CN102164562A - 具有抗微生物剂的涂层 - Google Patents
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Abstract
本发明提供了一种用于医疗装置的具有抗微生物剂的涂层。在一种方法中,有关方法涉及用室温硫化分散体涂覆高温硫化有机硅材料。
Description
背景技术
本公开涉及涂层,更具体来讲,涉及用于医疗应用的包括抗微生物剂的涂层。
已经对掺入抗微生物剂的涂层的领域进行了研究。某种研究已涉及牵涉到活性释放策略的涂层。已经研究了抗微生物剂之中的抗生素、银离子和防腐剂。
在用于医疗装置的抗微生物涂层领域中,无论是对于短期使用还是长期永久性的植入物,众多科学公开文献提到了其结合中心静脉导管、尿路导管和阴茎假体的使用。已经证明两种抗生素(利福平和米诺环素)的特定组合能成功减少这些特定装置上的挂膜。
之前也已经研究了用于涂覆医疗装置的有机硅表面的多种方法。在一个已知方法中,采用了将溶解在溶胀剂中的抗生素注入装置的方式。在其它方法中,涂覆步骤涉及涂覆硅油膜,随后涂覆粉末形式的抗微生物剂,或者掺入药剂的涂层的接枝聚合化。在另一种方法中,利用了包含抗生素陶瓷粒子的亲水性聚合物。
这些方式方法中的许多可被归类为“表面涂覆”,这是由于仅装置表面被抗生素涂覆。然而,还已知另一种方法,该方法被设计用于促进抗微生物剂在装置的整个体积中渗透(“注入”)。
在文献中公开或者在专利中报道的这些方法和其它相关方法会遭受多种限制。在一些情况下,涂层是表面性的(“表面涂覆”),由此在活性药物的初始突释之后仅提供对抗细菌的短时间有效保护。此外,当使用“注入”方法时,通过使形成装置的材料(例如,有机硅)溶胀并随后物理地将活性物质埋入其中而将药剂掺入装置的体积内,从而实现使抗微生物功效的时间延长的优点。然而,这常常需要大量的药剂,考虑到药剂对于装置材料具有高亲和力,大部分药剂将不能从表面得到,而是将留在装置的本体中。另外,使装置掺入药剂的最后溶胀处理可能对其机械性能具有不期望的效果,或者它可能将不必要的挥发性残留物引入到组合物(例如,凝胶)内。对于诸如乳房植入物的长期或永久性假体而言尤其是这样。
因此,需要一种具有抗微生物剂的涂层,其可以结合医疗装置使用,同时能提供延长的有效保护,而不需要大量的药剂来实现所需保护。本公开解决这些及其他需求。
发明内容
简要地且广义地,本公开涉及用于涂覆材料的方法和有关物质。更具体地讲,本公开涉及用掺入抗微生物剂的分散体涂覆材料。在一个具体方面,所述方法涉及用掺入用于医疗植入物的抗微生物剂的室温硫化(RTV)分散体涂覆高温硫化(HTV)有机硅材料。
在一个实施例中,一种方法涉及将活性药物的组合掺入RTV有机硅弹性体分散体,以及用所述分散体涂覆之前已固化的HTV弹性体材料。尽管可以采用各种药剂,但是利福平和米诺环素在预期的活性成分之中。可以通过浸渍、喷涂、刷涂或其它物理沉积或常规方法将带有药剂的RTV分散体涂覆至HTV材料。可以准确地控制涂层的厚度,以在有机硅中得到精确量的活性药物。然后,可以在受控的温度和湿度条件下固化涂覆的材料。因此将抗微生物剂掺入所述装置的有机硅外壳的最外层。
根据以下结合附图的具体实施方式,其它特征和优点将变得清楚,所述附图以举例的方式示出各种实施例的特征。
具体实施方式
本公开解决了对用于医疗装置的包含抗微生物剂的涂层的需求。该涂层提供延长的有效保护而不需要大量的药剂来实现保护目的。
本方法涉及将活性药物直接掺入有机硅基质中,而不用使形成所讨论装置的材料溶胀。以此方式,药剂可分布在有机硅外壳的最外侧RTV部分内以发挥更长时间的功效,而没有像常规“注入”方法一样被大量浪费在所述材料的整个体积内。可以精确地控制RTV层的厚度,以实现药剂所需的浓度体积分布。这之所以可行是由于创新地使用了固化到HTV弹性体基底上的包含抗微生物药剂的RTV有机硅弹性体的组合。
与其中药剂仅存在于装置表面上的那些方法相比,用于涂覆的本方法由于将药剂掺入有机硅基质中而能提供长期抗微生物保护功效。此外,与注入方法相比,预期方法允许使用浓度低很多的药剂,由此在保持相同的抗微生物功效的同时将材料成本降至最低。因此,本发明所公开的方法使得可以准确地控制掺入的药剂量以及涂层的厚度,以便优化释放动力学并根据特定应用的需要定制浓度。
明显地,本涂覆工序不会向材料溶胀后的最终装置引入任何明显的机械应力。另外,本方法不会将溶剂引入最终装置的凝胶中(可能需要进一步处理来提取挥发物),并且本方法与诸如喷涂和浸渍之类的各种物理涂覆技术相容,从而大大简化了制造工艺。
