CN201558397U - slow-release amikacin catheter - Google Patents
slow-release amikacin catheter Download PDFInfo
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- CN201558397U CN201558397U CN2009201284005U CN200920128400U CN201558397U CN 201558397 U CN201558397 U CN 201558397U CN 2009201284005 U CN2009201284005 U CN 2009201284005U CN 200920128400 U CN200920128400 U CN 200920128400U CN 201558397 U CN201558397 U CN 201558397U
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- 229960004821 amikacin Drugs 0.000 title claims abstract description 37
- LKCWBDHBTVXHDL-RMDFUYIESA-N amikacin Chemical compound O([C@@H]1[C@@H](N)C[C@H]([C@@H]([C@H]1O)O[C@@H]1[C@@H]([C@@H](N)[C@H](O)[C@@H](CO)O1)O)NC(=O)[C@@H](O)CCN)[C@H]1O[C@H](CN)[C@@H](O)[C@H](O)[C@H]1O LKCWBDHBTVXHDL-RMDFUYIESA-N 0.000 title claims abstract description 37
- 229920000954 Polyglycolide Polymers 0.000 claims abstract description 5
- 239000011248 coating agent Substances 0.000 claims abstract description 5
- 238000000576 coating method Methods 0.000 claims abstract description 5
- 238000002347 injection Methods 0.000 claims abstract description 5
- 239000007924 injection Substances 0.000 claims abstract description 5
- 239000004633 polyglycolic acid Substances 0.000 claims abstract description 5
- 210000002700 urine Anatomy 0.000 claims abstract 2
- 230000002485 urinary effect Effects 0.000 claims description 18
- 239000010410 layer Substances 0.000 claims description 11
- 239000004816 latex Substances 0.000 claims description 7
- 229920000126 latex Polymers 0.000 claims description 7
- 229920002379 silicone rubber Polymers 0.000 claims description 6
- 239000004945 silicone rubber Substances 0.000 claims description 6
- RRHGJUQNOFWUDK-UHFFFAOYSA-N Isoprene Chemical compound CC(=C)C=C RRHGJUQNOFWUDK-UHFFFAOYSA-N 0.000 claims description 3
- 239000012792 core layer Substances 0.000 claims description 3
- 241000894006 Bacteria Species 0.000 abstract description 2
- 230000002459 sustained effect Effects 0.000 abstract 4
- 229920000747 poly(lactic acid) Polymers 0.000 abstract 1
- 239000004626 polylactic acid Substances 0.000 abstract 1
- 206010011409 Cross infection Diseases 0.000 description 6
- 244000052616 bacterial pathogen Species 0.000 description 6
- 208000019206 urinary tract infection Diseases 0.000 description 6
- 241000588724 Escherichia coli Species 0.000 description 4
- 230000000694 effects Effects 0.000 description 3
- 208000031729 Bacteremia Diseases 0.000 description 2
- 102000004190 Enzymes Human genes 0.000 description 2
- 108090000790 Enzymes Proteins 0.000 description 2
- 206010029803 Nosocomial infection Diseases 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- 230000000844 anti-bacterial effect Effects 0.000 description 2
- 230000001580 bacterial effect Effects 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 208000015181 infectious disease Diseases 0.000 description 2
- 230000035945 sensitivity Effects 0.000 description 2
- 241000589291 Acinetobacter Species 0.000 description 1
- 241000588986 Alcaligenes Species 0.000 description 1
- 108010077805 Bacterial Proteins Proteins 0.000 description 1
- 108020004256 Beta-lactamase Proteins 0.000 description 1
- 241000589874 Campylobacter fetus Species 0.000 description 1
- 241000588923 Citrobacter Species 0.000 description 1
- 241000588914 Enterobacter Species 0.000 description 1
- 241000588921 Enterobacteriaceae Species 0.000 description 1
- 241000606768 Haemophilus influenzae Species 0.000 description 1
- 241000588748 Klebsiella Species 0.000 description 1
- 241000187479 Mycobacterium tuberculosis Species 0.000 description 1
- 241000588652 Neisseria gonorrhoeae Species 0.000 description 1
- 241000588650 Neisseria meningitidis Species 0.000 description 1
- 206010033892 Paraplegia Diseases 0.000 description 1
- 206010034133 Pathogen resistance Diseases 0.000 description 1
- 241000588769 Proteus <enterobacteria> Species 0.000 description 1
- 241000589516 Pseudomonas Species 0.000 description 1
- 241000589517 Pseudomonas aeruginosa Species 0.000 description 1
- 206010037597 Pyelonephritis acute Diseases 0.000 description 1
- 206010037601 Pyelonephritis chronic Diseases 0.000 description 1
