CN1250382A - 用于医疗装置表面涂层的结合层 - Google Patents
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Abstract
本发明公开了用薄的粘合层涂覆的医疗装置,所述粘结层为丙烯酸酯类、环氧类、乙缩醛类、乙烯共聚物、乙烯基聚合物、含羟基、胺、羧基、酰胺或其它活泼基团的聚合物以及它们的共聚物的涂层。可以涂覆外层,在水中长时间浸泡后,该外层仍能粘结在基体上。粘合层可以含有交联剂如脲树脂、蜜胺、异氰酸酯和酚醛树脂。优选的聚合物包括乙烯基吡咯烷酮-乙酸乙烯酯、苯乙烯丙烯酸酯类聚合物、乙烯丙烯酸共聚物、带羧基功能基的丙烯酸酯类聚合物、带羟基功能基的丙烯酸酯类聚合物和丙烯酸酯类分散体聚合物。该涂层可涂覆在医疗装置的惰性的金属或塑料表面,所述装置是例如针、导丝、导管、手术器械、内窥镜检查所用的装置、金属丝、支架、血管成形术气囊、伤口引流管、动静脉分流器、胃管、尿道插管、腹腔镜检查装置、小药丸和植入物。本发明还提供涂覆的方法和涂层液体。
Description
发明背景
发明领域
本发明涉及医疗装置的粘性涂层。更具体地讲,本发明涉及聚合物组合物,当将该组合物涂覆于可插入的医疗装置上时,可使涂层对该装置表面的粘结性得到改善,此外,本发明还涉及相关的方法。
背景技术
医疗装置如导管或导丝是通过气管、血管、尿道或其它体腔或组织,或通过导管或引流管等插入的。所述装置需要高度柔滑,以确保在引入所述装置时不会对放置过程中所遇到的组织造成创伤。可对这些表面的光滑度进一步提高,以防止当这些装置留在组织内时可能会引起的粘膜的损伤和炎症。对医疗装置表面的其它要求也是公认的。
在某些情况下,使医疗装置的表面能够作为各种生理活性物质如抗血栓形成物质、抗微生物剂、抗肿瘤剂、遗传物质、激素、活细胞物质等的储库是有利的。在医疗装置表面使用抗血栓形成物质如肝素与季铵化合物的复合物可防止在表面上形成血凝块,而在体外,血凝块可在血管修补物上迅速形成。建议在表面涂层中使用抗微生物剂如青霉素类、头孢菌素类、氟喹诺酮类、氨基苷类、银化合物、苯酚化合物、双胍等来控制经常发生在植入的修补物表面的医院内感染,US5,069,899、US5,525,348、US4,442,133。
导丝和导管等装置的构造存在有关插入的特殊问题。导丝通常包括由不锈钢形成的卷曲导丝和单丝导线,在所述导丝上可以有挤塑的塑料材料如聚氨酯、聚酰胺、聚烯烃等,以提供一个可以粘结涂层的表面,从而使表面柔滑、均匀。
导管通常由塑料管组成,可以有单个腔或多个腔。导管可以带有沿管固定的气囊,以阻塞血管或将导管固定在所需的位置。导管还可以在远侧末端有孔、沿长度的方向有侧孔,或完成具体任务所需的其它机械特征。导管可由连续的管组成,或者可以包含两节或多节被熔接在一起的由相同或不同材料制成的管,以便在沿导管长度方向的不同部位具有不同的性质。导管可以是锥形的,该锥形可以是在一个片段内,也可以是由不同直径的片段组成。用于构造管的典型材料包括聚酰胺、聚氨酯、聚氯乙烯、聚酯、聚烯烃、聚硅氧烷等。典型的直径范围从小于1毫米至大于8毫米。
通常,在预定的部位插入导管时,将导丝的尖端通过导管插入其尖端开口处,然后将带有导丝的导管经皮插入例如血管中,用导丝作为引导和支撑将导管沿血管进一步插入。这些操作会在医疗装置的表面产生摩擦力。导管内层表面和导丝之间的摩擦阻力小是有利的。导管和导丝之间相对较高的摩擦力不仅阻碍导丝插入导管中,并且还会阻碍导丝沿着导管的顺利移动,使得在预定的血管部位进行精细的血管内手术变得困难。有时无法将导丝从导管中撤出,致使虽然完成了血管内手术,但导管腔仍无法使用。
