CN102458327A - 具有高液体处理能力的伤口敷料 - Google Patents

具有高液体处理能力的伤口敷料 Download PDF

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Publication number
CN102458327A
CN102458327A CN2010800263609A CN201080026360A CN102458327A CN 102458327 A CN102458327 A CN 102458327A CN 2010800263609 A CN2010800263609 A CN 2010800263609A CN 201080026360 A CN201080026360 A CN 201080026360A CN 102458327 A CN102458327 A CN 102458327A
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liquid
layer
wound
wound dressing
dressing
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CN102458327B (zh
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安-布里特·杰尔格利
本特·涅茨纳
安德斯·达尔贝里
伊娃-卡琳·道恩
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Molnycke Health Care AB
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Molnycke Health Care AB
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Abstract

本发明涉及具有伤口垫片(2)和透气材料层(8)的伤口敷料(1)，所述透气材料层布置在伤口垫片(2)顶上并沿外周延伸在伤口垫片(2)外，而且透气层(8)的至少沿外周延伸在伤口垫片外的部分涂有粘附剂(4)。根据本发明，伤口垫片包括液体截留和液体输送层(6)，以及分别保持抵靠在液体截留和液体输送层(6)的顶部和下方的上分配层(7)和下分配层(5)。

Description

具有高液体处理能力的伤口敷料
技术领域
本发明涉及具有伤口垫片的伤口敷料，其包括：液体输送第一层；布置在第一层上的液体截留和液体输送第二层，布置在第一层与第二层之间的分配层，以及布置在第二层顶上并沿外周延伸在伤口垫片外的透气材料层，其中至少透气层沿外周延伸在伤口垫片外的部分涂有粘附剂。
背景技术
这种敷料已知形式有瑞典Gothenburg
Figure BDA0000119911480000011
Health CareAB售卖的Mepilex
Figure BDA0000119911480000012
这种敷料的一大优点是由于它控制来自伤口的液体的方式，它可以相当长时间地保持在伤口上而无需更换。就液体处理而言，该敷料在泄漏之前不需要更换。公知的是更换敷料趋于破坏伤口痊愈，这意味着敷料需要更换越少则越好。当然，减少更换敷料还意味着护理人员的工作减轻以及成本下降。
本发明的目的是提高这种敷料处理伤口液体的能力，以使它能够更长时间地保持在伤口上或能够在相同时间段处理更多液体。
发明内容
该目的通过具有伤口垫片和透气材料层的伤口敷料来实现，其中透气材料层布置在伤口垫片顶上并沿外周延伸在伤口垫片外，而且透气层的至少沿外周延伸在伤口垫片外的部分涂有粘附剂，所述伤口敷料的特征在于伤口垫片包括液体截留和液体输送层，以及分别保持抵靠在液体截留和液体输送层的顶部和下方的上分配层和下分配层。上分配层增加通过蒸发离开敷料的液体量，并因此增加敷料能够处理的液体量。根据本发明的敷料可以比所述已知敷料更长时间地保持在伤口上而不必更换，或者它能够在已知敷料意欲保持在伤口上的相同时间段处理更多液体。
