CN102166377A - Composition, preparation method and use method of lubricating hydrophilic coating for medical catheter - Google Patents
Composition, preparation method and use method of lubricating hydrophilic coating for medical catheter Download PDFInfo
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Abstract
Description
技术领域technical field
本发明涉及一种亲水涂层，尤其是一种医用导管润滑亲水涂层的组合物、制备方法与使用方法。The invention relates to a hydrophilic coating, in particular to a composition, a preparation method and a use method of a lubricating hydrophilic coating for medical catheters.
背景技术Background technique
随着血管介入类医疗器械的发展，现在出现了越来越多的医用导管，如微导管、导引导管、各种支架或栓塞保护器的输送鞘管，这些导管都是需要进入到人体的各种血管内，为了提高这类与血液接触的医用导管的血液相容性及减小导管在血管内穿行的阻力，有必要对这类导管的表面进行亲水涂层的修饰，大量临床结果表明，经亲水涂层修饰的医用导管既可以减轻病人的痛苦，同时对医生的手术操作极为方便。With the development of vascular interventional medical devices, there are more and more medical catheters, such as microcatheters, guiding catheters, delivery sheaths for various stents or embolic protectors, all of which need to enter the human body In various blood vessels, in order to improve the blood compatibility of this type of medical catheter in contact with blood and reduce the resistance of the catheter passing through the blood vessel, it is necessary to modify the surface of this type of catheter with a hydrophilic coating. A large number of clinical results It shows that the medical catheter modified by the hydrophilic coating can not only reduce the pain of the patient, but also facilitate the operation of the doctor.
关于亲水涂层的专利国内外已经公布很多，例如，欧洲专利0586324A1中阐述了一种制备可减少医疗用具表面摩擦的亲水涂层的方法，亲水涂层中除了含有粘合性聚合物、亲水聚合物外，还加入了一种可提高涂层渗透压的无机化合物，如NaCl，这种涂层的缺陷在于在制备涂层液时NaCl很难溶于有机溶剂中，只能以悬浮液的形式存在，最终得到的涂层会比较粗糙；美国专利6221425B1中公开了一种可用于医疗器械的亲水涂层，首先在器械表面涂一层可聚合的单体溶液，在一定条件下聚合形成打底聚合物，然后再涂上一层亲水聚合物，干燥处理后得到亲水涂层，这种方法的缺陷是操作步骤比较繁琐，而且容易形成一些不易去除的残留单体，影响使用的安全性；中国专利03121883.0公开了一种可涂覆于医用导管表面降低摩擦阻力的医用润滑液，润滑液由纤维素酯类聚合物、粘附性聚合物、增塑剂、亲水聚合物组成，该涂层方法也是由两步完成，而且由于纤维素酯类聚合物与某些高分子基体的附着力较小，造成涂层的不稳定。A lot of patents about hydrophilic coatings have been published at home and abroad. For example, European patent 0586324A1 describes a method for preparing a hydrophilic coating that can reduce friction on the surface of medical appliances. In addition to containing adhesive polymers, the hydrophilic coating , hydrophilic polymer, also added an inorganic compound that can increase the osmotic pressure of the coating, such as NaCl, the defect of this coating is that NaCl is difficult to dissolve in the organic solvent when preparing the coating liquid, and can only be used The form of the suspension exists, and the final coating will be relatively rough; US Patent 6221425B1 discloses a hydrophilic coating that can be used for medical devices. First, a layer of polymerizable monomer solution is coated on the surface of the device. Polymerize to form a primer polymer, then coat a layer of hydrophilic polymer, and obtain a hydrophilic coating after drying. The disadvantage of this method is that the operation steps are cumbersome, and it is easy to form some residual monomers that are not easy to remove. Affect the safety of use; Chinese patent 03121883.0 discloses a medical lubricating fluid that can be coated on the surface of medical catheters to reduce frictional resistance. The lubricating fluid is composed of cellulose ester polymers, adhesive polymers, plasticizers, hydrophilic Composed of polymers, the coating method is also completed in two steps, and due to the low adhesion of cellulose ester polymers to certain polymer substrates, the coating is unstable.
