CN102177016B - 抗微生物纤维和相关制品与方法 - Google Patents

抗微生物纤维和相关制品与方法 Download PDF

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CN102177016B
CN102177016B CN200980140146.3A CN200980140146A CN102177016B CN 102177016 B CN102177016 B CN 102177016B CN 200980140146 A CN200980140146 A CN 200980140146A CN 102177016 B CN102177016 B CN 102177016B
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antimicrobial
fiber
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wound dressing
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CN102177016A (zh
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E·D·芬克
R·F·维塔里斯
C·B·沙
S·A·马利根
B·多德
S·奥尔
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Covidien LP
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    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/204—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with nitrogen-containing functional groups, e.g. aminoxides, nitriles, guanidines
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
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    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings
    • A61L2300/608—Coatings having two or more layers
    • A61L2300/61—Coatings having two or more layers containing two or more active agents in different layers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
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Abstract

公开了一种抗微生物纤维，它包括：里层和外层；其中里层和外层包括至少一个下述特征：(I)里层和外层包括不同浓度或不同释放速度的至少一种抗微生物剂；和(II)里层和外层包括不同的抗微生物剂。替代的抗微生物纤维包括与可溶解物质配混或组合的抗微生物剂，以便促进抗微生物剂的释放或结合。还公开了相关制品。

