CN1048875A - 具有保护性光滑涂层的医疗器具 - Google Patents

具有保护性光滑涂层的医疗器具 Download PDF

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CN1048875A
CN1048875A CN90106541A CN90106541A CN1048875A CN 1048875 A CN1048875 A CN 1048875A CN 90106541 A CN90106541 A CN 90106541A CN 90106541 A CN90106541 A CN 90106541A CN 1048875 A CN1048875 A CN 1048875A
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玛格丽特·帕尔玛·基祖拉斯
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Abstract

描述了一种制备具有保护性光滑涂层的医疗器 具的方法。该方法包括制备涂料溶液，把该溶液涂敷 在医疗器具的表面上并使涂料凝固。该涂料溶液含 有一保护性化合物比如氨基甲酸乙酯、一滑润性添加 剂比如硅氧烷，和一作为选择使用的保护性化合物的 交联剂比如多官能氮丙啶。所得表面涂层光滑、坚韧 并且柔软。该涂层尤其适合与用作为囊体导管组分 的物质一起使用。

Description

在冠状血管成形术及相关技术中使用一带有连接在其端侧的可膨胀囊体的导管。已知这样的囊体会由于在操作和使用时的磨擦和刺破以及过量膨胀所导致的损坏而失效。此外，导管和在其上固定的囊体一般具有比便于使用时的要求更高的摩擦系数。因此，由于器具与其所通过的容器之间的摩擦，经常难以把导管引入病人体内所期望的位置。
本领域已知多种作为医疗应用的氨基甲酸乙酯基的涂料组合物。例如，Creasy等的美国专利4，642，267描述了用于涂敷导管和其它表面的亲水性聚合物混合物。该涂料含有一种热塑性聚氨基甲酸乙酯以及一种亲水性聚（N-乙烯基内酰胺）如聚乙烯吡咯烷酮。该混合物中可加入其它组分如交联剂和蜡分散体。Ward，Jr.的美国专利4，675，361涉及用于涂敷具有与血液和细胞组织接触用途表面的聚合物体系。该体系包含一种基体聚合物，如一种聚氨基甲酸乙酯，该基体聚合物含有至少一种包含一具有软硬两种链段的嵌段共聚物的聚合物添加剂。
尽管这些专利每一件都描述了一种包含生物医疗器具的应用，但是仍然需要一种简单的、易于涂敷的涂层，该涂层为生物相容的、光滑的并且在被涂敷表面能提供一保护性薄层。
广义地说，本发明包括一种含有保护性化合物和滑润性添加剂的涂层的医疗器具。保护性化合物用于保护被涂敷的表面并提供一种包含滑润性添加剂的网状物。由于氨基甲酸乙酯类的保护性能，尤其希望把其作为保护性化合物;且由于水基氨基甲酸乙酯类向涂层提供羧基官能度的能力，该化合物是最佳的。羧基官能度使得涂层与存在于器具表面上的羧基基团交联从而使涂层粘结到表面上，羧基官能度还使得氨基甲酸乙酯本身交联从而使涂层的强度和韧性增加。
在表面上形成涂层的方法包括制备一种含有约2%至约80%固体，更佳是约15%至约25%固体的涂料溶液，该涂料溶液含有保护性化合物、滑润性添加剂、并还可以作为选择用的含有保护性化合物的交联剂;可用任何表面涂敷的方法将该溶液涂敷于表面上，并使涂料在器具表面上凝固成保护性光滑薄层。
在较佳的实施方案中，保护性化合物为氨基甲酸乙酯，滑润性添加剂为二甲基硅氧烷，氨基甲酸乙酯的交联剂为多官能氮丙啶。
这种涂料和方法特别适于用在如聚对苯二甲酸乙二醇酯（PET）的材料上，该材料是一种具有许多使之适合用做血管成形术囊体的性能的聚合物材料。
这里术语“医疗器具”是指适用于医疗用途，特别是在活体内使用的器具。这种器具具体地包括，但不限定于，囊体、导管、导向线、细探子以及插管器。使用本发明特别指的是诸如那些设计用于血管成形术和瓣膜成形术的具有可膨胀囊体的导管，以及导向管和导向线。
这里所用的术语“滑润性添加剂”是指能够被包含在保护性网状物中从而使网状物表面具有更低的摩擦系数的化合物。这些化合物包括但不限定于硅基化合物，如聚硅氧烷类和硅氧烷类;含氟化合物如聚四氟乙烯（PTFE），以及多种蜡。
