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Animal experimental evaluation of a new sealing device for indwelling arterial catheters

机译:新型留置动脉导管密封装置的动物实验评估

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Background: Hematoma is a common complication following arterial puncture. To date no device that allows sealing of an arterial puncture site with in-situ catheter has been developed. Purpose: To evaluate a newly developed arterial sealing device for endovascular catheters in an in-vivo experimental setting. Material and Methods: A peelable collagen-based vascular sealing device for endovascular catheters was tested in acute (follow-up: 4 h; n = 2) and chronic (follow-up: 1 week; n = 4) settings in the femoral artery (FA) of sheep. After implantation correct position of the device as well as patency of the FA were verified angiographically. In the chronic group, hematoma was excluded and patency of FA was assured using color Doppler ultrasound 1 and 3 days after the procedure. After 1 week a final ultrasound and an angiography were performed for final evaluation. Thereafter, the animals were sacrificed and the puncture site was dissected and analyzed macroscopically. Results: Sufficient sealing of the puncture site could be observed in all animals. In acute and chronic experiments, neither a hematoma at the puncture site nor other complications were observed after positioning the sealing device. Follow-up color Doppler ultrasounds (CDUS) and final angiography revealed patent FAs in all animals. Macroscopic evaluation of dissection material proved collagen plug and catheter being in place. Conclusion: Our preliminary in-vivo results demonstrate a safe and convenient vascular sealing system for endovascular catheters. No acute or chronic complications were observed.
机译:背景:血肿是动脉穿刺后的常见并发症。迄今为止,尚未开发出允许用原位导管密封动脉穿刺部位的装置。目的:在体内实验环境中评估一种新开发的用于血管内导管的动脉密封装置。材料和方法:在股动脉的急性(随访时间:4小时; n = 2)和慢性(随访时间:1周; n = 4)环境中,对用于血管内导管的可剥离的基于胶原蛋白的血管密封装置进行了测试。 (FA)绵羊。植入后,通过血管造影检查该装置的正确位置以及FA的通畅性。在慢性组中,术后1天和3天使用彩色多普勒超声排除血肿,并确保FA的通畅。 1周后,进行最终的超声检查和血管造影以进行最终评估。此后,处死动物并解剖穿刺部位并进行宏观分析。结果:在所有动物中都可以观察到足够的刺孔密封。在急性和慢性实验中,放置密封装置后,既未观察到穿刺部位的血肿,也未观察到其他并发症。后续的彩色多普勒超声(CDUS)和最终的血管造影显示,所有动物的FA均已获得专利。解剖材料的宏观评估证明胶原蛋白堵塞物和导管已就位。结论:我们的初步体内结果证明了用于血管内导管的安全便捷的血管密封系统。没有观察到急性或慢性并发症。

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