CN1874806A - 原位创口清洁装置 - Google Patents

原位创口清洁装置 Download PDF

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CN1874806A
CN1874806A CNA2004800321011A CN200480032101A CN1874806A CN 1874806 A CN1874806 A CN 1874806A CN A2004800321011 A CNA2004800321011 A CN A2004800321011A CN 200480032101 A CN200480032101 A CN 200480032101A CN 1874806 A CN1874806 A CN 1874806A
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wound
fluid
exudate
burnisher
cleaning
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P·L·布洛特
B·格林纳
E·Y·哈特维尔
J·李-韦布
D·尼科利尼
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Smith and Nephew PLC
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Abstract

用于清洁创口的装置，其中来自连接到可适应创口敷料的储室的冲洗剂流体和来自敷料的创口渗出物借助于用于移动流体的设备循环通过流动路径，所述流动路径通过所述敷料和流体清洁工具并回到所述敷料，并且其中在使用中所述清洁工具安置在创口中。所述清洁工具(其可以是单相例如微过滤系统或多相例如透析系统)除去对创口愈合有害的物质，并且仍旧含有对促进创口愈合有益的物质的经过清洁的流体被返回创面。以及敷料和使用该装置的治疗方法。

Description

原位创口清洁装置
本发明涉及用于清洁创口的装置和医疗创口敷料，以及使用这种装置处理创口的方法。
本发明特别涉及能够容易地施用到各种创口特别是慢性创口上，以便从创口清洁对创口愈合有害的物质，同时保留特别是对创口愈合有益的物质的这种装置、创口敷料和方法。
在本发明之前，抽吸和/或冲洗装置是已知的并通常用于在创口治疗期间除去创口渗出物。在这种创口治疗的已知形式中，创口的排出物，特别是当在高渗出状态时，被排放到废物例如排放到收集袋中。
通过这种方式，对创口有害的物质被除去。但是，当实施这种治疗时，对促进创口愈合有益的物质，例如生长因子、细胞基质成分和其它创口渗出物的生理活性成分，离开了它们可能是潜在地最有益的位置也就是创面(wound bed)。
因此这种已知形式的创口敷料以及抽吸和/或冲洗治疗系统通常在创口敷料下产生这样的创口环境，这种创口环境可能造成失去身体自身组织愈合过程的最优性能和造成缓慢的愈合，和/或造成弱的新组织生长，所述弱的新组织生长不具有良好地粘附到创面以及从创面生长的强三维结构。这是明显的缺点，尤其是对于慢性创口。
因此，希望提供治疗系统，其
a)能够从创口渗出物除去对创口愈合有害的物质，同时
a)保持对促进创口愈合有益的物质与创面接触。
透析是系统地体外处理身体流体例如血液以从所述流体清除对身体有害物质的已知方法。通过与透析液接触除去这些物质是透析的主要目的，同时还保留例如血液、细胞和蛋白质的物质。通过透析膜其它可能具有额外正面治疗作用的物质可能从系统损失，透析膜对这些物质也是可透过的。再循环的身体流体中这些物质的平衡因此可能进一步被减少。
希望提供能够从创口渗出物除去对创口愈合有害的物质并且基本不稀释当与创面接触时对促进创口愈合有益的物质的治疗系统，并且这种治疗系统可以同时向创口连续提供和再循环这些物质。
处理身体流体的透析也是系统治疗，因为经处理的流体被返回进入体内。这与其中被处理的流体在体外例如创口循环的局部治疗相反。
透析还需要大量的身体流体例如血液或者透析液，因此相关的设备不太可能是便携式的。即使是在高度渗出的状态下，与内部身体系统相比慢性创口也产生相对少的待处理流体和相对少的准备保留在创口中和/或其环境中的对一些治疗方面有益的物质。
本发明的一个目标是
a)消除至少一些上述已知抽吸和/或冲洗治疗系统的缺点，和
b)提供治疗系统，该系统能
i)从创口渗出物除去对创口愈合有害的物质，同时
ii)保留当与创面接触时对促进创口愈合有益的物质。
本发明的另一个目标是
a)消除至少一些上述已知透析系统的缺点，和
b)提供治疗系统，该系统能从创口渗出物除去对创口愈合有害的物质，同时保留对促进创口愈合有益的物质与创面接触，
c)不系统地影响身体。
本发明的另外一个目标是
a)消除至少一些上述已知透析系统的缺点，和
b)提供治疗系统，该系统能从创口渗出物除去对创口愈合有害的物质，同时保留对促进创口愈合有益的物质与创面接触，和
c)是便携的。
创口下面和创口周围的组织的脉管供给以及所述组织中的循环通常是受损的。本发明的另一个目标是提供治疗系统，该系统保留并提供有益于扭转这种影响的治疗活性数量的物质同时除去有害物质，从而促进创口愈合。
因此，根据本发明的第一方面，提供用于清洁创口的装置，该装置包括
可适应的(conformable)创口敷料，该创口敷料具有能够在创口上形成相对流体不漏的密封或闭合的衬层和特征在于其还包括
a)用于从创口渗出物选择性的除去对创口愈合有害的物质的清洁工具(cleansing means)，该工具在使用中在衬层以下并且安置在下面的创口中和
b)用于移动液体通过清洁工具的移动设备，和
c)任选的用于排放所述清洁工具的排放工具。
术语‘用于排放所述清洁工具的排放工具，包括与所述清洁工具流体连接的任何排放工具(bleed means)。
对创口愈合有害的物质被所述清洁工具除去，并且经清洁的流体保留在创口中和/或被送回创口。
因此，流体以治疗活性数量保留潜在地对创口愈合有益的创口渗出物中的天然产生的物质。
本发明第一方面的清洁创口的装置是基于下面的原理：通过移动流体经过清洁工具，移动设备连续地使对创口愈合有害的物质和清洁工具发生相互的动态接触，而不是依靠这些物质的被动移动，例如通过流体中化学势梯度下的扩散。使用这种流体移动从创口渗出物除去有害物质能更加快速地发生。
对于不同类型的应用，存在本发明第一方面装置的各种实施方案，特别是包括下面详细描述的那些。不论它们可以是如何地不同，相信它们都可以被分类到下面的功能类型中，这些功能类型特征在于何种流体通过清洁工具：
1.‘单相系统’
在这种系统中，移动通过流体清洁工具的流体是任选与冲洗剂混合的创口渗出物。该流体进入、通过并流出清洁工具，例如衬层下的腔室，并回到创面。在将经过清洁的液体送回创面之前，对创口愈合有害的物质进入流体清洁工具并被流体清洁工具除去。
2.‘多相系统’
在这种系统中，创口渗出物保留在创口中并不大规模进入清洁工具。流体清洁工具通常包含含有第二清洁流体的腔室，所述第二清洁流体最通常是流体(透析液)相。后者通过可透过的整体模块(integer)与创口渗出物分开，所述可透过的整体模块通常例如是聚合物膜(film)、片或薄膜(membrane)。被流体移动设备移动通过流体清洁工具的流体是清洁流体和/或任选与冲洗剂混合的创口渗出物。
在单相和多相系统中，都可以合适的去设计并运行所述设备以移动流体通过创口或清洁工具从而作为‘循环系统’操作所述系统。
在这种系统中，相关流体只以一个方向一次或多次通过清洁工具。
或者，在合适的情况下所述系统可以以‘换向系统(reversingsystem)’形式提供。也就是说，相关流体至少一次是以相反方向通过清洁工具。
但是本发明第一方面的装置在不同应用类型中可以是既作为循环系统操作又作为换向系统操作的，其中相关流体至少一次以相同方向和以相反方向通过清洁工具。(参见后面的图2)。
所述清洁工具的类型可以确定运行本发明装置的适当设计模式。
如所希望的，所述清洁工具可以作为‘单一通过系统’进行操作，即相关流体只通过清洁工具一次。
或者，在合适的情况下所述清洁工具可以以‘多通过系统’的形式提供，其中相关流体通过清洁工具和/或创面数次。
可以看出这些参数的组合产生了本发明的一些主要实施方案。总结起来，这些实施方案是：
1.‘单相系统’
a)作为‘循环系统’，其中创口渗出物和任选的冲洗剂只以一个方向通过清洁工具一次或多次(这类系统的例子显示在后面的图2，4，8，9，11和15中。)，或
b)作为‘换向系统’，即创口渗出物和任选的冲洗剂以相反方向通过清洁工具至少一次。(这类系统的例子显示在后面的图1，2，3，6，7，10和14中。)
这种类型的清洁可以作为如下的系统进行操作
i)‘单一通过系统’，即相关流体只通过清洁工具一次，或
ii)作为‘多通过系统’，其中相关流体通过清洁工具和/或创面数次。
2.‘多相系统’
a)作为‘循环系统’，其中
(i)创口渗出物和任选的冲洗剂和/或
(ii)清洁流体
只以一个方向各自通过清洁工具一次或多次(这类系统的例子显示在后面的图12和13中。)，或
b)作为‘换向系统’，即
(i)创口渗出物和任选的冲洗剂和/或
(ii)清洁流体
各自至少一次以相反方向通过清洁工具。
这种类型的清洁可以作为如下的系统进行操作
i)‘单一通过系统’，即相关流体只通过清洁工具一次，或
ii)作为‘多通过系统’，其中相关流体通过清洁工具和/或创面数次。
在这种‘多相系统’中，在清洁流体和/或任选与冲洗剂混合的创口渗出物都移动的情况下，所述流动可以是同向流或逆向流，优选逆向流。
这种循环系统的例子显示在：
图12a和13中，其中渗出物是静止的而清洁流体只以一个方向通过清洁工具一次或多次，和
图12b，其中渗出物和任选的冲洗剂和清洁流体各自只以一个方向通过清洁工具一次或多次，在这里彼此是逆向流。
现在将描述本发明敷料的一般特征，然后描述与敷料内特定清洁工具有关的特定特征。
在用于清洁创口的本发明第一方面的装置的所有实施方案中，特别的优点是创口敷料符合其所施加在上面的身体部分的形状的趋势。