为了避免上述问题,现有技术中曾尝试在导丝的外表面涂覆低摩擦阻力的特氟隆和硅油。涂抹硅油无法保持光滑性,因为聚硅氧烷涂层会迅速损耗。经常涂抹会增加摩擦阻力,同样会造成上述问题。
因此需要具有低摩擦阻力表面的导管和导丝,所述导管和导丝可以进行更精细的血管内手术并能够容易地插入并保留在其它导管在放置过程中难以控制的位点。
聚氨酯涂层被直接涂覆于金属的表面(US4,876,126)。但是,该技术的商业产品需要较厚(60-80微米厚)的层。实践中,较厚的层在涂层的金属基体上连续地延伸。这些层具有良好的粘结力,从而可以牢固地结合在金属表面上,尽管这些层并不需要对这些金属表面具有良好的粘结性。所述涂层的缺点是,由于聚氨酯及其它塑料层太厚,以至于导丝内层金属的直径必需相应的降低。这对于非常细的导丝如用于冠状动脉成形术或神经介入导管插入术所用的导丝是非常困难的。这些导丝的内径为约0.010″(约250微米),并且直径的大部分(约120-170微米)是由塑料而不是金属构成的。另一种方法是使用低摩擦材料如聚四氟乙烯涂层,其摩擦力低于金属和大部分其它的塑料材料并且可以直接涂覆在金属基体上。曾尝试过其它材料如高密度聚乙烯,但这些材料的摩擦系数不够低。也曾使用过油并且摩擦系数低。但是,该处理是暂时的,因为它们会在使用过程中被损耗掉。
已知水凝胶涂层可对可插入装置提供润滑表面。但是,金属和某些塑料材料如聚烯烃、聚酰胺、聚硅氧烷、聚酯等的表面是惰性的,当在所述表面涂覆表面涂层、包括水凝胶时,通常难以达到可接受的粘结力。
当置于含水环境中时,水凝胶可以吸附数倍于其重量的水。通常,水凝胶层可以附着在疏水性亚层上,并且会有大量水凝胶聚合物分子渗透到疏水性亚层中。两层的聚合物分子处于分子间混合的状态,特别是在两层之间的界面区域。由于分子间的混合作用,水凝胶中所摄取的水可以进入到基体和疏水性涂层之间的交界处。湿度通常会对疏水层和基体之间的粘结性产生不利影响,并通常造成密着破坏。当涂层较薄时,则湿度引起的密着破坏过程会大大加剧。
含有纤维素酯和丙烯酸聚合物的薄疏水性层可以直接涂在金属基体上(US5,001,009)。水凝胶涂层可以直接涂覆在该层上。该体系在螺旋型的导丝上效果很好,因为涂层可以通过在螺旋导丝之间渗透而获得另外的粘结力。但是,当涂覆于心轴型金属基体时,由于该层对水分的渗透作为太强而会导致粘着力的降低。
发明概述
本发明的目的是提供可以在层内直接涂覆在医疗装置表面的材料,在所述表面上难以获得涂层粘结力,并且所述表面允许在其上涂层以改善所述装置的性能和生物相容性。本发明的另一个目的是提供制备所述医疗装置的方法。
本发明的又一个目的是提供导丝、导管、引流管、饲管和其它用于和人体组织和体液接触的装置,这些装置具有生物相容性改善了的表面,并且在与体液接触时会变得非常润滑。本发明的再一个目的是含有可以抵抗由于体外放置和使用所述医疗装置所引起的感染、血凝块、炎症和其它疾病的物质的上述装置。
根据本发明的第一个方面,本发明提供一种医疗装置,该装置含有一个需要涂层的表面的基体。该表面的特征为相对惰性并且在表面上没有活泼的功能基。在基体的表面提供一聚合物涂层,该涂层可以是单一的或混合的聚合物层并且该涂层与基体表面牢固结合。装置表面的聚合物层的作用是,可以使涂覆在其上的其它层与该层牢固结合。