发明内容Contents of the invention
针对上述问题中存在的不足之处，本发明提供一种可以实现生物安全、润滑性高、稳定耐磨的医用导管润滑亲水涂层的组合物、制备方法与使用方法。In view of the deficiencies in the above problems, the present invention provides a composition, preparation method and application method of a lubricating hydrophilic coating for medical catheters that can achieve biological safety, high lubricity, and stable wear resistance.
为实现上述目的，本发明提供一种医用导管润滑亲水涂层的组合物，该组合物由缩醛类聚合物、亲水聚合物与柠檬酸酸酯增塑剂组成，上述组分的重量配比范围为缩醛类聚合物15～40％、亲水聚合物30～70％、柠檬酸酸酯增塑剂15～30％；所述亲水聚合物的分子量为100000～1500000。To achieve the above object, the present invention provides a composition of medical catheter lubricating hydrophilic coating, the composition is made up of acetal polymer, hydrophilic polymer and citric acid ester plasticizer, the weight of the above components The proportioning range is 15-40% of acetal polymer, 30-70% of hydrophilic polymer and 15-30% of citric acid ester plasticizer; the molecular weight of the hydrophilic polymer is 100000-1500000.
所述缩醛类聚合物为聚乙烯醇缩丁醛；所述亲水聚合物为聚乙二醇、聚乙烯吡咯烷酮、聚氧化乙烯中的一种或几种；所述柠檬酸酸酯增塑剂为柠檬酸三乙酯、柠檬酸三丁酯、乙酰柠檬酸三丁酯中的一种。The acetal polymer is polyvinyl butyral; the hydrophilic polymer is one or more of polyethylene glycol, polyvinylpyrrolidone, and polyethylene oxide; the citric acid ester is plasticized The agent is one of triethyl citrate, tributyl citrate, and acetyl tributyl citrate.
本发明同时还提供一种医用导管润滑亲水涂层的组合物的制备方法，其将所述组合物与有机溶剂混合后充分搅拌待完全溶解后形成均一的亲水涂层溶液，亲水涂层溶液的浓度范围为2～6％。所述有机溶剂为N，N-二甲基甲酰胺、四氢呋喃、乙酸乙酯、乙酸丁酯、丁酮、无水乙醇、异丙醇、丙酮、三氯甲烷、甲苯中的一种或几种。The present invention also provides a preparation method of a lubricating hydrophilic coating composition for medical catheters, which comprises mixing the composition with an organic solvent, stirring it sufficiently to form a uniform hydrophilic coating solution after it is completely dissolved, and the hydrophilic coating The concentration range of the layer solution is 2-6%. The organic solvent is one or more of N,N-dimethylformamide, tetrahydrofuran, ethyl acetate, butyl acetate, butanone, absolute ethanol, isopropanol, acetone, chloroform, toluene .
本发明还同时提供一种医用导管润滑亲水涂层的组合物的使用方法，将尼龙导管浸渍在制备后的亲水涂层溶液1～2分钟后取出，然后在常温下进行晾干处理，再对医用导管进行干燥。对医用导管干燥处理所需要的温度为50～80℃，而干燥所需要的时间为10～60分钟。另外，还可以通过喷涂设备将制备后的亲水涂层溶液喷涂在医用导管表面，从而在医用导管的表面形成有均匀的涂层，经喷涂后的涂层需要在常温下进行晾干处理，再将医用导管进行干燥。The present invention also provides a method for using a lubricating hydrophilic coating composition for a medical catheter. The nylon catheter is dipped in the prepared hydrophilic coating solution for 1 to 2 minutes, taken out, and then dried at room temperature. The medical catheter is then dried. The temperature required for drying the medical catheter is 50-80° C., and the time required for drying is 10-60 minutes. In addition, the prepared hydrophilic coating solution can also be sprayed on the surface of the medical catheter by spraying equipment, thereby forming a uniform coating on the surface of the medical catheter, and the sprayed coating needs to be dried at room temperature. The medical catheter is then dried.