在较佳实施方案中，涂料呈含有约15%至约25%固体含量的溶液形式供用，该溶液含有一种水基氨基甲酸乙酯分散体、一种含有至少约15%固体的二甲基硅氧烷乳状液以及一种多官能氮丙啶。除非另有说明，这里叙述的所有百分数均为重量百分数。其它物质如颜料和不透射线化合物也可添加。
以一种高分子量的、硬的、不发黄的水基氨基甲酸乙酯作为涂料的树脂为好。尤其好的是一种在包含水、N-甲基-2-吡咯烷酮（CAS＃872-50-4）和三乙胺（CAS＃121-44-8）的混合物的溶液中固体含量为约30%至约50%的氨基甲酸乙酯分散体。这种分散体可以UE41-222从Permuthane（Peabody，MA）得到。尤其希望的是把保护性化合物分散在一种不会损害被涂料涂敷的表面的液体中。因此，对于如PET囊体一样的表面，氨基甲酸乙酯以在一水介质中的分散体供用为好。
滑润性添加剂以一种工业级二甲基硅氧烷在水中的乳状液为好，其硅氧烷含量至少约为15%，尽管可使用高达约100%硅氧烷或聚硅氧烷的滑润性添加剂，但是该物质稀释到大约15%固体的水乳状液在涂料溶液混合时更易于操作。较佳的二甲基硅氧烷可以Q2-3238从Dow  Corning  Corporation（Midland，MI）获得。这种现有的是纯态，可随后与水混合形成含有约15%二甲基硅氧烷的乳状液。
当用于氨基甲酸乙酯基涂料中时，交联剂以多官能氮丙啶为好。尽管在使用前可把这种物质稀释，但是较好是使用纯态以使涂料溶液的进一步稀释减至最小。最佳的是以KM10-1703从Permuthane（Peabody，MA）得到该物质。这种物质会在水或潮湿空气中水解并与酸迅速反应。一但加入到涂料溶液中，如果维持室温条件，则应在约48小时内使用。提高温度会引起水解加剧、材料的不活动性并促进涂料的交联，造成更高的涂料粘度。由于氮丙啶组分是腐蚀性的，被涂敷的医疗器具在适合于活体内使用之前，必须使其完全反应或水解。
最佳的涂料配方是在使用时固体含量大约为17%并含有一种含有约42.55%UE41-222氨基甲酸乙酯分散体、12.77%Q2-3238硅氧烷分散体、2.13%KM10-1703多官能氮丙啶和42.55%蒸馏水的混合物。配方可通过把硅氧烷乳状液与蒸馏水混合并随后添加氨基甲酸乙酯分散体来制成。然后将其在一有盖的玻璃容器中用磁搅拌器混合直至所有部分完全混合。随后在刚好把涂料涂敷表面之前把交联剂加到溶液中。恰在涂敷涂料之前添加交联剂防止了氨基甲酸乙酯仅与自身的交联，从而使得在涂层中有足够的羧基基团浓度能与被敷的表面交联。
可使用各种方法把物质涂敷在表面上。其中较佳的是浸涂、喷涂、滚涂和刷涂。在现行的涂敷步骤之后，把被涂敷的器具进行处理。最好把被涂敷的器具放在大约50℃的烘箱中进行处理，直到氨基甲酸乙酯完全交联。
所得涂层是柔性的、耐久的且光滑的，可在一持久的时期内保持其润滑性。这些性质是保护性化合物作为一种粘合剂保存滑润性添加剂范围能力的直接结果。从而耐久的粘合剂通过防止滑润性添加剂从基质表面移走而增强了润滑性。此外，保护性化合物向基质表面提供一磨损阻力，从而使得器件误用的影响减至最小。
在PET囊体的情况下，特别希望由涂层提供磨损阻力，因为它大大地减少了对囊体表面的损伤。这样就减少了在囊体制备或使用时由于误操作引起囊体破裂的可能性。
在氨基甲酸乙酯基涂层的情况下，涂层向被其涂敷的基质表面的接合可通过存在于氨基甲酸乙酯中的羧基官能团与存在于基质表面上的羧基官能团间的交联反应来实现。实现这种接合的一个方法包括利用一种前述多官能氮丙啶的交联反应，通过多官能氮丙啶产生连结。
在最佳的应用中，希望用涂料溶液向血管成形术囊体表面提供一柔性的、保护性的且为光滑的涂层。这些囊体可由多种物质比如聚氯乙烯和聚乙烯制成，但以聚对苯二甲酸乙二醇酯（PET）为好。遗憾的是，PET不能达到用于使氨基甲酸乙酯基涂层与表面满意接合所必需的现有羧基基团的密度。因此，经常希望在PET囊体表面和涂层之间使用一底层涂料物质的第一薄层。
一种较佳的底层涂料为一含有乙烯丙烯酸（EAA）树脂的分散体。较佳的EAA树脂比如从Dow.Corning  Corporation（Midland，MI）可买到的Primacor  5980可在水溶液中混合以得到含有大约25%固体的组成。对于面涂配方，EAA树脂必须在不会损害被涂敷的器具表面的溶剂中使用。当把底层涂料用于PET囊体时，EAA应溶解于水溶剂中。因为EAA树脂在水中的溶解度非常低，必须首先把EAA转变成可溶性盐。这可通过把树脂与足以中和其中所含的羧基基团的大量氨结合来完成。
