CN113797425A - 一种溶栓导管封堵导丝的制作方法 - Google Patents
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Abstract
本发明公开了一种溶栓导管封堵导丝的制作方法,包括以下步骤:制备医用不锈钢等制造导丝的原材料;将原材料进行高温融化,放入模具进行冷却开模,成为芯丝;本发明通过设置空心塑料管和不锈钢导丝,解决了弹簧与芯丝焊接工艺复杂,工艺技术要求高,不易操作;焊接设备价格高昂,经济性差;焊接过程中易产生烟雾粉尘,易造成生产环境污染和易导致与人体发生反应造成过敏,感染的问题,该一种溶栓导管封堵导丝的制作方法,具备焊接工艺简单,工艺技术要求低,易操作;焊接设备价格较低廉,经济性好;焊接过程无其他粉尘产生,可在洁净车间生产和性能稳定无刺激,具有较好的抗菌性能的优点。
Description
技术领域
本发明涉及一次性使用医疗器械技术领域,具体为一种溶栓导管封堵导丝的制作方法。
背景技术
医疗介入金属导丝是作用于人体内,在植入或介入人体的过程中,通常都是与人体的器官或组织如血管等直接接触摩擦反应,因此对医疗介入金属导丝的性能要求也越来越高,除开医疗介入金属导丝的原材料、加工成形方法外,生物医用合金的表面状态如抗溶血凝血性、抗菌性等生物相容性十分重要,生物医学材料除需要满足临床医学无毒性、不致癌、不导致过敏、不致畸形等基本要求外,还有不引起人体细胞的突发和组织细胞的反应、与人体生物相容性好、化学性质稳定、与天然组织相适应的物理机械特性等多重要求;医用导丝是导管穿刺过程中用于支撑导管的核心部件,在导丝前端一般设有弹性区域以便引导导丝前端的插拔,为了确保导丝与弹性区域之间连接的可靠性,本发明将导丝前端设为截面积较小的扁平状结构,该结构一方面能够提高导丝与弹性部件之间的连接可靠性,另一方面能够提高扭矩传递效率。然而导丝的直径一般在0.5mm以下,导丝前端宽度更是低于0.1mm。
如发明专利(201080010146.4)所公开的“(一种医用导丝)”,其弹簧与芯丝焊接工艺复杂,工艺技术要求高,不易操作;焊接设备价格高昂,经济性差;焊接过程中易产生烟雾粉尘,易造成生产环境污染,为此提出一种溶栓导管封堵导丝的制作方法,来解决此问题。
发明内容
本发明的目的在于提供一种溶栓导管封堵导丝的制作方法,具备焊接工艺简单,工艺技术要求低,易操作;焊接设备价格较低廉,经济性好;焊接过程无其他粉尘产生,可在洁净车间生产和性能稳定无刺激,具有较好的抗菌性能的优点,解决了弹簧与芯丝焊接工艺复杂,工艺技术要求高,不易操作;焊接设备价格高昂,经济性差;焊接过程中易产生烟雾粉尘,易造成生产环境污染和易导致与人体发生反应造成过敏,感染的问题。
为实现上述目的,本发明提供如下技术方案:一种溶栓导管封堵导丝的制作方法,包括以下步骤:
步骤1制备医用不锈钢等制造导丝的原材料;
步骤2:将原材料进行高温融化,放入模具进行冷却开模,成为芯丝;
步骤3:配置具有抗感染性能的功能性涂覆溶液;
步骤4:将制备好的芯丝浸泡在功能性涂膜溶液中,浸泡一段时间后,取出芯丝在去离子水与乙醇液体超声清洗三次,干燥;
步骤5:选取空心塑料管,空心塑料管进行超声清洗,超声清洗介质采用具有抗菌成分的缓冲液;
步骤6:将芯丝的一端与塑料管的一端通过热成型方式连接。
优选的,所述在步骤1中,不锈钢的成份是铁与铬还有碳等原素所组合而成的,430不锈钢(18-0);铁+18%以上的铬无镍。