- 241000607142 Salmonella Species 0.000 description 1
- 206010040047 Sepsis Diseases 0.000 description 1
- 241000607720 Serratia Species 0.000 description 1
- 241000607768 Shigella Species 0.000 description 1
- 241000607734 Yersinia <bacteria> Species 0.000 description 1
- 201000001555 acute pyelonephritis Diseases 0.000 description 1
- 229940126575 aminoglycoside Drugs 0.000 description 1
- 229940126574 aminoglycoside antibiotic Drugs 0.000 description 1
- 239000002647 aminoglycoside antibiotic agent Substances 0.000 description 1
- 239000003242 anti bacterial agent Substances 0.000 description 1
- 230000002924 anti-infective effect Effects 0.000 description 1
- 229940088710 antibiotic agent Drugs 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 102000006635 beta-lactamase Human genes 0.000 description 1
- 230000032770 biofilm formation Effects 0.000 description 1
- 201000006368 chronic pyelonephritis Diseases 0.000 description 1
- 201000003146 cystitis Diseases 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 229940047650 haemophilus influenzae Drugs 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 230000000415 inactivating effect Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 230000010534 mechanism of action Effects 0.000 description 1
- 239000012567 medical material Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 238000012544 monitoring process Methods 0.000 description 1
- 238000011587 new zealand white rabbit Methods 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 201000007094 prostatitis Diseases 0.000 description 1
- 238000001243 protein synthesis Methods 0.000 description 1
- 210000002345 respiratory system Anatomy 0.000 description 1
- 210000003705 ribosome Anatomy 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 238000013268 sustained release Methods 0.000 description 1
- 239000012730 sustained-release form Substances 0.000 description 1
- 230000014616 translation Effects 0.000 description 1
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- Materials For Medical Uses (AREA)
Abstract
Description
技术领域technical field
本实用新型属于医疗用材料，具体地说，是一种外表面覆盖有缓释阿米卡星的导尿管。The utility model belongs to medical materials, in particular to a urinary catheter whose outer surface is covered with slow-release amikacin.
背景技术Background technique
导管相关尿路感染(catheter-associated urinary tract infection，CAUTI)是留置导尿一种常见的医院感染。美国疾病控制中心的一项统计表明：住院病人发生的医院感染中尿路感染占42％，居医院感染的首位。日本广岛大学附院的561例医院感染中83％属于尿路感染，而其中的93％是留置尿管引起的。霍红旭等调查留置导尿管引起的相关感染约占医院感染的20.8％～30％，仅次于呼吸系统感染。在留置导尿管的人群中，有2％～4％的患者发生菌血症和败血症，其病死率可高达13％～30％。由于长期导尿伴发的尿路感染是截瘫患者死亡的首要原因。CAUTI可以导致膀胱炎、前列腺炎、急性肾盂肾炎、慢性肾盂肾炎，甚至菌血症的严重后果。CAUTI将会增加住院天数2.4d，每病人次增加住院费用2000美元以上，同时死亡率提高了3倍。由此可见，CAUTI不仅增加了病人的痛苦，而且明显增加了住院的费用。Catheter-associated urinary tract infection (CAUTI) is a common nosocomial infection caused by indwelling catheterization. A statistic from the U.S. Centers for Disease Control and Prevention shows that urinary tract infections account for 42% of nosocomial infections among hospitalized patients, ranking first in nosocomial infections. 83% of the 561 nosocomial infections in the Affiliated Hospital of Hiroshima University in Japan were urinary tract infections, and 93% of them were caused by indwelling catheters. Huo Hongxu et al. investigated that related infections caused by indwelling urinary catheters accounted for about 20.8% to 30% of nosocomial infections, second only to respiratory system infections. Bacteremia and sepsis occur in 2% to 4% of patients with indwelling catheters, and the fatality rate can be as high as 13% to 30%. Urinary tract infection due to long-term catheterization is the leading cause of death in paraplegic patients. CAUTI can lead to serious consequences of cystitis, prostatitis, acute pyelonephritis, chronic pyelonephritis, and even bacteremia. CAUTI will increase the number of days of hospitalization by 2.4 days, increase the cost of hospitalization by more than 2,000 US dollars per patient, and increase the mortality rate by 3 times. It can be seen that CAUTI not only increases the suffering of patients, but also significantly increases the cost of hospitalization.