所讨论的涂覆方法的一个优选实施例涉及形成有效浓度的抗微生物组合物,以防止医疗装置表面出现细菌定植。如所述的,预期利福平和米诺环素可以用作活性成分。然后,将抗微生物剂溶解或细微地分散在有机溶剂中。可使用的有机溶剂包括乙酸和二甲苯。
接着,将抗微生物溶液(或抗微生物分散体)掺入未固化的RTV有机硅弹性体分散体中。对混合物进行加热和搅动,直到各溶液(或分散体)被均匀地掺入有机硅分散体内。
在医疗装置专有的应用中,将包括抗微生物剂的分散体涂覆到由已固化的HTV有机硅弹性体制成的目标医疗装置的表面上。在涂覆过程中,可以使用将分散体喷涂到医疗装置上的步骤。此后,在90°F至200°F的温度下,将被涂覆的装置固化约60至180分钟的时间,直到掺入抗微生物剂的分散体完全固化。
在一个具体实例中,可以在搅动的条件下,在80℃的加热板上将100mg的利福平分散在2ml的二甲苯中。然后,可以在搅动15分钟的条件下,在80℃的加热板上将量为50mg的米诺环素溶解在0.5ml的乙酸中。然后,将量为1g的RTV有机硅分散体缓慢加入米诺环素溶液中并搅动几分钟。然后,在搅动的条件下,将米诺环素和RTV分散体的混合物加入19g的RTV有机硅分散体中。
随后,在搅动的条件下,将利福平分散体加入所述混合物中。在80℃的加热板上搅动所述混合物,直到达到均匀外观和颜色的蜂蜜稠度。可使用喷涂或其它常规方法将所述混合物在HTV有机硅材料的固化外壳上形成膜。
应当认识到,上述方法可涉及使用抗生素、抗真菌物质或防腐剂的任何其它所需组合。此外,应该理解,所述方法可涉及采用除乙酸和二甲苯之外的有机溶剂。另外,所述方法可包括通过物理涂覆方法(即,浸渍或喷涂)将分散体涂覆到HTV材料上。此方法的一种应用是用于乳房植入物,但是应当认识到,本发明所公开的方法可应用于其它领域。
上述各种实施例只是以举例说明的方式提供,而不应该被理解为限制本发明所公开的实施例。本领域的技术人员应该很容易认识到,在不遵循本文图示和描述的示例实施例和应用且不脱离所附权利要求书阐述的所公开实施例的真实精神和范围的情况下,可以对本发明所公开的实施例进行各种修改和变化。
Claims (20)
1.一种用活性药物涂覆材料的方法,其包括:
将活性药物掺入未固化的第一材料中;
形成包括所述活性药物和所述未固化的材料的涂层;
将所述涂层涂覆至固化的第二材料,其中所述第一材料和所述第二材料由相同的物质形成。
2.根据权利要求1所述的方法,其中所述第一材料和所述第二材料由有机硅弹性体形成。
3.根据权利要求2所述的方法,其中所述未固化的第一材料是未固化RTV有机硅弹性体。
4.根据权利要求3所述的方法,其中所述第二材料是固化的HTV有机硅弹性体。
5.根据权利要求1所述的方法,其中所述活性药物是利福平和米诺环素中的一种或多种。
6.根据权利要求1所述的方法,其包括涂覆一定量以提供有效浓度,以防止细菌定植。
7.根据权利要求6所述的方法,其包括涂覆医疗装置。
8.根据权利要求7所述的方法,其包括涂覆乳房植入物的一部分。
9.根据权利要求7所述的方法,其包括将所述活性药物掺入所述医疗装置的有机硅弹性体外壳的外层中。
10.根据权利要求9所述的方法,其包括在不溶胀有机硅弹性体材料的情况下涂覆所述医疗装置。
11.根据权利要求10所述的方法,其包括为所述医疗装置提供延长的抗微生物功效。
12.根据权利要求1所述的方法,其包括将所述活性药物溶解或最终分散在有机溶剂中,以形成抗微生物溶液或分散体。
13.根据权利要求12所述的方法,其中所述有机溶剂是乙酸和二甲苯中的一种或多种。
14.根据权利要求12所述的方法,其包括将所述抗微生物溶液或分散体掺入未固化的RTV有机硅弹性体分散体中,以形成混合物。
15.根据权利要求14所述的方法,其包括对所述混合物进行加热和搅动,以均匀地掺入所述抗微生物溶液或分散体。
16.根据权利要求15所述的方法,其包括将所述混合物涂覆到所述医疗装置的固化的HTV有机硅弹性体表面上。
17.根据权利要求16所述的方法,其包括固化所述装置。
18.根据权利要求17所述的方法,其包括在90至200华氏度的温度下固化约60至180分钟。
19.一种用于由固化的HTV有机硅弹性体形成的装置的涂层,其包括:
抗微生物物质;以及
未固化的RTV有机硅弹性体;
其中所述抗微生物物质形成用于涂覆到所述固化的HTV有机硅弹性体的混合物。
20.一种医疗装置,其包括:
主体,所述主体由固化的HTV有机硅弹性体形成;以及
