CN107497034A - 一种带涂层的螺纹导尿管 - Google Patents
一种带涂层的螺纹导尿管 Download PDFInfo
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Abstract
本发明公开了一种带涂层的螺纹导尿管,包括一导尿管管体,所述导尿管管体上靠近导尿管管体头端的位置处设有一球囊,所述导尿管管体外表面、紧靠所述球囊的位置处设有螺纹凸起,并形成一螺纹段;所述螺纹段上沿所述导尿管管体的长度方向设有凹槽,并沿所述螺纹段的外周等间距设置。所述导尿管管体的螺纹段外周还涂覆有涂层,所述涂层为Se‑SiO2涂层,其由纳米Se‑SiO2材料和壳聚糖混合形成,所述纳米Se‑SiO2材料为多孔SiO2包裹的Se颗粒构成。本发明带涂层的螺纹导尿管,一方面增加涂层的涂覆面积,另一方面抑制前列腺创面氧化应激的同时,避免Se颗粒释放较快达到中毒剂量,促进前列腺术后的快速恢复。
Description
技术领域
本发明涉及医疗器械技术领域,具体地说,是一种带涂层的螺纹导尿管。
背景技术
导尿管为术后患者常规的护理干预,于无菌条件下经尿道插入膀胱引流尿液,被广泛应用于术后、麻醉及排尿困难者。
目前,公知的医用导尿管是以天然橡胶、硅橡胶或聚氯乙烯(PVC)等材料制成,可以经由尿道插入膀胱以便引流尿液出来,导尿管插入膀胱后,靠近导尿管头端处有一个水囊,注水后该水囊可膨大,固定导尿管留在膀胱内而不易脱出,且引流管连接尿袋收集尿液。
患者在前列腺术后不能很快恢复正常排尿功能,因此需要插导尿管并保留一段时间,根据病情决定留置时间的长短。为此许多学者研制了不同种类的涂层导尿管,通过药物的持久缓释作用达到促进前列腺术后创面快速愈合、减少出血的目的。但是,由于普通三腔气囊导尿管所涂覆的涂层面积有限,因此无法达到良好的预期效能。
另外,临床上前列腺切除术后创面在愈合的过程中会产生过多的活性氧及降解产物,从而造成各种氧化应激的生物学标记物升高,创面组织的促氧化能力增加,导致创伤后出现氧化应激。在创面愈合的炎症阶段,氧化应激作为促氧化剂与抗氧化剂的内环境平衡失调,致使组织损害。因此,长期的氧化应激对于创面的修复是不利的,可能是术后创面难愈的原因之一,给治疗带来一定的困难。
Se作为一种还原性物质,可有效抑制创面的氧化应激,从而可将Se用于前列腺术后的愈合过程,进而促进前列腺创面的修复,但由于Se的治疗剂量和毒性剂量窗口很小,治疗过程中容易发生中毒,故限制了其临床应用。
此外,由于Se还是机体生命活动不可缺少的一种微量元素,与人体的多种疾病密切相关,从而研究发现,适量摄入Se,具有增强机体免疫,延缓生物衰老等功效,但是Se在最佳浓度和致毒浓度之间的安全限度非常狭窄,使用剂量无法精确控制。由于纳米硒具有低毒作用,现有技术已经提出了一种Se-SiO2粒子,由多孔SiO2材料包裹Se颗粒形成,其中多孔SiO2材料的多孔结构可以有效控制Se的释放速率和剂量。现阶段该Se-SiO2粒子一般制成药物,进行抗癌、增强人体细胞的免疫力等。
