重新审视 SFA 支架技术：机械支架性能的最新概述。

Revisiting SFA stent technology: an updated overview on mechanical stent performance.

机构信息

University Medical Center Rostock, Institute for Biomedical Engineering, Friedrich-Barnewitz-Str. 4, Rostock, 18119, Germany.

Institute for ImplantTechnology and Biomaterials - IIB e.V., Rostock-Warnemuende, Germany.

出版信息

Biomed Tech (Berl). 2023 May 15;68(5):523-535. doi: 10.1515/bmt-2022-0412. Print 2023 Oct 26.

DOI:10.1515/bmt-2022-0412

PMID:37183602

Abstract

OBJECTIVES

The study investigated mechanical parameters of stent systems indicated for treatment of femoropopliteal (FP) arterial disease to support interpretation of clinical results and the related causalities.

METHODS

Eight stent system types of same dimensions were investigated (n=2). Parameters were the profile of stent delivery system (SDS), radiopacity, trackability and pushability, bending stiffness (flexibility) and axial stiffness of expanded stents, length change during expansion, radial force, crush resistance, strut thickness and general surface condition.

RESULTS

The trackability ranged from 0.237 to 0.920 N and the pushability was 47.9-67.6 %. The bending stiffness of SDS was between 108.42 and 412.68 N mm. The length change during stent release to 5 mm was low, with one exception. The bending stiffness of the expanded stents was 2.73-41.67 N mm. The normalized radial forces at 5 mm diameter ranged from 0.133 N/mm to 0.503 N/mm. During non-radial compression by 50 %, the forces were 3.07-8.42 N, with one exception (58.7 N). The strut thickness was 153-231 µm.

CONCLUSIONS

Large differences occurred for flexibility, radial force and length change during expansion. The data should be used when choosing the proper device for restoring vascular function.

摘要

目的

本研究旨在调查适用于股腘动脉（FP）疾病治疗的支架系统的机械参数，以支持对临床结果及其相关因果关系的解读。

方法

对 8 种相同尺寸的支架系统类型（n=2）进行了研究。参数包括支架输送系统（SDS）的轮廓、放射线不透性、跟踪性和推送性、扩张支架的弯曲刚度（柔韧性）和轴向刚度、扩张过程中的长度变化、径向力、抗压能力、支架厚度和一般表面状况。

结果

跟踪性范围为 0.237 至 0.920 N，推送性为 47.9-67.6%。SDS 的弯曲刚度在 108.42 至 412.68 N•mm 之间。支架释放至 5mm 时的长度变化很小，只有一个例外。扩张支架的弯曲刚度为 2.73-41.67 N•mm。在 5mm 直径下归一化的径向力范围为 0.133 N/mm 至 0.503 N/mm。在 50%的非径向压缩下，力为 3.07-8.42 N，只有一个例外（58.7 N）。支架厚度为 153-231 µm。