CN111002673A - 一种医用管材及其制备方法 - Google Patents
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Abstract
本发明公开了一种医用管材及其制备方法,所述医用管材包括由内向外依次设置的聚四氟乙烯内层、编织层和外层,所述聚四氟乙烯内层和所述编织层之间和/或所述编织层和所述外层之间设置有粘结层。本发明提供的医用管材及其制备方法通过在医用管材的层与层之间增加粘结层,有效的防止了医用管材各层间的分层异常,降低了医疗终端使用事故率,还在保持原有管材的柔韧性能的同时,提高医用管材的扭控性能。
Description
技术领域
本发明涉及医疗器械技术领域,尤其涉及一种医用管材及其制备方法。
背景技术
医用复合管材通常由多层组成,由于各层材质不一致,粘结性能不同而导致分层异常。在管材构造中,分层是一种严重的失效模式,对产品性能有很大影响。但是,分层现象在产品最终测试之前很难检测到,在管材组装完成之后测试时发现分层问题,会导致相当大的成本损失。
发明内容
本发明的目的在于提供一种医用管材及其制备方法,能够增强层与层之间的粘附力,防止各层间的分层异常。
为解决上述技术问题,本发明提供了一种医用管材,包括由内向外依次设置的聚四氟乙烯内层、编织层和外层,所述聚四氟乙烯内层和所述编织层之间和/或所述编织层和所述外层之间设置有粘结层。
优选地,所述粘结层的材料为聚酰胺、聚酰亚胺、聚醚嵌段酰胺、热塑性聚氨酯中的至少一种。
优选地,所述外层的材料为聚醚嵌段酰胺、尼龙6、尼龙12、聚酰亚胺或热塑性聚氨酯。
优选地,所述聚四氟乙烯内层具有经刻蚀的表面。
优选地,所述粘结层的厚度为0.0001毫米-0.0025毫米。
为解决上述技术问题,本发明还提供了一种医用管材的制备方法,包括如下步骤:S1:将聚四氟乙烯内层固定在芯棒上,并将所述芯棒浸入具有粘结剂的浸渍槽中,使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上;S2:将所述芯棒放入烘炉中,对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化,在所述聚四氟乙烯内层的外表面上形成粘结层;S3:将编织丝编织在所述粘结层上形成编织层;S4:在所述编织层的外部套上外层,并进行热焊接粘合。
优选地,所述粘结剂的固含量为10-20%。
优选地,所述步骤S1中,将所述将聚四氟乙烯内层固定在芯棒上之前,对所述聚四氟乙烯内层进行刻蚀。
优选地,所述步骤S2中,对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化的温度范围为100~260℃。
优选地,还包括步骤S5:在所述外层上套上套管,并进行热焊接,制成医用管材。
本发明对比现有技术有如下的有益效果:本发明提供的医用管材及其制备方法通过在医用管材的聚四氟乙烯内层和编织层之间和/或编织层和外层之间增加粘结层,粘结层形成可熔融粘合的表面,以增强层与层之间的粘附力,从而有效的防止了医用管材特别是医用管材各层间的分层异常,降低了医疗终端使用事故率,还在保持原有管材的柔韧性能的同时,提高医用管材的扭控性能。
附图说明
图1为本发明实施例中医用管材的结构示意图;
具体实施方式
下面结合附图和实施例对本发明作进一步的描述。
在以下描述中,为了提供本发明的透彻理解,阐述了很多具体的细节。然而,本发明可以在没有这些具体的细节的情况下实践,这对本领域普通该技术人员来说将是显而易见的。因此,具体的细节阐述仅仅是示例性的,具体的细节可以由奔放的精神和范围而变化并且仍被认为是在本发明的精神和范围内。
为了实现上述目的,本发明以医用管材为例,通过在医用管材的聚四氟乙烯内层和编织层之间和/或编织层和外层之间增加粘结层,粘结层形成可熔融粘合的表面,以增强层与层之间的粘附力,从而有效的防止了管材各管层间的分层异常。在本发明中,所述粘结层可设置于医用管材的内层与编织层之间,编织层与外层之间,外层与套管之间等,事实上,还可以将本发明中的粘结层应用到任何圆形棒材上。