中国专利文献CN201621112707.2,申请日20161011,专利名称为:一种UV固化涂层导尿管,包括导尿管本体和外套在导尿管本体外的包装袋;所述导尿管本体设有深入人体膀胱的中空导管,中空导管的头端设置为封闭端,中空导管的尾端设有接头,在中空导管的前部靠近头端处设有尿液入口,在中空导管的前部外壁上设有插管过程中减少病人痛苦的UV固化涂层;所述包装袋的内部设置有湿润UV固化涂层的密封润滑腔和放置接头的接头放置腔,在密封润滑腔内填充有始终保证UV固化涂层润滑的无菌水。
上述专利文献的UV固化涂层导尿管,设计合理、结构简单、插管容易、成分安全,能够有效防止对尿道粘膜造成损伤,但是关于一种带涂层的螺纹导尿管,增加导尿管外涂层的表面积,使涂层材料可以获得更长的作用时间,从而达到更强的效果的技术方案则无相应的公开。
综上所述,需要一种带涂层的螺纹导尿管,增加导尿管外涂层的表面积,使涂层材料可以获得更长的作用时间,从而达到更强的效果。而关于这种带涂层的螺纹导尿管目前还未见报道。
发明内容
本发明的目的是针对现有技术中的不足,提供一种带涂层的螺纹导尿管,增加导尿管外涂层的表面积,使涂层材料可以获得更长的作用时间,从而达到更强的效果。
本发明的再一目的是提供一种带涂层的螺纹导尿管的制备方法。
为实现上述目的,本发明采取的技术方案是:
一种带涂层的螺纹导尿管,包括一导尿管管体,所述导尿管管体上靠近导尿管管体头端的位置处设有一球囊,其特征在于:所述导尿管管体外表面、紧靠所述球囊的位置处设有螺纹凸起,并形成一螺纹段,所述导尿管管体的螺纹段外周涂覆有涂层。
本发明的带涂层的螺纹导尿管的改进在于,所述螺纹段上设有凹槽。
本发明的带涂层的螺纹导尿管的改进在于,所述凹槽沿所述导尿管管体的长度方向设置。
本发明的带涂层的螺纹导尿管的改进在于,所述凹槽数量设置为4个。
本发明的带涂层的螺纹导尿管的改进在于,所述凹槽沿所述螺纹段的外周等间距设置。
本发明的带涂层的螺纹导尿管的改进在于,所述螺纹段的长度为3cm。
本发明的带涂层的螺纹导尿管的改进在于,所述螺纹段设置在导尿管管体上与患者前列腺部位相对应的位置处,且导尿管在工厂制作时即依照螺纹段的设计位置对导尿管进行制作形成螺纹段。
本发明的带涂层的螺纹导尿管的改进在于,所述涂层为Se-SiO2涂层。
为实现上述第二个目的,本发明采取的技术方案是:
一种带涂层的螺纹导尿管的制备方法,包括以下步骤:
步骤S1,将Cu 2-xSe纳米粒子分散于正己烷中,得到Cu 2-xSe正己烷分散液;
步骤S2,往Cu 2-xSe正己烷分散液中加入去离子水、正己醇、聚乙二醇辛基苯基醚和正己烷,搅拌,滴加正硅酸四乙酯,充分混合,1~60min后再滴加氨水,搅拌反应,加入丙酮并离心分离,分离产物洗涤后分散于去离子水中,制得纳米Se-SiO 2分散液;
步骤S3,将聚乙烯吡咯烷酮加入纳米Se-SiO 2分散液中,搅拌混合后,停止搅拌并加热进行热液处理,然后冷却至室温,离心洗涤,即制得多孔Se-SiO 2纳米粒子;
步骤S4,将多孔Se-SiO 2纳米粒子加入到壳聚糖液体中,进行充分混合;
步骤S5,将导尿管管体的螺纹段浸泡在醇溶液中,一般浸泡5-20分钟,以将螺纹段表面的油脂等去除,起到清洁导尿管表面的作用;
步骤S6,从醇溶液取出导尿管管体的螺纹段,用纯化水进行清洗,然后浸泡壳聚糖以及Se-SiO 2纳米粒子的混合溶液中;