优选的,所述在步骤3中,所述功能性涂覆浴液是按下列方法制备的溶液;量取1000mlTrisHCI缓冲溶液,称取多巴胺或其衍生物200-5000mg溶于前述缓冲溶液中充分溶解,然后称取20-4000mg有机/无机抗菌剂加入到该溶液中,使其充分溶解,形成功能性涂覆溶液。
优选的,所述TrisHCI缓冲溶液的pH值为71-90。
优选的,所述有机或无机抗菌剂包括季铵盐类抗菌剂、胍类有机抗菌剂、多肽类抗菌剂、酚类有机抗菌剂、银离子无机抗菌剂、锌离子无机抗菌剂铜离子无机抗菌剂中的任何一种和多种。
优选的,所述在步骤4中,所述浸泡时间为6-48H,在浸泡过程中可对浸泡液进行搅拌,也可对其进行轻微加热,加快浸泡时间。
优选的,所述芯丝在离子水与乙醇溶液中对芯丝表面进行消毒清洁,超声清洗对附着在芯丝表面微笑的污垢进行剥落二次清洁,使芯丝达到完美清洁的效果。
优选的,所述在步骤5中,所述缓冲液配方为:Tris-HCl缓冲液1000ml、聚硅氧烷季铵盐抗菌剂0.5%、甲基硅油0.1%、柠檬酸钠0.6%、乙胺丁醇0.02%、磺胺二甲基嘧啶0.05%、甘氨酸0.2%、脯氨酸0.03%、甘油3%。
优选的,所述在步骤6中,所述热成型是将热塑性空心塑料管在框架上加热到软化状态,在外力作用下,使其紧贴芯丝的一端,冷却定型后,经修整即成制品。
与现有技术相比,本发明的有益效果是:本发明通过设置空心塑料管和不锈钢导丝,解决了弹簧与芯丝焊接工艺复杂,工艺技术要求高,不易操作;焊接设备价格高昂,经济性差;焊接过程中易产生烟雾粉尘,易造成生产环境污染和易导致与人体发生反应造成过敏,感染的问题,该一种溶栓导管封堵导丝的制作方法,具备焊接工艺简单,工艺技术要求低,易操作;焊接设备价格较低廉,经济性好;焊接过程无其他粉尘产生,可在洁净车间生产和性能稳定无刺激,具有较好的抗菌性能的优点。
附图说明
图1为本发明专利结构安装前示意图;
图2为本发明专利结构安装后示意图。
具体实施方式
下面将通过实施例的方式对本发明作更详细的描述,这些实施例仅是举例说明性的而没有任何对本发明范围的限制。
本发明提供一种技术方案:一种溶栓导管封堵导丝的制作方法,包括以下步骤:
步骤1:制备医用不锈钢等制造导丝的原材料;
步骤2:将原材料进行高温融化,放入模具进行冷却开模,成为芯丝;
步骤3:配置具有抗感染性能的功能性涂覆溶液;
步骤4:将制备好的芯丝浸泡在功能性涂膜溶液中,浸泡一段时间后,取出芯丝在去离子水与乙醇液体超声清洗三次,干燥;
步骤5:选取空心塑料管,空心塑料管进行超声清洗,超声清洗介质采用具有抗菌成分的缓冲液;
步骤6:将芯丝的一端与塑料管的一端通过热成型方式连接。
实施例一:
制备医用不锈钢等制造导丝的原材料;将原材料进行高温融化,放入模具进行冷却开模,成为芯丝;配置具有抗感染性能的功能性涂覆溶液;将制备好的芯丝浸泡在功能性涂膜溶液中,浸泡一段时间后,取出芯丝在去离子水与乙醇液体超声清洗三次,干燥;选取空心塑料管,空心塑料管进行超声清洗,超声清洗介质采用具有抗菌成分的缓冲液;将芯丝的一端与塑料管的一端通过热成型方式连接。
实施例二:
在实施例一中,再加上下述工序:
制备医用不锈钢等制造导丝的原材料;不锈钢的成份是铁与铬还有碳等原素所组合而成的,430不锈钢(18-0);铁+18%以上的铬无镍;将原材料进行高温融化,放入模具进行冷却开模,成为芯丝;配置具有抗感染性能的功能性涂覆溶液;功能性涂覆浴液是按下列方法制备的溶液;量取1000mlTrisHCI缓冲溶液,该缓冲溶液的pH值为71-90,称取多巴胺或其衍生物200-5000mg溶于前述缓冲溶液中充分溶解,然后称取20-4000mg有机/无机抗菌剂加入到该溶液中,使其充分溶解,形成功能性涂覆溶液;有机或无机抗菌剂包括季铵盐类抗菌剂、胍类有机抗菌剂、多肽类抗菌剂、酚类有机抗菌剂、银离子无机抗菌剂、锌离子无机抗菌剂铜离子无机抗菌剂中的任何一种和多种;将制备好的芯丝浸泡在功能性涂膜溶液中,浸泡一段时间后,取出芯丝在去离子水与乙醇液体超声清洗三次,干燥;选取空心塑料管,空心塑料管进行超声清洗,超声清洗介质采用具有抗菌成分的缓冲液;将芯丝的一端与塑料管的一端通过热成型方式连接。
实施例三:
在实施例二中,再加上下述工序:
制备医用不锈钢等制造导丝的原材料;不锈钢的成份是铁与铬还有碳等原素所组合而成的,430不锈钢(18-0);铁+18%以上的铬无镍;将原材料进行高温融化,放入模具进行冷却开模,成为芯丝;配置具有抗感染性能的功能性涂覆溶液;功能性涂覆浴液是按下列方法制备的溶液;量取1000mlTrisHCI缓冲溶液,该缓冲溶液的pH值为71-90,称取多巴胺或其衍生物200-5000mg溶于前述缓冲溶液中充分溶解,然后称取20-4000mg有机/无机抗菌剂加入到该溶液中,使其充分溶解,形成功能性涂覆溶液;有机或无机抗菌剂包括季铵盐类抗菌剂、胍类有机抗菌剂、多肽类抗菌剂、酚类有机抗菌剂、银离子无机抗菌剂、锌离子无机抗菌剂铜离子无机抗菌剂中的任何一种和多种;将制备好的芯丝浸泡在功能性涂膜溶液中,浸泡一段时间后,取出芯丝在去离子水与乙醇液体超声清洗三次,干燥;浸泡时间为6-48H,在浸泡过程中可对浸泡液进行搅拌,也可对其进行轻微加热,加快浸泡时间;芯丝在离子水与乙醇溶液中对芯丝表面进行消毒清洁,超声清洗对附着在芯丝表面微笑的污垢进行剥落二次清洁,使芯丝达到完美清洁的效果;选取空心塑料管,空心塑料管进行超声清洗,超声清洗介质采用具有抗菌成分的缓冲液;缓冲液配方为:Tris-HCl缓冲液1000ml、聚硅氧烷季铵盐抗菌剂0.5%、甲基硅油0.1%、柠檬酸钠0.6%、乙胺丁醇0.02%、磺胺二甲基嘧啶0.05%、甘氨酸0.2%、脯氨酸0.03%、甘油3%;将芯丝的一端与塑料管的一端通过热成型方式连接。
实施例四:
制备医用不锈钢等制造导丝的原材料;不锈钢的成份是铁与铬还有碳等原素所组合而成的,430不锈钢(18-0);铁+18%以上的铬无镍;将原材料进行高温融化,放入模具进行冷却开模,成为芯丝;配置具有抗感染性能的功能性涂覆溶液;功能性涂覆浴液是按下列方法制备的溶液;量取1000mlTrisHCI缓冲溶液,该缓冲溶液的pH值为71-90,称取多巴胺或其衍生物200-5000mg溶于前述缓冲溶液中充分溶解,然后称取20-4000mg有机/无机抗菌剂加入到该溶液中,使其充分溶解,形成功能性涂覆溶液;有机或无机抗菌剂包括季铵盐类抗菌剂、胍类有机抗菌剂、多肽类抗菌剂、酚类有机抗菌剂、银离子无机抗菌剂、锌离子无机抗菌剂铜离子无机抗菌剂中的任何一种和多种;将制备好的芯丝浸泡在功能性涂膜溶液中,浸泡一段时间后,取出芯丝在去离子水与乙醇液体超声清洗三次,干燥;浸泡时间为6-48H,在浸泡过程中可对浸泡液进行搅拌,也可对其进行轻微加热,加快浸泡时间;芯丝在离子水与乙醇溶液中对芯丝表面进行消毒清洁,超声清洗对附着在芯丝表面微笑的污垢进行剥落二次清洁,使芯丝达到完美清洁的效果;选取空心塑料管,空心塑料管进行超声清洗,超声清洗介质采用具有抗菌成分的缓冲液;缓冲液配方为:Tris-HCl缓冲液1000ml、聚硅氧烷季铵盐抗菌剂0.5%、甲基硅油0.1%、柠檬酸钠0.6%、乙胺丁醇0.02%、磺胺二甲基嘧啶0.05%、甘氨酸0.2%、脯氨酸0.03%、甘油3%;将芯丝的一端与塑料管的一端通过热成型方式连接;热成型是将热塑性空心塑料管在框架上加热到软化状态,在外力作用下,使其紧贴芯丝的一端,冷却定型后,经修整即成制品;热成型方式进行焊接,其焊接工艺简单,工艺技术要求低,容易操作,焊接使用的机械设备价格低廉,减少成本控制,避免弹簧与芯丝焊接工艺复杂。