所述创口敷料包括具有面对创口的面的衬层，该面对创口的面能够在创口上形成相对流体不漏的密封或闭合。
术语‘相对流体不漏的密封或闭合’用在这里是指流体和微生物不可透过的并且允许正或负的高达50％atm更加常见地高达15％atm的压力施加到创口上的密封或闭合。术语‘流体’用作这里是包括，凝胶例如稠渗出物，液体例如水，和气体例如空气、氮气等。
所施加的衬层的形状可以是适合于在整个创口面积上抽吸、冲洗和/或清洁创口的任意形状。
其例子包括基本平坦的膜、片或薄膜，或能容纳所需流体的袋、室、囊或衬层的其它结构，例如聚合物膜衬层。
所述衬层可以是膜、片或薄膜，通常厚度(一般是均匀的)最高达100微米，优选最高50微米，更优选最高25微米，并且最小厚度是10微米。
它的最大横跨尺寸可以高达500mm(例如对于大的躯干创口)，高达100mm(例如对于腋下和腹股沟创口)和对于四肢创口高达200mm(例如对于慢性创口，例如静脉腿部溃疡和糖尿病足部溃疡。
理想地，所述敷料是弹性可变形的，因为这可以增加患者舒适度和减少创口发炎的危险。
用于所述创口敷料的合适材料包括不吸收含水流体的合成聚合物材料，例如
聚烯烃，例如聚乙烯例如高密度聚乙烯，聚丙烯，它们的共聚物，例如与醋酸乙烯酯和聚乙烯醇的共聚物，以及它们的混合物；
聚硅氧烷；
聚酯，例如聚碳酸酯；
聚酰胺，例如6-6和6-10，和
疏水聚氨酯。
它们可以是亲水的，因此也包括亲水聚氨酯。
它们也包括热塑性弹性体和弹性体共混物，例如共聚物，例如乙烯醋酸乙烯酯共聚物，任选或按照需要与高抗冲聚苯乙烯共混。
它们进一步包括弹性体聚氨酯，特别是通过溶液流铸形成的聚氨酯。
用于本发明创口敷料的优选材料包括热塑性弹性体和可固化体系。
所述衬层能够在创口上面和/或在入口管和出口管周围形成相对流体不漏的密封或闭合。
但是，特别是在创口敷料边缘的周围，在相对流体不漏的密封以外，优选是具有高水蒸汽透过性的材料，来防止创口周围皮肤的浸软(maceration)。其也可以是当与液体例如水、血液或创口渗出物接触时具有更高的水蒸气透过性的可变换(switchable)的材料。这可以是例如用于Smith&Nephew’s AllevynTM、IV3000TM和OpSiteTM敷料中的材料。
衬层面对创口的面的边缘例如可以带有胶粘剂膜，用于将衬层粘合到创口周围的皮肤上。
这可以是例如压敏胶粘剂，如果这足以将创口敷料保持在位置上并且创口敷料面对创口的面边缘周围处于流体不漏的密封。
可选择的或额外的，在适当的情况下可以使用光可变换胶粘剂以保证敷料在位置上来防止泄漏。(光可变换胶粘剂是其附着力被光固化降低的胶粘剂。它的使用对于减少除去敷料时的损伤是有益的。)
因此，所述衬层可以具有在衬层靠近身体一面的周围延伸的凸缘(flange)或缘边(lip)，所述边缘或缘边是透明或半透明材料的(对于这种材料，可以理解上述列出的材料处于合适的材料范围之内)。
所述边缘或缘边在其靠近身体的一面(proximal face)上负载有光可变换胶粘剂膜以保证敷料在位置上以防止泄漏，以及在其远离身体的一面(distal face)上负载有不透明材料层。
为了除去敷料且在除去敷料中不导致过量的损伤，在创口周围延伸的所述边缘或缘边的远离身体一面上的不透明材料层，在向所述边缘或缘边施加适当波长辐射之前被除去。
如果创口敷料的边缘，在相对流体不漏密封的外面，所述边缘负载有将其粘合到创口周围皮肤上的胶粘剂膜，是具有高水蒸气透过性的材料或是可变换材料，那么胶粘剂膜，如果是连续的，应该也具有高或可变换的水蒸汽透过性，例如是用于例如Smith&Nephew’sAllevynTM、IV3000TM和OpSiteTM敷料中的粘合剂。
在本发明的一些主要实施方案中(总结如上)，冲洗剂和/或创口渗出物被移进或移出敷料。
这可以在作用于创口敷料上的负压下进行。这种真空可以用于在创口敷料面对创口的面边缘周围处于流体不漏的密封的情况下将创口敷料保持在位置上。
这除去了对胶粘剂的需求和对患者皮肤的相关损伤，创口敷料可以仅仅带有硅氧烷边缘或缘边以将创口敷料密封在创口周围。
或者，冲洗剂和/或创口渗出物流进和流出敷料可以在正压下进行，所述正压将作用于边缘点以将敷料从创口周围的皮肤提起并除去。
在装置的这种用法中，因此可能需要提供对抗这种创口上的正压用于形成并保持在创口上的密封或闭合的工具，从而为此目的作用在边缘点上。
此类工具的例子包括如上所述的光可变换胶粘剂，以保证敷料在位置上从而防止泄漏。
由于光可变换胶粘剂的附着力被光固化减小，所以减小了除去创口敷料的损伤，可以例如在凸缘上使用如上的更加具有侵略性的胶粘剂膜。
用于更加极端的其中对患者皮肤的损害可以容忍的条件中的合适流体胶粘剂的例子包括基本由氰基丙烯酸酯组成的那些和类似的组织胶粘剂，施用在创口边缘周围和/或创口敷料衬层靠近身体的那一面上，例如施用在凸缘或缘边上。
此类工具进一步合适的例子包括胶粘剂(例如压敏胶粘剂)和非胶粘剂，以及弹性和非弹性带、条、环、长条、系材、扎带，例如压迫性扎带、片、覆盖物、袖子、外套、护套、包裹材料、长袜和短袜。
后者包括例如弹性管状短袜(hose)或弹性管状长袜(stockings)，当以这种方式实施治疗时，所述弹性管状短袜或弹性管状长袜压缩配合到四肢创口上以向创口施加适当的压力。
合适的例子还包括可膨胀的袖口、袖子、外套、裤子、护套、包裹材料、长袜和短袜，当以这种方式实施治疗时它们压缩配合到四肢创口上以向创口施加适当的压力。这些工具可以各自放置在创口敷料之上以延伸超出创口敷料衬层的边缘。
在合适的情况下它们可以粘附到或紧固到创口周围的皮肤和/或它自己上，并且在合适的情况下将施加压缩(例如用弹性扎带、长袜)到足以将创口敷料保持在位置上并且创口边缘周围处于流体不漏的密封的程度，
这些工具可以各自与敷料的其它组件特别是衬层是一个整体。
或者，它可以用例如胶粘剂膜永久地连接到或可释放地连接到敷料特别是衬层上，或者这些组件可以是VelcroTM、推进接头(push snap)或相互配合的扭转锁。
所述工具和创口敷料可以是分开的结构，相互永不连接。
在对于创口上的较高正压的更加合适的设计中，如前所定义的，刚性凸缘或缘边伸出创口敷料衬层靠近身体的那一面的边缘周围。
所述凸缘或缘边在其靠近身体的那一面是凹形的，从而限定了边缘通道或管道。
它具有通过凸缘或缘边与所述通道或管道连通的抽吸出口并且可以连接到用于施加真空的设备，例如泵或管供真空。
衬层可以与其靠近身体的那一面周围伸出的凸缘或缘边是一个整体或者通过例如热封连接到所述凸缘或缘边上。
在该装置的使用中，为了在创口上形成所需的相对流体不漏的密封或闭合和为了防止冲洗剂和/或渗出物在创口敷料面对创口那一面的边缘下通过，创口敷料安装在创口周围的皮肤上。
所述设备然后对所述凸缘或缘边的内部施加真空，从而形成并保持作用在创口周围边缘点上的密封或闭合，对抗创口上的正压。
根据所有前述连接工具和用于在创口上形成和保持密封或闭合在创口周围边缘点上对抗创口上的正或负压的工具，创口敷料密封边缘优选是大致圆形的形状，例如椭圆，并且特别是圆形的。
如上面指出的，用于从创口渗出物选择性除去对创口愈合有害的物质的清洁工具，所述清洁工具在衬层以下并且在使用中安置在下面的创口中，通常包含腔室。可透过整体模块，例如片、膜或薄膜，形成所述腔室壁的一部分。
在单相系统中，作为‘循环系统’或换向系统，移动流体的设备通过可透过整体模块将创口渗出物移进和移出清洁工具。
在两相系统中，所述腔室含有清洁流体，最常见的是流体(透析液)相。后者通过可透过整体模块从创口渗出物分离。被至少一个用于移动流体的设备在流体清洁工具之内移动的流体是清洁流体和/或任选与冲洗剂混合的创口渗出物。
现在将描述本发明清洁工具的一般特征，然后描述与敷料内的特定清洁工具相关的特定特征。
所述清洁腔室是回弹性柔韧的，例如弹性体的，并且优选是软的对创口形状具有良好适应性(conformability)的结构。有利地它是被它自己的弹性推动顶着衬层以在创面上施加柔和的压力。
所述清洁腔室可以与敷料的其它组件特别是衬层是一个整体。或者，它可以例如使用胶粘剂膜或通过热封永久连接到其它部件上，例如连接到从靠近身体的表面伸出的凸缘或缘边上，从而不会破坏所需的创口之上的相对流体不漏的密封或闭合。
偶尔，所述清洁腔室是例如用胶粘剂膜可释放的连接到衬层上，或这些组件可以是推进接头或相互配合的扭转锁。
清洁腔室和衬层可以是分开的结构，相互永不连接。
它可以是可适应中空体的形式或包含一个或多个可适应中空体，所述可适应中空体由膜、片或薄膜限定，例如袋、桶、囊或其它类似结构。
所述膜、片或薄膜，通常具有的厚度(通常是均匀的)是最高1mm，优选最高500微米，更优选20微米-500微米最小厚度，并且通常是回弹性柔软的，例如弹性体的，并优选是软的。
这些膜、片或薄膜通常与敷料的其它组件特别是衬层是一个整体，或者例如使用胶粘剂膜或通过热封永久连接到其它部件上，例如连接到凸缘上。
但是，当用在这里时术语‘腔室’包括膜、片或薄膜限定的任意中空体，并且不限于袋、囊或其它类似结构。
它可以由更加卷绕形式的聚合物材料的膜、片或薄膜形成。这可以是伸长结构的形式，例如管、管中空纤维或纤丝或细管，例如在其间存在空间的阵列中，在入口和出口歧管之间流动。
所述腔室，特别是当它是其中含有清洁流体的袋、桶、囊或其它类似结构时，当在创口治疗期间使用时可以合适地填充很大部分或全部创口空间。在不是这种情形的情况下，可能希望用填料来限制衬层下面的剩余创口空间体积或来调整腔室的体积来做到这一点。
在腔室和衬层是分离结构不直接相互连接的情况下，这种填料方便地可以位于腔室和衬层之间以分离所述结构，或在腔室之内，从而腔室可以处于直接与创面接触的位置。
所述填料有利地是回弹性柔韧的，例如是弹性体的，并且优选是软的对创口形状具有良好适应性的结构。所述腔室可以被它自己的回弹性和填料的回弹性推动以在创面上施加柔和的压力。
这些创口填料的合适形式的例子包括合适材料例如弹性热塑性塑料形成的泡沫体。对于本发明创口敷料的优选材料包括带有小口或孔的网状过滤聚氨酯泡沫体。(这种填料的例子示于后面的图7、10、11和13中。)