步骤S7,将导尿管管体的螺纹段从壳聚糖以及Se-SiO 2纳米粒子的混合溶液中取出,然后进行清洗、烘干、包装和灭菌,根据需要,重复步骤S6-S7的步骤,以获得满足要求的Se-SiO 2涂层。
本发明优点在于:
1、本发明的带涂层的螺纹导尿管,在导尿管所需涂覆涂层的位置处设置螺纹凸起,并形成一螺纹段,从而增加涂层的涂覆面积,使涂层达到更好的治愈效果,促进前列腺术后的快速恢复。
2、螺纹凸起以及凹槽的设置,增加涂层涂覆面积的同时避免出现涂覆不均匀的现象,保证患者前列腺创面快速、健康的修复;
3、在所述导尿管管体外表面、紧靠所述球囊的位置处设有螺纹凸起,并形成一螺纹段,该螺纹段在使用状态下位于前列腺部位处。该设计方案的作用是:螺纹段可直接与手术创面直接接触,配合涂层上的药物可对创面实现针对性局部治疗,可局部止血,促进创面愈合;
4、通过多孔SiO2的多孔结构使Se颗粒缓慢释放,从而抑制前列腺创面氧化应激的同时,避免Se颗粒释放较快达到中毒剂量,引起Se中毒,从而促进前列腺创面的修复;
5、壳聚糖一方面使纳米Se-SiO2材料成为可涂覆在导尿管管体上的液体涂层,另一方面还可充当Se颗粒释放的缓释剂,进一步起到避免Se中毒的作用;
6、有效抑制氧化应激促进创面修复的同时,又避免引起严重的不良反应,具有良好的可控性;且成本低廉,合成周期短(1个月);可载药,有较大的应用前景;保存条件不苛刻,可在4℃下保存。
附图说明
附图1为本发明带涂层的螺纹导尿管的结构示意图。
附图2为本发明中导尿管管体的头端的结构示意图。
附图3为本发明中导尿管管体的球囊的结构示意图。
附图4为本发明中导尿管管体的螺纹段的结构示意图。
附图5为本发明中导尿管管体的螺纹段的局部放大示意图。
附图6为本发明中导尿管管体的螺纹段的俯视示意图。
具体实施方式
下面结合附图对本发明提供的具体实施方式作详细说明。
附图中涉及的附图标记和组成部分如下所示:
10.导尿管管体 11.尾端
12.注水腔 13.注药腔
14.排液腔 15.单向阀
16.注药孔 17.排液孔
18.球囊 19.头端
20.螺纹段 21.螺纹凸起
22.凹槽 30.涂层
实施例1螺纹段+涂层式导尿管
请参照图1所示,三腔气囊导尿管包括一导尿管管体10,所述导尿管管体10的两端分别为头端19和尾端11。该三腔气囊导尿管的尾端11处设有三个腔体,分别为注水腔12、注药腔13以及排液腔14,且该尾端11处还具有一控制注水腔12的单向阀15。
请参照图2所示,该三腔气囊导尿管的头端19处分别设有一侧开注药孔16和一侧开排液孔17。
请参照图3所示,导尿管管体10上靠近头端19的位置处设有一球囊18,该球囊18经由注水腔12注水后膨胀,从而将导尿管固定在膀胱内,避免脱出。上述三腔气囊导尿管为现有技术,在此不再赘述。
请参照图4所示,本发明带涂层30的螺纹导尿管,在所述导尿管管体10外表面、紧靠所述球囊18的位置处设有螺纹凸起21,并形成一螺纹段20,该螺纹段20在使用状态下位于前列腺部位处,即,导尿管管体10插入患者膀胱内时,位于尿道前列腺部位处的一段导尿管管体10设为螺纹段20,在本实施例中,螺纹段20的长度为3cm;在该导尿管管体10的螺纹段20的外周还涂覆有涂层30。藉此,螺纹凸起21用以增加涂层30的涂覆面积,提高涂层30的治疗效果。
