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新型纤维复合磁共振导丝的体内临床前评估

Preclinical evaluation of a novel fiber compound MR guidewire in vivo.

作者信息

Krämer Nils A, Krüger Sascha, Schmitz Sebastian, Linssen Marita, Schade Heinz, Weiss Steffen, Spüntrup Elmar, Günther Rolf W, Bücker Arno, Krombach Gabriele A

机构信息

Clinic of Diagnostic Radiology, University of Technology Aachen, Aachen, Germany.

出版信息

Invest Radiol. 2009 Jul;44(7):390-7. doi: 10.1097/RLI.0b013e3181a66ab5.

Abstract

PURPOSE

Interventional magnetic resonance imaging requires dedicated and MR-compatible devices. The guidewire is a key item for intravascular interventions. Mechanical stability, good visibility during real-time imaging, and RF safety are essential. A novel fiber-compound MR guidewire (GW) was evaluated in different MR-guided interventional scenarios.

MATERIALS AND METHODS

The GW (diameter 0.032") consists of a fiber-compound produced using a micropultrusion technique doped with iron particles and a 10-cm Nitinol tip. Several iron splints are additionally attached at regular distances to visualize GW-movement. A protective polymer jacket with hydrophilic coating covers the core material. As approved by the government committee on animal investigations, the GW was evaluated in 5 pigs. Under complete MR-guidance, catheterization of the carotid and renal arteries, segmental arteries of the kidneys, the contralateral inguinal artery, and the left ventricle was performed using real-time gradient echo sequences in a 1.5 Tesla scanner. Different interventional applications including balloon dilatation, stent deployment, and embolization of small vessels were investigated. The time to probe the vessels under magnetic resonance imaging guidance and visibility of the GW are assessed. Handling and visibility under fluoroscopy were compared with a standard Nitinol guidewire as a benchmark.

RESULTS

On real-time magnetic resonance imaging, the iron-induced artifacts enabled a distinct visualization of the GW shaft and of its markings with a mean size of 2.6 mm and 5.4 mm, respectively. This facilitated fast navigation to the target vessels (averages: renal arteries 16 seconds, carotid artery 5 seconds, and contralateral inguinal artery 42 seconds.) with an exact depiction of the respective vessel. All interventional procedures were performed successfully. No GW-related side effects as kinking or breakage of the wire or GW induced blood-clotting were observed. All interventionalists assessed handling of the GW to be nearly equal in terms of stiffness, flexibility, and guidance compared with a standard Nitinol guidewire. X-ray visibility was less distinct but still diagnostically good.

CONCLUSION

With the aid of the GW, different fully real-time MR-guided endovascular interventions become feasible.

摘要

目的

介入性磁共振成像需要专用的且与磁共振兼容的设备。导丝是血管内介入的关键物品。机械稳定性、实时成像期间的良好可视性以及射频安全性至关重要。在不同的磁共振引导介入场景中对一种新型纤维复合磁共振导丝(GW)进行了评估。

材料与方法

GW(直径0.032英寸)由采用微拉挤技术生产的、掺杂有铁颗粒的纤维复合材料以及一个10厘米长的镍钛诺尖端组成。另外以规则间距附着了几个铁夹板以可视化GW的移动。带有亲水涂层的保护性聚合物护套覆盖核心材料。经政府动物研究委员会批准,在5头猪身上对GW进行了评估。在完全磁共振引导下,使用1.5特斯拉扫描仪中的实时梯度回波序列对颈动脉、肾动脉、肾段动脉、对侧腹股沟动脉和左心室进行插管。研究了包括球囊扩张、支架置入和小血管栓塞在内的不同介入应用。评估了在磁共振成像引导下探测血管的时间以及GW的可视性。将荧光透视下的操作性和可视性与作为基准的标准镍钛诺导丝进行比较。

结果

在实时磁共振成像上,铁诱导的伪影使GW轴及其标记清晰可见,其平均尺寸分别为2.6毫米和5.4毫米。这有助于快速导航至目标血管(平均值:肾动脉16秒、颈动脉5秒、对侧腹股沟动脉42秒),并能精确描绘相应血管。所有介入操作均成功完成。未观察到与GW相关的副作用,如导丝扭结或断裂或GW诱导的血液凝固。所有介入医生评估,与标准镍钛诺导丝相比,GW在硬度、柔韧性和导向方面的操作性几乎相同。X射线可视性不太清晰,但仍具有良好的诊断性。

结论

借助GW,不同的完全实时磁共振引导的血管内介入变得可行。

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