CN101168071A - 具有抗微生物表面的外科缝合材料以及在外科缝合材料上设置抗微生物涂层的方法 - Google Patents

具有抗微生物表面的外科缝合材料以及在外科缝合材料上设置抗微生物涂层的方法 Download PDF

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CN101168071A
CN101168071A CNA2007101631720A CN200710163172A CN101168071A CN 101168071 A CN101168071 A CN 101168071A CN A2007101631720 A CNA2007101631720 A CN A2007101631720A CN 200710163172 A CN200710163172 A CN 200710163172A CN 101168071 A CN101168071 A CN 101168071A
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S·福格特
K·D·屈恩
H·比希纳
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Abstract

本发明描述了一种具有抗微生物表面的外科缝合材料，该表面展示出这样一种涂层，其中所述涂层含有：至少一种脂肪酸，奥替尼啶二氯化物和/或地喹氯铵，以及可任选的低聚乳酸酯。此外，本发明描述了一种对外科缝合材料进行涂敷的方法，其特征在于：使用含奥替尼啶二氯化物和/或地喹氯铵的均相甲醇溶液将丝状材料润湿，并随后将甲醇蒸发，从而在所述丝的表面形成涂层。

Description

具有抗微生物表面的外科缝合材料以及在外科缝合材料上设置抗微生物涂层的方法
技术领域
本发明的主题由具有抗微生物涂层的外科缝合材料以及在外科缝合材料上设置抗微生物涂层的方法两部分构成。
背景技术
基于外科缝合材料结构的不同，可将其分为单丝和复丝。复丝可表现出所谓的芯吸效应。这是指在毛细管作用下，组织液会沿着丝迁移。微生物也可能随之一同迁移，从而使得感染沿丝状材料扩散。因此，人们期望对外科缝合材料设置终饰层，使得微生物在丝表面上固定，从而有效地预防微生物沿丝迁移。
对于可吸收缝合材料而言，编织聚乙交酯复丝尤其具有实用上的重要性。到目前为止，从市场上仅可得到Ethicon公司出售的一种涂有抗菌三氯生的聚乙交酯类丝状材料。这种抗菌剂是对革兰氏阳性菌有抗菌作用的氯化联苯衍生物。但是，人们期望得到具有广得多的抗菌作用的丝状材料，其抗菌作用可涵盖针对革兰氏阴性菌、酵母菌和真菌的抗菌作用。非吸收性的丝状材料类通常也采用复丝形式。例如，复丝形式的外科用钢丝被用于(例如)胸部手术。目前，还不知道有市售的具有抗微生物终饰层的非吸收性缝合材料。
在过去的几十年中，已知许多具有抗菌作用的物质并且它们被用于医学领域。除了用于口腔护理的水溶性的氯己定的盐外，Schüle&Mayr公司出售的商品名为Octenisept的奥替尼啶二氯化物溶液被广泛用于手术中的伤口消毒和表面消毒。Octenisept为奥替尼啶二氯化物与苯氧乙醇的醇水溶液。与其它阳离子抗菌剂相比，奥替尼啶二氯化物(1，1′-(1，10-癸烷二基)双[4-(辛氨基)吡啶]二氯化物)的特点在于奥替尼啶二氯化物带有两个正电荷。奥替尼啶二氯化物具有非常宽的活性范围，其活性范围包括针对革兰氏阳性菌和革兰氏阴性菌以及酵母菌和真菌的活性。奥替尼啶二氯化物是Sterling公司于1977年研制的。
地喹氯铵也具有带两个阳离子中心的相似结构。Allen&Hanburys于1957年对地喹氯铵(1，10-十亚甲基-双(4-氨基-2-甲基喹啉)二氯化物)进行了描述。
奥替尼啶二氯化物与地喹氯铵的特征均为具有非常宽的活性范围，并且其对于软组织，尤其是黏膜而言具有很好的耐受性。因此，已对(例如)含有奥替尼啶二氯化物的制剂用于伤口和黏膜的消毒进行了描述(参见专利文献DE 101 09 925 A1)。但是，奥替尼啶二氯化物与地喹氯铵并未表现出对常用缝合材料的表面具有任何显著的黏附作用。
发明内容
本发明基于这样一个目的，即要研制出一种外科缝合材料，该外科缝合材料被终饰，使得其被保护，以避免微生物的定居，并且该抗微生物保护作用涵盖了宽范围的病菌。此外，还要研制出一种简单的方法，该方法可将抗微生物涂料施加于市售缝合材料上。该方法被这样设计，使得缝合材料的结构不会受到涂敷工艺的负面影响。
令人足够惊讶的是，通过加入至少一种脂肪酸，发现可使得奥替尼啶二氯化物以及地喹氯铵黏附于缝合材料的表面。可将抗菌剂奥替尼啶二氯化物和地喹氯铵与作为助黏剂的脂肪酸一同施加到外科缝合材料表面。接下来将由混合物构成的涂料施加到丝的表面，其中所述混合物含有至少一种脂肪酸和奥替尼啶二氯化物和/或地喹氯铵。
脂肪酸优选为月桂酸、棕榈酸和硬脂酸。不需要使用纯的脂肪酸。也可使用被单脂肪酸甘油酯、二脂肪酸甘油酯和三脂肪酸甘油酯污染的脂肪酸。此外，可使用脂肪酸与低聚乳酸酯的混合物。奥替尼啶二氯化物或地喹氯铵与脂肪酸的重量比优选为1∶0.1至1∶5，更优选为1∶1。
本发明的目的也通过这样一种工艺达到，该工艺在这样一种情况下对外科缝合材料进行涂敷，其中所述材料用含奥替尼啶二氯化物和/或地喹氯铵以及至少一种脂肪酸的均相甲醇溶液湿润，且随后将甲醇蒸发，从而在所述丝表面形成涂层。也可使用由甲醇和其它诸如乙醇、丙醇和异丙醇的低级醇构成的混合物来代替甲醇。使用甲醇溶液的优点在于甲醇的短期作用不会造成常用的聚乙交酯丝、聚二氧杂环己酮丝和聚(ε-己内酯-co-L-丙交酯)丝的膨胀，因此使丝的结构得以保持不变。
具体实施方式
通过下述实施例对本发明进行进一步详细描述，这些实施例并不限定本发明。
实施例1：
在室温下将300mg地喹氯铵(Solmag)和300mg棕榈酸(Fluka)溶于28.800g甲醇(Fluka)中。形成澄清溶液。将一段长为50cm的编织聚乙交酯丝(USP 2.0)浸入该溶液中。随后在室温下将甲醇蒸发。用重量分析确定涂层质量。涂层质量为0.6mg。
实施例2：
在室温下将600mg奥替尼啶二氯化物(DishmanPharmaceuticals)和600mg棕榈酸(Fluka)溶于28.800g甲醇(Fluka)中。形成澄清溶液。将一段长为50cm的编织聚乙交酯丝(USP 2.0)浸入该溶液中。随后在室温下将甲醇蒸发。用重量分析确定涂层质量。涂层质量为1.4mg。