可以涂覆本发明涂层的基体包括金属如不锈钢、镍、金、铬、镍钛合金、铂等;塑料如聚硅氧烷、聚乙烯、其它聚烯烃、聚酯等。优选的装置包括针、导丝、导管、手术器械、内窥镜检查所用的装置、金属丝、支架、血管成形术气囊、伤口引流管、动静脉分流器、胃管、尿道插管、腹腔镜检查装置、小药丸或植入物。特别优选的实施方案包括涂层的导丝、特别是心轴型导丝、导管、引流管、起搏器的绝缘层和用于冠状动脉成形术或神经介入术或需要导丝的厚度小于约10-20毫英寸(250-500微米)的其它手术的光滑细丝。
根据本发明的第二个方面,本发明提供制备医疗装置的方法,该方法包括,将医疗装置的表面用适当组成的薄的聚合物层涂覆使该薄层与基体表面良好地结合,从而使随后的涂层可以与所述的薄聚合物层牢固结合。然后将该装置用旨在提高医疗装置的性能和生物相容性的其它层涂覆。所述层可以包括:可作为生理活性成分表面储库的药物涂层,以便在装置表面的附近释放有效浓度的所述试剂;用来产生表面光滑性的水凝胶涂层;有颜色的涂层;抗腐蚀涂层;上述涂层中的一种或多种的组合,以及用于提高装置性能的其它涂层。
本发明满足了长期以来对用于留置医疗装置的薄的、结合牢固的光滑涂层的需要。尽管在现有技术中进行了大量的尝试,但在医疗装置上结合表面层方面均告失败,而在这一点上,本发明却获得了成功。本发明消除了对厚的涂层的需要并且使性能得到改善。本发明的材料和方法是以前从未知晓或建议过的,其优点也是以前无法感受的。通过以下的详细描述,本发明的其它目的和优点将是显而易见的。发明详述
为了清楚起见,在描述附图中所示的本发明的优选实施方案时采用了特定的术语。但是,本发明并不仅限于所选定的特定术语,并且应当理解,每一特定的要素均包括在相同的方式下操作以达到相同目的的所有技术等同物。本发明的薄的结合或粘结层可以涂覆在难以结合的基体上,以便使通常无法结合在所述基体上的其它层可以令人满意地结合。本发明的聚合物层可以有效地抵抗后继层中溶剂的降解作用,从而当浸泡在水中时,涂层不会丧失其粘结性并且水分无法透过表面扩散。
可以采用的聚合物种类包括基于如下单体的丙烯酸酯类聚合物和共聚物,例如甲基丙烯酸甲酯、甲基丙烯酸丁酯、甲基丙烯酸异丁酯、甲基丙烯酸乙酯、丙烯酸甲酯、丙烯酸、苯乙烯甲基丙烯酸酯(styrenemethacrylate)、苯乙烯丙烯酸酯(styrene acrylate)等;乙烯基聚合物和共聚物,例如聚乙烯吡咯烷酮、乙烯基吡咯烷酮-乙酸乙烯酯共聚物、乙烯丙烯酸共聚物、环氧聚合物等。可用于本发明的市售产品的例子包括丙烯酸聚合物如ARYLOIDR(Rohm & Hass)AT-63、AT-51、AT-81、WR-97;聚乙烯吡咯烷酮聚乙酸乙烯酯共聚物如PVP/VA(GAF)E-335、E-635;乙烯丙烯酸共聚物如PRIMACORTM(DOW)5989、5990;蜜胺树脂如CYMEL(CYTEC Industries)303、370、380;环氧树脂类如EPON(Shell)1001。具有所需特性的其它适宜聚合物对本领域技术人员是显而易见的。
优选(但并不是必需)聚合物含有活泼基团或反应性位点如羟基;伯胺、仲胺或叔胺;酸如羧基、酰胺或表示化学反应性位点的其它基团。聚合物和反应性位点可对医疗装置表面以及涂覆于其上的其它涂层产生吸引力如氢键。所述结合非常强烈,可以阻止表层涂层和水的渗透而无需在装置表面和薄的聚合物结合涂层之间存在共价键或其它离子键。
优选带有活泼基团的聚合物以有助于同金属等基体结合。但是,也可使用不带所述基团的聚合物如丙烯酸或苯乙烯聚合物。