国内不同地区对尿路感染标本的分析发现，革兰氏阴性杆菌是主要致病菌，检出率高达56.57％～90.20％。其中，大肠埃希菌的检出率最高，可达54.62％，而产生超广谱β内酰胺酶(ESBLs)的菌株为43％左右，且呈逐渐上升的趋势。2008年西南医院院内感染致病菌培养结果显示，产ESBLs的菌株占大肠埃希菌株的66.50％。虽然这些致病菌对抗生素多重耐药，但在地区性大规模的细菌耐药性监测中可以发现，阿米卡星对革兰阴性杆菌仍保持较高的敏感率，对产ESBLs大肠杆菌亦如此，敏感率约为83.3％左右。不但如此，阿米卡星的价格还极其便宜，故其常常作为临床上治疗尿路感染的首选药物。阿米卡星，又名丁胺卡那霉素，是一种氨基糖苷类抗生素，临床常用的是硫酸制剂，为白色或类白色的结晶性粉末或疏松块状物，或者为水溶液。阿米卡星对多数肠杆菌科细菌，如大肠埃希菌、克雷伯菌属、肠杆菌属、变形杆菌属、志贺菌属、沙门菌属、枸橼酸杆菌属、沙雷菌属等均具有良好作用，对铜绿假单胞菌及其他假单胞菌、不动杆菌属、产碱杆菌属等亦有良好作用；对脑膜炎奈瑟菌、淋病奈瑟菌、流感嗜血杆菌、耶尔森菌属、胎儿弯曲菌、结核杆菌及某些非结核分枝杆菌属亦具良好抗菌作用。最突出的优点是阿米卡星对许多肠道革兰阴性杆菌所产生的氨基糖苷类钝化酶稳定，不会被此类酶钝化而失去抗菌活性。阿米卡星的作用机制为作用于细菌核糖体的30S亚单位，抑制细菌合成蛋白质。The analysis of urinary tract infection specimens in different regions in China found that Gram-negative bacilli were the main pathogenic bacteria, and the detection rate was as high as 56.57% to 90.20%. Among them, the detection rate of Escherichia coli was the highest, up to 54.62%, and the strains producing extended-spectrum β-lactamases (ESBLs) were about 43%, and it showed a gradual upward trend. The results of nosocomial infection pathogenic bacteria culture in Southwest Hospital in 2008 showed that ESBLs-producing strains accounted for 66.50% of Escherichia coli strains. Although these pathogenic bacteria are multi-drug resistant to antibiotics, it can be found in regional large-scale bacterial resistance monitoring that amikacin still maintains a high sensitivity rate to Gram-negative bacilli, and also to ESBLs-producing Escherichia coli. Thus, the sensitivity rate is about 83.3%. Not only that, but the price of amikacin is extremely cheap, so it is often used as the drug of choice for the clinical treatment of urinary tract infections. Amikacin, also known as amikacin, is an aminoglycoside antibiotic commonly used in clinic as a sulfuric acid preparation, which is a white or off-white crystalline powder or loose block, or an aqueous solution. Amikacin is effective against most Enterobacteriaceae bacteria, such as Escherichia coli, Klebsiella, Enterobacter, Proteus, Shigella, Salmonella, Citrobacter, and Serratia etc. have good effects, and also have good effects on Pseudomonas aeruginosa and other Pseudomonas, Acinetobacter, Alcaligenes, etc.; on Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus influenzae , Yersinia, Campylobacter fetus, Mycobacterium tuberculosis and some non-tuberculous mycobacteria also have good antibacterial effect. The most prominent advantage is that amikacin is stable to aminoglycoside inactivating enzymes produced by many intestinal gram-negative bacilli, and will not be inactivated by such enzymes to lose antibacterial activity. The mechanism of action of amikacin is to act on the 30S subunit of bacterial ribosomes and inhibit bacterial protein synthesis.
实用新型内容Utility model content
本实用新型所要解决的技术问题在于提供一种强力抗感染和抑制细菌生物膜形成的载缓释阿米卡星导尿管。The technical problem to be solved by the utility model is to provide a slow-release amikacin-loaded urinary catheter with strong anti-infection and inhibition of bacterial biofilm formation.
本实用新型的技术方案如下：一种载缓释阿米卡星导尿管，具有导尿管本体，该导尿管本体尾部连接有注气支管和出尿管，其关键在于：所述导尿管本体外表面覆盖有阿米卡星缓释层，所述阿米卡星缓释层为结合有阿米卡星的聚乳酸-聚羟基乙酸涂层。The technical scheme of the utility model is as follows: a slow-release amikacin-loaded urinary catheter has a catheter body, and the tail of the catheter body is connected with an air injection branch pipe and a urinary catheter. The key lies in: the catheter The outer surface of the urinary catheter body is covered with an amikacin slow-release layer, and the amikacin slow-release layer is a polylactic acid-polyglycolic acid coating combined with amikacin.
载缓释阿米卡星导尿管经体内(新西兰白兔)及体外药物动力学检测证实，具有降低CAUTI发生率的作用。The in vivo (New Zealand white rabbit) and in vitro pharmacokinetic tests of the sustained-release amikacin-loaded urinary catheter confirmed that it has the effect of reducing the incidence of CAUTI.
