带定位中心的介入用支架输送器研究

Researching for Stent Conveyor which with Positioning the Center of Intervention

现阶段涂药支架或放射性支架在临床使用的频率越来越高,但初期的支架雏形均是在支架外表面采用特殊的工艺将药物均匀的涂在支架表面,但临床使用效果表明某些药物支架与人体管腔正常组织接触后,带来了不确定的组织损伤。临床要求该种药物支架在进行工艺改进后能够只针对管腔病变位置实施治疗而不涉及正常管腔组织,但如何将该种药物支架的涂药部位在手术时准确定位在人体管腔病变位置是个急需解决的问题。目前临床介入科及腔镜科均使用普通的支架输送器或预置支架的球囊扩张导管将支架置入到人体病变部位。如果需要将局部涂药的支架置入到人体病变部位就需要研究一种带定位中心的输送器,该输送器除了具备普通输送器在生物相容性等方面的要求外还必须具备可实施定位置入支架的要求。由于X射线不能透过金属材料,所以可以考虑将金属线加入到导管材料中,并在导管的径向和轴向加工定型一个十字靶心,在支架出厂时可以将支架局部涂药的部位对准导管的十字靶心进行预置,这样在临床放置支架时只需在X射线的观察下将十字靶心定位于已实施影像检查的人体管腔病变部位即可。实验结果表明将带定位中心的介入用支架输送器置于X射线人体测试模拟体模内在70kV、3mA曝光条件下实施透视及70kV、200mA曝光条件下实施摄影,其影像非常清晰能够使临床医生能够准确地将局部涂药支架定位于人体管腔病变位置。

Drug-coated stent or radioactive stent are used more and more in clinical at present. The special process which has the stent coated with drugs is used to initial prototype, but the results show that uncertainly tissue damage has been induced by drug stent which contact with normal tissues.The stent must just contact with the disease tissues with exclusion of the normal tissues after the process improvement. But how to locate the disease lumens accurately in surgical is an urgent problem. Ordinary stent conveyor or balloon catheter is used in Endoscopic Division and Intervention Division to place the stent into the disease part nowadays. A new conveyor with positioning function is needed to be developed. This new conveyor can place the stent which only have drug coated on special part into the disease part. As the X-ray can not through metal materials, the metal line can be added to the tube. We can process a cross bull with it. The cross bull can be used to locate the position by installing in the radial and axial of the tube on ex-factory. Under X-ray＇s help the partly drug-coated stent with a cross bull in it can be located accurately in clinical. The experimental results show that the image under X-ray is very clear, and the clinician can accurately locate the disease location of simulated body. The exposure condition is 70KV, 3mA and 70KV, 200mA.