可选择的或额外的，它可以是可适应中空体的形式或包含一个或多个可适应中空体，所述可适应中空体由膜、片或薄膜限定并填充有推动它到创口形状上的流体或固体，例如袋、囊或其它类似结构。
包含在由膜、片或薄膜限定的中空体中的合适流体的例子包括气体，例如空气、氮气和氩气，更通常是空气，处在大气压之上的小正压；和液体，例如水，盐水。
例子还包括凝胶，例如硅氧烷凝胶，例如CaviCareTM凝胶，或优选纤维素凝胶，例如亲水的交联纤维素凝胶，例如IntrasiteTM交联材料。例子还包括气溶胶泡沫体，其中气溶胶体系的气相是空气或惰性气体，例如氮气或氩气，更通常是空气，处在大气压之上的小正压；和固体颗粒，例如塑料团粒。
这些填料可以是通过流体可膨胀和可收缩的，所述流体例如气体，例如空气或氮气，或液体，例如水或盐水，以向腔室和创口空间提供各种压力，如果装配有一个或多个入口和/或出口管的话。
当然，如果衬层是足够可适应的和/或例如是向下凹陷的片，那么衬层可以位于创口填料下面，而不是相反。图6给出了这种回弹性柔韧的(resiliently flexible)、气球填料，其是通过流体可膨胀和可收缩的，由衬层和刚性聚合物顶盖限定，所述刚性聚合物顶盖是不可透过的并且永久连接到衬层远离身体的那一面。
在这种类型的设计中，为了使创口填料向着创面推动创口敷料，它通常必须牢固地粘合到或可释放地连接到创口周围的皮肤上。在其中创口填料和衬层是分离结构相互永不连接的那些实施方案中，尤其是这种情况。图7显示了这种回弹性柔韧的气球填料在衬层之上的装置的变型。
腔室的特定性质将主要取决于所使用的清洁工具的类型。
本发明用于抽吸、冲洗和/或清洁创口的装置装配有用于流体清洁的工具，其可以是
a)单相系统，例如超滤单元，或化学吸附单元；或
b)两相系统，例如透析单元。
在前者中，来自创口的流体通过单一流动路径，其中对创口愈合有害的物质被除去并且仍旧含有对促进创口愈合有益物质的经清洁的流体被送回创口。
这种系统的实施例表示在下面的图1和2中。
在这样的系统中用于流体清洁的工具可包括宏观过滤(macrofiltration)或微观过滤(microfiltration)单元，所述过滤单元适当地包含一个或多个宏观和/或微观过滤器。这些是用于保留颗粒例如细胞碎片和微生物，允许蛋白质和营养物通过。
所述膜优选地可以是亲水聚合物材料，例如乙酸-硝酸纤维素混合物、聚偏二氯乙烯和例如亲水聚氨酯。
优选程度更小的材料的例子包括疏水材料，也包括聚酯，例如聚碳酸酯、PTFE和聚酰胺，例如6-6和6-10，和疏水聚氨酯，以及石英和玻璃纤维。
它具有微口或微孔，所述微口或微孔的最大横跨尺寸将主要取决于有待于通过这种方式选择性去除的物质种类和对其来说可透过的种类。
前者可以用微口或微孔除去，所述微口或微孔例如典型的最大横跨尺寸是20-700微米，例如20-50nm(例如对于不希望的蛋白质)，50-100nm，100-250nm，250-500nm和500-700nm。
或者，用于创口渗出物清洁的工具的这部分基本上可以是一叠这种过滤器，所述过滤器在流体流动方向按照微口或微孔横跨尺寸下降的顺序依次连接。
它可以包括适当地包含一个或多个超滤过滤器的超滤单元，例如其中清洁整体模块是用于过滤对创口愈合有害物质的过滤器的超滤单元，例如是高处理量低蛋白质结合的聚合物膜、片或薄膜，所述聚合物膜、片或薄膜对于对创口愈合有害的物质是选择性不透过性的，对创口愈合有害的物质被除去并且仍旧含有对促进创口愈合有益的物质的经清洁的流体通过它。
在这种系统中的可透过整体模块可以是具有相对小的口或孔的选择性‘低通过’系统膜、片或薄膜。
用于该过滤器的合适材料包括上述为宏观过滤器和微观过滤器所列出的那些有机聚合物。
有利地是将带有这种类型清洁工具的装置作为‘循环’系统设计并运行，其中相关流体只以一个方向一次或多次通过清洁工具，因为这对于将过滤器残留物保持在创口渗出物以外是必需的。
(以‘换向系统’的形式来运行所述系统将是不合适的，因为流体至少一次以相反方向通过清洁工具将会把这些物质送回创口。)
所述过滤器整体模块可以是聚合物材料的平片或薄膜，或是更加卷绕的形式(不太常见)，例如是伸长结构，例如管、细管等形式。
所述腔室或敷料可能倾向于分别是一次性的。在这种情况下，用于将流体移动通过创口渗出物清洁工具的设备启动并运转直到没有显著量的对创口愈合有害的材料保留在创口中。
然后除去并抛弃创口敷料和/或衬层下面的清洁腔室，以从创口渗出物除去对创口愈合有害的材料。
单相系统清洁工具可包括化学吸附单元，例如其中颗粒如沸石或层例如官能化的聚合物层位于其表面上的吸附单元，其能够在来自创口的流体在它们上面通过时除去对创口愈合有害的物质。
所述物质可以通过例如螯合剂和/或离子交换剂以及降解剂通过破坏或者结合对创口愈合有害的物质来除去，所述降解剂可以是酶。
在这种类型中，所述腔室壁的膜、片或薄膜不是对创口愈合有害的物质的选择性可透过的整体模块。但是，所述腔室含有一种或多种物质，所述一种或多种物质是对创口愈合有害的物质的拮抗剂从而可以从创口渗出物除去这些有害物质种类。
例如，在创口渗出物含有下面物质的情况下：
蛋白酶，例如丝氨酸蛋白酶，例如弹性蛋白酶和凝血酶；半胱氨酸蛋白酶，基质金属蛋白酶，例如胶原酶；和羧基(酸)蛋白酶；
内毒素，例如脂多糖；
血管生成抑制剂例如凝血栓蛋白-1(TSP-1)、纤溶酶原激活物抑制剂或血管抑素(angiostatin)(纤溶酶原片断)；
促炎细胞因子例如肿瘤坏死因子α(TNFα)和白细胞介素1β(IL-1β)，氧化剂，例如自由基，例如过氧化物和超氧化物；和金属离子，例如铁II和铁III；涉及创面上氧化应激的所有物质，或
负面影响创口渗出物中pH的碱性或酸性物质种类(species)，例如质子，
所述清洁腔室，在可透过整体模块后面，合适地可以含有至少一种下面的拮抗剂，所述拮抗剂束缚在其中所述拮抗剂可以与冲洗剂和/或创口渗出物接触的腔室部分中：
蛋白酶抑制剂，例如丝氨酸蛋白酶抑制剂，例如4-(2-氨基乙基)-苯磺酰氟(AEBSF，PefaBloc)和Nα-p-甲苯磺酰基-L-赖氨酸氯甲基酮(TLCK)和ε-氨基己酰基-p-氯代苄基酰胺；半胱氨酸蛋白酶抑制剂；基质金属蛋白酶抑制剂；和羧基(酸)蛋白酶抑制剂；
粘合剂和/或降解剂，例如结合或破坏脂多糖的抗炎物质，例如拟肽(peptidomimetics)；
抗氧化剂，例如3-羟基酪胺(多巴胺)、抗坏血酸(维生素C)，维生素E和谷胱甘肽，和它们的稳定衍生物，和它们的混合物；以减轻创面上的氧化应激；
金属离子螯合剂和/或离子交换剂，例如过渡金属离子螯合剂，例如铁III螯合剂(FeIII参予创面上的氧化应激。)，例如去铁胺(DFO)、3-羟基酪胺(多巴胺)；
铁III还原剂；或
用于调节创口渗出物中pH的试剂，例如碱或酸清除剂和/或离子交换剂，或其它种类，其可以是稳定的、不溶和/或固定的)种类，例如ScavengePore苯乙基吗啉(Aldrich)。
适当地是将带有这种类型清洁工具的装置作为‘循环’系统或以‘换向系统’的形式设计并运行，因为至少一次以相反方向通过清洁工具的流体将不会把这些物质送回创口。)
这些系统的例子尤其表示在下面的图1、6和7(换向系统)和2、8和9(循环系统)中。
可能需要第二选择性可透过的整体模块(其同样合适地是聚合物材料的平片或薄膜)以在装置任何合适的部分形成在流动路径中的远离身体腔室壁的一部分，以在腔室中保留对创口愈合有害的物质和拮抗剂或其它活性物质。
这种形式系统的特定优点是，当能够从创口渗出物除去对创口愈合有害的物质的物质是(细胞)毒性或生物不相容的或对任何对促进创口愈合有益的组分是非惰性的情况下，所述系统不允许任何显著量的这种物质通过进入创口。
在两相系统中，所述腔室含有清洁流体，最常见是流体(透析液)相。后者通过可透过整体模块从创口渗出物分离。
至少一种流体被至少一个设备移动通过流体清洁工具，特别是穿过可透过整体模块，例如聚合物膜、片或薄膜。
这促进了相对高浓度的溶质或分散相物质种类包括有害物质从创口渗出物向清洁流体和所述腔室以及任选所述系统的通过，其中所述清洁流体在所述系统中再循环。这些系统进一步在下面描述。
被所述流体移动设备移动通过流体清洁工具的流体是
a)所述清洁流体或
b)任选与冲洗剂混合的创口渗出物，或
c)上述两者。
这些系统的例子示出在下面的图12和13中，其中
图12a和13显示了这样的系统、透析单元，其中只有从创口渗出物分离的清洁流体是移动流体。
图12b显示了这样的系统、透析单元，其中清洁流体和任选与冲洗剂混合的创口渗出物是移动流体。
清洁流体很少像图4中一样是静止的，因为这可能不是一个具有足够(动态)表面积以便以有实际意义的速率从创口渗出物除去对创口愈合有害的物质的系统。
在本发明用于抽吸、冲洗和/或清洁创口的装置中，流体清洁透析工具中的典型透析液流动速率是常规类型两相系统例如系统治疗透析单元中所使用的那些速率。所述整体模块可以是膜、片或薄膜，通常与常规两相系统例如系统治疗透析单元中所使用的那些具有相同的类型和相同的厚度(通常是均匀的)。
如上面所指出的，所述膜、片或薄膜可以基本是平的，但特别是在所述清洁流体循环的情况下，它更合适地可以是管、小管或细管的阵列的形式。
任何这些膜、片或薄膜的表面积可以合适地是不少于50mm2，例如100-1000000mm2，例如500-25000mm2。
如果两种流体都移动，那么可以是同向流或优选逆向流方向。
同样，对创口愈合有害的物质被除去进入透析液，而仍旧含有对促进创口愈合有益的物质的经清洁的流体保留下来或通过再循环送回创口。
如上所述的这些有害物质的例子包括
氧化剂，例如自由基，例如过氧化物和超氧化物；
铁II和铁III；涉及创面上氧化应激的所有物质；
蛋白酶，例如丝氨酸蛋白酶，例如弹性蛋白酶和凝血酶；半胱氨酸蛋白酶，基质金属蛋白酶，例如胶原酶；和羧基(酸)蛋白酶；
内毒素，例如脂多糖；
自体诱导物信号分子(autoinducer signalling molecules)，例如高丝氨酸内酯衍生物，例如氧代-烷基衍生物；