该实施例需要说明的是:在所述导尿管管体10外表面、紧靠所述球囊18的位置处设有螺纹凸起21,并形成一螺纹段20,该螺纹段20在使用状态下位于前列腺部位处。该设计方案的作用是:1.因手术创面位于尿道内以及膀胱颈处,本实施例的螺纹段20可直接与手术创面直接接触,配合涂层30上的药物可对创面实现针对性局部治疗,可局部止血,促进创面愈合。而现有技术中因手术创面位置的特殊性,局部止血和药物应用均不方便。也有的传统方法是持续膀胱冲洗联合全身药物治疗,而牵引气囊压迫止血的方法对患者造成的痛苦大,局部容易缺血而坏死,使病情复杂化,预后欠佳;2.螺纹段20作为涂层30的载体,螺纹段20为螺纹凸起21的结构形式,对应的涂层30与螺纹段20的形状结构一致,增加了涂层30涂覆面积,使得药物治疗的局部浓度高,提高涂层30的治疗效果。
该实施例中,螺纹段20的长度为3cm,该尺寸规格是根据临床经验设计而成的,促进前列腺术后创面快速愈合、减少出血效果好。
实施例2带有凹槽的螺纹段+涂层式导尿管
本实施例与实施例1基本相同,其不同之处在于:请参照图5和图6,所述螺纹段20上沿所述导尿管管体10的长度方向设置有凹槽22,涂层30涂覆在螺纹段20上时,该凹槽22形成涂层30上下扩散的通道,在增大涂覆面积的同时也防止某些患者尿道与导尿管管体10上的螺纹凸起21严密贴合,造成涂层30分布不均、利用不完全。在本实施例中,凹槽22的数量为4个,并沿所述螺纹段20的外周等间距设置。
实施例3带有凹槽的螺纹段+Se-SiO2涂层式导尿管
本实施例与实施例2基本相同,其不同之处在于:本实施例采用Se-SiO2涂层30对前列腺创面的氧化应激进行有效抑制,所述Se-SiO2涂层30包括纳米Se-SiO2材料,该纳米Se-SiO2材料由多孔SiO2材料包裹Se颗粒形成,多孔SiO2材料的多孔结构可以有效控制Se的释放速率和剂量,从而避免发生中毒现象,但是所述纳米Se-SiO2材料为粉末状,无法涂覆在导尿管管体10上。由于壳聚糖能被生物体内的溶菌酶降解生成天然的代谢物,具有无毒、能被生物体完全吸收的特点,因此用它作药物缓释剂具有较大的优越性,并且所述壳聚糖呈液体状,可涂覆在导尿管管体10上。故在本发明中,将所述粉末状的纳米Se-SiO2材料溶于壳聚糖中,经过充分均匀混合后形成Se-SiO2涂层30,所述Se-SiO2涂层30涂覆在导尿管管体10的螺纹段20上,加快前列腺创面的修复。
结合图1至图6,在完成前列腺切除术后,术者将本发明带涂层30的螺纹导尿管插入患者尿道内,并通过注水腔12向球囊18内注入30cc无菌生理盐水,使球囊18充起,并且单向阀15保证球囊18内的水不会倒流,从而充满水的球囊18卡在患者膀胱颈部,避免导尿管管体10脱出。此时,螺纹段20正好位于患者前列腺部位处,且螺纹段20与患者前列腺创面平行,从而涂覆在螺纹段20外周的涂层30也与前列腺创面平行,由于螺纹凸起21的设置使涂层30的涂覆面积增大,进而增加螺纹段20的载药量,加快涂层30对前列腺创面的修复。此外,螺纹段20上凹槽22的设置,形成涂层30沿螺纹段20扩散的通道,因此,增大涂层30涂覆面积的同时防止某些患者尿道与螺纹凸起21严密贴合,导致涂层30释放分布不均、利用不完全,并且凹槽2240等间距设置,进一步保证螺纹段20外周的涂层30涂覆均匀。