活泼基团还可以反应形成交联的基质或有助于形成交联的基质。如需要,可掺入交联剂如脲树脂、蜜胺、异氰酸酯、酚醛树脂等,以便通过与聚合物链上的化学反应性位点反应使本发明的聚合物之间发生交联。或者,交联剂之间可以发生反应形成在其中掺入了粘结层聚合物的交联基质,形成耐溶剂层。薄的聚合物粘结层内的交联(在主要聚合物之间或在其周围)可以通过确保后继涂层中所用的溶剂不能侵蚀和降解粘结层聚合物以及通过防止水的渗透而促进有效地粘结。当粘结层受到过度的溶剂侵蚀时,聚合物粘结层可被后继涂层稀释,从而降低粘结层和医疗装置表面之间的粘性结合。过量水的渗透也会降低粘结性。
本发明的涂层可以用不含反应性位点的聚合物制备,例如丙烯酸或苯乙烯聚合物或共聚物。同样,涂层也可以是未交联的。但是,对于这些涂层,可能需要比由带有反应性位点的聚合物制备的涂层和交联的涂层更厚的粘结层厚度,以达到对本发明后继层的高度粘结性。例如,由带有活泼基团的聚合物制备的交联涂层可以是大约2-10微米厚,而对于实施例1的涂层,透水性丙烯酸苯乙烯共聚物被涂覆在金属上,在其上有水凝胶层,其总厚度为约30-40微米。
本发明的粘结层非常持久,即使浸在水中很长一段时间也是如此。如实施例所示,不锈钢上的涂层可在水中浸泡数月而不丧失其粘性,即使将水凝胶层涂覆在样品上也是如此。水凝胶层通常可吸附数倍于其重量的水并可作为水扩散到水凝胶层和医疗装置表面之间的涂层的通路。这种与水的接触,特别是长时间的接触,对本发明的粘结层提出了强有力的挑战,事实上,本发明的粘结层可以接受该挑战而不会产生脱胶,该结果是出人意料的。本发明的粘结层非常薄,通常低于5微米,则该粘结性更为出众。
本发明的涂层可以很薄,其规格为0.0002″-0.0005″(5-12微米),但在需要时也可以加厚。优选涂层在约2-100微米的范围内,更优选低于约80微米或60微米,特别优选的实施方案为低于约15微米。约2-10微米的结合涂层通常已经足够。如果涂层较厚,在某些需要薄涂层的应用中会造成其它问题。
本发明的涂层可以含有一个约5微米的结合涂层和一个两层的水凝胶层,所述水凝胶层包括一个5微米的底层和一个5微米的表层涂层,总的涂层厚度为约15微米。
以下列出基体以及对其有效的结合涂层配方。根据本发明的教导,许多其它的组合方式对于本领域普通技术人员是显而易见的。不锈钢:环氧树脂;乙烯基吡咯烷酮-乙酸乙烯酯共聚物;苯乙烯丙烯
酸酯类含水分散液;乙烯丙烯酸共聚物+蜜胺树脂;乙烯丙
烯酸共聚物+蜜胺树脂+羟基功能基丙烯酸聚合物+异氰酸
酯聚合物;羧基功能基丙烯酸聚合物+环氧树脂;丙烯酸酯
类分散体聚合物聚乙烯 乙烯丙烯酸共聚物+蜜胺树脂+羟基功能基丙烯酸聚合物+
异氰酸酯聚合物;聚硅氧烷 乙烯丙烯酸共聚物+蜜胺树脂+羟基功能基丙烯酸聚合物+
异氰酸酯聚合物+氧等离子体;聚酯 乙烯丙烯酸共聚物+蜜胺树脂+羟基功能基丙烯酸聚合物+
异氰酸酯聚合物;聚酰胺 氧等离子体+聚乙烯醇缩丁醛
涂层是连贯的,从而形成连续的表面层。当用表层涂层涂覆时,得到的涂层可在含水液体中长时间浸泡而不被除去,并且对多种基体具有粘性。
有多种有用的涂层粘结性试验,包括本发明的结合涂层。其中的两种试验是干法胶带试验(dry adhesion tape test)和湿法摩擦试验(wet rubtest)。与粘结层与底层涂层如纤维素酯层粘结一样,无遮盖的粘结层通常可以与基体很好地粘结,但当涂覆了表面涂层如水凝胶后,则经常会出现问题。湿法摩擦试验以及在干燥后的胶带试验表明,本发明的完整涂层可以在水中经受至少1小时的浸泡而仍保持粘性,并且不会由于摩擦而被除去。
在湿法摩擦试验中,用剃刀或刀片沿涂层作平行切口。将涂层在水中浸泡预定的时间如1小时。然后用手指沿切口轻快地摩擦。涂层的脱壳表明脱胶。在干法摩擦试验中,将胶带紧紧地压在涂层上,然后迅速剥离。涂层被除去表明脱胶。