把所需量的氨加到一定体积的已混入足量EAA而形成分散体的水中。然后把已倒入组分的容器密封并加热至约110℃保持约15至30分钟。然后使溶液冷却在此即可使用。应当注意，在混合步骤中希望使用冷凝器以防止任何组分在混合容器密封之前蒸发。
对于面涂溶液，把底层涂料涂敷在基质表面可使用多种方法，它包括但不限定于，浸涂、喷涂、滚涂和刷涂。一但被涂敷，底层涂料就应处理直至完全干燥。已发现在大约50℃的加热处理对前述的EAA底层涂料是合适的。然后，可使用前述的方法把面涂溶液涂在已涂过底层涂料的器件表面。
如果不使用底层涂料，则可采用其它各种技术在基质表面获得表面官能度。例如，可使用等离子体放电或电晕放电或者通过把表面暴露在火焰下来获得表面官能度。在等离子放电或电晕放电情况下，可通过使用操作气氛变换对表面获得的官能度进行调整。因此，当想要由氧衍生的官能度（即-OH或-COOH）时，可把表面在含氧气氛下进行等离子体处理。另一方面，如果胺官能度更好，处理过程可在含氮气氛下进行。
当欲涂敷的表面包含一装有导管的囊体时，最好在施加底层涂料和或面涂之前把囊体吹胀。这就可形成、厚度大致均匀的涂层并且也阻止了在放气状态下会彼此接触的气球囊体表面间的粘结。应当留意以保证在导管的任何开口腔内不允许留有底层涂料或面涂料，因为这将很可能引起不希望的腔阻塞。在施加涂层之后使用合适的遮敝材料把导管末端和任何外露的腔孔遮敝会防止这种阻塞。另一方面，可使用空气或惰性气体把导管腔吹净。
由于较好的面涂溶液既含有滑润性添加剂又含有保护性化合物的交联剂，经一次涂过就可把溶液涂在具有足够官能团密度的表面上。这样就获得了操作效率，因为在把涂料涂敷在基质表面之后免除了进行交联步骤的需要。
当涂在PET囊体表面时，这里所述的涂层就使得刮伤阻力增强并使摩擦系数下降而不会显著地改变囊体的外形或柔软性。
应当注意，尽管这里所述的较佳的涂料配方含有一水基氨基甲酸乙酯树脂和一多官能氮丙啶交联剂，本发明并不认为限定于此。倒不如说本发明意在应用具有保护性光滑涂层的医疗器具，该涂层是由含有滑润性添加剂和任一作为选择性使用的交联剂的保护性树脂体系所形成的，其中交联剂选自使得涂料与被涂料所涂的表面相容的多种交联剂。例如，包括但不限定于丙烯酸酯类、1，1-二氯乙烯类和乙烯类树脂体系可用作保护性化合物，甲醛衍生物类（蜜胺、脲、等）、异氰酸酯类、以及碳化二亚胺类是其它可用作交联剂的物质实例。在另一实方案中。氨基甲酸乙酯树脂可与一即可作为粘合剂又可作为滑润性添加剂的含氟化合物树脂结合使用。较佳含氟化合物为市售的可从3M  Company买到的FC-10和可从ICI  Corporation买到的Lumiflon。这些体系可用异氰酸酯类交联。
实施例
按照本发明的讲述制备涂料溶液，其配方如下：
组分  厂商/名称  重量%
氨基甲酸乙酯  Permuthane/UE41-222  42.55
二甲基硅氧烷  Dow/QZ-3238  12.77
氮丙啶  Permuthane/KM10-1703  2.13
水  ……  42.55
通过把吹胀的导管浸在一定容量的涂料混合物中而把涂料溶液涂到囊体导管上，囊体导管为用紫外线活化的粘合剂把3.0×20mm的PET囊体接合到导管上的。浸涂之后，把涂敷的器具在大约50℃进行加热处理直至干燥然后用环氧乙烷消毒。该导管的测试在以一未涂敷的囊体导管作为对比下进行。
使这两个导管分别通过一个8F（0.072″）的管路，该管路有一复制成FL4导向管最后弯道的弯曲部分。使用-0.14″的涂敷PTFE的导向线。对不同插入长度测量推拉导管的作用力并对涂敷的和未涂敷的导管在10个推拉循环中确定其平均最小力和平均最大力（以克为单位）。测试的结果总结如下：
样品  推力  推力  拉力  拉力
（最小）  （最大）  （最小）  （最大）
涂敷的  11.0  32.5  8.4  25.4
未涂敷的  20.5  42.5  16.7  33.0
涂敷的相
对于未涂敷  46%  21%  50%  23%
的提高%
由上可见，涂敷的导管对通过管路时的推拉作用表现出较低的阻力。当把已涂的导管与未涂的对比导管比较时，这种阻力的下降显示的平均总提高约为34%。