在本实施例中,Se-SiO2涂层30位于患者前列腺部位处时,Se-SiO2涂层30在水溶液环境中其壳聚糖缓慢降解,在壳聚糖缓慢降解的过程中,药物Se颗粒可通过SiO2的多孔结构缓慢且稳定地释放,不仅增加药物与创面的接触面积,而且可通过多孔SiO2有效控制Se的释放速率和剂量,从而抑制前列腺创面的氧化过激,即加强患者前列腺创面修复效果的同时又避免到达Se的毒性剂量。之后通过注药腔13向患者膀胱内注入生理盐水,保证导尿管不会被血凝块堵塞,患者尿液自排液腔14中缓慢流出。
本发明带涂层30的螺纹导尿管,其螺纹段20设置在导尿管管体10上与患者前列腺部位相对应的位置处,且导尿管在工厂制作时即依照螺纹段20的设计位置对导尿管进行制作形成螺纹段20。
实施例4Se-SiO2涂层30的制备方法
一种Se-SiO2涂层30的制备方法,其特征在于,包括以下步骤:
步骤S1,将Cu 2-xSe纳米粒子分散于正己烷中,得到Cu 2-xSe正己烷分散液;
步骤S2,往Cu 2-xSe正己烷分散液中加入去离子水、正己醇、聚乙二醇辛基苯基醚和正己烷,搅拌,滴加正硅酸四乙酯,充分混合,1~60min后再滴加氨水,搅拌反应,加入丙酮并离心分离,分离产物洗涤后分散于去离子水中,制得纳米Se-SiO 2分散液;
步骤S3,将聚乙烯吡咯烷酮加入纳米Se-SiO 2分散液中,搅拌混合后,停止搅拌并加热进行热液处理,然后冷却至室温,离心洗涤,即制得多孔Se-SiO 2纳米粒子。
步骤S4,将多孔Se-SiO 2纳米粒子加入到壳聚糖液体中,进行充分混合;
步骤S5,将导尿管管体10的螺纹段20浸泡在醇溶液中,一般浸泡5-20分钟,以将螺纹段20表面的油脂等去除,起到清洁导尿管表面的作用。该醇溶液优选为乙醇溶液、异丙醇溶液、丁醇溶液或甲基丁醇溶液;
步骤S6,从醇溶液取出导尿管管体10的螺纹段20,用纯化水进行清洗,然后浸泡壳聚糖以及Se-SiO 2纳米粒子的混合溶液中;
步骤S7,将导尿管管体10的螺纹段20从壳聚糖以及Se-SiO 2纳米粒子的混合溶液中取出,然后进行清洗、烘干、包装和灭菌,根据需要,重复步骤S6-S7的步骤,以获得满足要求的Se-SiO 2涂层30。
该实施例方法所获得的Se-SiO2涂层30,在壳聚糖缓慢降解的过程中,药物Se颗粒可通过SiO2的多孔结构缓慢且稳定地释放,不仅增加药物与创面的接触面积,而且可通过多孔SiO2有效控制Se的释放速率和剂量,从而抑制前列腺创面的氧化过激,即加强患者前列腺创面修复效果的同时又避免到达Se的毒性剂量。
本发明带涂层30的螺纹导尿管具有以下有益效果:
1)螺纹凸起21以及凹槽22的设置,增加涂层30涂覆面积的同时避免出现涂覆不均匀的现象,保证患者前列腺创面快速、健康的修复;
2)在所述导尿管管体10外表面、紧靠所述球囊18的位置处设有螺纹凸起21,并形成一螺纹段20,该螺纹段20在使用状态下位于前列腺部位处。该设计方案的作用是:螺纹段20可直接与手术创面直接接触,配合涂层30上的药物可对创面实现针对性局部治疗,可局部止血,促进创面愈合;
3)通过多孔SiO2的多孔结构使Se颗粒缓慢释放,从而抑制前列腺创面氧化应激的同时,避免Se颗粒释放较快达到中毒剂量,引起Se中毒,从而促进前列腺创面的修复;