与现有技术相比，本发明具有以下优点：Compared with the prior art, the present invention has the following advantages:
本发明提供的医用导管润滑亲水涂层的组合物，该组合物由缩醛类聚合物、亲水聚合物与柠檬酸酸酯增塑剂组成，上述组分的重量配比范围为缩醛类聚合物15～40％、亲水聚合物30～70％、柠檬酸酸酯增塑剂15～30％；亲水聚合物的分子量为100000～1500000。将上述组合物与有机溶剂混合后充分搅拌，待完全溶解后形成均一的亲水涂层溶液。将医用导管浸渍在亲水涂层溶液后或采用喷涂的方法，带有亲水涂层的医用导管在室温晾干后再在一定的温度下进行干燥处理，从而在医用导管的表面形成稳定的涂层。本发明可以实现生物安全、润滑性高、稳定耐磨的亲水涂层，成本较低，方法简单。这种涂层在干燥状态下不具有润滑性，但与人体血液接触后具有很好的润滑性和耐磨性，可以极大的减少病人在手术中的痛苦，而且这种涂层所选用的聚合物均是对人体无毒的，生物安全性高。另外，本发明所制备的涂层还可以广泛应用于血管介入类导管，如微导管、导引导管、支架输送鞘管等。The composition of the medical catheter lubricating hydrophilic coating provided by the present invention is composed of an acetal polymer, a hydrophilic polymer and a citrate plasticizer, and the weight ratio range of the above components is acetal 15-40% of quasi-polymer, 30-70% of hydrophilic polymer, 15-30% of citric acid ester plasticizer; the molecular weight of hydrophilic polymer is 100000-1500000. The above composition is mixed with an organic solvent and then fully stirred to form a uniform hydrophilic coating solution after being completely dissolved. After the medical catheter is dipped in the hydrophilic coating solution or sprayed, the medical catheter with the hydrophilic coating is dried at room temperature and then dried at a certain temperature, thereby forming a stable surface on the surface of the medical catheter. coating. The invention can realize biological safety, high lubricity, stable and wear-resistant hydrophilic coating with low cost and simple method. This coating does not have lubricity in a dry state, but it has good lubricity and wear resistance after contact with human blood, which can greatly reduce the pain of patients during surgery. The polymers are non-toxic to the human body and have high biological safety. In addition, the coating prepared by the present invention can also be widely used in vascular intervention catheters, such as microcatheters, guide catheters, stent delivery sheaths and the like.
具体实施方式Detailed ways
本发明提供一种医用导管润滑亲水涂层的组合物，该组合物由缩醛类聚合物、亲水聚合物与柠檬酸酸酯增塑剂组成，上述组分的重量配比范围为缩醛类聚合物15～40％、亲水聚合物30～70％、柠檬酸酸酯增塑剂15～30％；亲水聚合物的分子量为100000～1500000。The invention provides a composition for lubricating and hydrophilic coatings of medical catheters. The composition is composed of acetal polymers, hydrophilic polymers and citric acid ester plasticizers. The weight ratio range of the above components is Aldehyde polymer 15-40%, hydrophilic polymer 30-70%, citrate plasticizer 15-30%; the molecular weight of the hydrophilic polymer is 100000-1500000.
缩醛类聚合物为聚乙烯醇缩丁醛；亲水聚合物为聚乙二醇、聚乙烯吡咯烷酮、聚氧化乙烯中的一种或几种；柠檬酸酸酯增塑剂为柠檬酸三乙酯、柠檬酸三丁酯、乙酰柠檬酸三丁酯中的一种。The acetal polymer is polyvinyl butyral; the hydrophilic polymer is one or more of polyethylene glycol, polyvinylpyrrolidone, and polyethylene oxide; the citric acid ester plasticizer is triethyl citrate One of esters, tributyl citrate, and acetyl tributyl citrate.
本发明同时还提供一种医用导管润滑亲水涂层的组合物的制备方法，其将组合物与有机溶剂混合后充分搅拌待完全溶解后形成均一的亲水涂层溶液，亲水涂层溶液的浓度范围为2～6％。其中，有机溶剂为N，N-二甲基甲酰胺、四氢呋喃、乙酸乙酯、乙酸丁酯、丁酮、无水乙醇、异丙醇、丙酮、三氯甲烷、甲苯中的一种或几种。At the same time, the present invention also provides a preparation method of a lubricating hydrophilic coating composition for a medical catheter, which comprises mixing the composition with an organic solvent and fully stirring to form a uniform hydrophilic coating solution after being completely dissolved. The hydrophilic coating solution The concentration range is 2-6%. Among them, the organic solvent is one or more of N,N-dimethylformamide, tetrahydrofuran, ethyl acetate, butyl acetate, butanone, absolute ethanol, isopropanol, acetone, chloroform, toluene .