本发明的涂层可以以足够的厚度和持久性涂覆在生物医学装置或其它装置的表面,使得在涂层装置的整个使用寿命内保持所需的涂层质量。它们足够的薄,从而可用于现有技术中的涂层不适用的多种应用。本发明的涂层在活体组织内是惰性的并且在血液中不会引起血栓形成。
可用各种技术涂覆该涂层,例如浸、喷雾、刷、擦或本领域技术人员已知的其它方法。涂层溶液具有低的粘度,通常小于100CPS,并且具有良好的涂覆性。将涂层在升高的温度、通常为50℃-100℃下烘烤以除去有机溶剂。
根据常规的方法,可用气体等离子体处理。抽真空,通入气体如氧气或氨气,用Rf激发,然后使表面与生成的等离子体接触足够的时间如20分钟,以在表面产生功能基。氧气可产生羟基表面基团,氨气产生与聚合物表面共价结合的氨基。一段时间后,这些基团趋向于折回表面内并且活性降低,因此,用等离子体处理的表面最好立即使用。
本文所述的涂层系统可以产生在含水液体中仍能结合在聚乙烯、聚丙烯、聚酰胺、聚酯、聚硅氧烷和金属如不锈钢、铂、金、镍、钛、镍-钛合金、铬等表面以及其它通常认为存在粘结问题的表面上的涂层。可能需要对某些表面用气体等离子体处理或用其它离子化处理方法处理,以促进对基体的粘结。以下实施例给出了一些如何使用本发明的实施方案。
实施例1
将不锈钢表面用如下溶液刷涂,然后于85℃干燥30分钟。按顺序加入,搅拌至溶解。环氧树脂 5.55克二甲苯 2.37克四氢呋喃(THF) 62.08克环己酮 10.0克乙醇 2.5克乙烯吡咯烷酮-乙酸乙烯酯共聚物 2.5克
用刀片在涂层上切割,将涂层在水中浸泡后用手指沿切口轻快地摩擦,以测试涂层的粘结性。湿法摩擦试验后未发生脱胶(即脱壳)。然后,将Universal Tape83436胶带(United Stationers Supply,Co,)紧紧地压在涂层上并迅速剥离胶带,对涂层进行干法粘结试验。该试验没有造成涂层的脱落。该样品在胶带试验中未发生脱胶。
实施例2
将苯乙烯丙烯酸水分散聚合物(55%固体)刷涂在不锈钢表面用,然后于85℃干燥30分钟。当按照实施例1的方法进行试验时,该涂层显示出极佳的粘结性。
实施例3
将实施例2的样品用具有如下组成的水凝胶组合物涂覆:聚乙烯吡咯烷酮(PVP) 9.4克乙醇 136.1克丁内酯 30.6克0.0625%硝酸纤维素的环己酮溶液 3.8克
将涂层于85℃干燥25小时。该涂层通过了按照实施例1进行的湿法和干法粘结试验。
实施例4
将如下溶液刷涂在不锈钢表面,然后于85℃干燥2小时。5%(w/w)乙烯丙烯酸共聚物的四氢呋喃(THF)溶液 15克环己酮 2克蜜胺树脂 0.24克二甲苯 0.23克丁醇 0.07克三氯乙酸 0.1克
将该涂层于85℃干燥15小时。按照实施例1测试涂层的粘结性,该涂层在湿法和干法条件下均具有良好的粘结性。
实施例5
将实施例4的样品用如下溶液涂覆并于85℃干燥2小时。硝酸纤维素溶液* 170.6克环己酮 88.0克苄醇 48.0克10%(w/w)聚氨酯的THF溶液 86.0克带有羟基功能基的丙烯酸酯类聚合物 18.0克蜜胺树脂 4.5克二甲苯 17.55克丁醇 4.95克三氯乙酸 0.5克*硝酸纤维素溶液:″RS硝酸纤维素 687克乙酸丁酯 459克甲苯 360克乙酸乙酯 894克樟脑 132克邻苯二甲酸二丁酯 180克
然后,将样品用如下水凝胶溶液涂覆并于85℃干燥4小时。PVP 9.4克乙醇 136.1克丁内酯 30.6克0.0625%硝酸纤维素的环己酮溶液 3.8克
按照实施例1测试涂层的粘结性,该涂层在湿法和干法条件下均具有良好的粘结性。样品具有良好的湿润滑性(wet lubricity)。如果没有第一层涂层,则在该试验条件下会发生脱胶。实施例6