根据第一优选实施方案，伤口垫片包括液体输送第一层，其布置在下分配层下并且抵靠在其上。伤口垫片的这些层优选彼此粘附连接或机械连接，而且透气材料层粘附连接到伤口垫片。伤口垫片的这些层可以在热和压力辅助下或在超声波辅助下彼此连接。这确保敷料内部的毛细作用力和润湿力具有预定效果。
而且，液体截留和液体输送第二层由包含粉末、纤维或其它形式的亲水性或亲水化吸收性纤维和高吸收性材料的混合物的一层或多个层构成。粘合纤维可以混入液体截留和液体输送第二层中。由此可以在该层的液体输送和截留之间实现期望的适当平衡。
这种情况下液体截留和液体输送层有利地具有不同尺寸的毛细管，其中与第二分配层接触的毛细管小于液体截留和液体输送第二层的其它区域中的毛细管。而且，就高吸收性材料在吸收性纤维和高吸收性材料的混合物中的比例而言，在液体截留和液体输送层的上部中的比例大于在其下部中的比例。
分配层之一或者这两个分配层可以与液体截留和液体输送层构成整体。
在一种变化方案中，液体截留和液体输送第二层可以由聚合物泡沫混合或不混合高吸收性材料的情况下构成。
液体输送第一层有利地可以由聚合物泡沫构成。
分配层可以由纸、亲水性无纺材料或聚合物泡沫构成。
透气层优选由按照ASTM D6701测量的透气率大于2000g/m2/24小时的聚合物膜构成。
伤口垫片可以在其下方涂有粘附剂透液层，其中在液体输送第一层上的粘附剂涂层可以是非连续的并且由设置在穿孔支撑体上的硅氧烷粘附剂构成，所述涂层进而固定到伤口垫片的下方和透气膜沿外周延伸在伤口垫片外的部分。
附图说明
现在参照附图描述本发明，其中：
图1示出根据本发明的第一优选实施方案的伤口敷料的示意性截面图；和
图2示出根据本发明的第二优选实施方案的伤口敷料的类似图1的视图。
实施方案详述
图1示出了根据本发明的伤口敷料1的第一优选实施方案。敷料1包括伤口垫片2，伤口垫片2的下方涂有皮肤相容性粘附剂层4。术语“下方”指图1中伤口垫片2的下表面，其在敷料使用中最接近伤口。
要认识到，根据敷料将要施用到身体的位置，敷料可以置于使得图1所示的下方例如可以面朝上。术语“在......上”、“在......下”、“上”、“下”、“在......顶部”以及本说明书和权利要求书中所用表示位置的类似术语都指当敷料为图1所示状态时各部分相对于彼此的相对位置。
透气材料层8延伸在伤口垫片2的顶部并沿外周延伸在伤口垫片外。
在该优选实施方案中，层4由涂有硅氧烷粘附剂的穿孔聚氨酯层形式的支撑体构成，所述粘附剂涂覆在这些穿孔之间的区域上，而且该层4还延伸在层8沿外周延伸在伤口垫片2外的部分上。该穿孔支撑层优选胶合到伤口垫片2和覆层8上。
伤口垫片2包括液体输送第一层3，第一分配层5延伸在第一层3的顶面上。第一分配层5的顶部布置有液体截留和液体输送层6。最后，伤口垫片2具有布置在液体截留和液体输送层6顶面的第二分配层7。
分配层指厚度小于5mm，优选小于3mm的吸收性材料层，其能够将所吸收的液体在与厚度方向成直角的方向上进行分配。
如已提到的，透气聚合物膜覆层8延伸在第二分配层的顶面和层3-7的侧边缘上，它还延伸在这些层位于粘附剂层4所处平面的外周外。聚合物膜8至少在延伸在吸收层3-7的外周外的部分的下方涂有粘附剂；粘附剂如图1所示可以代表粘附剂层4的继续或部分。
本发明敷料1的粘附剂层4具有两种作用。第一，用于防止伤口垫片2变成缠在伤口中；第二，用于确保敷料牢固地保持在皮肤上。而且，当然必须允许伤口垫片吸收伤口的液体。因此，粘附剂涂层4必须是液体可渗透的，为此通过存在穿孔图案将其不连续地布置。
另一种可能性是应用本身液体可渗透的粘附剂涂层，或者如果伤口垫片2几乎不会趋于变成缠在伤口中，则在伤口垫片2的下方不设置粘附剂涂层。但是，覆层8的下方至少在沿外周延伸在伤口垫片外的部分必须总是设置有粘附剂涂层。
当然例如如果用于将敷料固定在皮肤上的粘附剂趋于变成缠在伤口中，还可以在伤口垫片2与伤口区之间布置几乎不会趋于变成缠在伤口中的聚合物材料的网或穿孔膜，或例如双组分纤维层。
粘附剂涂层4可以由已知用于伤口敷料的任何皮肤相容性粘附剂构成。但是，优选皮肤相容性软粘附剂如聚丙烯酸酯类或硅氧烷粘附剂。软粘附剂的一大优点是它们能正常从皮肤上移除而不损伤皮肤。硅氧烷粘附剂特别优选，因为它还具有对皮肤的粘附不会随时间发生可感觉到的增加的性质，这对于设计用于长时间(如若干天)保持在伤口上的敷料特别有利。加成-固化RTV(室温固化)的硅氧烷体系在混合后交联并形成自粘附弹性体，它们是合适粘附剂的例子。EP0300620A1给出了这种硅氧烷体系的例子。