Description

抗微生物纤维和相关制品与方法
发明领域
本发明涉及抗微生物纤维，含所述纤维的制品，和相关方法。
发明背景
在本说明书中当其中提到或讨论文献、学位论文(act)或知识信息(itemofknowledge)时，这一种提到或讨论不是承认该文献、学位论文或知识信息或其任何结合在优先权日时，公众可获知，公众公知，是普通技术知识的一部分，或者在其他情况下，根据合适的法律规定，构成现有技术；或者已知与尝试解决本说明书所涉及的任何问题有关。
提出了各种抗微生物组合物，制品和方法。然而，这种组合物、制品和方法在抗微生物效率方面具有各种缺陷和缺点。
本领域仍需要在减少和/或防止形成不想要的微生物有机物方面的有效性增加，安全并提供伤口护理控制效率改进和成本低廉的组合物、制品和方法。
尽管讨论了常规技术的一些方面以有助于理解本发明的公开内容，但申请人决不放弃保护这些技术方面，且认为要求保护的发明可包括此处讨论的一个或更多个常规技术性方面。
定义
除非另有说明，此处所使用的术语“微生物有机物”或“微生物”用于指代微小的有机物，其中包括真菌，细菌和/或病毒有机物。因此，此处所使用的术语“抗微生物剂”是指杀灭或在其他情况下抑制这种真菌、细菌和/或病毒有机物生长的组合物或试剂。
发明概述
本发明可解决以上讨论的现有技术中的一个或更多个问题和缺陷。然而，认为本发明可证明可用于解决其他问题和缺陷，或者在许多技术领域中提供优势和优点。因此，要求保护的发明不应当必然解释为限制到解决此处讨论的任何特定问题或缺陷上。
本发明可任选地具有一个或更多个以下的优势或优点：(i)为了例如创伤敷料更加协同的效果，调节单一或组合的抗微生物剂的效率；(ii)在单一敷料中使用多种抗微生物剂，提供较长的磨耗时间和增加的微生物对数下降。
本发明也可任选地具有一个或更多个下述特征、优势和/或优点：(i)抗微生物敷料，其中可基于特定的应用/需求，调节抗微生物剂的用量和释放曲线；(ii)可程序化或可调节的抗微生物敷料，它允许临床医师根据伤口或环境或微生物条件，选择合适的处理强度特征。
根据一个方面，本发明提供抗微生物纤维，它包括：里层和外层；其中里层和外层包括至少一个下述特征：(I)里层和外层包括不同浓度或不同释放速度的至少一种抗微生物剂；和(II)里层和外层包括不同的抗微生物剂。
根据进一步的方面，本发明提供抗微生物纤维，它包括与可溶解的物质配混或组合的抗微生物剂，以促进释放或粘结抗微生物剂。
根据另一方面，本发明提供一种制品，它包括多种抗微生物纤维，其中该制品包括纤维密度梯度或孔度梯度，从而提供具有抗微生物剂浓度梯度的制品。
根据额外的方面，本发明提供一种制品，它包括多种抗微生物纤维，其中该制品包括均一纤维密度的纤维的均匀共混物，其中纤维的第一部分具有第一抗微生物剂浓度水平或第一抗微生物剂洗脱速度，和其中纤维的第二部分具有第二抗微生物剂浓度或第二抗微生物剂洗脱速度。
附图简述
图1是本发明纤维的截面视图。
图2是根据本发明替代实施方案构造的纤维的截面视图。
图3是根据本发明进一步的替代实施方案构造的纤维的截面视图。
详细说明
根据本发明，用一种或更多种抗微生物剂处理一种或更多种纤维。任何合适的抗微生物剂可用于这一目的。这些试剂包括，但不限于，下述的一种或更多种：聚合的双胍，例如PHMB和PEHMB；金属，例如银、金、铜或锌；和季铵化合物(例如，葡萄糖酸洗必太)。而且，可使用任何合适的纤维。这些纤维可以是天然、合成或半合成的。纤维可由其形成的合适的材料包括，但不限于，纤维素，乙酸纤维素，氧化纤维素，藻酸盐(酯)，棉，聚丙烯，聚乙烯醇，人造丝，芳族聚酰胺纤维，尼龙，丙烯酸类，聚酯，PTFE，Kevlar，壳聚糖，聚氨酯，PGA，胶原，聚(对苯二甲酸乙二酯)(PET)，水凝胶，水性胶体，可降解的聚合物材料(例如，PLA，PGA，PLGA，PLLA，PCL，和氨基酸基聚酯酰胺共聚物)及其组合。
由于各种原因，尤其与一种或更多种特定的抗微生物剂的相容性，可选择所使用的纤维类型。例如，在各种浓度下，纤维素或人造丝纤维有效地粘结PHMB。一些纤维，例如尼龙或聚酯可与银抗微生物剂配混。
可通过任何合适的技术，组合抗微生物剂与纤维。因此，例如，可用含合适抗微生物剂的溶液涂布纤维或在其内浸渍纤维。或者，可在本体材料，例如纤维可由其形成的树脂内包含抗微生物剂。基础树脂和抗微生物剂的组合的浓度可程序设计，以便调节抗微生物效率适合最终产品的需求。
