Schmidt W, Andresen R, Behrens P, Schmitz K P
Institut für Biomedizinische Technik, Universität Rostock, Germany.
Rofo. 2002 Nov;174(11):1430-7. doi: 10.1055/s-2002-35345.
To measure in vitro geometric-mechanical characteristics of balloon-expandable peripheral stent systems for determining suitability for specific vascular regions.
Balloon-expandable stents including their delivery systems manufactured by Guidant (OTW Megalink trade mark ), Inflow Dynamics (Antares), Medtronic (AVE Bridge trade mark ), Biotronik (Peiron trade mark ) and Cordis (Corinthian IQ trade mark ) were selected for this study. When expanded, all stents had a nominal diameter of 8 mm. The length was 38 - 40 mm. Stent profile, trackability, length change on expansion, stiffness, elastic recoil, and radio-opacity in the crimped and expanded state of these stent systems were determined with specially developed test methods.
The Corinthian IQ trade mark, Megalink trade mark and Peiron trade mark required the smallest force to pass through the vascular model. While the Bridge trade mark system had the largest profile with a diameter of 2.430 mm, all other stent systems had a significantly smaller diameter ranging from 1.970 mm for the Peiron trade mark to 2.078 mm for the Corinthian IQ trade mark. In the distal region of the stent delivery system, the Megalink trade mark was the most flexible and the Bridge trade mark system the stiffest. Elastic recoil for all stents was in the range of 2.5 % to 3.5 %, with the exception of the Bridge trade mark stent, which had an elastic recoil of 4.79 %. The Corinthian IQ trade mark stent had noticeably the highest radial stiffness. In the expanded condition, the Peiron trade mark was the most flexible while the Corinthian IQ trade mark and the Antares trade mark were found to be the stiffest. Length change (shrinkage on expansion) ranged from 0.54 to 6.57%, with the exception of the Corinthian IQ, which shrunk > 7mm (18.5%) on expansion. All stent systems in the crimped and expanded state were readily visible radiographically.
Specific data of significant parameters are available to aid in the selection of balloon expandable stents systems to be deployed in complex vascular regions. All examined stent systems showed adequate mechanical properties, but clinically relevant differences were found in stent trackability, bending stiffness and shrinkage on expansion.
测量球囊扩张式外周支架系统的体外几何力学特性,以确定其是否适用于特定血管区域。
本研究选用了由Guidant(OTW Megalink商标)、Inflow Dynamics(Antares)、美敦力(AVE Bridge商标)、百多力(Peiron商标)和科迪斯(Corinthian IQ商标)生产的球囊扩张式支架及其输送系统。所有支架扩张后的标称直径均为8mm,长度为38 - 40mm。采用专门开发的测试方法,测定了这些支架系统在卷曲和扩张状态下的支架外形、可跟踪性、扩张时的长度变化、刚度、弹性回缩和射线不透性。
Corinthian IQ商标、Megalink商标和Peiron商标的支架穿过血管模型所需的力最小。虽然Bridge商标系统的外形最大,直径为2.430mm,但所有其他支架系统的直径明显较小,从Peiron商标的1.970mm到Corinthian IQ商标的2.078mm不等。在支架输送系统的远端区域,Megalink商标的支架最灵活,Bridge商标系统的支架最硬。所有支架的弹性回缩率在2.5%至3.5%之间,但Bridge商标的支架除外,其弹性回缩率为4.79%。Corinthian IQ商标的支架径向刚度明显最高。在扩张状态下,Peiron商标的支架最灵活,而Corinthian IQ商标和Antares商标的支架最硬。长度变化(扩张时收缩)范围为0.54%至6.57%,Corinthian IQ商标的支架除外,其扩张时收缩超过7mm(18.5%)。所有支架系统在卷曲和扩张状态下在放射影像上都清晰可见。
提供了重要参数的具体数据,有助于选择用于复杂血管区域的球囊扩张式支架系统。所有检测的支架系统均显示出足够的机械性能,但在支架可跟踪性、弯曲刚度和扩张时收缩方面发现了与临床相关的差异。