Wacker SilGel 612是可从德国慕尼黑Wacker-Chemie GmbH商购的RTV硅氧烷体系。通过改变该体系中所包含的两种组分之间的比例，可以改变所形成弹性体的柔软度和粘附水平。该硅氧烷体系特别适用于粘附剂涂层4。
软硅氧烷弹性体的其它例子是美国Carpintieria，NusilTechnology和美国Midland，Dow Corning Corporation的NusilMED-6340、Nusil MED3-6300、Nusil MED12-6300。
类似美国NJ，Bridgewater，National Starch and ChemicalCompany的
Figure BDA0000119911480000041
70-4647的热熔粘附剂也可以使用。
液体输送材料的第一层3的作用是尽可能快地吸取伤口的多余液体。为此它应位于伤口区附近，这意味着粘附剂层4应该薄。
有利地，层3可以由吸收性泡沫材料构成，如聚氨酯泡沫(例如参见US6,051,747)。泡沫材料以外的吸收性材料也可以使用，例如基于纤维素纤维或其它吸收性纤维的纤维材料。
第一分配层5用于排走从层3吸收的液体，为此具有比层3中的毛细管小的毛细管。这意味着当敷料在使用中按图1所示放置时，并且在所吸收的液体已到达层3的顶面后，液体在第一层3中的流动基本垂直。这进而降低了层3中所吸收的液体从层3的下边缘流出至侧面和塑料膜8下的风险，这也意味着伤口渗出物损伤新生皮肤的风险降至对应程度。
第一分配层5的另一目的是确保从层3吸收的液体横向分配。由于薄分配层5中的毛细管主要都是水平的，并且小于层3中的毛细管，因此液体在该层中沿横向输送的程度大于在吸收性材料的第一层3中。
分配层5优选由包含亲水性或亲水化纤维的纤维基材料构成，例如由纸浆纤维或纤维素基纤维如人造丝或其它吸收性纤维如棉纤维组成或包含它们的纸或无纺材料。在这种材料中，许多毛细管都水平延伸。可构想其它材料也可以用作分配层，例如纺织或编织的织物材料。用于分配层5的合适材料的例子是芬兰Tampere，Suominen Corp.的Fibrella 2000，其单位面积的重量为30至50g/m2。还可构想使用薄聚合物泡沫材料作为分配层。
液体截留和液体输送层6一方面必须具有高的截留能力，即必须确保在存在外压的情况下从伤口吸收的液体不会从敷料返回伤口区；另一方面必须能够将液体从第一分配层输送到第二分配层。由于存在第一分配层5，层6的大表面区域快速接触所吸收的液体，为此层6的大部分将参与将所吸收的液体输送到层6的顶面并由此到第二分配层7。因此，液体从第一分配层5至液体截留和液体输送层6的输送将在第一分配层5开始从底下层3吸取液体之后立即发生。在所示实施方案中，液体截留和液体输送层6具有比液体输送层3中小的毛细管。由此层6中毛细管的吸取力大于层3中毛细管的吸取力，这意味着是层6而不是层3首先从第一分配层5吸取液体。
在优选实施方案中，液体截留和液体输送层6由呈粉末形式、纤维形式或其它形式的纤维和高吸收性材料如聚丙烯酸酯类的混合物构成。纤维可以由如下组成：亲水性或亲水化吸收性纤维如粘胶纤维、棉纤维等，和粘合纤维如热塑性材料(如聚酯)的合成纤维。在这种混合物中，吸收性纤维起到液体输送的作用，高吸收性材料起到在压力作用下增加液体截留能力的作用。通过适当混合，可以在截留能力与输送能力要求之间达到最佳平衡。而且，液体截留和液体输送层6可以由两层或更多层纤维和高吸收性材料的不同混合物构成。例如，液体截留和液体输送层可以由三个这样的层构成，其中高吸收性材料的比例在中间层最大。高吸收性材料在吸收性纤维和高吸收性材料的混合物中的比例适当为5至60wt％。
液体截留和液体输送层6也可以由与底下层3相同的材料在与高吸收性颗粒混合或不混合的情况下构成。不是聚氨酯的泡沫材料也可用于层3和6。
液体截留和液体输送层6中所吸收的液体一到达该层的顶面，第二分配层7就从液体截留和液体输送层6吸取液体。为加速液体输送到液体截留和液体输送层6的顶面，该层中的毛细管可以具有其中尺寸沿向上方向减小的尺寸梯度。
第二分配层7可以由与第一分配层5相同的材料构成。合适材料的例子是Fibrella 2000。
