The Experiments Of Biocompatibility For The Materials Of Artificial Airube

Objective:Nowadays, recondition and anastomosis are considered the best treatment after the air tube cutting. Wite the particularity of human air tube,it is hard to join the broken ends if a longer air tube was cut,or there is nothing surrogate be suitable on human bodys,the same time,the complication of the surgery would be much more,so to study and find a new biomaterial with nice biocompatibility is very important for the development of the air tube surgery. We would be on the result of the domain of international and intemal,to weave a pipe with carbon nanofibers,to apply collagen protein/nm HAP on the inner and parietal wall. Our research to carry out some experiment of biocompatibility with these biomaterials, to supply reliable support for the next clinical test.Methods:With the standardizations of ISO10993-1: 1992 and the GB/T 16886. 1—1997 government standard of《Chinese biological assessment of medical apparatus and instrument》, take some experiments of biocompatibility for the materials of artificial airube, include cytotoxicity test, genotoxicity test, acute systemic toxicity test, skin hypersusceptibility test, invivo biodegradation test, immune reaction test hemolysis test and pyrogen test.Results:1) The growth of the L-929 cells in every array of the biomaterials are all well in the cytotoxicity test,wih litter difference to the negative control;The rank of the cytotoxicity of every array always occupy 0 rank in MTT experiment;In DNA experiment ,the RGR of every array is 35.22%～39.05%,and the PI is 78.79%～87.36%. 2) In the genotoxicity test,the result of the leaching liquor of every materials are close to the negative control, and are consistent with the negative evaluation criterion. 3) In the acute systemic toxicity test,all the mice are live,with litter difference to the negative control. 4) The rate of the allergize is 0 for every array. 5) The carbon nanofibers have a litter and slowly degradation invivo,and the structure could be kept;There was no disvolution,necrosis or paraplasm of collagen protein/nm HAP invivo,and would be degrded and absorbed follow the time. 6) The leaching liquor of every materials would cause light immune reaction for animals, to achieve in 4 weeks,then to recover in 8 weeks. 7) The rate of haemolysis of the leaching liquor of every materials are all<5%. 8) In pyrogen test,the sum total of the fervescence of the rabbits is< 1.4℃,without new pyrogen.Conclusion:1) The biomaterials of artificial airube that carbon nanofibers, collagen protein and nm HAP are all without cytotoxicity or genetoxic. 2) The leaching liquor of every materials made according to the standard are all wihout sensitivity response,pyrogen,acute systemic toxicity or hemoclasis. 3) The carbon nanofibers have a litter and slow degradation invivo,would keep the elementary structure, collagen protein and nm HAP would be degrded and absorbed follow the time invivo. 4) All the biomaterials could cause light immune reaction for animals,and would recover to the normal in a short time.So,these biomaterials have nice cell compatibility, blood compatibility and biocompatibility. Our research could supply reliable support for the next animal model of the artificial airube and the clinical test.