State Key Laboratory of Molecular Engineering of Polymers, Department of Macromolecular Science, Fudan University, Shanghai, China.
National and Local Joint Engineering Laboratory of Interventional Medical Biotechnology and System, Biotyx Medical (Shenzhen) Co., Ltd, Lifetech Scientific (Shenzhen) Co. Ltd., Shenzhen, China.
Nat Commun. 2024 Sep 10;15(1):7903. doi: 10.1038/s41467-024-52288-4.
While chronic limb-threatening ischemia is a serious peripheral artery disease, the lack of an appropriate stent significantly limits the potential of interventional treatment. In spite of much progress in coronary stents, little is towards peripheral stents, which are expected to be both long and biodegradable and thus require a breakthrough in core techniques. Herein, we develop a long and biodegradable stent with a length of up to 118 mm based on a metal-polymer composite material. To achieve a well-prepared homogeneous coating on a long stent during ultrasonic spraying, a magnetic levitation is employed. In vivo degradation of the stent is investigated in rabbit abdominal aorta/iliac arteries, and its preclinical safety is evaluated in canine infrapopliteal arteries. First-in-man implantation of the stent is carried out in the below-the-knee artery. The 13 months' follow-ups demonstrate the feasibility of the long and biodegradable stent in clinical applications.
虽然慢性肢体威胁性缺血是一种严重的外周动脉疾病，但缺乏合适的支架极大地限制了介入治疗的潜力。尽管冠状动脉支架取得了很大进展，但外周支架的进展却很少，外周支架需要既长又可生物降解，因此需要在核心技术上取得突破。在这里，我们基于金属-聚合物复合材料开发了一种长达 118mm 的长且可生物降解的支架。为了在超声喷涂过程中实现长支架上准备良好的均匀涂层，采用了磁悬浮。在兔腹主动脉/髂动脉中研究了支架的体内降解，并在犬后肢小动脉中评估了其临床前安全性。首例人体植入支架是在膝下动脉进行的。13 个月的随访结果表明，长且可生物降解的支架在临床应用中是可行的。