已吸收在分配层7中的液体将通过透气聚合物膜8蒸发。已发现蒸发速率即通过透气膜输送的蒸气量随该膜下方区域以及当液体接触膜下侧时的液体浓度增加。通过提供分配层7，该膜下方的区域达到最高可能的液体浓度，同时分配层确保尽可能大的表面积具有高浓度液体。为确保分配层7尽可能快速达到饱和，分配层7优选具有非常小的毛细管并有利地薄。
要提到的是，尽管液体输送以上述方式进行，但底下层不是全空没有液体，而是为伤口区提供湿环境，这对于痊愈有利。
对于液体从伤口区至第二分配层7发生期望输送重要的是伤口垫片的各层彼此良好接触，并且透气层8与第二分配层7良好接触。为此，层3优选通过薄胶层例如具有10g/m2单位面积重量的粘附剂涂层固定到第一分配层5。层6在第一分配层5和/或第二分配层7上气流成网(air-laid)，并且由此通过机械粘合与所述层/多个层良好接触。可以通过缠绕或针刺进一步增加层5和6、6和7、或5、6和7之间的接触。例如如果层6由泡沫材料制成，还可以在粘附剂、热和压力或超声波的辅助下确保良好接触。第二分配层7优选借助粘附剂薄层固定到层6和膜8上。
用于实现纤维材料分配层5、7与液体截留和液体输送层6之间良好接触的方法是其中在该层的气流成网过程中，首先将待形成分配层5或7的纤维薄层气流成网，随后将形成层6的各种纤维气流成网，接着对待形成分配层7或5的纤维薄层完成气流成网，随后例如在热和压力的辅助下将各层5、6和7粘合在一起以形成整体单元的方法。当然，可构想采用该方法将仅一个分配层与层6构成整体。
为确保液体不会从层3-7的侧边缘漏出并向下流而可能流回到伤口区，有利地膜可以紧密固定到这些边缘。膜8是透气的事实还允许在膜沿外周延伸在吸收材料层3-7的边缘外的那部分下的皮肤水分蒸发，这自然是在粘附剂涂层4在该区域也是透气的条件下进行。为更容易将聚合物膜8固定到层3-7上，可以利用真空成形赋予其与这些层的形状相对应的三维形状。即使该膜不是粘附固定到层3-7的边缘，这种预成型也是有利的。
另一防止泄漏的方式是将边缘熔接到伤口垫片2上。聚合物膜8可以由聚乙烯、聚酯、聚四氟乙烯或聚氨酯膜构成，该膜是微孔的或以某种其它方式制成透气的。透气膜表示该塑料膜在正常条件下允许气体通过，但不允许液体通过。聚合物膜8的透气率(WVTR：水气传送速率)按照ASTM D6701测量必须大于2000g/m2/24小时。聚合物膜优选由单片膜构成，即该膜接触液体时透气率显著增加的膜。这种膜的例子是德国Bomlitz EpurexsFilms GmbH&Co KG的2202。
根据本发明的敷料用于保持在伤口上若干天而不必更换。伤口由此能够在一段长时间内没有中断地痊愈，这有助于痊愈过程。决定敷料可以在流出液体的伤口上保持多长时间的关键因素在于敷料的液体处理能力。液体处理能力指敷料在停止作用即不能再吸收伤口所释放的伤口流出物(泄漏发生即表明此)之前能够从伤口吸取的液体量。因此液体处理能力取决于敷料可以贮存的液体量和蒸发的液体量。虽然可以贮存的最高液体量与时间无关，但蒸发的液体量是时间相关的，并且代表意在长时间使用的敷料的重要参数。通过在液体截留和液体输送层与聚合物膜之间布置第二分配层，液体截留和液体输送层所吸收的液体一到达后者的顶面，蒸发就在大表面积上最高程度地进行。而且，分配层的毛细管中的毛细作用如此大以致于当液体截留和液体输送层6吸收的液体接触第二分配层7的毛细管时，液体在该层中的输送速度上升。总之，这意味着与膜直接布置抵靠在液体截留和液体输送层上而没有中间分配层相比，在膜7下更早出现湿表面。因此，本发明意味着由于该最大蒸发时间段通过在聚合物膜与液体截留和液体输送层之间提供分配层而显著增加，由此敷料在设定的时间段能够处理的液体量也增加，因此聚合物膜8的透气性能够以比以前更好的方式加以利用。对于设计用于长时间保持在伤口上的敷料而言，蒸发参数非常重要。
而且，第一分配层5具有更快速排干下层3的作用，以致于所吸收的液体快速到达层6并可通过所述层的表面而被吸取。这意味着所吸收的液体快速到达上分配层。