所述粘结层需要具备生物相容性,例如USP Class VI(美国药典标准VI级检测)认可的热塑性材料可用于粘结层涂层。所述粘结层还需要具备热融性,易于熔化并与套管热缩工艺相结合,以形成强烈的热焊接粘合。另外,所述粘结层需要具备良好的粘合强度,例如与非层压护套结构相比,所述粘结层可将线性粘合强度提高至少2.5倍。所述粘结层的材料可根据需粘结的管层材质进行选择,粘结层的材料可以为聚酰胺(PA)、聚酰亚胺(PI)、热塑性聚氨酯(TPU)或聚醚嵌段酰胺(PEBA)等。所述粘结层可以为薄层,粘结层的厚度可低至0.0025mm,以降低管材的厚度。
如图1所示,本实施例提供的医用管材包括由内向外依次设置的聚四氟乙烯内层2、粘结层3、编织层4、外层5和套管6,所述医用管材套设于芯棒1上。聚四氟乙烯内层2、编织层4与粘结层3通过机械耦合连接在一起。在一定的温度下,粘结层3熔化后与聚四氟乙烯内层2、外层5相互粘结。在本实施例中,所述聚四氟乙烯内层还具有经刻蚀的表面。
本实施例中,医用管材的制备方法包括以下步骤:
步骤S1:首先对所述聚四氟乙烯内层进行刻蚀,将刻蚀的聚四氟乙烯内层固定在芯棒上,并将芯棒浸入具有粘结剂的浸渍槽,使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上。其中,浸渍槽内的粘结剂可以是聚酰胺、聚酰亚胺、聚醚嵌段酰胺(PEBA)和热塑性聚氨酯(TPU)等中的至少一种。粘结剂的固含量可以为10-20%,本发明中的固含量是指粘结剂烘干后剩余部分占总量的质量百分数。粘结剂的作用是为了使复合管材的层与层之间更好的粘结在一起。
步骤S2:将所述芯棒垂直放入烘炉中,对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化,固化温度根据粘结剂特性进行设置,在所述聚四氟乙烯内层的外表面上形成粘结层。本步骤中将所述芯棒垂直放入烘炉中进行垂直提拉,可以形成厚度均匀的粘结层涂层。
步骤S3:使用编织机,将编织丝编织在所述粘结层上,形成编织层。
步骤S4:在所述编织层上套上外层,用焊接机进行热焊接粘合。外层的材料和粘结层的材料相匹配,两者的相容性要好,不然会分层,不能粘结在一起,因此,外层管所用的医用高分子材料优选为热塑性塑料,例如:聚醚嵌段酰胺(PEBA)、尼龙6(PA6)、尼龙12(PA12)、聚酰亚胺(PI)以及热塑性聚氨酯(TPU)等。
步骤S5:在所述外层上套上套管,用焊接机进行热焊接,制成所述医用管材。
下面结合具体实施例,进一步阐述本发明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明公开的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1
芯棒1选用带有聚四氟乙烯涂层的不锈钢棒。将刻蚀的聚四氟乙烯内层套在芯棒1上,并将芯棒1浸入具有粘结剂的浸渍槽,使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上。其中,浸渍槽内的粘结剂是聚醚嵌段酰胺(PEBA),固含量为20%。将所述芯棒1垂直放入烘炉中,对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化,加热固化温度范围100~240℃,在所述聚四氟乙烯内层的外表面上形成粘结层。使用编织机将编织丝编织在所述粘结层上,形成编织层;在所述编织层的外部套上外层,并用焊接机进行热焊接粘合。外层材质为聚醚嵌段酰胺(PEBA)。在所述外层上套上套管,并用焊接机进行热焊接,制成医用管材。
实施例2
芯棒1选用带有聚四氟乙烯涂层的不锈钢棒。将刻蚀的聚四氟乙烯内层套在芯棒1上,并将芯棒1浸入具有粘结剂的浸渍槽,使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上。其中,浸渍槽内的粘结剂是尼龙6(PA6),固含量为20%。将所述芯棒1垂直放入烘炉中,对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化,加热固化温度范围100~260℃,在所述聚四氟乙烯内层的外表面上形成粘结层。使用编织机将编织丝编织在所述粘结层上,形成编织层;在所述编织层的外部套上外层,并用焊接机进行热焊接粘合。外层材质为聚醚嵌段酰胺(Pebax)。在所述外层上套上套管,并用焊接机进行热焊接,制成医用管材。