涂层,所述涂层由包括抗微生物物质的未固化的RTV有机硅弹性体形成,所述抗微生物物质被掺入所述未固化的RTV有机硅弹性体中。
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US12/233949 | 2008-09-19 | ||
US12/233,949 US8420153B2 (en) | 2008-09-19 | 2008-09-19 | Coating with antimicrobial agents |
PCT/US2009/057243 WO2010033656A1 (en) | 2008-09-19 | 2009-09-17 | Coating with antimicrobial agents |
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US (1) | US8420153B2 (zh) |
EP (1) | EP2323589A1 (zh) |
CN (1) | CN102164562A (zh) |
AU (1) | AU2009293249B2 (zh) |
BR (1) | BRPI0918557A2 (zh) |
CA (1) | CA2737746C (zh) |
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US8420153B2 (en) | 2008-09-19 | 2013-04-16 | Mentor Worldwide Llc | Coating with antimicrobial agents |
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- 2009-09-17 AU AU2009293249A patent/AU2009293249B2/en not_active Ceased
- 2009-09-17 CN CN2009801373980A patent/CN102164562A/zh active Pending
- 2009-09-17 WO PCT/US2009/057243 patent/WO2010033656A1/en active Application Filing
- 2009-09-17 EP EP20090792641 patent/EP2323589A1/en not_active Withdrawn
- 2009-09-17 BR BRPI0918557A patent/BRPI0918557A2/pt not_active Application Discontinuation
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2011
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CN104394801A (zh) * | 2012-04-27 | 2015-03-04 | 冷冬解决方案有限责任公司 | 用于治疗环假体乳房植入物感染的乳房植入物垫片 |
CN104394801B (zh) * | 2012-04-27 | 2016-12-21 | 冷冬解决方案有限责任公司 | 用于治疗环假体乳房植入物感染的乳房植入物垫片 |
Also Published As
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WO2010033656A1 (en) | 2010-03-25 |
CA2737746A1 (en) | 2010-03-25 |
EP2323589A1 (en) | 2011-05-25 |
CA2737746C (en) | 2016-08-09 |
AU2009293249A1 (en) | 2010-03-25 |
BRPI0918557A2 (pt) | 2015-12-01 |
AU2009293249B2 (en) | 2014-07-17 |
US8420153B2 (en) | 2013-04-16 |
US20100076113A1 (en) | 2010-03-25 |
CR20110212A (es) | 2011-11-10 |
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