CN102933664B - 具有抗微生物剂的涂料 - Google Patents
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Abstract
本发明提供了一种用于医疗装置的含有抗微生物剂的涂料。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
相关专利申请的交叉引用
本专利申请是提交于2008年9月19日的美国专利申请No.12/233,949的部分继续申请，该专利申请的全部公开内容以引用方式明确并入本文中。
背景技术
本公开涉及涂料，更具体地讲，涉及用于医疗应用的包括抗微生物剂的涂料。
已经对掺入抗微生物剂的涂料的领域进行了研究。某种研究已涉及牵涉到活性释放策略的涂料。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料领域中，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在这些特定装置上的生物膜定植。
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。在其他方法中，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，或者掺入药剂的涂料的接枝聚合化。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他相关方法会遭受多种限制。在一些情况下，涂料是表面性的(“表面涂覆”)，由此在活性药剂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料，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。在一个具体实施例中，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。在另一个实施例中，上述掺入抗微生物剂的RTV分散体可涂覆在固化的RTV有机硅材料上。
在一个实施例中，一种方法涉及将活性药剂的组合掺入RTV有机硅弹性体分散体，以及用该分散体涂覆之前已固化的HTV或RTV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。还预期盐酸奥替尼啶也可能在活性成分之中。可以通过浸渍、喷涂、刷涂或其他物理沉积或常规方法将带有药剂的RTV分散体涂覆至HTV或RTV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剂。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，其他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料的需求。该涂料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剂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。上述包含抗微生物药剂的RTV有机硅弹性体也可固化到RTV弹性体基底或外壳上。
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精细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固化的HTV有机硅弹性体制成的目标医疗装置的表面上。在另一个实施例中，该目标医疗装置也可由固化的RTV有机硅弹性体制成。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19gRTV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。可使用喷涂或其他常规方法将所述混合物在HTV或RTV有机硅材料的固化外壳上形成膜。
又如，盐酸奥替尼啶可作为溶解或分散在有机溶剂中的抗微生物组合物的活性成分。在一个实施例中，可在58.90g RTV有机硅聚合物的二甲苯分散体中加入溶于5.0g溶剂的176mg盐酸奥替尼啶。搅拌该混合物直至其成为均匀的混合物，然后将混合物进行脱气以去除夹带的气泡。然后，可使用喷涂或其他常规方法将该均匀混合物涂覆在固化的HTV或RTV有机硅材料外壳上或在固化外壳上形成膜。
进行的一项实验测试了通过在聚二甲基硅氧烷薄板上如上文所述涂覆含有盐酸奥替尼啶的RTV有机硅分散体而使表面细菌附着减少量。将上述含有盐酸奥替尼啶的均匀混合物涂覆到0.5mm的固化有机硅聚合物薄板上。在该实验中，使用迈耶棒将混合物涂覆在固化的有机硅聚合物薄板上。然后，被涂覆的薄板在约325°F(162.8℃)的温度下固化约10小时。固化后，该薄板在约240°F(115.6℃)的温度下进行大约36小时的消毒。使用附着物对数减少量微生物学测试法，将最终的被涂覆的薄板的抗细菌粘附能力与未涂覆的有机硅薄板进行比较。
附着物对数减少量测试用于指示表面生物膜形成的可能性。在该实验中，测试了有机硅聚合材料表面生物膜形成的可能性，该有机硅聚合材料涂覆有包含盐酸奥替尼啶的抗微生物溶液。该实验使用的细菌为金黄色酿脓葡萄球菌，并将其附接到涂覆有盐酸奥替尼啶的有机硅聚合物表面。另外还使用了对照物，并且将金黄色酿脓葡萄球菌附接到未包含盐酸奥替尼啶的有机硅薄板上。该测定在含有血清的培养基中于37℃下以60rpm的转速振荡24小时。测定结果在下表中列出。
