摘要
目的:分析聚碳酸酯材质的医用制品的应力分布状况,以及对在高油脂使用环境下的应力集中导致的制品开裂原因进行分析,探索主要的解决的方法。方法:用聚碳酸酯材质的一次性腹腔穿刺器套管做样本,用含厚脂肪的猪肉来模拟高油脂环境,利用偏振光应力仪和数字图像应力仪对样本进行应力分布状况检测。改变样本的制造过程中的模具温度、料筒温度、退火工艺以及结构特征等主要因素,进行各种试验,最后以综合的改进方案进一步验证。结果和结论:为避免聚碳酸酯材质的医用制品由于内应力分布不均,从而在高油脂环境下产生开裂的问题,必须在产品结构设计、注塑工艺、后处理等主要生产环节综合考虑。在产品结构设计方面,尽量避免结构(如壁厚、直径等)突变现象,从而减少取向内应力;在注塑工艺方面,模具温度较高为好,一般需要超过120℃,料筒温度应该适当,不宜太高或太低,一般在290℃左右(上下偏差10℃)为好;退火工艺方面,提高退火温度比延长退火时间效果更好,退火温度以110℃左右(上下偏差10℃),退火时间超过1 h效果较好。综合考虑上述各种因素后,可以降低或消除聚碳酸酯材质的医用制品的内应力分布不均,避免在高油脂使用环境下产生开裂,确保产品在临床应用中的安全性。
Objective To analyze stress distribution of polycarbonate medical products and the cause of stress-cracking of products in high grease, and to search the main solution. Methods The disposable polycarbonate cannula of abdominocentesis was took as sample, and fat meat was used to simulate the high grease environment. Polarized-light stress device and digital image stress device were applied to test the stress distribution of the sample. The mold temperature, charging barrel temperature, annealing process and structural features in sample manufacturing process were changed to carry out different kinds of tests, obtaining the final solution. Results and Conclusion Product structure design, injection molding and after processing need to be considered overall to avoid the uneven stress distribution of polycarbonate medical products and stress cracking in high grease. Structure, such as wall thickness and diameter, should be avoid mutation as much as possible in the design process to reduce orientation internal stress. For injection molding, the mold temperature should be higher, generally higher than 12 ℃, while the barrel temperature should be suitable, not too high or too low, generally （290± 10） ℃. Raising annealing temperature （110± 10） ℃ is better than increasing the annealing time for annealing process, and the suitable annealing time should be over 1 hour. After considering all the above factors, the stress cracking in high grease can be avoided by reducing or eliminating the uneven stress distribution ofpolycarbonate medical products, to insure the clinical safety.
出处
《中国医学物理学杂志》
CSCD
2015年第3期419-423,共5页
Chinese Journal of Medical Physics
关键词
聚碳酸酯
油脂
应力
医用制品
polycarbonate
grease
stress
medical products
作者简介
勾成俊（1966-），男，硕士，高级工程师，E—mail：china383@126．com．
【通信作者】勾成明（1963-），男，E-mail：china383@126．com。