血管生成抑制剂例如凝血栓蛋白-1(TSP-1)、纤溶酶原激活物抑制剂或血管抑素(纤溶酶原片断)；
促炎细胞因子例如肿瘤坏死因子α(TNFα)和白细胞介素1β(IL-1β)；和
炎症性物质(inflammatories)，例如脂多糖，和例如组胺；和
负面影响创口渗出物中pH的碱性或酸性物质种类，例如质子。
用于膜、片或薄膜的合适材料的例子(通常是由膜、片或薄膜限定的可适应中空体的形式，例如前面描述的结构)包括天然和合成聚合物材料。
所述薄膜可以是一种或多种亲水聚合物材料的薄膜，例如纤维素衍生物，例如再生纤维素，纤维素单、二或三酯，例如纤维素单、二或三醋酸酯，苄基纤维素和Hemophan，以及它们的混合物。
其它材料的例子包括疏水材料，例如芳香族聚砜、聚醚砜、聚醚醚砜、聚酮、聚醚酮和聚醚醚酮，和它们的磺化衍生物，和它们的混合物。
其它材料的例子包括疏水材料，例如聚酯，例如聚碳酸酯和聚酰胺，例如聚己二酰己二胺(6-6)和聚己二酰癸二胺(6-10)；聚丙烯酸酯，包括例如聚(甲基丙烯酸甲酯)，聚丙烯腈和它们的共聚物，例如丙烯腈-sodium metallosulphonate共聚物；和聚(偏二氯乙烯)。
用于本发明薄膜的合适材料包括热塑性聚烯烃，例如聚乙烯例如高密度聚乙烯，聚丙烯，它们的共聚物，例如与醋酸乙烯酯和聚乙烯醇的共聚物，以及它们的混合物。
所述透析膜应该选择具有允许对创口愈合有害的物质种类进行选择性灌注的截留分子量(MWCO)，其中所述对创口愈合有害的物质种类已经被靶定要从创口除去。例如，丝氨酸蛋白酶弹性蛋白酶(分子量25900Dalton)的灌注将需要MWCO＞25900Dalton的薄膜。MWCO阈值可以在1-3000000Dalton之间变化以适应各种应用。
优选地，MWCO应该与这个分子量尽可能的接近以排除更大一些的竞争物质种类的干扰。
例如，MWCO＞25900Dalton的这种薄膜不允许任何显著量的针对弹性蛋白酶(α-1-抗胰蛋白酶(AAT)(分子量54000Dalton))的拮抗剂自由扩散出创口流体进入透析液，所述α-1-抗胰蛋白酶在创口中自然出现。对于促进慢性创口愈合有益的该抑制剂保持和创面接触并且可以有益地作用于创口上，而对创口愈合有害的弹性蛋白酶被除去。
本发明装置的这种用途是例如对慢性创口中的创口愈合过程是有利的，所述慢性创口是例如糖尿病足部溃疡特别是褥疮压疮。
如下面指出的，在薄膜透析液一侧的拮抗剂例如降解酶或弹性蛋白酶螯合剂，可以用于增强从创口渗出物除去这种蛋白酶。
一种不太常见类型的两相系统(见前面)可以用作流体清洁工具。在这种类型中，透析聚合物膜、片或薄膜不是对创口愈合有害的物质选择性可透过的整体模块，所述有害的物质例如
蛋白酶，例如丝氨酸蛋白酶，例如弹性蛋白酶和凝血酶；半胱氨酸蛋白酶，基质金属蛋白酶，例如胶原酶；和羧基(酸)蛋白酶；
内毒素，例如脂多糖；
血管生成抑制剂例如凝血栓蛋白-1(TSP-1)、纤溶酶原激活物抑制剂或血管抑素(纤溶酶原片断)；
促炎细胞因子例如肿瘤坏死因子α(TNFα)和白细胞介素1β(IL-1β)；氧化剂，例如自由基，例如过氧化物和超氧化物；和金属离子，例如铁II和铁III；涉及创面上氧化应激的所有物质；和
负面影响创口渗出物中pH的碱性或酸性物质种类，例如质子。
但是它也将允许创口渗出物和/或冲洗剂流体的组分进入并通过它，所述组分可以是更大或更小的分子但有益地参予创口愈合。在透析液中，或优选在一个或多个具有至少一个与透析液接触的表面的固体结构整体模块中，在流体清洁工具中，存在能够从创口渗出物除去对创口有害物质的一种或多种物质，所述一种或多种物质是
针对这些物质种类例如酶或其它物质的拮抗剂，例如蛋白酶抑制剂，例如丝氨酸蛋白酶抑制剂，例如4-(2-氨基乙基)-苯磺酰氟(AEBSF，PefaBloc)和Nα-p-甲苯磺酰基-L-赖氨酸氯甲基酮(TLCK)和ε-氨基己酰基-p-氯代苄基酰胺；半胱氨酸蛋白酶抑制剂；基质金属蛋白酶抑制剂；和羧基(酸)蛋白酶抑制剂；
粘合剂和/或降解剂，例如结合或破坏脂多糖的抗炎物质，例如拟肽；抗氧化剂，例如3-羟基酪胺(多巴胺)、抗坏血酸(维生素C)，维生素E和谷胱甘肽，和它们的稳定衍生物，和它们的混合物；以减轻创面上的氧化应激；
金属离子螯合剂和/或离子交换剂，例如过渡金属离子螯合剂，例如铁III螯合剂(FeIII参予创面上的氧化应激。)，例如去铁胺(DFO)、3-羟基酪胺(多巴胺)；
铁III还原剂；和
用于调节创口渗出物中pH的试剂，例如碱或酸清除剂和/或离子交换剂，或其它物质种类，其可以是稳定的、不溶和/或固定的)物质种类，例如ScavengePore苯乙基吗啉(Aldrich)。
它们进一步包括肽(包括细胞因子，例如细菌细胞因子，例如α-氨基-γ-丁内酯和L-高肌肽)；和
潜在地或实际地对促进创口愈合有益的牺牲氧化还原物质，例如铁III还原剂；和/或这种类型的可再生物质，例如谷胱甘肽氧化还原体系；和
其它生理活性组分。
在这种不太常见类型的两相系统透析单元的使用中，通常广谱的物质种类将从渗出物进入透析液。
一些(主要是离子的)物质种类将通过透析聚合物膜、片或薄膜从透析液进入冲洗剂和/或创口渗出物，其中所述透析聚合物膜、片或薄膜对于对创口愈合有害的物质不是非常选择性可透过的。
创口渗出物和/或冲洗剂流体的组分将通过它自由扩散出去以及回来。
最终在透析液和冲洗剂和/或创口渗出物之间建立稳态浓度平衡，所述冲洗剂和/或创口渗出物从创口敷料被‘装满(topped up)’。
循环创口流体促进更快的实现对促进创口愈合有益的物质的这种平衡。
它还把对促进创口愈合有益的物质送回到这些物质潜在地可以最有益的位置，即创面。
对创口愈合有害的目标物质也通过透析聚合物膜、片或薄膜从渗出物进入透析液，其中所述透析聚合物膜、片或薄膜对于对创口愈合有害的物质不是非常选择性可透过的。
不像创口渗出物和/或冲洗剂流体的其它组分，对创口愈合有害的目标物质与透析液或优选与一个或多个具有至少一个在透析液中的表面的固体结构整体模块接触，并被合适的拮抗剂、粘合剂和/或降解剂、螯合剂和/或离子交换剂和氧化还原试剂等除去。经过清洁的流体，仍旧含有一些对促进创口愈合有益的物质，被送回创口。
不像创口渗出物和/或冲洗剂流体的其它组分，目标物质被恒定地从透析液除去，非常少的这些物质种类会从透析液进入冲洗剂和/或创口渗出物，并且没有建立稳态浓度平衡，即使所述物质种类被恒定地从创口敷料‘装满’。
据信，循环一种或全部这两种流体帮助从再循环从创口渗出物除去对创口愈合有害的物质，同时保持对促进创口愈合有益的物质与创口接触。
这种形式两相系统的特定优点是，当能够从创口渗出物除去对创口愈合有害的物质的物质是(细胞)毒性或生物不相容的或对任何对促进创口愈合有益的组分是非惰性的情况下，所述系统不允许任何显著量的拮抗剂自由扩散出透析液进入创口流体。但是活性物质可以有益地作用于该流体上。
所述膜片或薄膜优选是截留分子量(MWCO)(如常规所定义的)选择为允许被靶定螯合或破坏的物质种类的灌注的透析薄膜。
例如，丝氨酸蛋白酶弹性蛋白酶的螯合(分子量25900Dalton)将需要MWCO＞25900Dalton的薄膜。
MWCO阈值可以在1-3000000Dalton之间变化以适应各种应用。优选地，MWCO应该与这个分子量尽可能的接近以排除更大一些的竞争物质种类的鳌合干扰。
将会看到，在用于清洁创口的本发明第一方面装置的很多实施方案中，冲洗剂和/或创口渗出物和/或清洁流体通过或在衬层下面从创口敷料通过并经由返回路径返回创口敷料，所述衬层具有面对创口的面，所述面对创口的面能够在创口上形成相对流体不漏的密封或闭合。
每个返回路径将需要
至少一个用于连接到流体返回管的入口管，该入口管通过衬层的面对创口的面，和
至少一个用于连接到流体排出管的出口管，该出口管通过衬层的面对创口的面，
位点，该入口管或每一个入口管和该出口管或每一个出口管在所述位点通过面对创口的面或在面对创口的面下面，所述面对创口的面在创口上形成相对流体不漏的密封或闭合。
当任何管在关于所述装置的操作中被描述为连接到或用于连接到小管(接合端)的情况下，所述管和小管可以形成单一整体模块。
在本发明装置的运行模式是处于‘换向系统’形式的情况下，所述至少一个入口管和所述至少一个出口管，和所述至少一个流体提供管和所述至少一个出口管，可以分别是相同的整体模块。
这通常是冲洗剂和/或创口渗出物‘多通过系统’，其中该流体从创口敷料通过并返回创口，在这两种情况下都是经由清洁工具进行，例如在往复泵例如注射器或活塞泵运动的作用下。
该或每一个入口管或出口管可以具有口的形式，例如分别作为包容元件用于连接到作为插入部分的流体返回管或流体排出管的接合端(任选或按照需要通过用于形成小管、管或软管或喷嘴的工具)上的漏斗、洞、开口、管口、luer、槽口或端口。
在所述组件是整体的情况下，它们通常将由相同的材料制成(对于这一点可以理解上述所列材料处于合适的材料之内)。
或者，在它们是推进接头(push，snap)或相互配合的扭转锁的情况下，它们可以是相同的材料或是不同的材料。不论哪种情况，上述所列材料都处在对所有组件都合适的材料范围内。
衬层通常可具有刚性和/或回弹性柔韧或坚硬区域以抵御任何该或每一个管和该或每一个接合小管之间的实质摆动(substantialplay)或在压力下在任何方向的变形。
衬层通常可以被远离身体突出的凸出物(从创口向外)强化、加强或增强。
这通常在每一个用于连接到流体返回管或流体排出管的接合端的相关小管、管或软管、或喷嘴、洞、开口、管口、luer、槽口或端口的周围。
可选择的或额外的，在合适的情况下衬层可以具有在衬层靠近身体的那一面周围延伸的刚性凸缘或缘边以强化、加强或增强衬层。
单相系统例如超滤单元和两相系统例如透析单元都可以是可以相对容易地从本发明的装置卸除的模块化形式。
每个返回流动路径(不论是在单相系统中或是在两相系统例如透析单元中)都需要用于移动流体的工具。
合适的工具对有经验的技术人员来说是显而易见的，但是按照需要可以使用下面类型的小泵：
小往复泵，例如：
隔膜泵-其中一或两个柔韧隔膜的脉动移动液体而止回阀控制流体流动的方向。