实施例3
芯棒1选用带有聚四氟乙烯涂层的不锈钢棒。将刻蚀的聚四氟乙烯内层套在芯棒1上,并将芯棒1浸入具有粘结剂的浸渍槽,使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上。其中,浸渍槽内的粘结剂是尼龙12(PA12),固含量为20%。将所述芯棒1垂直放入烘炉中,对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化,加热固化温度范围100~260℃,在所述聚四氟乙烯内层的外表面上形成粘结层。使用编织机将编织丝编织在所述粘结层上,,形成编织层;在所述编织层的外部套上外层,并用焊接机进行热焊接粘合。外层材质为聚醚嵌段酰胺(Pebax)。在所述外层上套上套管,并用焊接机进行热焊接,制成医用管材。
实施例4
本实施例与实施例1的医用管材,不同点在于粘结剂的选择,本实例中的粘结剂为热塑性聚氨酯(TPU)。对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化的温度范围为100~240℃。
综上,本发明例提供的医用管材及其制备方法至少具有以下优点:
1)相比现有医用管材,本发明在医用管材的层与层之间增加粘结层,有效防止了各管层间的分层现象,降低了医疗终端使用事故率。
2)本发明提供的制备方法工艺简单,可间断性生产,也可以进行连续性的规模化生产。
3)本发明提供的制备方法适用于任何圆形棒材复合多层管,应用范围较广。
4)本发明中的粘结层,在熔融粘结过程,有效的固定了编织丝,在保持原有管材的柔韧性能的同时,提高了医用管材的扭控性能。
虽然本发明已以较佳实施例揭示如上,然其并非用以限定本发明,任何本领域技术人员,在不脱离本发明的精神和范围内,当可作些许的修改和完善,因此本发明的保护范围当以权利要求书所界定的为准。
Claims (10)
1.一种医用管材,其特征在于,包括由内向外依次设置的聚四氟乙烯内层、编织层和外层,所述聚四氟乙烯内层和所述编织层之间和/或所述编织层和所述外层之间设置有粘结层。
2.如权利要求1所述的医用管材,其特征在于,所述粘结层的材料为聚酰胺、聚酰亚胺、聚醚嵌段酰胺、热塑性聚氨酯中的至少一种。
3.如权利要求1所述的医用管材,其特征在于,所述外层的材料为聚醚嵌段酰胺、尼龙6、尼龙12、聚酰亚胺或热塑性聚氨酯。
4.如权利要求1所述的医用管材,其特征在于,所述聚四氟乙烯内层具有经刻蚀的表面。
5.如权利要求1所述的医用管材,其特征在于,所述粘结层的厚度为0.0001毫米-0.0025毫米。
6.一种医用管材的制备方法,其特征在于,包括如下步骤:
S1:将聚四氟乙烯内层固定在芯棒上,并将所述芯棒浸入具有粘结剂的浸渍槽中,使所述粘结剂涂覆在所述聚四氟乙烯内层的外表面上;
S2:将所述芯棒放入烘炉中,对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化,在所述聚四氟乙烯内层的外表面上形成粘结层;
S3:将编织丝编织在所述粘结层上形成编织层;
S4:在所述编织层的外部套上外层,并进行热焊接粘合。
7.如权利要求6所述的医用管材的制备方法,其特征在于,所述粘结剂的固含量为10-20%。
8.如权利要求6所述的医用管材的制备方法,其特征在于,所述步骤S1中,将所述将聚四氟乙烯内层固定在芯棒上之前,对所述聚四氟乙烯内层进行刻蚀。
9.如权利要求6所述的医用管材的制备方法,其特征在于,所述步骤S2中,对所述聚四氟乙烯内层的外表面上的粘结剂进行加热固化的温度范围为100~260℃。
10.如权利要求6所述的医用管材的制备方法,其特征在于,还包括步骤S5:在所述外层上套上套管,并进行热焊接,制成医用管材。
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