan 17.

Abstract

INTRODUCTION

Despite the prevalence of hypospadias surgery and the common use of postoperative urethral stents, there has been no evaluation of the material properties of common stents. Our study sets out to close this gap with a literature review of recent publications comparing outcomes after hypospadias surgery for different urethral stent types and an evaluation of the material properties of four common urethral stents.

STUDY DESIGN

A review of the English language literature from 2011 to 2021 was performed. Thermal analysis and mechanical analysis of the Zaontz Urethral Stent, the Firlit-Kluge Urethral Stent, the Koyle Diaper Stent, and the Bard Premature Infant Feeding Tube was also undertaken.

RESULTS

Out of 165 papers, four met inclusion criteria. There was limited research on this topic, and no significant evidence that different stent materials impacted surgical complication rates. One study found improved comfort with the Zaontz stent, and another found a reduction emergency room visits with the Koyle stent. Using a foley balloon was associated with increased fistula rates, though this was likely due to the balloon design and not the material. Analysis of stents shows that all four are rubbery polymers at body temperature (Summary Table). The Zaontz and Koyle stents are thermoplastic elastomers with strong melting transitions above body temperature, but the Firlit-Kluge stent is amorphous at 37 °C and is likely covalently cross-linked to generate the network. The Bard feeding tube was the stiffest, with a Young's Modulus of 14.0 ± 0.78 (compared to 4.12 ± 0.56 for Zaontz, 4.92 ± 0.63 for Firlit-Kluge, and 4.09 ± 0.49 for Koyle). The Bard Feeding Tube is also the least extensible, fracturing at just over 300% strain compared to the other stents that can be stretched to greater than 2000% strain before fracture. Cyclic deformation studies demonstrate that the Zaontz, Firlit-Kluge, and Koyle stents are able to stretch and recover their shape more completely, a finding determined by the lower amount of plastic deformation those stents display compared to the Bard Feeding Tube.

DISCUSSION

While there is little information associating urethral stent type with outcomes after hypospadias surgery, material properties may account for findings of prior studies. Stiffer stents may contribute to decreased postoperative comfort, while a stent that is too soft and extensible may have issues with dislodgement, kinking and breaking.

CONCLUSION

This study provides the foundation for future work optimizing urethral stents, designing support for regenerative medicine applications, and improving hypospadias outcomes.

摘要

简介

尽管尿道下裂手术普遍存在,术后尿道支架也常被使用,但目前还没有对常见支架材料性能的评估。我们的研究旨在通过对 2011 年至 2021 年期间发表的比较不同尿道支架类型的尿道下裂手术后结果的文献进行综述,并对四种常见尿道支架的材料性能进行评估,来填补这一空白。

研究设计

对 2011 年至 2021 年期间发表的英文文献进行了综述。还对 Zaontz 尿道支架、Firlit-Kluge 尿道支架、Koyle 尿布支架和 Bard 早产儿喂养管进行了热分析和机械分析。

结果

在 165 篇论文中,有 4 篇符合纳入标准。关于这个主题的研究很少,没有证据表明不同的支架材料会影响手术并发症的发生率。一项研究发现 Zaontz 支架的舒适度有所提高,另一项研究发现 Koyle 支架减少了急诊就诊次数。使用 Foley 球囊与瘘管发生率增加有关,但这可能是由于球囊设计而不是材料造成的。支架分析表明,四种支架在体温下均为橡胶状聚合物(总结表)。Zaontz 和 Koyle 支架是热塑性弹性体,在体温以上具有较强的熔融转变,但 Firlit-Kluge 支架在 37°C 时呈无定形,可能通过共价交联生成网络。Bard 喂养管最硬,杨氏模量为 14.0±0.78(相比之下,Zaontz 为 4.12±0.56,Firlit-Kluge 为 4.92±0.63,Koyle 为 4.09±0.49)。Bard 喂养管的延展性也最差,断裂前只能拉伸至超过 300%的应变,而其他支架可拉伸至超过 2000%的应变才断裂。循环变形研究表明,Zaontz、Firlit-Kluge 和 Koyle 支架能够更完全地拉伸和恢复形状,这一发现是由这些支架显示的塑性变形量低于 Bard 喂养管决定的。

讨论

虽然尿道支架类型与尿道下裂手术后结果的关联信息很少,但材料性能可能解释了先前研究的结果。支架较硬可能会导致术后舒适度下降,而支架太软且延展性太好可能会导致移位、扭结和断裂。

结论

本研究为未来优化尿道支架、设计再生医学应用的支架以及改善尿道下裂治疗结果提供了基础。

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