本发明还同时提供一种医用导管润滑亲水涂层的组合物的使用方法，将医用导管浸渍在制备的亲水涂层溶液1～2分钟后取出或采用喷涂的方法，然后在常温下进行晾干，再对导管进行干燥处理。对医用导管干燥处理时所需要的温度为50～80℃，而干燥所需要的时间为10～60分钟。The present invention also provides a method for using a lubricating hydrophilic coating composition for a medical catheter. The medical catheter is dipped in the prepared hydrophilic coating solution for 1 to 2 minutes, taken out or sprayed, and then carried out at room temperature. Allow to dry before drying the catheter. The temperature required for drying the medical catheter is 50-80°C, and the drying time is 10-60 minutes.
实施例一Embodiment one
本发明提供一种医用导管润滑亲水涂层的组合物，该组合物由缩醛类聚合物、亲水聚合物与柠檬酸酸酯增塑剂组成，上述组分的重量配比范围为缩醛类聚合物15％、亲水聚合物70％、柠檬酸酸酯增塑剂15％；亲水聚合物的分子量为100000。其中，缩醛类聚合物为聚乙烯醇缩丁醛；亲水聚合物为聚乙二醇、聚乙烯吡咯烷酮、聚氧化乙烯中的一种或几种；柠檬酸酸酯增塑剂为柠檬酸三乙酯、柠檬酸三丁酯、乙酰柠檬酸三丁酯中的一种。The invention provides a composition for lubricating and hydrophilic coatings of medical catheters. The composition is composed of acetal polymers, hydrophilic polymers and citric acid ester plasticizers. The weight ratio range of the above components is Aldehyde polymer 15%, hydrophilic polymer 70%, citrate plasticizer 15%; the molecular weight of the hydrophilic polymer is 100,000. Among them, the acetal polymer is polyvinyl butyral; the hydrophilic polymer is one or more of polyethylene glycol, polyvinylpyrrolidone, and polyethylene oxide; the citric acid ester plasticizer is citric acid One of triethyl ester, tributyl citrate, and acetyl tributyl citrate.
将上述组合物与有机溶剂混合后充分搅拌待完全溶解后形成均一的亲水涂层溶液，亲水涂层溶液的浓度范围为2％。其中，有机溶剂为N，N-二甲基甲酰胺、四氢呋喃、乙酸乙酯、乙酸丁酯、丁酮、无水乙醇、异丙醇、丙酮、三氯甲烷、甲苯中的一种或几种。该有机溶剂由20ml的丁酮、50ml的无水乙醇、15ml的乙酸乙酯与15ml的N，N-二甲基甲酰胺混合制成。The above composition is mixed with an organic solvent and then fully stirred to form a uniform hydrophilic coating solution after being completely dissolved, and the concentration range of the hydrophilic coating solution is 2%. Among them, the organic solvent is one or more of N,N-dimethylformamide, tetrahydrofuran, ethyl acetate, butyl acetate, butanone, absolute ethanol, isopropanol, acetone, chloroform, toluene . The organic solvent is prepared by mixing 20ml of butanone, 50ml of absolute ethanol, 15ml of ethyl acetate and 15ml of N,N-dimethylformamide.
将医用导管浸渍在制备后的亲水涂层溶液1分钟后取出，然后先在常温下进行晾干，再对医用导管的表面进行干燥处理。其中，对医用导管干燥时所需要的温度为50℃，而干燥所需要的时间为10分钟。The medical catheter is soaked in the prepared hydrophilic coating solution for 1 minute, then taken out, and then firstly dried at normal temperature, and then the surface of the medical catheter is dried. Wherein, the temperature required for drying the medical catheter is 50° C., and the time required for drying is 10 minutes.
医用导管基体的材质为尼龙、聚氨酯、聚乙烯、聚氯乙烯、Pebax等。The material of the medical catheter base is nylon, polyurethane, polyethylene, polyvinyl chloride, Pebax, etc.
