抗感染尿管获中国专利现况

Chinese patent of anti-infective urinary catheter

背景:导管相关尿路感染为临床诊治难点,其致病关键在于材料表面细菌生物膜形成,通过构建具有抗感染功能尿管成为研发热点。目的:回顾抗感染尿管获中国专利的现况。方法:以Google专利(http://www.google.com/advanced_patent_search)为检索平台,以"返回具有以下专利名的专利:尿管"进行检索,检索截至2014-03-26。结果与结论:初检共获得949条结果,剔除无关专利,仅纳入明确陈述抗感染或抗菌尿管专利,共计23条中国专利结果纳入分析。结果表明:1抗菌涂层药物选择:大多数专利为纳米无机金属离子抗菌剂,仅4项含有抗生素涂层。2药物涂层数:大部分为多层/复合涂层。3药物释放方式:大多专利陈述为缓释释放,但释放可控性未予以交代。4制备工艺:1项专利采用化学键或离子键结合方式,2项采取共混方式,1项采取镀复,1项采用高压静电纺丝技术,12项(52.17%)陈述采用物理浸渍方式。5抗菌方式:1项为超声抗菌、1项为无菌套筒、1项为亲水涂层、1项为抗感染剂与高分子材料共混制备导管,其余20项(82.61%)均为含抗菌剂药物液态涂层后干燥成膜。综上,目前尚未见抗感染尿管专利转化应用于临床,相关研究多为实验室或动物实验阶段,中文抗感染尿管相关专利研究方式较为局限,研究水平亟待加强、深入。

BACKGROUND： Catheter associated urinary tract infection is a difficult problem for clinical practice management, and its key pathogenesis is the bacterial biofilm formation on the surface of the catheter material. Therefore, developing a new anti-infective urinary catheter has become an area of interest in the current studies of anti-infective biological materials. OBJECTIVE： To review the research literatures on anti-infective urinary catheter, and provide a direction for further study and clinical application. METHODS： All related Chinese patent papers of anti-infective urinary catheters were retrieved by Google＇s proprietary search platform（http：//www.google.com/advanced_patent_search） until the deadline of March 26, 2014, with the search strategy of ‘Return the patents with the following proprietary name： urinary catheter＇. RESULTS AND CONCLUSION： According to the predefined search strategy, 949 potentially relevant patent papers were screened out for further identification, and 23 papers referred to anti-infective catheters that were obviously eligible were included. The analyses showed that：（1） The antibacterial coating agents of the majority of papers were antibacterial agents of nano-inorganic metal cations, only four papers used antibiotic coated.（2） The drug-eluting catheters were mainly composite-coated.（3） The drug release modes from coating were mainly extended-release but release mechanism was not clarified.（4） The preparation process was chemical bond or ionic bond in one paper, blending methods in one paper, repeated electroplating in one paper, electrospinningtechnology in one paper, and physical impregnation methods in 12 papers（52.17%）.（5） The antimicrobial mode was ultrasonic-antibacterial method in two patent papers, sterile sleeve in one paper, hydrophilic coating in one paper, catheter made by blending polymer material and anti-infective agents in one paper, drug coated films made by coating with antimicrobial drug liquid and drying process in 20 papers（82.61%）. In conclusion, there have been no translational and applied clinical researches about the anti-infective urinary catheter, and the relevant researches were only at the laboratory level. The research methods of Chinese patent for anti-infective urinary catheter were limited, and need to be further improved.