文章摘要
球囊导尿管材料的研究进展
Research Progress of Materials for Foley Catheters
投稿时间:2019-10-21  修订日期:2019-10-21
DOI:10.12136/j.issn.1000-890X.2020.10.0795
中文关键词: 球囊导尿管  原材料  天然胶乳  涂层  硅橡胶  水凝胶  聚四氟乙烯
英文关键词: Foley catheter  raw material  nature rubber latex  coating  silicone rubber  hydrogels  polytetrafluoroethylene
基金项目:
作者单位E-mail
任 英* 国家药品监督管理局 医疗器械技术审评中心 renying@cmde.org.cn 
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中文摘要:
      综述以天然胶乳为基础材料的球囊导尿管材料的研究进展。鉴于球囊导尿管临床使用中常见感染、包壳、堵塞和断裂等问题,总结为解决这些问题而使用的球囊导尿管材料。水凝胶、聚四氟乙烯和硅橡胶涂层都能改变球囊导尿管表面性能,硅橡胶是唯一能代替天然胶乳用于球囊制备的材料。目前球囊导尿管的设计和材料仍需改进。建议丰富球囊导尿管相关标准,为开发新型球囊导尿管提供参考,并确保产品的安全性和有效性。
英文摘要:
      The research progress of the materials used in Foley catheter based on natural rubber latex is reviewed.In order to solve the common problems in clinical use of Foley catheter,such as infection,encrustation,blockage and rupture,materials used in response to these problems are summarized.Hydrogels,polytetrafluoroethylene and silicone rubber coatings are effective to alter the properties of Foley catheter surfaces.Silicone rubber is the only material that can replace natural rubber latex for balloon preparation.The design and materials of the Foley catheters still need to be improved.It is suggested to enrich the related standards of Foley catheter,so as to provide reference for the development of new Foley catheters and ensure the safety and effectiveness of the product.
Author NameAffiliationE-mail
REN Ying Center for Medical Device Evaluation,National Medical Products Administration renying@cmde.org.cn 
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