另外，还可以通过喷涂设备将制备后的亲水涂层溶液喷涂在医用导管表面，从而在医用导管的表面形成均匀的涂层，经喷涂后的涂层需要在常温下进行晾干处理，再将医用导管进行干燥。In addition, the prepared hydrophilic coating solution can also be sprayed on the surface of the medical catheter by spraying equipment, thereby forming a uniform coating on the surface of the medical catheter. The sprayed coating needs to be dried at room temperature, and then Dry the medical catheter.
实施例二Embodiment two
本发明提供一种医用导管润滑亲水涂层的组合物，该组合物由缩醛类聚合物、亲水聚合物与柠檬酸酸酯增塑剂组成，上述组分的重量配比范围为缩醛类聚合物20％～35％、亲水聚合物40％～60％、柠檬酸酸酯增塑剂20％～30％；亲水聚合物的分子量为900000。其中，缩醛类聚合物为聚乙烯醇缩丁醛；亲水聚合物为聚乙二醇、聚乙烯吡咯烷酮、聚氧化乙烯中的一种或几种；柠檬酸酸酯增塑剂为柠檬酸三乙酯、柠檬酸三丁酯、乙酰柠檬酸三丁酯中的一种。The invention provides a composition for lubricating and hydrophilic coatings of medical catheters. The composition is composed of acetal polymers, hydrophilic polymers and citric acid ester plasticizers. The weight ratio range of the above components is 20%-35% of aldehyde polymer, 40%-60% of hydrophilic polymer, 20%-30% of citric acid ester plasticizer; the molecular weight of the hydrophilic polymer is 900,000. Among them, the acetal polymer is polyvinyl butyral; the hydrophilic polymer is one or more of polyethylene glycol, polyvinylpyrrolidone, and polyethylene oxide; the citric acid ester plasticizer is citric acid One of triethyl ester, tributyl citrate, and acetyl tributyl citrate.
将上述组合物与有机溶剂混合后充分搅拌待完全溶解后形成均一的亲水涂层溶液，亲水涂层溶液的浓度范围为3％。其中，有机溶剂为N，N-二甲基甲酰胺、四氢呋喃、乙酸乙酯、乙酸丁酯、丁酮、无水乙醇、异丙醇、丙酮、三氯甲烷、甲苯中的一种或几种。该有机溶液由20ml的丁酮、45ml的无水乙醇、10ml的乙酸乙酯、10ml的丙酮、15ml的N，N-二甲基甲酰胺混合制成。The above composition is mixed with an organic solvent and then fully stirred to form a uniform hydrophilic coating solution after being completely dissolved. The concentration range of the hydrophilic coating solution is 3%. Among them, the organic solvent is one or more of N,N-dimethylformamide, tetrahydrofuran, ethyl acetate, butyl acetate, butanone, absolute ethanol, isopropanol, acetone, chloroform, toluene . The organic solution is prepared by mixing 20ml of butanone, 45ml of absolute ethanol, 10ml of ethyl acetate, 10ml of acetone, and 15ml of N,N-dimethylformamide.
将医用导管浸渍在制备后的亲水涂层溶液1分钟后取出，然后先在常温下进行晾干，再对医用导管的表面进行干燥处理。其中，对医用导管干燥时所需要的温度为60℃，而干燥所需要的时间为60分钟。The medical catheter is soaked in the prepared hydrophilic coating solution for 1 minute, then taken out, and then firstly dried at normal temperature, and then the surface of the medical catheter is dried. Wherein, the temperature required for drying the medical catheter is 60° C., and the time required for drying is 60 minutes.
医用导管基体的材质为尼龙、聚氨酯、聚乙烯、聚氯乙烯、Pebax等。The material of the medical catheter base is nylon, polyurethane, polyethylene, polyvinyl chloride, Pebax, etc.
另外，还可以通过喷涂设备将制备后的亲水涂层溶液喷涂在医用导管表面，从而在医用导管的表面形成均匀的涂层，经喷涂后的涂层需要在常温下进行晾干处理，再将医用导管进行干燥。In addition, the prepared hydrophilic coating solution can also be sprayed on the surface of the medical catheter by spraying equipment, thereby forming a uniform coating on the surface of the medical catheter. The sprayed coating needs to be dried at room temperature, and then Dry the medical catheter.
