基于PCL/PLGA共混材料的可降解食管支架:降解速率调控与体外性能分析
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1.<2.sup>3.南京医科大学附属儿童医院心胸外科<4./sup>5.南京<6.医融达智能医学增材制造研究院;7.&8.amp;9.lt;10.sup&11.gt;12.南京医科大学附属儿童医院心胸外科&13./sup&

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南京市医学科技发展重点项目(ZKX22051)


Degradable Esophageal Stent Based on PCL/PLGA Blend: Degradation Rate Regulation and In Vitro Performance Analysis
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Nanjing Key program of medical science and technology development

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    摘要:

    目的:本研究旨在开发一种基于聚己内酯(PCL)与聚乳酸-羟基乙酸(PLGA)共混材料的可降解食管支架,通过调节PLGA比例(0%-35%)来平衡降解速率与力学性能,并探索其体外降解特性。方法:研究使用挤出式高温融溶旋转3D打印技术制备了八种不同配比的支架,并结合蜂窝状多孔结构设计(孔隙率60%-70%)。采用人工唾液(pH≈6.6)与人工胃液(pH≈4.0)进行8周的体外降解实验。结果:结果表明,PLGA比例显著影响降解速率,PLGA比例的增加能够加速支架的降解(失重率由5.3%增加至42.7%),并且PLGA与PCL的共混产生了协同效应(PLGA每增加10%,达到相同失重率的时间缩短约50-70%;),导致阶段性崩解现象(PLGA≥25%时)。结论:通过调整PLGA比例,可实现4-24周的降解周期,满足临床上从先天性狭窄到急性炎症的不同需求。此外,3D打印技术与仿生形态、多孔结构设计相结合,显著提高了支架的组织贴合性和抗移位性。本研究为个性化的可降解食管支架治疗提供了理论依据与技术支持。

    Abstract:

    Objective:This study aims to develop a biodegradable esophageal stent based on polycaprolactone (PCL) and poly(lactic-co-glycolic acid) (PLGA) blend materials. By adjusting the PLGA ratio (0%-35%), the study seeks to balance degradation rate and mechanical properties while exploring its in vitro degradation characteristics. Methods:Eight different stent formulations were prepared using Extrusion-based High-temperature Melt Rotary 3D Printing technology, combined with a honeycomb porous structure design (porosity 60%-70%). In vitro degradation experiments were conducted over 8 weeks using artificial saliva (pH ≈ 6.6) and artificial gastric juice (pH ≈ 4.0). Results:The results demonstrated that the PLGA ratio significantly affected the degradation rate, with higher PLGA content accelerating the degradation of the stent (weight loss increased from 5.3% to 42.7%). Additionally, the blend of PLGA and PCL exhibited a synergistic effect, leading to stage-wise disintegration phenomena (when PLGA content was ≥25%). Conclusion:By adjusting the PLGA ratio, a degradation cycle ranging from 4 to 24 weeks was achieved, meeting the diverse clinical needs from congenital stricture to acute inflammation. Furthermore, the combination of 3D printing technology with biomimetic morphology and porous structure design significantly improved the tissue conformity and anti-displacement properties of the stent. These findings provide a theoretical basis and technical support for personalized treatment with biodegradable esophageal stents.

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  • 收稿日期:2025-09-27
  • 最后修改日期:2026-01-02
  • 录用日期:2026-05-25
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