Claims (25)

1、为医疗器具表面提供一种保护性光滑涂层的方法，该方法包括：
a)制备一种固体含量约2%至约80%(重量)的涂料溶液，该涂料溶液包含一固体含量约30%至约50%的氨基甲酸乙酯的水分散体和一固体含量至少约15%的聚硅氧烷或硅氧烷乳状液；
b)把涂料溶液涂敷在医疗器具的表面上；及
c)使涂料在设备表面凝固成薄层。
2、权利要求1的方法，其中涂料溶液另外还含有氨基甲酸乙酯的交联剂。
3、权利要求2的方法，其中交联剂含有一种多官能氮丙啶。
4、权利要求1的方法，其中涂料涂敷在聚对苯二甲酸乙二醇酯表面上。
5、权利要求4的方法，其中在涂敷涂料之前把底层涂料涂敷在表面上。
6、权利要求5的方法，其中底层涂料含有乙烯丙烯酸。
7、权利要求1的方法，其中氨基甲酸乙酯分散在含有三乙胺和N-甲基-2-吡咯烷酮的水溶液中。
8、权利要求1的方法，其中硅氧烷以二甲基硅氧烷乳状液供用。
9、权利要求8的方法，其中乳状液的固体含量约为17%。
10、权利要求1的方法，其中涂料溶液的固体含量为约15%至约25%（重量）。
11、权利要求1的方法，其中医疗器具含有一囊体。
12、权利要求1的方法，其中医疗器具含有一导管。
13、权利要求1的方法，其中医疗器具含有一导向线。
14、一种带有保护性光滑表面涂层的医疗器具，该涂层含有交联的水基氨基甲酸乙酯化合物，该化合物含有聚硅氧烷或硅氧烷滑润性添加剂。
15、权利要求14的器具，其中滑润性添加剂包含二甲基硅氧烷。
16、权利要求14的器具，其中涂敷涂料的表面含有聚对苯二甲酸乙二醇酯。
17、权利要求16的器具，该器具含有一囊体。
18、权利要求14的器具，该器具含有一导管。
19、权利要求14的器具，该器具含有一导向线。
20、权利要求14的器具，在涂层和表面之间配置有一底层涂料薄层。
21、权利要求20的器具，其中底层涂料薄层具有适合于与涂层交联的官能度。
22、权利要求21的器具，其中底层涂料薄层具有羧基官能度。
23、权利要求22的器具，其中底层涂料薄层含有乙烯丙烯酸。
24、权利要求14的器具，其中涂层另外还含有一种氨基甲酸乙酯的交联剂。
25、权利要求24的器具，其中交联剂含有多官能氮丙啶。
CN90106541A 1989-06-23 1990-06-23 具有保护性光滑涂层的医疗器具 Pending CN1048875A (zh)

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