4)壳聚糖一方面使纳米Se-SiO2材料成为可涂覆在导尿管管体10上的液体涂层30,另一方面还可充当Se颗粒释放的缓释剂,进一步起到避免Se中毒的作用;
5)有效抑制氧化应激促进创面修复的同时,又避免引起严重的不良反应,具有良好的可控性;且成本低廉,合成周期短(1个月);可载药,有较大的应用前景;保存条件不苛刻,可在4℃下保存。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员,在不脱离本发明方法的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。
Claims (9)
1.一种带涂层的螺纹导尿管,包括一导尿管管体,所述导尿管管体上靠近导尿管管体头端的位置处设有一球囊,其特征在于:所述导尿管管体外表面、紧靠所述球囊的位置处设有螺纹凸起,并形成一螺纹段,所述导尿管管体的螺纹段外周涂覆有涂层。
2.根据权利要求1所述的带涂层的螺纹导尿管,其特征在于:所述螺纹段上设有凹槽。
3.根据权利要求2所述的带涂层的螺纹导尿管,其特征在于:所述凹槽沿所述导尿管管体的长度方向设置。
4.根据权利要求3所述的带涂层的螺纹导尿管,其特征在于:所述凹槽数量设置为4个。
5.根据权利要求4所述的带涂层的螺纹导尿管,其特征在于:所述凹槽沿所述螺纹段的外周等间距设置。
6.根据权利要求1所述的带涂层的螺纹导尿管,其特征在于:所述螺纹段的长度为3cm。
7.根据权利要求1所述的带涂层的螺纹导尿管,其特征在于:所述螺纹段设置在导尿管管体上与患者前列腺部位相对应的位置处,且导尿管在工厂制作时即依照螺纹段的设计位置对导尿管进行制作形成螺纹段。
8.根据权利要求1-7任一项所述的带涂层的螺纹导尿管,其特征在于:所述涂层为Se-SiO2涂层。
9.一种利用权利要求1-8任一所述的带涂层的螺纹导尿管,其特征在于:所述Se-SiO2涂层的制备方法包括以下步骤:
步骤S1,将Cu 2-xSe纳米粒子分散于正己烷中,得到Cu 2-xSe正己烷分散液;
步骤S2,往Cu 2-xSe正己烷分散液中加入去离子水、正己醇、聚乙二醇辛基苯基醚和正己烷,搅拌,滴加正硅酸四乙酯,充分混合,1~60min后再滴加氨水,搅拌反应,加入丙酮并离心分离,分离产物洗涤后分散于去离子水中,制得纳米Se-SiO 2分散液;
步骤S3,将聚乙烯吡咯烷酮加入纳米Se-SiO 2分散液中,搅拌混合后,停止搅拌并加热进行热液处理,然后冷却至室温,离心洗涤,即制得多孔Se-SiO 2纳米粒子;
步骤S4,将多孔Se-SiO 2纳米粒子加入到壳聚糖液体中,进行充分混合;
步骤S5,将导尿管管体的螺纹段浸泡在醇溶液中,一般浸泡5-20分钟,以将螺纹段表面的油脂等去除,起到清洁导尿管表面的作用;
步骤S6,从醇溶液取出导尿管管体的螺纹段,用纯化水进行清洗,然后浸泡壳聚糖以及Se-SiO 2纳米粒子的混合溶液中;
步骤S7,将导尿管管体的螺纹段从壳聚糖以及Se-SiO 2纳米粒子的混合溶液中取出,然后进行清洗、烘干、包装和灭菌,根据需要,重复步骤S6-S7的步骤,以获得满足要求的Se-SiO 2涂层。
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