所述导尿管本体可以选用硅化乳胶管或全硅橡胶管。The catheter body can be made of siliconized latex tube or full silicone rubber tube.
所述硅化乳胶管为天然乳胶管的芯层和硅橡胶管的外层组成。The siliconized latex tube is composed of a core layer of a natural latex tube and an outer layer of a silicone rubber tube.
有益效果：本实用新型具有明显降低CAUTI发生率的作用。导尿管在一定时间内自内而外的释放阿米卡星，直接杀灭尿管周围的细菌，并解决了阿米卡星不能够耐受高温的技术难题。Beneficial effects: the utility model has the function of obviously reducing the incidence of CAUTI. The urinary catheter releases amikacin from inside to outside within a certain period of time, directly kills the bacteria around the urinary catheter, and solves the technical problem that amikacin cannot withstand high temperature.
附图说明Description of drawings
图1是本实用新型的结构示意图；Fig. 1 is a structural representation of the utility model;
图2是本实用新型中全硅橡胶导尿管本体的A-A剖视图；Fig. 2 is the A-A cross-sectional view of the full silicone rubber catheter body in the utility model;
图3是本实用新型中硅化乳胶导尿管本体的A-A剖视图。Fig. 3 is the A-A sectional view of the siliconized latex urinary catheter body in the utility model.
具体实施方式Detailed ways
下面结合附图和实施例对本实用新型作进一步说明：Below in conjunction with accompanying drawing and embodiment the utility model is further described:
实施例1Example 1
如图1、图2所示，本实用新型载缓释阿米卡星导尿管，导尿管本体1尾部连接有注气支管4和出尿管5，所述导尿管本体1为硅化乳胶管，导尿管1外表面覆盖有阿米卡星缓释层2，所述阿米卡星缓释层2为结合有阿米卡星的聚乳酸-聚羟基乙酸涂层。As shown in Fig. 1 and Fig. 2, the utility model contains slow-release amikacin urinary catheter, and the tail of the
实施例2Example 2
如图1、图3所示，本实用新型载缓释阿米卡星导尿管，导尿管本体1尾部连接有注气支管4和出尿管5，所述导尿管本体为全硅橡胶管，硅化乳胶管为天然乳胶管的芯层1a和硅橡胶管的外层1b组成。导尿管本体1外表面覆盖有阿米卡星缓释层2，所述阿米卡星缓释层2为结合有阿米卡星的聚乳酸-聚羟基乙酸涂层。As shown in Figure 1 and Figure 3, the utility model is loaded with slow-release amikacin urinary catheter, the tail of
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2009201284005U CN201558397U (en) | 2009-08-11 | 2009-08-11 | slow-release amikacin catheter |
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| Application Number | Priority Date | Filing Date | Title |
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| CN2009201284005U CN201558397U (en) | 2009-08-11 | 2009-08-11 | slow-release amikacin catheter |
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| CN201558397U true CN201558397U (en) | 2010-08-25 |
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| CN2009201284005U Expired - Fee Related CN201558397U (en) | 2009-08-11 | 2009-08-11 | slow-release amikacin catheter |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105792776A (en) * | 2013-10-16 | 2016-07-20 | 安东尼奥·桑布塞蒂 | PGA tubular patch and associated optional tubular support made of absorbable material for tissue reconstruction of the removed segment of the urethra and/or ureter |
| WO2018219035A1 (en) | 2017-05-31 | 2018-12-06 | 苏州度博迈医疗科技有限公司 | Antimicrobial silicone rubber, preparation method therefor and use thereof |
| CN114425127A (en) * | 2022-02-23 | 2022-05-03 | 山东百多安医疗器械股份有限公司 | Disposable perianal abscess antibacterial drainage tube |
-
2009
- 2009-08-11 CN CN2009201284005U patent/CN201558397U/en not_active Expired - Fee Related
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105792776A (en) * | 2013-10-16 | 2016-07-20 | 安东尼奥·桑布塞蒂 | PGA tubular patch and associated optional tubular support made of absorbable material for tissue reconstruction of the removed segment of the urethra and/or ureter |
| WO2018219035A1 (en) | 2017-05-31 | 2018-12-06 | 苏州度博迈医疗科技有限公司 | Antimicrobial silicone rubber, preparation method therefor and use thereof |
| CN114425127A (en) * | 2022-02-23 | 2022-05-03 | 山东百多安医疗器械股份有限公司 | Disposable perianal abscess antibacterial drainage tube |
| CN114425127B (en) * | 2022-02-23 | 2023-10-20 | 山东百多安医疗器械股份有限公司 | Disposable perianal abscess antibacterial drainage tube |
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| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20100825 Termination date: 20140811 |
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| EXPY | Termination of patent right or utility model |