实施例三Embodiment three
本发明提供一种医用导管润滑亲水涂层的组合物，该组合物由缩醛类聚合物、亲水聚合物与柠檬酸酸酯增塑剂组成，上述组分的重量配比范围为缩醛类聚合物20％～30％、亲水聚合物40％～60％、柠檬酸酸酯增塑剂20％～25％；亲水聚合物的分子量为400000。其中，缩醛类聚合物为聚乙烯醇缩丁醛；亲水聚合物为聚乙二醇、聚乙烯吡咯烷酮、聚氧化乙烯中的一种或几种；柠檬酸酸酯增塑剂为柠檬酸三乙酯、柠檬酸三丁酯、乙酰柠檬酸三丁酯中的一种。The invention provides a composition for lubricating and hydrophilic coatings of medical catheters. The composition is composed of acetal polymers, hydrophilic polymers and citric acid ester plasticizers. The weight ratio range of the above components is 20%-30% of aldehyde polymer, 40%-60% of hydrophilic polymer, 20%-25% of citric acid ester plasticizer; the molecular weight of the hydrophilic polymer is 400,000. Among them, the acetal polymer is polyvinyl butyral; the hydrophilic polymer is one or more of polyethylene glycol, polyvinylpyrrolidone, and polyethylene oxide; the citric acid ester plasticizer is citric acid One of triethyl ester, tributyl citrate, and acetyl tributyl citrate.
将上述组合物与有机溶剂混合后充分搅拌待完全溶解后形成均一的亲水涂层溶液，亲水涂层溶液的浓度范围为4％。其中，有机溶剂为N，N-二甲基甲酰胺、四氢呋喃、乙酸乙酯、乙酸丁酯、丁酮、无水乙醇、异丙醇、丙酮、三氯甲烷、甲苯中的一种或几种。该有机溶液由25ml的丁酮、65ml的无水乙醇、20ml的乙酸丁酯、20ml的N，N-二甲基甲酰胺混合制成。The above composition is mixed with an organic solvent and then fully stirred to form a uniform hydrophilic coating solution after being completely dissolved. The concentration range of the hydrophilic coating solution is 4%. Among them, the organic solvent is one or more of N,N-dimethylformamide, tetrahydrofuran, ethyl acetate, butyl acetate, butanone, absolute ethanol, isopropanol, acetone, chloroform, toluene . The organic solution is prepared by mixing 25ml of butanone, 65ml of absolute ethanol, 20ml of butyl acetate, and 20ml of N,N-dimethylformamide.
将医用导管浸渍在制备后的亲水涂层溶液1分钟后取出，然后先在常温下进行晾干，再对医用导管的表面进行干燥处理。其中，对医用导管干燥时所需要的温度为60℃，而干燥所需要的时间为30分钟。The medical catheter is soaked in the prepared hydrophilic coating solution for 1 minute, then taken out, and then firstly dried at normal temperature, and then the surface of the medical catheter is dried. Wherein, the temperature required for drying the medical catheter is 60° C., and the time required for drying is 30 minutes.
医用导管基体的材质为尼龙、聚氨酯、聚乙烯、聚氯乙烯、Pebax等。The material of the medical catheter base is nylon, polyurethane, polyethylene, polyvinyl chloride, Pebax, etc.
另外，还可以通过喷涂设备将制备后的亲水涂层溶液喷涂在医用导管表面，从而在医用导管的表面形成均匀的涂层，经喷涂后的涂层需要在常温下进行晾干处理，再将医用导管进行干燥。In addition, the prepared hydrophilic coating solution can also be sprayed on the surface of the medical catheter by spraying equipment, thereby forming a uniform coating on the surface of the medical catheter. The sprayed coating needs to be dried at room temperature, and then Dry the medical catheter.