Claims (7)

1.一种具有抗微生物表面的外科缝合材料，所述外科缝合材料的特征在于所述表面展示出这样一种涂层，其中所述涂层含有：
至少一种脂肪酸，
奥替尼啶二氯化物和/或地喹氯铵，以及
可任选的低聚乳酸酯。
2.根据权利要求1所述的外科缝合材料，所述外科缝合材料的特征在于所述至少一种脂肪酸选自：月桂酸、棕榈酸和硬脂酸。
3.根据权利要求1所述的外科缝合材料，所述外科缝合材料的特征在于奥替尼啶二氯化物或地喹氯铵与脂肪酸或脂肪酸总和的重量比为1.0∶0.1至1.0∶5.0。
4.根据权利要求3所述的外科缝合材料，所述重量比为1.0∶1.0。
5.一种对外科缝合材料进行涂敷的方法，所述方法包括以下步骤：
使用含奥替尼啶二氯化物和/或地喹氯铵以及至少一种脂肪酸的均相甲醇溶液将丝状材料润湿，
随后将所述甲醇蒸发。
6.根据权利要求5所述的方法，所述甲醇溶液是通过甲醇与其它低级醇的混合物形成的。
7.根据权利要求6所述的方法，所述低级醇选自乙醇、丙醇和异丙醇。
CN2007101631720A 2006-10-25 2007-10-16 具有抗微生物表面的外科缝合材料以及在外科缝合材料上设置抗微生物涂层的方法 Expired - Fee Related CN101168071B (zh)

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DE102005048131A1 (de) * 2005-10-06 2007-04-12 Bayer Innovation Gmbh Antimikrobielle Kunststoffzusammensetzung mit niedriger Elutionsrate und langer Wirksamkeit

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CN114901069B (zh) * 2019-12-31 2023-10-20 3M创新有限公司 奥替尼啶盐抗微生物医疗制品

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ES2374840T3 (es) 2012-02-22
PL1964581T3 (pl) 2012-03-30
EP1964581A1 (de) 2008-09-03
US7829133B2 (en) 2010-11-09
US20080103526A1 (en) 2008-05-01
ATE531396T1 (de) 2011-11-15
PT1964581E (pt) 2012-01-12
US20110015673A1 (en) 2011-01-20
AU2007221974B2 (en) 2010-07-22
ZA200709124B (en) 2008-12-31
DE102006051093B4 (de) 2011-03-17
DE102006051093A1 (de) 2008-05-08
EP1964581B1 (de) 2011-11-02
CN101168071B (zh) 2011-09-14
US8012173B2 (en) 2011-09-06
EP2359871A1 (de) 2011-08-24
JP2008104881A (ja) 2008-05-08
JP4996417B2 (ja) 2012-08-08
CA2604514A1 (en) 2008-04-25
AU2007221974A1 (en) 2008-05-15
BRPI0704047B1 (pt) 2018-04-03
DK1964581T3 (da) 2012-02-06

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