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七种药物洗脱支架系统的机械性能特征比较。

A comparison of the mechanical performance characteristics of seven drug-eluting stent systems.

作者信息

Schmidt W, Lanzer P, Behrens P, Topoleski L D T, Schmitz K-P

机构信息

Institute for Biomedical Engineering, University of Rostock, Rostock, Germany.

出版信息

Catheter Cardiovasc Interv. 2009 Feb 15;73(3):350-60. doi: 10.1002/ccd.21832.

Abstract

OBJECTIVES

Mechanical properties of drug eluting stents (DES) will be measured to provide comparable numerical data to assess deliverability, and thus clinical performance.

BACKGROUND

DES are routinely used in coronary interventions to reduce the rates of restenosis and target vessel revascularizations. Current research is primarily concerned with issues related to late stent thrombosis. However, mechanical properties of DES are a critical determinant of deliverability, and consequently the ultimate arbiter of their clinical performance.

METHODS

Mechanical properties (pushability, trackability, crossability) were measured under standardized in-vitro conditions. The vessel models were derived from typical vessel anatomy but adapted to the individual tests. Additionally, profile and bending forces of the stent segment of the delivery system were measured. Seven different commercially available balloon-expandable coronary DES systems were included. All stents were 3.0 mm diameter with a stent length from 14 to 18 mm.

RESULTS

The pushability expressed as the ratio of distal force at a specific proximal push force (4N) ranged between 38.66 and 18.53%. The trackability as the mean track-forces ranged from 0.551 N to 1.137 N. One stent system could not pass this test. The mean crossing forces at a 1.4 mm stenosis model ranged from 0.038 N up to 0.103 N. The mean crimped stent profiles ranged from 1.055 mm to 1.198 mm and the bending stiffness of the crimped stent was 17.22 to 47.20 Nmm2.

CONCLUSION

Better understanding of mechanical properties of DES shall improve tactile skills of the interventionists during PCI and to improve criteria for DES selection in specific clinical settings.

摘要

目的

测量药物洗脱支架(DES)的机械性能,以提供可比较的数值数据,用于评估输送性能,进而评估临床性能。

背景

DES常用于冠状动脉介入治疗,以降低再狭窄率和靶血管血运重建率。目前的研究主要关注与晚期支架血栓形成相关的问题。然而,DES的机械性能是输送性能的关键决定因素,因此也是其临床性能的最终裁决者。

方法

在标准化的体外条件下测量机械性能(推送性、跟踪性、通过性)。血管模型源自典型的血管解剖结构,但根据个别测试进行了调整。此外,还测量了输送系统支架段的外形和弯曲力。纳入了七种不同的市售球囊扩张式冠状动脉DES系统。所有支架的直径均为3.0 mm,支架长度为14至18 mm。

结果

以特定近端推注力(4N)下的远端力比值表示的推送性在38.66%至18.53%之间。跟踪性以平均跟踪力计,范围为0.551 N至1.137 N。有一个支架系统未能通过此测试。在1.4 mm狭窄模型下的平均通过力范围为0.038 N至0.103 N。平均压缩后支架外形范围为1.055 mm至1.198 mm,压缩后支架的弯曲刚度为17.22至47.20 Nmm2。

结论

更好地了解DES的机械性能应能提高介入医生在经皮冠状动脉介入治疗(PCI)过程中的触觉技能,并改善特定临床环境中DES选择的标准。

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