尽管已经示出和描述了本发明的实施例,对于本领域的普通技术人员而言,可以理解在不脱离本发明的原理和精神的情况下可以对这些实施例进行多种变化、修改、替换和变型,本发明的范围由所附权利要求及其等同物限定。
Claims (9)
1.一种溶栓导管封堵导丝的制作方法,其特征在于:包括以下步骤:
步骤1:制备医用不锈钢等制造导丝的原材料;
步骤2:将原材料进行高温融化,放入模具进行冷却开模,成为芯丝;
步骤3:配置具有抗感染性能的功能性涂覆溶液;
步骤4:将制备好的芯丝浸泡在功能性涂膜溶液中,浸泡一段时间后,取出芯丝在去离子水与乙醇液体超声清洗三次,干燥;
步骤5:选取空心塑料管,空心塑料管进行超声清洗,超声清洗介质采用具有抗菌成分的缓冲液;
步骤6:将芯丝的一端与塑料管的一端通过热成型方式连接。
2.根据权利要求1所述的一种溶栓导管封堵导丝的制作方法,其特征在于:所述在步骤1中,不锈钢的成份是铁与铬还有碳等原素所组合而成的,430不锈钢(18-0);铁+18%以上的铬无镍。
3.根据权利要求1所述的一种溶栓导管封堵导丝的制作方法,其特征在于:所述在步骤3中,所述功能性涂覆浴液是按下列方法制备的溶液;量取1000mlTrisHCI缓冲溶液,称取多巴胺或其衍生物200-5000mg溶于前述缓冲溶液中充分溶解,然后称取20-4000mg有机/无机抗菌剂加入到该溶液中,使其充分溶解,形成功能性涂覆溶液。
4.根据权利要求3所述的一种溶栓导管封堵导丝的制作方法,其特征在于:所述,所述TrisHCI缓冲溶液的pH值为71-90。
5.根据权利要求1所述的一种溶栓导管封堵导丝的制作方法,其特征在于:所述有机或无机抗菌剂包括季铵盐类抗菌剂、胍类有机抗菌剂、多肽类抗菌剂、酚类有机抗菌剂、银离子无机抗菌剂、锌离子无机抗菌剂铜离子无机抗菌剂中的任何一种和多种。
6.根据权利要求1所述的一种溶栓导管封堵导丝的制作方法,其特征在于:所述在步骤4中,浸泡时间为6-48H,在浸泡过程中可对浸泡液进行搅拌,也可对其进行轻微加热,加快浸泡时间。
7.根据权利要求1所述的一种溶栓导管封堵导丝的制作方法,其特征在于:所述芯丝在离子水与乙醇溶液中对芯丝表面进行消毒清洁,超声清洗对附着在芯丝表面微笑的污垢进行剥落二次清洁,使芯丝达到完美清洁的效果。
8.根据权利要求1所述的一种溶栓导管封堵导丝的制作方法,其特征在于:所述在步骤5中,所述缓冲液配方为:Tris-HCl缓冲液1000ml、聚硅氧烷季铵盐抗菌剂0.5%、甲基硅油0.1%、柠檬酸钠0.6%、乙胺丁醇0.02%、磺胺二甲基嘧啶0.05%、甘氨酸0.2%、脯氨酸0.03%、甘油3%。
9.根据权利要求1所述的一种溶栓导管封堵导丝的制作方法,其特征在于:所述在步骤6中,所述热成型是将热塑性空心塑料管在框架上加热到软化状态,在外力作用下,使其紧贴芯丝的一端,冷却定型后,经修整即成制品。
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