注射器和活塞泵-其中活塞任选通过止逆阀泵送流体，特别是对于创面上变化的和/或可逆的正和/或负压以及对于闭合的单相换向系统，其中创口渗出物和/或冲洗剂来回通过清洁工具。
小旋转泵，例如：
旋转叶轮泵-用连接到驱动轴的旋转叶轮移动流体，在旋转时没有脉动。可以限制出口而不会损坏该泵。
蠕动泵-转子臂上的外围滚筒作用在柔韧流体循环小管上以驱动流体流在小管中按转子的方向流动；特别是对于多相循环系统中的透析液相，其中透析液相只以一个方向通过。
所述设备的类型和/或容积将主要取决于创口愈合过程最优性能所需的冲洗剂和/或来自创口的创口渗出物合适或希望的流体体积流速，和例如便携性、功率消耗和从污染物的分离等的因素。
此类设备也可以合适地是能够实现脉冲的、连续的、可变的、可逆的和/或自动的和/或程序化的流体移动的设备。它特别可以是这些类型泵中的任意一种。
本发明的主要功能，即有利地是便携式的用于冲洗和/或清洁创口的装置，将主要决定所述泵的主要功能，即用于移动流体例如(慢性)创口渗出物通过清洁工具的移动设备，而不是用于抽吸或加压正被清洁的创口。
但是所述泵可以用于向创口提供最高50％atm更经常是最高15％atm的正或负压，如流体移动一样，压力的提供可以是脉冲的、连续的、可变的、可逆的、自动的和/或程序化的。
如果创口清洁准备以这种方式进行的话，那么在衬层边缘周围的流体不漏的密封或闭合变得更为关键。
所述装置有利地是小蠕动泵或隔膜泵，例如优选是小型便携隔膜泵或蠕动泵。为了特别是减小或消除泵的内部表面和移动部件与(慢性)创口渗出物的接触以及为了容易清洁，这些是优选类型的泵。
在泵是隔膜泵并优选是小便携式隔膜泵的情况下，移动液体的连接到产生脉动的工具上的一个或两个柔韧隔膜可以各自是例如聚合物膜、片或薄膜。其可以以任何便利的形式提供，特别是作为机电振荡器，压电换能器，螺线管核芯或其中电流方向交替变化的铁磁体整体模块和线圈，旋转凸轮和从动件等。
在本发明第一方面的用于清洁创口具有两相系统的装置的一个实施方案中，没有流体通过衬层从创口敷料通过或经由返回路径返回创口敷料，其中所述装置例如是具有透析单元的装置。
因此它不需要任何用于连接到流体返回小管的入口管或任何用于连接到流体排出小管的出口管，其通过衬层面对创口的面。
在这种实施方案中，所述移动设备的主要目的是移动清洁流体。在这种实施方案中，其中合适的设备是：
这种敷料的合适例子包括例如使用旋转推进器(rotaryimpellers)的那些，所述旋转推进器例如：具有连接到驱动轴的旋转叶轮的叶片推进器，驱动轴上的螺旋桨，等。
此类设备可以和所述敷料是一个整体。可以看出，相应的装置不利地需要保证，在移动设备通过腔室壁或创口敷料的任何部分的周围，腔室的流体不漏密封或闭合。它们可能(不利地)不是便携性的。
使用这种类型创口敷料的可能性可能主要取决于实现这种相对流体不漏密封或闭合的能力。可能会希望移动设备的任何一部分都不通过腔室壁或创口敷料。
它们可以是分开的结构，为了在位于腔室内部的‘多相系统’中有效地沿着期望的流动路径穿过选择性可透过的整体模块移动清洁流体，能够适当地发生相互作用。
所述移动设备可以远距离地驱动腔室内的清洁流体以使该流体处于运动中。
所述装置的这种实施方案有利地使得能够实现在创口上的紧密密封或闭合，并且使得不需要移动设备的任何部分通过腔室壁或创口敷料。
这避免了需要保证其周围腔室的流体不漏的密封或闭合。
所述腔室因此可以例如以这种形式提供：在其内部封闭有至少一个磁从动件，并通过磁搅拌器作用在其上以推动清洁流体。推动清洁流体的所述磁搅拌器可以安装例如可释放地连接到敷料的其它部件特别是衬层上，例如用VelcroTM连接件、胶粘剂(例如压敏胶粘剂的)膜或弹性或非弹性带、条、系材、扎带例如压迫性扎带、片或覆盖物，或是推进接头或与它/它们配合的扭转锁。
它可以安装在衬层上，例如安装在衬层中心在有效形成环形腔室的圆形或同心环形中空体上方，在该环形腔室中提供有至少一个磁从动体。在使用中，磁搅拌器推动分别封闭在圆形或环形腔室中的磁从动体从而导致创口清洁流体循环。
所述膜、片或薄膜通常是选择性可透过的，含有清洁流体，并且应该具有合适的对抗脉冲压力的回弹性以允许腔室进行压缩或解压缩以经过腔室再循环创口清洁流体。
所有这些远距离设备都可以与所述敷料是一个整体，或用例如胶粘剂膜或通过热封永久连接到所述敷料特别是衬层上。
这些组件可以是可释放地连接的，例如通过VelcroTM连接件，用胶粘剂膜(例如用压敏胶粘剂)或用弹性或非弹性带、条、系材、扎带例如压迫性扎带、片或覆盖物。
另一个这种设备可以以至少一个球或球体例如固体金属球或球体的形式提供。
这设定了在患者身体移动的作用下清洁流体在移动中与整体模块的表面接触，其中所述整体模块对创口渗出物中的物质是选择性可透过的。
或者，可压缩腔室的顶部可以提供有轨道，在轨道周围患者可以移动他或她的手指以使流体在腔室周围移动。
在实践中，即使是高渗出状态的创口，渗出物流动的这种速率也只是最高达到75微升/cm2/hr(其中cm2是指创口面积)的级别，并且所述流体可以是高度流动的(由于存在的蛋白酶)。
随着创口愈合，渗出物水平下降并且创口渗出物稠度发生变化，例如变为更高粘度的液体，例如对于同一创口变为等同于12.5-25微升/cm2/hr的水平。
在对创口愈合有害的物质通过两相系统(见下面)例如透析单元除去的情况下，对于该系统流体通过流体清洁工具也潜在地发生损失。
这例如可以通过透析聚合物膜、片或薄膜发生，其中所述聚合物膜、片或薄膜除了对于对创口愈合有害的物质是可透过的外，对于水也是可透过的。
再循环流体的平衡因此可能进一步降低。可能希望来调节冲洗剂和/或创口渗出物的体积从而来最小化这种不希望的损失。
随着创口愈合，如果创口渗出物的稠度改变例如变成更高粘度的液体，可能希望来调节冲洗剂和/或创口渗出物的体积从而来调节该液体的粘度，例如调节到等同于起始水平的水平。
如上面所指出的，用于清洁创口的本发明第一方面的装置，可以在创口空间处于大气压或处于最高50％atm更通常的最高15％atm的正压或负压的情况下使用，其中所述压力施加到创口上。
按照可能的需要，可以在创口治疗之前和/或治疗期间加入流体到创口空间或从创口空间除去流体，以调节冲洗剂和/或创口渗出物体积和/或调节创口上的中、正或负压。
因此，通过连续向创口空间加入冲洗剂，可以增加冲洗剂和/或来自创口的创口渗出物的体积。通过例如在创口敷料施用到创口以前用期望数量的冲洗剂浸没(flooding)创口和/或通过在运行期间连续向创口加入冲洗剂，可以向创口施加正压。通过从创口除去流体例如使用小泵可以向创口施加负压。
在所有情况下，这可以通过相关流体通道实现，所述流体通道通过流体调节器可以自由出入，所述流体调节器例如是阀或其它控制设备，例如通过转动在开和关之间切换的阀，所述流体控制器安装在管或小管中，所述管或小管通过衬层或在衬层下面。
例如，在使用期间如果在衬层下面渗出物的积累变得过量，可以打开排放阀将过量流体排出例如排放到废物容器，任何额外压力都被释放。
同样地，通过冲洗剂可以调节任何创口流体的任何损失或可以向创面施加正压(即大气压以上的压力)，所述冲洗剂通过类似的输入调节器通过衬层或在衬层下面到达创面，所述调节器例如是阀或其它控制设备，例如通过转动在开和关之间切换的阀。
通过从创口除去流体可以方便地向创面施加负压，例如使用小泵，通过类似的真空调节器例如阀或其它控制设备，例如一旦已经施加真空在真空源切断之前被旋转关闭的阀。
可选择的或额外的，在合适的情况下衬层可以具有调节器例如注入隔膜(injection septum)，通过该隔膜期望数量的相关流体例如冲洗剂可以被从创口除去或被提供给创口，例如使用小注射器或类似的泵来实现希望的效果。
同样地，可以通过用于排放或向相关流动路径提供流体的工具来调整任何清洁流体中的平衡。用于排放或向相关流动路径提供流体的工具可以位于与清洁流体接触的装置的任何合适的部分。
用于排放或向相关流动路径提供流体的工具可以是调节器，例如是阀或其它控制设备，例如通过转动在排放和关闭之间切换的阀，用于从装置排放流体例如排放到废物容器例如收集袋中，或在供应和关闭之间切换的阀用于向装置供应流体。
可选择的或额外的，在合适的情况下流动路径可以具有调节器例如注入隔膜，通过该隔膜期望数量的相关流体清洁剂可以被从流动路径除去或被提供给流动路径，例如使用小注射器或类似的泵来实现希望的效果。
入口和/或出口管、流体返回小管和流体排出小管等，在存在的情况下可以是常规类型，例如具有椭圆或圆形截面，并合适地可以在它们的整个长度具有均匀的圆柱内腔、管道、管路或通道。
取决于冲洗剂和/或来自创口的创口渗出物的期望流体体积流动速率和期望的再循环数量，适当地对于大躯干创口内腔的最大横跨尺寸可以高达10mm，对于四肢创口可以高达2mm。
小管壁合适地应该足够厚以承受住施加在壁上的任何正或负压。
如果通过连续向创口加入创口渗出物和/或流体增加再循环中的冲洗剂和/或来自创口的创口渗出物的体积，就尤其是这种情况，其中所述流体来自清洁流体并通过选择性可透过的整体模块，所述整体模块是例如两相系统如透析单元的聚合物膜、片或薄膜。但是，如上面对于泵所指出的，这些小管的主要目的是在装置流动路径的整个长度上运输冲洗剂和渗出物，而不是作为压力脉管。小管合适地可以至少是25微米厚。
一旦在使用中创口敷料是在创口之上，那么用于抽吸、冲洗和/或清洁创口的装置的整个长度应该是微生物不可透过的。
理想地，创口敷料和本发明用于抽吸、冲洗和/或清洁创口的装置的内部是无菌的。
流体可以在该流体在其中移动的系统中通过紫外、γ或电子束辐射被灭菌，所述系统包括流体清洁工具。这种方式特别减少或消除了内部表面和流体与任何杀菌剂的接触。
其它流体灭菌方法的例子还包括例如使用
通过微口或微孔的超滤，所述微口或微孔例如具有0.22-0.45微米的最大横跨尺寸，对微生物是选择性不可透过的；和
流体杀菌剂，例如化学品的溶液，所述化学品例如氯己定和聚乙烯吡咯烷酮碘；金属离子源例如银盐如硝酸银；和过氧化氢；
虽然后者包括用杀菌剂接触内表面和所述流体。
理想地，即使是对于高渗出状态的创口，创口敷料的内部、流体在其中进行再循环的系统的其余部分和/或创面，被保持为无菌，或者至少天然发生的微生物生长被抑制。