实施例四Embodiment four
本发明提供一种医用导管润滑亲水涂层的组合物，该组合物由缩醛类聚合物、亲水聚合物与柠檬酸酸酯增塑剂组成，上述组分的重量配比范围为缩醛类聚合物25％、亲水聚合物50％、柠檬酸酸酯增塑剂25％；亲水聚合物的分子量为600000。其中，缩醛类聚合物为聚乙烯醇缩丁醛；亲水聚合物为聚乙二醇、聚乙烯吡咯烷酮、聚氧化乙烯中的一种或几种；柠檬酸酸酯增塑剂为柠檬酸三乙酯、柠檬酸三丁酯、乙酰柠檬酸三丁酯中的一种。The invention provides a composition for lubricating and hydrophilic coatings of medical catheters. The composition is composed of acetal polymers, hydrophilic polymers and citric acid ester plasticizers. The weight ratio range of the above components is Aldehyde polymer 25%, hydrophilic polymer 50%, citrate plasticizer 25%; the molecular weight of the hydrophilic polymer is 600,000. Among them, the acetal polymer is polyvinyl butyral; the hydrophilic polymer is one or more of polyethylene glycol, polyvinylpyrrolidone, and polyethylene oxide; the citric acid ester plasticizer is citric acid One of triethyl ester, tributyl citrate, and acetyl tributyl citrate.
将上述组合物与有机溶剂混合后充分搅拌待完全溶解后形成均一的亲水涂层溶液，亲水涂层溶液的浓度范围为5％。其中，有机溶剂为N，N-二甲基甲酰胺、四氢呋喃、乙酸乙酯、乙酸丁酯、丁酮、无水乙醇、异丙醇、丙酮、三氯甲烷、甲苯中的一种或几种。该有机溶液由25ml的丁酮、70ml的无水乙醇、20ml的乙酸丁酯、20ml的N，N-二甲基甲酰胺混合制成。The above composition is mixed with an organic solvent and then fully stirred to form a uniform hydrophilic coating solution after being completely dissolved. The concentration range of the hydrophilic coating solution is 5%. Among them, the organic solvent is one or more of N,N-dimethylformamide, tetrahydrofuran, ethyl acetate, butyl acetate, butanone, absolute ethanol, isopropanol, acetone, chloroform, toluene . The organic solution is prepared by mixing 25ml of butanone, 70ml of absolute ethanol, 20ml of butyl acetate, and 20ml of N,N-dimethylformamide.
将医用导管浸渍在制备后的亲水涂层溶液1分钟后取出，然后先在常温下进行晾干，再对医用导管的表面进行干燥处理。其中，对医用导管干燥时所需要的温度为55℃，而干燥所需要的时间为60分钟。The medical catheter is soaked in the prepared hydrophilic coating solution for 1 minute, then taken out, and then firstly dried at normal temperature, and then the surface of the medical catheter is dried. Among them, the temperature required for drying the medical catheter is 55° C., and the time required for drying is 60 minutes.
医用导管基体的材质为尼龙、聚氨酯、聚乙烯、聚氯乙烯、Pebax等。The material of the medical catheter base is nylon, polyurethane, polyethylene, polyvinyl chloride, Pebax, etc.
另外，还可以通过喷涂设备将制备后的亲水涂层溶液喷涂在医用导管表面，从而在医用导管的表面形成均匀的涂层，经喷涂后的涂层需要在常温下进行晾干处理，再将医用导管进行干燥。In addition, the prepared hydrophilic coating solution can also be sprayed on the surface of the medical catheter by spraying equipment, thereby forming a uniform coating on the surface of the medical catheter. The sprayed coating needs to be dried at room temperature, and then Dry the medical catheter.
实施例五Embodiment five
本发明提供一种医用导管润滑亲水涂层的组合物，该组合物由缩醛类聚合物、亲水聚合物与柠檬酸酸酯增塑剂组成，上述组分的重量配比范围为缩醛类聚合物40％、亲水聚合物30％、柠檬酸酸酯增塑剂30％；亲水聚合物的分子量为1500000。其中，缩醛类聚合物为聚乙烯醇缩丁醛；亲水聚合物为聚乙二醇、聚乙烯吡咯烷酮、聚氧化乙烯中的一种或几种；柠檬酸酸酯增塑剂为柠檬酸三乙酯、柠檬酸三丁酯、乙酰柠檬酸三丁酯中的一种。The invention provides a composition for lubricating and hydrophilic coatings of medical catheters. The composition is composed of acetal polymers, hydrophilic polymers and citric acid ester plasticizers. The weight ratio range of the above components is Aldehyde polymer 40%, hydrophilic polymer 30%, citrate plasticizer 30%; the molecular weight of the hydrophilic polymer is 1,500,000. Among them, the acetal polymer is polyvinyl butyral; the hydrophilic polymer is one or more of polyethylene glycol, polyvinylpyrrolidone, and polyethylene oxide; the citric acid ester plasticizer is citric acid One of triethyl ester, tributyl citrate, and acetyl tributyl citrate.
