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一种用于排除主动脉瘤的新型血管内低轮廓装置的研发:一项实验性初步研究。

Development of a new intravascular low-profile device for exclusion of aortic aneurysm: an experimental pilot study.

作者信息

Strecker Ernst-Peter, Haberstroh Jörg, Boos Irene, Metz Stephan, Langer Mathias, Moliner Manuel Maynar

机构信息

Department of Imaging, Interventional Radiology and Nuclear Medicine, Diakonissen-Hospital, Karlsruhe, Germany.

出版信息

Cardiovasc Intervent Radiol. 2004 May-Jun;27(3):243-50. doi: 10.1007/s00270-004-0065-x. Epub 2004 Mar 25.

DOI:10.1007/s00270-004-0065-x
PMID:15037952
Abstract

PURPOSE

To present a new intravascular device for the treatment of aorto-iliac aneurysms.

METHODS

This new device was tested in five dogs with abdominal aortic aneurysm created experimentally by over-dilation of a balloon-expandable stent with a 16 or 18 mm wide PTA balloon catheter. The design of the device is based on a self-expanding aortic stent which consists of two stretchable circular frames filled with a textile Dacron mesh membrane that is suspended horizontally into the infrarenal abdominal aorta proximally to the aneurysm. The frames are part of a preshaped double helical structure that is introduced longitudinally through a catheter in a parallel fashion and forming the desired shape at the vessel site to be occluded. Two iliac stent-grafts are introduced in a low-profile status through the membrane sealing the aneurysm sac and holding the stent-grafts in place. After stent-graft expansion, a new bifurcation located more proximally than the natural one is created. The follow-up of the dogs was performed clinically and angiographically, and specimens were evaluated histomorphologically.

RESULTS

The membrane device can be introduced through a 9 Fr vascular sheath. Technical success was achieved in four of five dogs. Nine of ten stent-grafts could be fixed securely within the membrane, thus preventing dislocation. Aneurysms were excluded immediately, and blood flow to the external iliac arteries was restored by the stent-grafts. At 6-9 months follow-up of technically successful implanted devices, there were no endoleaks, no migration, no stenoses at contact sites between the implant material and vascular wall, and no stenosis or occlusion of the stent-grafts. At microscopic evaluation, the interspace between the membranes was filled with thrombotic material, thus ensuring exclusion of the aneurysm.

CONCLUSION

This new device was found to be flexible, low profile and useful in excluding abdominal aortic aneurysm in the experimental setting.

摘要

目的

介绍一种用于治疗主-髂动脉瘤的新型血管内装置。

方法

该新型装置在五只通过用16或18毫米宽的经皮腔内血管成形术(PTA)球囊导管过度扩张球囊可扩张支架而实验性制造腹主动脉瘤的犬身上进行了测试。该装置的设计基于一种自膨胀主动脉支架,其由两个可拉伸的圆形框架组成,框架内填充有纺织涤纶网膜,该网膜水平悬挂在肾下腹主动脉近端的动脉瘤处。框架是预成型双螺旋结构的一部分,该结构通过导管以平行方式纵向引入,并在要闭塞的血管部位形成所需形状。两个髂动脉支架移植物以低轮廓状态通过密封动脉瘤囊的膜引入,并将支架移植物固定到位。在支架移植物扩张后,会形成一个比自然分叉更靠近近端的新分叉。对犬进行了临床和血管造影随访,并对标本进行了组织形态学评估。

结果

膜装置可通过9F血管鞘引入。五只犬中有四只取得了技术成功。十个支架移植物中有九个能够牢固地固定在膜内,从而防止脱位。动脉瘤立即被隔绝,支架移植物恢复了向外髂动脉的血流。在对技术成功植入装置进行6至9个月的随访中,没有内漏、没有移位、植入材料与血管壁接触部位没有狭窄,并且支架移植物没有狭窄或闭塞。在显微镜评估中,膜之间的间隙充满了血栓物质,从而确保了动脉瘤的隔绝。

结论

在实验环境中,发现这种新型装置具有柔韧性、低轮廓且可有效隔绝腹主动脉瘤。

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