将如下溶液浸涂在不锈钢导丝上并与85℃干燥2小时。5%(w/w)乙烯丙烯酸共聚物的THF溶液 15克环己酮 4克羟基功能基丙烯酸酯类酯类聚合物 0.24克蜜胺树脂 0.06克80%(w/w)异氰酸酯聚合物的THF溶液 0.32克三氯乙酸 0.20克
然后,将样品用与实施例5相同的两种涂层溶液涂覆。当按照实施例1在湿法和干法条件下进行测试时,粘结性良好。在水上浸泡130天以上后,该样品仍显示出良好的粘结性。涂层具有良好的湿光滑度。
实施例7
将聚乙烯管用氧等离子体处理。然后将PE管用与实施例6相同的涂层涂覆。当按照实施例1在湿法和干法条件下进行测试时,粘结性良好。涂层具有良好的湿润滑性。
实施例8
将聚乙烯管按照实施例7进行处理,所不同的是位于水凝胶下层的中层涂层的组成为:″RS硝酸纤维素 2.89克邻苯二甲酸二丁酯 1.1克樟脑 0.8克聚氨酯 6.8克环己酮 28.3克甲乙酮 1.6克苄醇 1.7克THF 10.1克乙酸乙酯 2.3克乙醇 14.7克异丙醇 5.5克甲苯 22.9克乙酸丁酯 1.3克
当按照实施例1在湿法和干法条件下进行测试时,样品具有良好的粘结性,并且具有良好的湿润滑性。实施例9
将聚硅氧烷管按照实施例8进行处理。当按照实施例1在湿法和干法条件下进行测试时,涂层具有良好的粘结性,并且具有良好的湿润滑性。实施例10
将聚硅氧烷管置于抽空容器内并进行交替的加入氧和循环操作Rf电源的循环,由此对聚硅氧烷管进行氧等离子体处理。首先,以550±50mTorr通入氧气0.25分钟。关掉氧气,打开Rf电源,向前为450±50瓦,反向为≤50瓦,时间为2分钟。将以上两步骤重复5次,其余的氧气循环持续2分钟。在等离子体处理衰退前,在1或2天内将粘结层涂覆在等离子体处理的表面上。
然后,将处理过的管用如下溶液浸涂,然后于85℃干燥1小时。聚乙烯醇缩丁醛 18.0克乙醇 35.4克二甲苯 34.9克甲乙酮 43.4克丙二醇甲醚乙酸酯 48.9克二丙二醇甲醚乙酸酯 9.0克乙酸异丁酯 1.89克
将该涂层用与实施例3所用相同的水凝胶涂覆。当按照实施例1在湿法和干法条件下进行测试时,涂层样品具有良好的粘结性,并且具有良好的湿润滑性。实施例11
将不锈钢用如下溶液涂覆,然后于85℃干燥60分钟。聚乙烯醇缩丁醛 9.00克乙醇 17.7克二甲苯 18.19克甲乙酮 21.70克丙二醇甲醚乙酸酯 24.45克二丙二醇甲醚乙酸酯 4.5克乙酸异丁酯 0.90克带有羟基功能基的丙烯酸酯类聚合物 1.52克蜜胺树脂 0.38克丁醇 0.42克
然后,将该样品用涂覆实施例5的第一层涂层所用的后两种涂层涂覆。当按照实施例1在湿法和干法条件下进行测试时,该样品具有良好的粘结性,并且具有良好的湿润滑性。实施例12
将聚酯管的样品按照实施例8进行处理。当按照实施例1在湿法和干法条件下进行测试时,该样品具有良好的粘结性,并且具有良好的湿润滑性。实施例13
将不锈钢表面用如下粘结涂层溶液浸涂并于85℃干燥2小时。羧基功能基丙烯酸酯类聚合物 1.85克Aromatic150 2.32克丁基溶纤剂 0.33克THF 3.55克二甲苯 0.13克环氧树脂 0.39克
然后,将样品用与实施例3相同的水凝胶涂层涂覆并于85℃干燥2小时。当按照实施例1在湿法和干法条件下进行测试时,该样品具有良好的粘结性,并且具有良好的润滑性。实施例14
将不锈钢样品用与实施例1所用相同的粘结涂层溶液浸涂,然后于85℃干燥2小时。然后,将样品用实施例5的后两种涂层涂覆。当按照实施例1在湿法和干法条件下进行测试时,该样品具有良好的粘结性,并且当样品湿润时,具有良好的润滑性。实施例15