将上述组合物与有机溶剂混合后充分搅拌待完全溶解后形成均一的亲水涂层溶液，亲水涂层溶液的浓度范围为6％。其中，有机溶剂为N，N-二甲基甲酰胺、四氢呋喃、乙酸乙酯、乙酸丁酯、丁酮、无水乙醇、异丙醇、丙酮、三氯甲烷、甲苯中的一种或几种。该有机溶液由25ml的丁酮、70ml的无水乙醇、20ml的乙酸丁酯、20ml的N，N-二甲基甲酰胺混合制成。The above composition is mixed with an organic solvent and then fully stirred to form a uniform hydrophilic coating solution after being completely dissolved. The concentration range of the hydrophilic coating solution is 6%. Among them, the organic solvent is one or more of N,N-dimethylformamide, tetrahydrofuran, ethyl acetate, butyl acetate, butanone, absolute ethanol, isopropanol, acetone, chloroform, toluene . The organic solution is prepared by mixing 25ml of butanone, 70ml of absolute ethanol, 20ml of butyl acetate, and 20ml of N,N-dimethylformamide.
将医用导管浸渍在制备后的亲水涂层溶液2分钟后取出，然后先在常温下进行晾干，再对医用导管的表面进行干燥处理。其中，对医用导管干燥时所需要的温度为80℃，而干燥所需要的时间为60分钟。The medical catheter is soaked in the prepared hydrophilic coating solution for 2 minutes, taken out, and then firstly dried at normal temperature, and then the surface of the medical catheter is dried. Wherein, the temperature required for drying the medical catheter is 80° C., and the time required for drying is 60 minutes.
医用导管基体的材质为尼龙、聚氨酯、聚乙烯、聚氯乙烯、Pebax等。The material of the medical catheter base is nylon, polyurethane, polyethylene, polyvinyl chloride, Pebax, etc.
另外，还可以通过喷涂设备将制备后的亲水涂层溶液喷涂在医用导管表面，从而在医用导管的表面形成均匀的涂层，经喷涂后的涂层需要在常温下进行晾干处理，再将医用导管进行干燥。In addition, the prepared hydrophilic coating solution can also be sprayed on the surface of the medical catheter by spraying equipment, thereby forming a uniform coating on the surface of the medical catheter. The sprayed coating needs to be dried at room temperature, and then Dry the medical catheter.
惟以上所述者，仅为本发明的较佳实施例而已，举凡熟悉此项技艺的专业人士.在了解本发明的技术手段之后，自然能依据实际的需要，在本发明的教导下加以变化。因此凡依本发明申请专利范围所作的同等变化与修饰，曾应仍属本发明专利涵盖的范围内。But the above-mentioned person is only the preferred embodiment of the present invention, and all professionals who are familiar with this art. After understanding the technical means of the present invention, they can naturally change according to actual needs under the teaching of the present invention . Therefore, all equivalent changes and modifications made according to the patent scope of the present invention should still belong to the scope covered by the patent of the present invention.
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| CN103893832A (en) * | 2014-02-20 | 2014-07-02 | 威海洁瑞医用制品有限公司 | Polylactic acid venous indwelling needle guide pipe |
| CN104399168A (en) * | 2014-11-28 | 2015-03-11 | 中山市普利斯微创介入医械有限公司 | Anesthetic catheter with hydrophilic coating on front section |
| CN105530966A (en) * | 2013-07-15 | 2016-04-27 | 波士顿科学国际有限公司 | Lubricious coating compositions |
| CN110075364A (en) * | 2019-03-18 | 2019-08-02 | 科塞尔医疗科技（苏州）有限公司 | A kind of hydrophilic coating solution of interposing catheter and preparation method thereof and application method |
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