根据一个任选的实施方案，抗微生物剂以粉末形式与纤维缔合(associatedwith)。粉末的粒度可以变化，从而提供所需的表面积，并进而用作控制抗微生物剂释放速度的措施。这一作用的实例是，各种粒度的抗微生物剂组合到基础纤维树脂(它可以是亲水的)内。然后将该材料纺丝成纤维，其中当与湿气接触时，抗微生物剂变得具有活性。变化的粒度和所得表面积将提供抗微生物剂的动态获得。大的颗粒将在较长的时间段内供应抗微生物剂，而小的颗粒可提供抗微生物剂的更加快速的释放。
在进一步的替代实施方案中，抗微生物剂可与可溶解的物质配混或组合，以便可溶解物质的溶解起到促进抗微生物剂释放的作用。因此，可通过选择可溶解物质及其溶解速度，程序设计或调节抗微生物剂的释放速度(或其缺乏)。任何合适的可溶解物质可用于这一目的。非限定性实例包括，水凝胶，淀粉膜(或粉末)；和磷酸盐玻璃。这一作用的例举实例是使用含离子银的磷酸盐玻璃颗粒。磷酸盐玻璃与湿气接触时溶解，可通过改变磷酸盐玻璃的成分，调节溶解速度。此外，可改变与玻璃混合的离子银的用量，以视需要提供较高浓度的抗微生物剂。这些可溶解玻璃和离子银的变化的组合的结果可以是银从纤维中程序释放，所述程序释放可包括大的起始释放速度，接着在长的时间段内，比较缓慢的释放速度。最终应用可决定组合技术的最佳使用。其他实例可包括使用具有与磷酸盐玻璃类似的动态效果的水凝胶。当附着或组合到纤维上时，不同吸收特征的水凝胶可与变化程度的抗微生物剂组合使用，以提供所需的效率。
可将螯合剂，例如EDTA任选地加入到纤维中，以提高所有试剂的抗微生物效率。可通过前面所述的任何合适的方式，组合螯合剂与纤维和/或其他试剂。因此，例如螯合剂可与以上所述类型的合适的可溶解物质缔合，以提供所需的释放或组合机理。
本发明的抗微生物纤维可任选地提供有亲水或疏水性能。可通过由亲水或疏水材料形成纤维，或者通过处理纤维的基础材料，以便提供其亲水或疏水行为，从而提供这些性能。在纤维内亲水性能的实例可以是使用亲水树脂，例如，但不限于，当与流体接触时，吸收湿气的尼龙。尼龙纤维基础树脂可与亲水抗微生物技术，例如具有离子银的磷酸盐玻璃组合，以便当以纤维形式纺丝时，实现所需的抗微生物效果。相反，疏水材料，例如聚丙烯可以纺丝成纤维形式，并用抗微生物剂，例如PHMB涂布或处理，使得PHMB全部可获得作为抗微生物剂供快速作用。可预见，组合这两种疏水和亲水纤维将在宽范围的许多应用中实现协同的抗微生物效率。
如图1所示，根据本发明一些方面形成的纤维10可以是双组分或共挤出的结构，以便外层(鞘)12在里层或芯14上形成。这种结构提供许多不同的可能性。例如，外层或片材12可含有非常高含量的抗微生物剂(例如最多70wt％)，和内芯14可含有较低百分数的抗微生物剂(例如小于20wt％)，以维持纤维的完整度。可使用前面所述的任何合适的抗微生物剂。而且，根据进一步的替代实施方案，外层12和里层14可含有不同的抗微生物剂和/或螯合剂。例如，外层可含有高浓度的以上所述的快速释放的抗微生物剂，而里层可具有较低释放曲线，以提供较长期的效率。还将预见也可改变纤维材料，以便内芯可由亲水尼龙纺丝和外部芯由亲水性较低的聚酯纺丝。再者，添加改变含量的抗微生物剂也可提高纤维组合性能的效率。
如图2进一步所示，根据进一步的实施方案，纤维10可提供有在芯或里层上形成的多个层或鞘。因此，例如，可提供一个或更多个额外的层或鞘13。如上所述，芯或里层14和多层额外层或鞘12，13可含有不同浓度的共同的抗微生物剂和/或含有不同的抗微生物剂。
根据本发明形成的纤维不限于图1和2所示的截面几何结构。本发明的纤维可具有任何合适的几何结构。因此，如图3所示，本发明的纤维20可具有方形(quad)，或一个具有沟槽，进一步增加与伤口流体接触的纤维的表面积。纤维20可进一步含有在中心芯24上的另外的两层22，23，其中程序设计每一层，以预定的抗微生物剂释放方式或纤维完整度起作用。因此，例如芯24和多个额外层或鞘22，23可含有不同浓度的共同的抗微生物剂和/或含有不同的抗微生物剂。
可由以上所述的纤维形成许多不同的制品和伤口处理方法，或者采用以上所述的纤维来实践。也通过本发明来理解这种制品与方法。
因此，可由抗微生物处理的天然与合成纤维的组合形成制品，例如创伤敷料，且可构造为处理过的纤维的均匀共混物形式。可改变处理过的合成纤维相对于处理过的天然纤维的百分数，以适合最终用途。所选纤维可以是可吸收或不可吸收的。敷料可提供有均匀的纤维密度或密度梯度，以便较高浓度的抗微生物剂可以布置在与伤口表面相邻的位置。