将不锈钢样品用如下粘结层组合物浸涂,然后于85℃干燥2小时。水 8克10%Triton×100非离子表面活性剂 0.88克50%丙烯酸分散体聚合物 18.8克
然后,将样品用实施例5的后两种涂层涂覆。当按照实施例1在湿法和干法条件下进行测试时,该样品具有良好的粘结性,并且当样品湿润时,具有良好的润滑性。实施例16
将PEBAX聚酰胺管的样品按照实施例10进行处理。当按照实施例1在湿法和干法条件下进行测试时,该样品具有良好的粘结性,并且具有良好的湿润滑性。实施例17
将尼龙12管的样品按照实施例16进行处理,所不同的是不用氧等离子体进行处理。当按照实施例1在湿法和干法条件下进行测试时,该样品具有良好的粘结性,并且具有良好的湿润滑性。
本说明书中所说明和讨论的实施方案仅仅是用来教导本领域技术人员本发明人已知的使用本发明的最佳方式。说明书中的任何内容均不能认为是对本发明范围的限定。可以对本发明的上述实施方案进行修饰和改变而不超出本发明的范围,通过以上的教导,这对于本领域技术人员是显而易见的。因此,应当理解,在权利要求及其等同物的范围内,可以以与以上具体描述不同的方式实施本发明。
Claims (23)
1.一种可插入医疗装置,该装置包含涂覆在装置惰性表面上的生物相容性表面涂层,所述涂层包含厚度为约1至约100微米的粘结涂层,包含与装置惰性表面形成键的粘合聚合物,并且还含有粘结在粘合层上的外层,该涂层在水中长时间浸泡后仍能粘结在装置表面上并且可以抵抗磨蚀和被胶带从装置上除去。
2.权利要求1的装置,其中的粘合聚合物层选自丙烯酸类树脂、环氧树脂类、乙缩醛类、乙烯共聚物、含羟基、胺、羧基、酰胺或其它活泼基团的聚合物、苯乙烯丙烯酸酯类聚合物、乙烯丙烯酸共聚物、带羧基功能基的丙烯酸酯类聚合物、带羟基功能基的丙烯酸酯类聚合物、丙烯酸酯酯类分散体聚合物、基于甲基丙烯酸甲酯、甲基丙烯酸丁酯、甲基丙烯酸异丁酯、甲基丙烯酸乙酯、丙烯酸甲酯、丙烯酸乙酯、丙烯酸、苯乙烯甲基丙烯酸酯和苯乙烯丙烯酸酯的共聚物、聚乙烯吡咯烷酮、乙烯基吡咯烷酮-乙酸乙烯酯共聚物、其它乙烯基聚合物和共聚物、乙烯丙烯酸共聚物、环氧聚合物以及它们的共聚物。
3.权利要求1的装置,其中的聚合物含有活泼基团。
4.权利要求3的装置,其中的粘合层还含有与聚合物链上的活泼基团相互作用的交联剂,所述交联剂选自脲树脂、蜜胺、异氰酸酯、环氧树脂和酚醛树脂。
5.权利要求1的装置,其中的键包括非共价键。
6.权利要求1的装置,其中,粘合层的厚度为约1至约10微米。
7.权利要求1的装置,其中,总的涂层厚度小于约40微米。
8.权利要求1的装置,其中的惰性表面包括如下材料:不锈钢、镍、金、铬、镍钛合金、铂、其它金属、聚硅氧烷、聚乙烯、其它聚烯烃、聚酯和其它塑料。
9.权利要求1的装置,其中,所述医疗装置选自针、导丝、导管、手术器械、内窥镜检查所用的装置、金属丝、支架、血管成形术气囊、伤口引流管、动静脉分流器、胃管、尿道插管、腹腔镜检查装置、小药丸和植入物。
10.对具有惰性表面的医疗装置进行涂层的方法,该方法包括,在表面上涂覆含有溶剂和选定的粘合聚合物的涂层液体以便在表面形成粘合层,将液体干燥形成粘结在医疗装置表面的薄的粘合层,然后涂覆与粘合层粘结的外层,在水中长时间浸泡后,整个涂层仍能粘结在基体上并且可以抵抗磨蚀和被胶带除去。
11.权利要求10的方法,其中的外层包含至少一种润滑涂层、药物涂层、着色涂层和耐磨蚀涂层。
12.权利要求10的方法,其中的涂覆步骤包括浸、喷雾、刷或擦。
13.权利要求10的方法,还包括在涂覆步骤前将惰性表面用气体等离子体或其它离子化方法预处理。