还希望提供一种系统，其中对创口愈合有益的渗出物的生理活性组分在施加流体清洁之前或之后没有被除去，例如通过对促进创口愈合有益的物质的被动沉积被除去，所述对促进创口愈合有益的物质例如是蛋白质如生长因子。
所述沉积可以在系统中任何与对创口愈合有益的渗出物生理活性组分接触的点发生。
通常沉积将发生在系统中与渗出物接触的任何点上，通常是在单相系统中，但是沉积可以在多相系统的第二流体(透析液)相中发生其中在该装置的使用中对创口愈合潜在有益的创口渗出物中的物质自由扩散进入这个相中。
可以通过在与相关流体直接接触的任何点或任何整体模块上使用排斥涂层来对抗对促进创口愈合有益的物质的沉积。
涂覆在循环流体在其上通过的表面上的涂层材料例子包括
抗凝剂，例如肝素，和
高表面张力材料，例如PTFE和聚酰胺，
其对于生长因子、酶和其它蛋白质和衍生物是有用的。
在所述装置的所有实施方案中，在本发明整个装置中的用于冲洗和/或清洁创口的任何小管的类型和材料将主要取决于它们的功能。
为了适合于使用，特别是对于长期时间尺度，所述材料应该是非毒性的并且是生物相容性的，适当地对于冲洗剂和/或创口渗出物的以及任何透析液的任何活性组分是惰性的。在所述装置的使用中所述材料应该不允许任何显著量的可提取物自由扩散出该材料。
所述材料应该是通过紫外、γ或电子束辐射和/或使用流体杀菌剂如化学品溶液可灭菌的，一旦使用应该是流体-和微生物-不可透过的，并且是柔韧的。
合适材料的例子包括合成聚合物材料，例如聚烯烃，如聚乙烯，例如高密度聚乙烯和聚丙烯。
用于本发明目的的合适材料还包括它们的共聚物例如与醋酸乙烯酯的共聚物，和它们的混合物。用于本发明目的的合适材料进一步包括医疗级聚(氯乙烯)。
在本发明装置中为了流体清洁目的，单相系统如超滤单元和两相系统如透析单元都可以具有例如下面所述的捕获(captive)(稳定的、不溶和/或固定的)物质种类，所述捕获物质种类结合到不溶和/或固定的)基质上，来自创口敷料的冲洗剂和/或创口渗出物在所述基质之上通过和/或穿过所述基质通过并接着进入流体返回小管：抗氧化剂和自由基清除剂，例如3-羟基酪胺(多巴胺)、抗坏血酸(维生素C)，维生素E和谷胱甘肽，和它们的稳定衍生物，和它们的混合物；以减轻创面上的氧化应激；
金属离子螯合剂和/或离子交换剂，例如过渡金属离子螯合剂，例如铁III螯合剂(FeIII参予创面上的氧化应激。)，例如去铁胺(DFO)、3-羟基酪胺(多巴胺)；
铁III还原剂；
蛋白酶抑制剂，例如TIMPs和α1-抗胰蛋白酶(AAT)；丝氨酸蛋白酶抑制剂，例如4-(2-氨基乙基)-苯磺酰氟(AEBSF，PefaBloc)和N-α-p-甲苯磺酰基-L-赖氨酸氯甲基酮(TLCK)和ε-氨基己酰基-p-氯代苄基酰胺；半胱氨酸蛋白酶抑制剂；基质金属蛋白酶抑制剂；和羧基(酸)蛋白酶抑制剂；
通过除去触发氧化还原-敏感基因表达进入创口渗出物的物质而潜在地或实际地对促进创口愈合有益的牺牲氧化还原物质，其中所述氧化还原-敏感基因对创口愈合是有害的；
自体诱导物信号分子降解剂，其可以是酶；和结合或破坏脂多糖的抗炎物质例如拟肽；
用于调节创口渗出物中pH的试剂，例如碱或酸清除剂和/或离子交换剂，或其它物质种类，其可以是稳定的、不溶和/或固定的)物质种类，例如ScavengePore苯乙基吗啉(Aldrich)。
对创口愈合有害的渗出物的其它生理活性组分可以以这种方式除去。
这些有害物质可以使用合适的螯合剂和/或离子交换剂、降解剂或其它物质种类除去，所述降解剂可以是酶。
下述类型的官能化的基质在其表面上具有这样的位置，所述位置能够在来自创口的循环流体在它们上面通过时除去对创口愈合有害的物质：
非均相树脂，例如负载在二氧化硅上的反应剂如：
金属清除剂，
3-(二亚乙基三氨基)丙基-官能化的硅胶
2-(4-(亚乙基二氨基)苯)乙基-官能化的硅胶
3-(巯基)丙基-官能化的硅胶
3-(1-硫脲基)丙基-官能化的硅胶
三胺四乙酸盐(triamine tetraacetate)-官能化的硅胶
或亲电清除剂，
4-羧基丁基-官能化的硅胶
4-乙基苯磺酰氯-官能化的硅胶
丙酰氯-官能化的硅胶
3-(异氰基)丙基-官能化的硅胶
3-(氰硫基)丙基-官能化的硅胶
3-(2-琥珀酸酐)丙基-官能化的硅胶
3-(马来酰亚氨基)丙基-官能化的硅胶
或亲核清除剂，
3-氨基丙基-官能化的硅胶
3-(亚乙基二氨基)-官能化的硅胶
2-(4-(亚乙基二氨基)丙基-官能化的硅胶
3-(二亚乙基三氨基)丙基-官能化的硅胶
4-乙基-苯磺酰胺-官能化的硅胶
2-(4-甲苯磺酰基联氨基)乙基-官能化的硅胶
3-(巯基)丙基-官能化的硅胶
二甲基甲硅烷氧基-官能化的硅胶
或碱或酸清除剂，
3-(二甲基氨基)丙基-官能化的硅胶
3-(1，3，4，6，7，8-六氢-2H-嘧啶并-[1，2-α]嘧啶基)丙基-官能化的硅胶
3-(1-咪唑-1-基)丙基-官能化的硅胶
3-(1-吗啉代)丙基-官能化的硅胶
3-(1-哌嗪基)丙基-官能化的硅胶
3-(1-哌啶子基)丙基-官能化的硅胶
3-(4，4′-三甲基二哌啶子基)丙基-官能化的硅胶
2-(2-吡啶基)乙基-官能化的硅胶
3-(三甲基铵)丙基-官能化的硅胶
或下面的反应剂，
3-(1-环己基碳二亚氨基)丙基-官能化的硅胶
TEMPO-官能化的硅胶
2-(二苯基膦基)乙基-官能化的硅胶
2-(3，4-环己基二醇)丙基-官能化的硅胶
3-(环氧丙氧基)丙基-官能化的硅胶
2-(3，4-环氧环己基)丙基-官能化的硅胶
1-(烯丙基)甲基-官能化的硅胶
4-溴丙基-官能化的硅胶
4-溴苯基-官能化的硅胶
3-氯丙基-官能化的硅胶
4-苄基氯-官能化的硅胶
2-(甲氧羰基(carbomethoxy))丙基-官能化的硅胶
3-(4-硝基苯甲酰氨基)丙基-官能化的硅胶
3-(脲基)丙基-官能化的硅胶
或上述的任意组合。
这些捕获(稳定的、不溶和/或固定的)物质种类的使用，因为适合用于流体清洁工具，已经在此前进行了描述，其中所述捕获物质种类例如前面所述的那些，结合到不溶和/或固定的)基质上，来自创口敷料的冲洗剂和/或创口渗出物在所述基质之上通过和/或穿过所述基质通过。
但是，在合适的情况下它们可以额外地用于所述装置与冲洗剂和/或创口渗出物接触的任意部分，但通常在敷料内，以用于从创口除去对创口愈合有害的物质。
在本发明的第二方面，提供使用本发明用于清洁创口的装置治疗创口以促进创口愈合的方法。
下面将参考附图仅通过举例的方式来描述本发明，其中：
图1-15是根据本发明第一方面用于清洁创口的装置的截面图。
图1-11和14示出了具有用于创口渗出物清洁的单相工具的装置，并且在这些之中：
图1、2、3、6、7和14示出了换向系统，其中创口渗出物和任选的冲洗剂通过清洗工具一次或多次，至少一次以相反方向通过；和
图2、4、5、8、9、11和15示出了循环系统，其中它/它们只以一个方向通过；和
图12和13示出了具有用于创口渗出物清洁的两相工具的装置，并且在这些之中：
图12和13示出了其中清洁相通过清洁工具的此类装置。
参见图1-10和14，用于清洁创口的装置(1)包括
可适应创口敷料(2)，具有衬层(3)，其能够在创口上形成相对流体不漏的密封或闭合并负载有胶粘剂膜以将衬层充分连接到皮肤上以便将创口敷料(2)固定在位置上；
清洁工具(4)，用于从创口渗出物选择性除去对创口愈合有害的物质，该装置在衬层(3)下面并在使用中安置在下面的创口中；和
移动设备(7)，用于移动流体通过清洁工具。
用于排放或用于向衬层下的清洁工具(4)或向渗出物提供流体的任选工具在多数图中都被省略了，所述任选工具例如调节器，例如阀。
在图1中，示出了换向系统(创口渗出物至少一次以相反方向通过清洁工具)。微生物不可透过的膜衬层(3)负载有连接在中心位置的靠近身体凸出的凹进凸出物(centrally attached proximallyprojecting recessed boss)。
安装在凸出物(11)的凹槽(recess)(14)中的多孔膜(12)和可透过薄膜(13)限定了清洁腔室(15)，该清洁腔室(15)含有固体颗粒(未示出)，所述固体颗粒用于螯合起始是从创口渗出物分离的有害物质。这些整体模块形成清洁工具(4)。
凸出物(11)周围的环形腔室(16)由流体不可透过的膜(17)限定，所述膜(17)在凸出物(11)和衬层的下面(3)之间伸展并连接到凸出物(11)和衬层(3)的下面上。所述环形腔室填充满柔韧弹性泡沫体(18)
入口和出口管(19)在中心位置穿过凸出物(11)并连通凸出物(11)内部和注射器筒体(20)，注射器筒体(20)是注射器移动设备(7)的一部分。
在使用中，注射器活塞(22)的移动吸取和推动创口渗出物来回穿过清洁工具(4)。
图(2)中的装置(1)可以作为循环系统操作，或既作为循环系统又作为换向系统操作。
它与图1在结构上是相似的，不同之处主要在于入口管返回环线(19)以弯管穿过凸出物(11)并经由非返回阀(21)连通腔室(16)内部和注射器筒体(20)，其对流动的阻力相对于清洁工具(4)的阻力要低。从腔室(16)排放流体的工具，例如阀，被从图2中省略了。
在使用中，注射器移动设备(7)的活塞(22)被抽出以吸取创口渗出物进入清洁工具(4)，清洁工具(4)从创口渗出物螯合有害物质。
注射器移动设备(7)的活塞(22)然后返回以强制经过清洁的创口渗出物经由阀(21)进入环形腔室(16)，并从那里穿过多孔膜(17)回到创口。
在注射器活塞的每次返回行程，一定比例经清洁的创口渗出物也经由清洁工具(4)被推动返回。该比例主要取决于返回环线(19)在注射器筒体上的位置。返回环线连接到注射器筒体的位置离注射器近端(proximal end)越远，泵送到环形腔室(16)的数量就越低，因为活塞在返回行程的后半段切断了返回环线(19)。
主要取决于在本发明装置的这个实施方案中所使用的清洁工具的类型，相对于清洁工具(4)的阻力阀(21)的阻力也可以影响通过腔室(16)和通过多孔膜(17)的这个比例。
腔室(16)中的多余压力，例如来自高渗出状态创口的创口渗出物，可以通过排放阀减小，如果安装有排放阀的话。