根据进一步的实施方案，本发明包括可程序释放抗微生物剂的制品，例如创伤敷料。可由用合适的抗微生物剂，例如聚合的双胍(例如PHMB和/或PEHMB)处理过的不同材料制造敷料。该材料由于具有织物/材料或结构导致具有不同浓度的抗微生物剂或释放不同水平的抗微生物剂。可在敷料的不同层内改变抗微生物剂浓度，以便一层或更多层具有比其他层高得多的浓度；实例可以是具有高浓度抗微生物剂，例如PHMB的中心层，以便更加有效地控制与被吸收的伤口渗出物(流体)缔合的高水平的微生物。可由各种纤维，例如前面所述的那些制造处理过的织物。织物可以是各种不同的结构：织造、非织造、编织、毡缩或编结或为垫子形式。该材料可提供密度梯度或控制的孔度，以促进垂直或水平芯吸。可提供具有不同释放速度和/或组合的抗微生物曲线的宽范围的平台或层。
此外，公开了纤维制品，例如创伤敷料，其中纤维是亲水的且用抗微生物剂处理或者含有抗微生物剂。所述纤维创伤敷料含有任意取向的宽范围的纤维丹尼尔，以产生递增丹尼尔梯度或者均匀混合物。较小丹尼尔的纤维产生较大量的纤维表面积，所以与较大丹尼尔的纤维相比，它们将更加快速地释放抗微生物剂或者含有抗微生物剂(假设洗脱恒定和纤维共混物恒定)。该特征还提供抗微生物剂的持续释放。纤维也可以是疏水的，以便伤口渗出物将容易穿过敷料结构，被所选抗微生物剂(或其组合)处理并分散到创伤敷料外。
还将预见可由具有不同丹尼尔，不同材料和不同抗微生物剂的不同纤维的共混物形成各种制品，例如纤维创伤敷料。例如，敷料可含有聚合的双胍，例如PHMB，其以许多可能的方式与金属抗微生物剂，例如银组合。PHMB的抗微生物效果比较快速，而银比较持久。加入到基础纤维材料内的银含量范围可以是0.5-40wt％，这取决于在产品内所需的银离子洗脱水平。PHMB的浓度可从500ppm(0.05％)变化到100,000(10％)ppm重量。
根据本发明的制品，例如创伤敷料可由此处所述类型的多种(assortment)双组分纤维组成，其中外鞘含有抗微生物剂，可溶解，且含创伤敷料的纤维具有不同的溶解速度。类似地，所公开的敷料可由一系列(anarrayof)双组分纤维组成，其中内芯含有在鞘溶解之后释放的抗微生物剂。在双组分复合物内使用的不同材料中的抗微生物剂水平可以不同，以便理想或程序释放的试剂存在于每一组分内。例如，纤维中的外鞘可由与抗微生物剂共混的更加亲水的聚合物组成，这将允许所述抗微生物剂试剂更加可控地释放。为了纤维更好的完整度，内芯可以是具有较大强度的材料。可调节纤维的组合，以便实现各种抗微生物剂的程序设计的效率。例如，一种试剂可在起始阶段内具有活性，而另一试剂在随后较长的时间段内具有活性。
制品，例如创伤敷料当然可包括额外的活性成分或试剂，例如治疗剂、特殊感觉剂(organolepticagent)，生长因子，止痛药，组织支架剂、止血剂、蛋白质抑制剂，胶原，酶，抗血栓剂，麻醉药，消炎药，抗癌剂，血管舒张物质，伤口愈合剂，血管生成剂，血管抑制(angiostatic)剂，免疫促进剂，皮肤封闭剂，诱导定向细菌生长的试剂，赋予杀菌或抑菌活性的试剂，使微生物的新陈代谢作用和/或生物膜形成去稳定或破坏的电子转移试剂，其组合和类似物。可通过各种方式，例如电场或信号、温度、时间、压力、湿度、光(例如，紫外光)、超声能、超声、其组合和类似方式，触发活性试剂的释放。
在本说明书中所使用的表达各成分、组成、反应条件等等用量的任何数值应当理解为在所有情况下用术语“约”修饰。尽管列出了数值范围和参数，但此处列出的主题的宽范围是近似值，所列出的数值尽可能精确地表示。然而，任何数值可固有地包含一定的误差，这根据它们各自的测量技术中发现的标准偏差看出。此处引证的特征无一应当解释为援引35U.S.C.§112，6，除非明确地使用术语“方式(means)”。
尽管结合本发明的优选实施方案描述了本发明，但本领域的技术人员要理解，可在没有脱离本发明的精神和范围的情况下，做出没有具体地描述的增加，删除，改性和替代。

Claims (3)

1.一种创伤敷料，它包括多种抗微生物纤维，其中该多种抗微生物纤维限定创伤敷料表面的纤维丹尼尔梯度沿敷料的厚度增加，并且其中该纤维丹尼尔梯度导致创伤敷料呈现沿创伤敷料厚度的抗微生物浓度梯度。
2.权利要求1的创伤敷料，其中抗微生物浓度梯度包含在待施加到伤口的创伤敷料的表面相邻的位置的最高的抗微生物剂浓度。
3.权利要求1的创伤敷料，其中多种抗微生物纤维包括至少下述一种：包含不同纤维丹尼尔的纤维、包含不同基础纤维材料的纤维、包含不同抗微生物剂的纤维、或呈现不同抗微生物剂洗脱速度的纤维。
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