如上表所示，涂覆盐酸奥替尼啶的有机硅表面的ALR(附着物对数减少量)评分或值为4.9(CFU/个)。ALR评分是对照物的对数附着物(对数CFU/个)减去已处理表面的平均对数附着物(对数CFU/个)。该测定中4.9的ALR评分是指已使用盐酸奥替尼啶处理的有机硅表面附着细菌的回收率为对照物制品回收率的0.001％。
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他所需组合。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或RTV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他领域。
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 (12)
1.一种使用抗微生物剂涂覆材料的方法，包括：
将盐酸奥替尼啶和有机溶剂与未固化的有机硅聚合物混合以形成涂料混合物，其中混合包括搅拌直到涂料混合物具有均匀的颜色和稠度；
对所述混合物进行脱气以去除夹带的气泡；并且
将所述涂料混合物涂覆到固化的乳房植入物有机硅聚合物上，
其中涂料混合物为没有溶胀固化的有机硅聚合物的最外层。
2.根据权利要求1所述的方法，其中所述未固化的有机硅聚合物是未固化的RTV有机硅弹性体。
3.根据权利要求2所述的方法，其中所述固化的有机硅聚合物是固化的HTV有机硅弹性体。
4.根据权利要求2所述的方法，其中所述固化的有机硅聚合物是固化的RTV有机硅弹性体。
5.根据权利要求1所述的方法，其中盐酸奥替尼啶以有效减少细菌定植的浓度存在。
6.根据权利要求1所述的方法，还包括为所述乳房植入物提供延长的抗微生物功效。
7.一种用于由固化的有机硅弹性体形成的乳房植入物的涂料，包含：
含有盐酸奥替尼啶和有机溶剂的抗微生物溶液；以及
未固化的RTV有机硅弹性体；
其中所述抗微生物溶液与所述未固化的RTV有机硅弹性体形成具有均匀的颜色和稠度、夹带的气泡被去除的混合物，并且所述混合物形成没有溶胀固化的有机硅弹性体的乳房植入物最外层。
8.根据权利要求7所述的涂料，其中所述未固化的RTV有机硅弹性体分散在二甲苯中。
9.一种乳房植入物，包括：
主体，所述主体由固化的有机硅弹性体形成；以及
具有均匀的颜色和稠度的涂层，所述涂层由RTV有机硅弹性体的二甲苯分散体和含有盐酸奥替尼啶和有机溶剂的夹带的气泡被去除的抗微生物溶液形成，其中所述涂层至少部分地涂覆在所述主体上，并形成没有溶胀固化的有机硅弹性体的乳房植入物最外层。
10.根据权利要求9所述的乳房植入物，其中所述主体由固化的HTV有机硅弹性体形成。
11.根据权利要求9所述的乳房植入物，其中所述主体由固化的RTV有机硅弹性体形成。
12.根据权利要求9所述的乳房植入物，其中控制涂覆到所述主体上的所述涂层厚度，以实现所需盐酸奥替尼啶的浓度体积分布。
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| PCT/US2011/027122 WO2011112430A1 (en) | 2010-03-12 | 2011-03-04 | Coatging with antimicrobial agents |
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| US8808372B2 (en) | 2012-04-27 | 2014-08-19 | Cold Winter Solutions, L.L.C. | Breast implant spacers for the treatment of periprosthetic breast implant infections |
| JP7314271B2 (ja) * | 2018-11-29 | 2023-07-25 | エシコン・インコーポレイテッド | 抗菌剤含有シリコーン潤滑性コーティング |
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| AU2011224699A1 (en) | 2012-09-27 |
| CN102933664A (zh) | 2013-02-13 |
| EP2545126A1 (en) | 2013-01-16 |
| CA2792431A1 (en) | 2011-09-15 |
| BR112012023024A2 (pt) | 2016-05-31 |
| US8419793B2 (en) | 2013-04-16 |
| WO2011112430A1 (en) | 2011-09-15 |
| EP2545126B1 (en) | 2018-04-25 |
| US20100198350A1 (en) | 2010-08-05 |
| CA2792431C (en) | 2018-06-12 |
| AU2011224699B2 (en) | 2015-02-19 |
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