新型胰管支架材料研发进展：从惰性植入到智能降解的医工融合创新

Advances in the development of novel pancreatic duct stent materials: from inert implantation to intelligent degradation through medical-engineering integration

摘要:

胰管支架是治疗慢性胰腺炎、胰管狭窄及术后胰瘘等疾病的重要介入器械。传统塑料或金属支架虽能有效引流胰液、减轻导管压力，但长期留置易引发异物反应、感染和再狭窄。理想的胰管支架应具备良好生物相容性、高效引流及可控降解性能。随着医工融合与材料科学的发展，胰管支架材料正经历由“惰性植入”向“智能降解”的转变。可降解高分子与金属材料尤其是镁合金（Mg-Zn-Mn）因具备可调力学性能、耐腐蚀性及体内降解特性，成为研究热点。Mg-2Zn-1.0Mn通过成分优化与表面改性可实现稳定的力学支撑与可控降解；聚乳酸、聚二氧环己酮等高分子材料经结构编织与复合设计，可提升通畅性并避免二次取出。复合可降解支架（如ARCHIMEDES）已实现多档降解速率并获多国批准。结合三维打印与药物洗脱、形状记忆等技术，新一代胰管支架有望实现支撑、修复与抗瘤一体化功能。未来，需通过医工协同优化材料设计，完善降解动力学研究与长期安全性评估，加速临床转化。

Abstract:

Pancreatic duct stents are essential devices for managing chronic pancreatitis, ductal strictures, and postoperative fistula. Conventional plastic and metal stents effectively facilitate pancreatic drainage but often cause infection, restenosis, or migration upon long-term implantation. An ideal stent should provide excellent biocompatibility, efficient drainage, and controllable biodegradation. With advances in material science and medical-engineering integration, stent technology has evolved from inert implantation to intelligent degradation. Biodegradable polymers and metals, particularly magnesium alloys (Mg-Zn-Mn), offer tunable mechanical strength, corrosion resistance, and in vivo degradability. Mg-2Zn-1.0Mn alloy achieves balanced strength and corrosion control through compositional optimization and surface modification. Polymeric stents such as polylactic acid and polydioxanone demonstrate favorable drainage and avoid secondary removal. Composite biodegradable stents, exemplified by the multi-rate ARCHIMEDES model, have received international approval. Supported by 3D printing and smart functionalization-such as drug-eluting or shape-memory designs-next-generation pancreatic stents may achieve integrated functions of support, repair, and tumor inhibition. Future research should emphasize interdisciplinary material design, degradation kinetics under physiological conditions, and long-term biocompatibility to accelerate clinical translation.