14.权利要求10的方法,还包括将涂层加热到至少约50℃以除去溶剂。
15.用于在具有惰性表面的医疗装置上涂覆粘合层的涂层液体,该液体含有溶剂和可与医疗装置的惰性表面粘合的聚合物,并且还含有粘结在粘合层上的外层,该涂层在水中长时间浸泡后仍能粘结在基体上并且可以抵抗磨蚀和被胶带除去。
16.权利要求15的涂层液体,还含有可与聚合物上的活泼基团相互作用的交联剂。
17.权利要求15的涂层液体,其中的交联剂选自脲树脂、蜜胺、异氰酸酯、环氧树脂和酚醛树脂。
18.权利要求15的涂层液体,其中的粘度小于约100cps。
19.权利要求15的涂层液体,其中的溶剂选自水、二甲苯、四氢呋喃、环己酮、乙醇、丁内酯、丁醇、三氯乙酸、苄醇、乙酸异丁酯、甲乙酮、Aromatic150、丁基溶纤剂和甲苯。
20.权利要求15的涂层液体,其中还含有表面活性剂。
21.权利要求1的装置,在粘合层和外层之间存在界面,两层的成分在该界面处相互渗透。
22.适于在医疗装置的惰性表面形成生物相容性表面涂层的组合物,该组合物含有可与装置的惰性表面粘合形成粘合层的生物相容性粘合聚合物,对该粘合聚合物进一步的选择是可与涂覆在粘合层上的外层粘结,该涂层在水中长时间浸泡后仍能粘结在基体上并且可以抵抗腐蚀和被胶带除去。
23.用于具有惰性表面的可插入医疗装置的生物相容性涂层,其特征包括由可与装置的惰性表面粘合的粘合聚合物形成的粘结层,所述粘合聚合物进一步与涂覆在粘合层上的外层粘结,该涂层在水中长时间浸泡后仍能粘结在基体上并且可以抵抗磨蚀和被胶带除去。
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US08/791,440 | 1997-01-27 | ||
US08/791,440 US5997517A (en) | 1997-01-27 | 1997-01-27 | Bonding layers for medical device surface coatings |
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EP (1) | EP0971753B1 (zh) |
JP (2) | JP2001509052A (zh) |
CN (1) | CN1250382A (zh) |
AT (1) | ATE306952T1 (zh) |
CA (1) | CA2278706A1 (zh) |
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EP0971753B1 (en) | 2005-10-19 |
CA2278706A1 (en) | 1998-07-30 |
US5997517A (en) | 1999-12-07 |
EP0971753A1 (en) | 2000-01-19 |
JP2001509052A (ja) | 2001-07-10 |
JP2010029688A (ja) | 2010-02-12 |
DE69831939T2 (de) | 2006-07-27 |
US6306176B1 (en) | 2001-10-23 |
WO1998032474A1 (en) | 1998-07-30 |
ATE306952T1 (de) | 2005-11-15 |
DE69831939D1 (de) | 2006-03-02 |
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