图(3)中装置(1)与图2中装置的主要不同之处在于流动路径中多孔膜(12)的位置。
使用模式是相同的：注射器活塞(22)的移动穿过清洁工具(4)吸取创口渗出物并强制创口渗出物返回。
图(4)中装置(1)与图2中装置的不同之处在于移动装置设备(7)。
这是按钮泵而不是注射器。该泵(7)安装在衬层(3)远离身体的那一面上。
它包括回弹性可压缩吸入腔室(26)，腔室(26)通过出口管(19)连接到清洁工具(4)并通过转移管(27)经由低阻力第一非返回阀(31)连接到回弹性可压缩排出腔室(36)，腔室(36)经由入口管(20)和低阻力第二非返回阀(32)连接到腔室(16)的内部。
在使用中，吸入腔室(26)被手工压缩并释放，它到其原始构型的恢复导致创口渗出物被抽吸通过清洁工具(4)。
排出腔室(36)然后被手工压缩并释放，它到其原始构型的恢复导致经清洁的创口渗出物被从吸入腔室(26)抽吸通过第一非返回阀(31)。
吸入腔室(26)然后再次被手工压缩并释放，它的压缩导致经清洁的创口渗出物通过第一非返回阀(31)从吸入腔室(26)被泵送进入排出腔室(36)，并且它到其原始构型的恢复导致创口渗出物被抽吸通过清洁工具(4)。
排出腔室(36)然后再次被手工压缩并释放，它的压缩导致经清洁的创口渗出物从排出腔室(36)通过第二非返回阀(32)被泵送进腔室(16)，并且它到其原始构型的恢复导致经清洁的创口渗出物被抽吸通过吸入腔室(26)。
只要需要可以一直重复这个循环，并且从第二个循环开始，当手工压缩排出腔室(36)时，它导致经清洁的创口渗出物被强迫通过环形腔室(16)并从那里通过多孔膜(17)返回创口。
参见图5-7和10，每幅图中的装置(1)都包括包含腔室(5)的清洁工具(4)，在这里是可适应中空袋，由衬层(3)和聚合物膜(6)限定，所述聚合物膜(6)是可透过的并且永久连接到衬层(3)靠近身体的那一面上。
使用中所述清洁工具(4)在圆顶形的衬层(3)下位于下面的被处理的创口中，并含有吸收在回弹性柔韧泡沫体(41)中的清洁流体。
图5-7和10示出了将创口渗出物移进和移出清洁装置(4)的不同方法。
在图5中，与衬层(3)接触安装在中心位置的机电振荡器或压电换能器(43)安装在刚性框架(44)上并电连接到适当的交流电源(45)(示意性示出)，所述刚性框架(44)安装在衬层(3)的边缘。腔室(5)装配有排放阀(8)。如果在使用期间衬层(3)下面渗出物的积累变得过量，可以打开排放阀(8)并将过量的流体排出，任何超出的压力被释放。
在图(6)中，泡沫体(41)具有回弹性柔韧的气球核芯(47)，气球核芯(47)是流体可膨胀和可收缩的，所述流体例如气体如空气或氮气或者液体如水或盐水，以便经由安装在衬层(3)边缘的入口和出口管(48)向腔室(5)施加不同的压力。
管(48)连接到合适的移动设备(58)(未示出)，该设备用于将膨胀流体移进和移出核芯(47)从而将创口渗出物移进和移出清洁工具(4)。这种设备合适的是能够实现任选脉冲地可逆移动流体的设备。
所述设备特别可以是小蠕动泵或隔膜泵，例如优选电池驱动的小型便携式隔膜泵或蠕动泵，例如安装在衬层(3)中心位置的上面在腔室(5)之上并可释放的连接到衬层(3)。
图7示出了图6装置(1)的变化形式。衬层(3)下面的回弹性柔韧气球核芯(47)被回弹性柔韧气球腔室(49)取代，所述气球腔室(49)由衬层(3)和刚性聚合物圆顶(50)限定，所述刚性聚合物圆顶(50)是不可透过的并且永久连接到衬层(3)远离身体的那一面。
由衬层(3)和刚性聚合物圆顶(50)限定的气球腔室(49)也是流体可膨胀和可收缩的，所述流体例如气体如空气或氮气或者液体如水或盐水，以便经由安装在背衬圆顶(50)边缘的入口和出口管(51)向腔室(5)施加不同的压力。
合适的移动设备(58)(未示出)用于将膨胀流体移进和移出气球腔室(49)从而将创口渗出物移进和移出清洁工具(4)，如在图6中所指出的，该设备可以安装在圆顶(50)上面而不是衬层(3)上面。
在图10中，在电线圈(54)内部的电磁螺线管核芯(53)与衬层(3)接触在中心位置安装在刚性凸缘(55)上。电线圈(54)电连接到适当的交流电源(60)(示意性示出)。
腔室(5)在其底部提供有铁磁材料的连接盘(attached disc)(56)，所述连接盘(56)针对创口渗出物和清洁流体被包覆。
随着电流的方向交替变化，螺线管核芯跟随着变化，从而压缩和释放腔室(5)，因而导致创口渗出物被强迫进出清洁工具(4)。
图8和9示出了图1和4的装置(1)的变化形式。在两种情况下分别取代注射器和按钮泵的移动装置(7)是小蠕动泵或隔膜泵。所述移动装置(7)优选是电池驱动的小型便携式隔膜泵或蠕动泵，例如安装在衬层(3)中心位置的上面在腔室(5)之上并可释放的连接到衬层(3)。
图11示出了带有用于创口渗出物清洁的单相工具的装置，其中创口渗出物只以一个方向一次或多次通过清洁工具。在结构上其与图5-7和10中示出的装置相似。
装置(1)包括包含腔室(5)的清洁工具(4)，所述清洁工具(4)在这里是可适应中空袋，由衬层(3)和聚合物膜(6)限定，所述聚合物膜(6)是可透过的并且永久连接到衬层(3)靠近身体的那一面上。它含有吸收在弹性柔韧泡沫体(41)中的清洁流体。
回弹性柔韧泡沫体(41)包含在可透过薄膜(43)中并含有从创口渗出物螯合有害物质的物质。
这些整体模块形成清洁工具(4)。
出口管(69)在中心位置通过衬层(3)并连通腔室(5)内部和泵，所述泵例如优选是电池驱动的小型便携式隔膜泵或蠕动泵，例如安装在衬层(3)中心位置的上面在腔室(5)之上并可释放的连接到衬层(3)。
入口管(20)在边缘位置通过衬层(3)并连通创口空间和所述泵。
在使用中，创口渗出物被泵(7)移动通过清洁工具(4)，并且泡沫体(41)从创口渗出物螯合有害物质。
图12示出了具有用于创口渗出物清洁的两相工具的装置，其中清洁相移动。
图12a示出了其中只有清洁相移动的装置
图12b示出了其中清洁相和创口渗出物移动的装置。
在两个图中，装置(1)都包括包含腔室(5)的清洁工具(4)，在此处清洁工具(4)是在阵列中的细管的形式，在衬层(3)下面在第一凸出物(71)和第二凸出物(72)之间，所述第一凸出物(71)和第二凸出物(72)都安装在衬层(3)中。所述细管由聚合物薄膜制成并含有透析液流体，所述聚合物薄膜对创口渗出物中的有害物质是选择性可透过的。
入口管(20)从第一凸出物(71)通过并连通腔室(5)内部和泵(7)，所述泵例如优选是电池驱动的小型便携式隔膜泵或蠕动泵，例如安装在衬层(3)中心位置的上面在腔室(5)之上并可释放的连接到衬层(3)。出口管(21)从第二凸出物(72)通过并连通腔室(5)内部和泵(7)。
在使用中，透析液流体被泵(7)移动通过清洁工具(4)并且它从创口渗出物除去有害物质。
在图12b中，第三凸出物(78)具有在中心位置通过它的创口渗出物出口和第四凸出物(79)具有在中心位置通过它的创口渗出物入口，第三凸出物(78)和第四凸出物(79)都安装在衬层(3)的边缘并且相互正好相反地相对安装。
创口渗出物出口管(80)连接到第三凸出物(78)并连通创口内部和第二泵(82)(未示出)的入口，所述第二泵(82)优选是电池驱动的小型便携式隔膜泵或蠕动泵，安装在衬层(3)中心位置的上面。
创口渗出物入口管(81)连接到第四凸出物(79)并连通创口内部和第二泵的出口。
在使用中，不仅透析液流体被第一泵(7)移动通过清洁工具(4)，其中所述透析液流体从创口渗出物除去有害物质，而且创口渗出物相被第二泵以逆流方向在衬层(3)下面移动通过创口空间以增强从创口渗出物的除去。
图13示出了具有用于创口渗出物清洁的两相工具的装置，其中清洁相移动。
装置(1)包括包含腔室(5)的清洁工具(4)，所述清洁工具(4)在这里是袋的形式，在衬层(3)下面和在泡沫体填充物(81)下面。
所述袋由聚合物薄膜制成并含有透析液流体，所述透析液流体作为溶质或分散相物质种类含有用于螯合或降解来自创口渗出物的有害物质的物质。所述薄膜选择为是选择性可透过的，以允许被靶定螯合或破坏的有害物质物质种类从创口渗出物进入透析液的灌注，但不允许任何显著量的透析液流体相中的拮抗剂自由扩散出透析液进入创口流体。
出口管(89)通过衬层(3)并连通腔室(5)内部和泵，所述泵例如优选是电池驱动的小型便携式隔膜泵或蠕动泵，例如安装在衬层(3)中心位置的上面在腔室(5)之上并可释放地连接到衬层(3)。入口管(90)在边缘位置通过衬层(3)并连通腔室(5)和所述泵。
在使用中，透析液被泵(7)移动通过清洁工具(4)。被靶定螯合或破坏的有害物质物质种类从创口渗出物进入透析液，其中透析液流体相中的拮抗剂从创口渗出物除去有害物质而不扩散出来进入渗出物。
在图14中，示出了在结构上与图1和3中示出的装置相似的换向系统(创口渗出物至少以相反方向通过清洁工具一次)。
由溶液流铸或挤出形成的微生物不可透过的聚氨酯膜衬层(3)，负载有连接在中心位置的靠近身体凸出的凸出物(11)，该凸出物(11)带有用于连接到流体供应和排出小管(19)接合端的luer，小管(19)连通凸出物(11)内部和注射器筒体(20)，该筒体是注射器移动设备(7)的一部分。
下面的多孔膜(12)和中间多孔薄膜(13)，都是由带有小口或孔的可透过聚氨酯薄膜制成，限定了包含固体颗粒(未示出)的清洁腔室(15)。所述固体颗粒是用于从创口渗出物螯合有害物质，所述有害物质起始是从创口渗出物分离的。这些整体模块与共同延伸的不可透过上部片(24)形成上腔室(25)，并且所有这些一起形成清洁工具(4)，其中所述上部片(24)具有调整到与凸出物(11)中的管路相配合的上部口。上部片安装在凸出物(11)的下部面上并且所述上部口与凸出物(11)中的管路相配合。
在使用中，注射器活塞(22)的移动吸取并强迫创口渗出物来回通过清洁工具(4)。
图15中的装置(1)是循环系统(创口渗出物只以一个方向一次或多次通过清洁工具)。其是图8和9的装置(1)的变化形式。
