Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems

Importancia y uso:

3.1 This guide can be used to obtain force versus deflection or midspan bending moment versus midspan curvature curves for stents and stent systems subjected to three-point bending conditions. Bending flexibility of a stent system may be a factor in its ability to track through the vascular anatomy, and may be a factor in vascular trauma along the delivery pathway distal to the guide catheter. Bending flexibility of a deployed stent may be one measure of its ability to flex with a vessel, or to conform to the natural curvature of a vessel. Bending flexibility of a delivery system may also be of interest if it is desired to assess the separate contributions of the delivery system and the mounted stent to the overall flexibility of the stent system.

3.2 This guide is not intended to determine material properties, stent system trackability (ability of a stent system to follow a guide wire and/or guide catheter through vascular tortuosity), or stent system deliverability (ability of a stent system to deliver a stent to the implantation site(s) or through particular level(s) of vascular tortuosity). While this guide does not determine stent system trackability or deliverability, it can provide quantitative insight into how stent system bending flexibility affects trackability and deliverability. Similarly, while this guide does not determine conformability of a deployed stent, it can provide quantitative insight into how stent and/or stent system bending flexibility affects deployed stent conformability. Since this guide quantifies bending flexibility, it may be useful in determining the magnitude of bending flexibility effects on bending-related performance differences between the test article and control devices.

3.3 The three-point bending procedures provided in this guide are intended to be used to characterize balloon-expandable stent and stent system flexibility during product development. They may not necessarily satisfy any particular requirements of national or international regulatory bodies.

Subcomité:

F04.30

Referida por:

F3510-21, F3036-21

Volúmen:

13.02

Número ICS:

11.040.40 (Implants for surgery, prothetics and orthotics)

Palabras clave:

bending; delivery system; elasticity; flexibility; flexural; flexure; stent; stent system; stiffness;