Tissue Capability And Blood Reciprocity Reaction Researches Of Nitinol Intravascular Stent

PURPOSE: By refered to GB/T16886.4-2003/ISO10993:2002,GB/T 16886.6-1997/ISO10993-6:1994 national standards ,our object is evaluate the feasibility of application of a new tinitinol-wallstent. Our experiment include in vivo planted response experiment, blood reciprocity reaction experiment and Nitinol intravascular stent physical capability mensurated. Those experiments is to find out whether the Nitinol intravascular stent can be used in human body intravascular therapy or not by observed and estimated the reactions of material which have been planted in vivo . METHOD: We choose ten New Zealand rabbits that is five male and five female at in vivo planted response experiment. In the back muscle of rabbit, one side of spine is planted polyethylene terephthalate (PET). Another side of spine is planted silicone rubber, which is comparison material. Then , we observe the reactions of tissue which around the material within one week,four week,twelve week,twenty-six week and fifty-two week. In blood reciprocity reaction experiment, we planted the Nitinol intravascular stents in ten sheeps's vascular,which is five maleand five female and weight from 20 to 27kg. Then , we observe the reactions of tissue which around the material and within four weeks,six weeks, eight weeks twelve weeks and twenty-four weeks. In vitro, we put the Nitinol intravascular stents into test tube that contains anti-coagulate human blood ,then, mensurate dissociate hemachrome . We have been mensuratesd Nitinol intravascular stent physical capability. RESULT: The reaction degree of muscle tissue ,which judge by naked eye and pathology ,accord with national index of reaction degree of tissue, we have not finded the blood vessel closed or the stent distortion and moved by examined with DSA, MRI and pathology. The apparatus around or near the blood vessel is normal. The component of blood, such as blood platelet, have not changed. The function of liver and nephridium is normal. In vitro experiment approved there are not hemolysis when put the Nitinol intravascular stents into test tube. The Nitinol intravascular stents have good physical and mechanism capability. CONCLUSION: Our experiment clewed the Nitinol intravascular stents have nice tissue capability and usability.