由溶液流铸形成的微生物不可透过的聚氨酯膜衬层(3)，负载有连接在中心位置的靠近身体凸出的凸出物(11)，该凸出物(11)带有穿过它的均匀圆柱内腔管路和用于连接到流体供应小管(20)接合端的luer，小管(20)连通凸出物(11)内部和移动设备(7)的出口。
移动设备(7)是电池驱动的小型便携式隔膜泵或蠕动泵，安装在衬层(3)中心位置的上面并可释放的连接到衬层(3)。
带有用于连接到流体排出小管(83)接合端的luer的第二靠近身体凸出的凸出物(82)，安装在衬层(3)的边缘位置。流体排出小管(83)连通创口空间和泵(7)的入口。
下面的多孔膜(12)和中间多孔薄膜(13)，都是由带有小口或孔的可透过聚氨酯薄膜制成，限定了包含固体颗粒(未示出)的清洁腔室(15)，所述固体颗粒是用于从创口渗出物螯合有害物质，所述有害物质起始是从创口渗出物分离的。这些整体模块与共同延伸的不可透过上部片(24)形成上腔室(25)，并且所有这些一起形成清洁工具(4)，其中所述上部片(24)具有调整到与凸出物(11)中的管路相配合的上部口。上部片安装在凸出物(11)的下部面上并且所述上部口与凸出物(11)中的管路相配合。
在使用中，创口渗出物被泵(7)移动通过清洁工具(4)，并且所述颗粒(未示出)从创口渗出物螯合有害物质。
下面将通过举例方式仅以下述实施例说明本发明装置的用途：
实施例1：用图1的装置从水溶液清洁Fe(II)：单相手动注射器泵送的含有固体螯合剂的敷料(卡地姆-去铁胺)
组装如图14中所示的手工注射器泵送的敷料。清洁腔室(15)含有负载在卡地姆上的固体颗粒(未示出)去铁胺(50mg)以从替代渗出物中螯合并除去有害的Fe(II)离子。
多孔膜(12)和可透过薄膜(13)，都是由Porvair可透过薄膜制成，选择为在注射器泵送下允许灌注和流动通过所述清洁器但是含有所述固体反应剂。
在三次试验中，将如图1所示的敷料施用到9.60ml容积的环形创口空穴(浇铸在Perspex中)，所述创口空穴含有四水合氯化亚铁(Aldrich)水溶液(9.60ml，200μmolar)。
使用所述设备注射器将所述溶于重复地完全抽出并完全重新注回。在每一次抽出时，使用如下的ferrozine分析检验100微升量的溶液：将每100微升量的溶液立即加入1.5ml容积、含有1ml Ferrozine储备溶液(73.93mg Ferrozine用蒸馏水稀释至250ml(600μM))、光程长度1cm的UV比色皿中。在培养至少5min之后读取吸收率(562nm)读数。使用UNICAM UV4-100 UV-Vis分光光度计V3.32(序列号022405)测量吸收率。以4分钟为间隔，总共通过六次。在没有流动(即没有注射器泵送通过清洁器)的情况下重复同样的方法并在等同的时间点取样。
结果和结论
对得到的铁浓度曲线进行平均并确定标准偏差。在3个完全循环(12分钟)之后Fe(II)浓度被有效降低到背景水平。在对照试验中，在相同的时间周期内，没有发生显著的浓度变化。如图1中所示的敷料有效地从水溶液例如水、盐水或创口渗出物螯合Fe(II)。
实施例2：用图15的装置中和酸性溶液pH：单相再循环泵送的含有固体酸清除剂ScavengePore苯乙基吗啉的敷料。
组装如图15中所示的再循环泵送的敷料。清洁腔室(15)含有ScavengePore苯乙基吗啉(Aldrich)的固体颗粒(50mg)(未示出)，其是低膨胀大孔高度交联的聚苯乙烯/二乙烯基苯离子交换剂树脂基质，具有200-400微米的颗粒尺寸，用于从替代渗出物清除和除去质子，其中质子是不利地影响创口渗出物中pH的酸性物质种类。
多孔膜(12)和可透过薄膜(13)，都是由Porvair可透过薄膜制成，选择为在泵送下允许灌注和流动通过所述清洁器但是含有所述离子交换反应剂。
在三次试验中，使用三份4.80ml DMEM，设备2施用到9.60ml容积的环形创口空穴(浇铸在Perspex中)，所述创口空穴含有Dulbecco’s Modified Eagles Medium(DMEM)(Sigma)(4.80ml，使用盐酸(0.975N水溶液，75μl)调节pH到pH6.6)。剩余的空穴体积用玻璃珠填充。所述溶液以2.35ml min-1的流速循环通过空穴。在5min时间点取样100μl直到40min，并使用平板(flat-bed)pH计记录pH。在没有流动(即没有泵送循环溶液)的情况下重复同样的方法并在等同的时间点取样。
结果和结论
对得到的pH曲线进行平均并确定标准偏差。在40分钟内pH被有效地调节到pH7.4。在对照试验中，在相同的时间周期内观察到pH的变化较慢，pH变化到pH7。
实施例3：使用图12的装置利用扩散通过透析薄膜从水溶液清洁弹性蛋白酶：两相再循环泵送的不含反应剂的敷料
组装如图12所示的再循环泵送的敷料。清洁腔室(5)是细管的形式，所述细管由对创口渗出物中的有害物质(弹性蛋白酶)是选择性可透过的聚合物薄膜制成。这些细管排成阵列，在衬层(3)下面在创口空间之内位于第一凸出物(71)和第二凸出物(72)之间，第一凸出物(71)和第二凸出物(72)都安装在衬层(3)之中。所述细管含有透析液流体并且与泵(7)处于环路之中。
在三次试验中，将如图12中所示的敷料施用到9.60ml容积的环形创口空穴(浇铸在Perspex中)，所述创口空穴含有弹性蛋白酶溶液(猪胰腺弹性蛋白酶，Sigma)(4.80ml，0.5mg ml-1在TRIS缓冲液中，pH8.2，0.2M)。剩余的空穴体积用玻璃珠填充。入口和出口端口连接到循环泵。
所述透析液系统预填充有TRIS(pH8.0，0.2M)。透析液以2.35mlmin-1的流速循环通过敷料。在5min时间点取10μl循环溶液样品直到45min，并使用标准N-琥珀酰基-(丙氨酸(ala))3-对硝基苯胺比色测试测量活性。在没有流动(即没有泵送循环溶液)的情况下重复同样的方法并在等同的时间点取样。
结果和结论
使用UV/Vis分光光度计从样品在405nm的吸收率测定样品活性。平均结果并确定标准偏差。在45分钟内发现弹性蛋白酶通过透析薄膜的有效转移。在对照试验中，在相同的时间周期内没有发现有效的转移。
实施例4：使用图13的装置从水溶液清洁Fe(II)：两相再循环泵送的含有液体相螯合剂(淀粉-去铁胺(DFO)结合物(conjugate))的敷料
组装图13中装置(1)的类似装置，即具有循环系统(创口渗出物只以一个方向一次或多次通过清洁工具)，该循环系统具有用于创口渗出物清洁的两相工具，其中清洁相移动。
装置(1)包括清洁工具(4)，清洁工具(4)包括由聚合物薄膜制成并含有透析液流体的腔室(5)，所述透析液流体作为溶质或分散相物质种类含有用于从创口渗出物螯合或降解有害物质的物质。
所述薄膜选择为是选择性可透过的，以允许被靶定螯合或破坏的有害物质物质种类从创口渗出物进入透析液的灌注，但不允许任何显著量的透析液流体相中的拮抗剂自由扩散出透析液进入创口流体。
所述类似装置是含有0.5-1.0ml容积的Slide-A-Lyzer透析单元的回路，所述透析单元具有上腔室和下腔室其中创口渗出物和清洁流体被聚合物薄膜相互分开，所述聚合物薄膜选择为具有上述性质(MWCO10000)。
清洁流体通过的下腔室，具有斜对着相对放置的用针打开的入口和出口端口，所述端口连接到5ml容积的回路，所述回路包括透析液储室和电池驱动的小型便携式隔膜泵或蠕动泵。所述回路含有高分子量淀粉-DFO结合物水溶液(5ml，4mg/ml)。
将等分量的四水合氯化亚铁(Aldrich)溶液(0.5ml 3mM)放入slide的上空穴中并用回路中3.6ml/min的流动进行透析，并且(作为对照)在回路中没有流动的情况下进行透析。
间隔以5分钟在30分钟内(包括t＝0)每次取样10微升等分量。使用上述实施例1中描述的ferrozine铁(II)测试方法测定所述10微升等分量的溶液。这些试验平行进行三次。
结果和结论
对得到的铁浓度曲线进行平均并确定标准偏差。在30分钟内Fe(II)浓度被有效降低到起始水平的约50％。在相同的时间周期内，在没有回路流动的情况下，Fe(II)浓度被有效降低到起始值的约75％。

Claims (10)

1.用于清洁创口的装置，包括
可适应创口敷料，具有
衬层，其能够在创口上形成相对流体不漏的密封或闭合，和
特征在于该装置还包括
a)用于从创口渗出物选择性除去对创口愈合有害的物质的清洁工具，该工具在衬层下面并且使用中安置在下面的创口中和
b)在清洁工具内移动流体的移动设备，和
c)任选的用于排放该清洁工具的排放工具。
2.权利要求1的用于清洁创口的装置，特征在于所述装置是单相系统，其中被移动通过流体清洁工具的流体是任选与冲洗剂混合的创口渗出物，所述创口渗出物进入、通过并流出清洁工具回到创面。
3.权利要求1的用于清洁创口的装置，特征在于所述装置是多相系统，其中流体清洁工具包括含有清洁流体的腔室，所述清洁流体借助于可透过整体模块与创口渗出物分开，和所述清洁流体和/或任选与冲洗剂混合的创口渗出物被移动流体的设备移动通过该流体清洁工具。
4.权利要求1的用于清洁创口的装置，特征在于所述装置是作为循环系统操作，其中相关流体只以一个方向一次或多次通过所述清洁工具。
5.权利要求1的用于清洁创口的装置，特征在于所述装置是作为换向系统操作，其中相关流体至少一次以相反方向通过所述清洁工具。
6.权利要求3的用于清洁创口的装置，特征在于移动流体只是所述清洁流体。
7.权利要求3的用于清洁创口的装置，特征在于移动流体是所述清洁流体和任选与冲洗剂混合的创口渗出物。
8.权利要求3的用于清洁创口的装置，特征在于所述可透过整体模块对于创口渗出物中的对创口愈合有害的物质是选择性可透过的。
9.权利要求3的用于清洁创口的装置，特征在于所述可透过整体模块不是对于对创口愈合有害的物质是选择性可透过的整体模块，并且特征在于在清洁流体中，或在一个或多个具有至少一个与清洁流体接触的表面的固体整体模块中，在流体清洁工具中，存在一种或多种能够除去创口渗出物中对创口愈合有害的物质的物质。
10.使用权利要求1的清洁创口装置治疗创口以促进创口愈合的方法。
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