图2示出根据本发明第二实施方案的敷料1’。敷料1’中与根据图1的敷料1中的类似部分相对应的部分已给出为加有单引号的相同附图标记。伤口垫片2’因此包括布置在两个分配层5’和7’之间的液体截留和液体输送层6’。伤口所释放的液体因此首先吸收在分配层5’中，并通过其表面扩展。由于该分配层薄且具有小毛细管，因此它快速变得饱和，分配层5’中所吸收的液体快速与液体输送层6’接触，后者将液体向上输送到第二分配层7’，由此液体通过透气膜8’蒸发。层6’中所吸收的一部分液体将贮存在任选存在的高吸收性颗粒中。当伤口垫片的贮存能力已用到极限时，即当层6’中的吸收性纤维和高吸收性材料充满液体时，如果单位时间能够蒸发的液体量大于或等于伤口区释放的液体量，则敷料能够继续发挥作用。
所述实施方案可以在不偏离本发明范围下修改。例如，各层可以具有不同的表面积，如上层可以具有比下层小的表面积。而且，伤口垫片中的层可以具有与透气聚合物膜不同或相同的形状，如带圆角的矩形或方形、圆形、椭圆形等。如果伤口敷料的各层包含可熔接的组分，可以在热和压力的辅助下或在超声波辅助下通过熔接使它们彼此紧密接触。透气层可以由聚合物膜和无纺物，优选疏水性无纺物层合体构成。本发明的范围因此仅受所附权利要求的内容限制。

Claims (15)

1.伤口敷料(1；1’)，其具有伤口垫片(2；2’)和透气材料层(8；8’)，所述透气材料层(8；8’)布置在伤口垫片(2；2’)顶上并沿外周延伸在伤口垫片(2；2’)外，其中所述透气层(8；8’)的至少沿外周延伸在伤口垫片外的部分涂有粘附剂(4；4’)，所述伤口敷料的特征在于所述伤口垫片包括液体截留和液体输送层(6；6’)，以及分别抵靠在液体截留和液体输送层(6；6’)的顶部和下方的上分配层(7；7’)和下分配层(5；5’)。
2.根据权利要求1的伤口敷料(1)，其中伤口垫片(2)包括液体输送第一层(3)，其布置在所述分配层(5，7)的下分配层(5)下并且抵靠在其上。
3.根据权利要求1或2的伤口敷料，其中伤口垫片(2；2’)的这些层(3，5，6，7；5’，6’，7’)彼此粘附连接或机械连接，而且透气材料层(8；8’)粘附连接到伤口垫片(2；2’)上。
4.根据权利要求1的伤口敷料，其中伤口垫片的这些层在热和压力辅助下或在超声波辅助下彼此连接。
5.根据权利要求1至4中任一项的伤口敷料，其中液体截留和液体输送层(6；6’)由包含粉末形式、纤维形式或其它形式的亲水性或亲水化吸收性纤维和高吸收性材料的混合物的一层或多个层构成。
6.根据权利要求5的伤口敷料，其中粘合纤维混入液体截留和液体输送第二层(6；6’)中。
7.根据权利要求5的伤口敷料，其中液体截留和液体输送层(6；6’)具有不同尺寸的毛细管，其中与上分配层(7；7’)接触的毛细管小于液体截留和液体输送层(6；6’)的其它区域中的毛细管。
8.根据权利要求5至7中任一项的伤口敷料，其中就高吸收性材料在吸收性纤维和高吸收性材料的混合物中的比例而言，在液体截留和液体输送层(6；6’)的上部中的所述比例大于在其下部中的所述比例。
9.根据权利要求5至7中任一项的伤口敷料，其中所述分配层(5；7)之一或者这两个分配层与液体截留和液体输送层(6)构成整体。
10.根据权利要求1、2、3或4的伤口敷料，其中液体截留和液体输送层(6；6’)由聚合物泡沫混合或不混合高吸收性材料的情况下构成。
11.根据前述权利要求中任一项的伤口敷料，其中液体输送第一层(3)由聚合物泡沫构成。
12.根据前述权利要求中任一项的伤口敷料，其中所述分配层(5，7；5’，7’)的至少之一由纸、亲水性无纺材料或聚合物泡沫构成。
13.根据权利要求1至12中任一项的伤口敷料，其中透气层(8；8’)由按照ASTM D6701测量的透气率大于2000g/m2/24小时的聚合物膜构成。
14.根据权利要求1至13中任一项的伤口敷料，其中伤口垫片(2；2’)在其下方涂有粘附剂透液层(4；4’)。
15.根据权利要求14的伤口敷料，其中粘附剂涂层(4；4’)由设置在穿孔支撑体上的硅氧烷粘附剂构成，所述涂层进而固定到伤口垫片(2；2’)的下方和透气膜(8；8’)沿外周延伸在伤口垫片(2；2’)外的部分。
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WO2010147533A1 (en) 2010-12-23
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