CN1732028A - 抽吸、冲洗和净化创伤用装置 - Google Patents

抽吸、冲洗和净化创伤用装置 Download PDF

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CN1732028A
CN1732028A CNA2003801078427A CN200380107842A CN1732028A CN 1732028 A CN1732028 A CN 1732028A CN A2003801078427 A CNA2003801078427 A CN A2003801078427A CN 200380107842 A CN200380107842 A CN 200380107842A CN 1732028 A CN1732028 A CN 1732028A
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wound
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P·L·布洛特
B·格林纳
E·Y·哈特维尔
T·M·沃尔克
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Smith and Nephew PLC
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Abstract

本发明提供了一种净化创伤的装置，其中来自与共形性创伤敷料(3)连接的储存器(12)的冲洗流体和来自敷料的创伤渗出物通过用于使流体移动通过流路的设备(18)进行再循环，所述流路穿过敷料和流体净化机构(17)并返回到敷料。净化机构(该净化机构可以是单相系统如微滤系统，或双相系统如渗析系统)除去对创伤愈合有害的物质，并使仍包含对促进创伤愈合有益的物质的净化过的流体返回到创伤层。本发明提供了敷料和使用该装置的治疗方法。

Description

抽吸、冲洗和净化创伤用装置
本发明涉及抽吸、冲洗和/或净化创伤用装置和医用创伤敷料，和使用这种抽吸、冲洗和/或净化创伤用装置处理创伤的方法。
本发明具体涉及的装置、创伤敷料和方法可容易地应用于多种创伤，特别是长期创伤，以净化创伤，除去对创伤愈合有害的物质，同时保留在某些治疗方面有益的物质，特别是对创伤愈合有益的物质。
在本发明之前，用于此目的的抽吸和/或冲洗装置为已知的，多用于除去创伤治疗过程中的创伤渗出物。在这种创伤治疗的已知形式中，来自创伤、特别是处于高度渗出状态的创伤的排除物作为废液被排放到如收集袋中。
使用这种方法除去对创伤愈合有害的物质。
然而，当进行这种治疗时，对于促进创伤愈合有益的物质，如来自创伤渗出物的生长因子、细胞基质组分、和其它生理学活性组分也离开了它们的可能最有利的位置，即创伤层。
这种已知的创伤敷料和抽吸和/或冲洗治疗系统形式经常在敷料下产生可能导致丧失身体自身组织愈合过程的最佳性能，并推迟愈合和/或导致不具有良好地结合于创伤层并从创伤层上长成的强壮三维结构的弱的新组织生长的创伤环境。这是显著的缺点，特别是在长期创伤中。
因此，希望能够提供一种治疗系统，其能够从创伤渗出物除去对创伤愈合有害的物质，同时保留对促进创伤愈合有益的物质与创伤层接触。
渗析为体外处理体液如血液以从其中除去对全身有害的物质的已知方法。渗析的主要目的是通过与渗析液接触除去这种物质，同时还保留如血液、细胞和蛋白质的物质。其它可能具有附加的积极治疗作用的物质有可能通过对该物质可渗透的渗析膜而从系统中损失。因而在循环体液中余量的这种物质就可能被耗尽。
希望提供一种治疗系统，其可从创伤渗出物除去对创伤愈合有害的物质，而基本上不稀释与创伤层接触的对促进创伤愈合有益的物质，所述治疗系统可同时连续地提供这种物质并使其再循环到达创伤。
因为处理过的流体返回到体内，所以用于处理体液的渗析还是一种全身治疗。
这与其中将处理过的流体在体外再循环到如创伤的局部治疗不同。
大多数渗析还需要大量体液如血液，因此使相关的设备不便移动。
即使在高度渗出状态下，与身体内部系统相比，长期创伤产生相对少的待处理流体，并且需要在创伤和/或创伤环境中保留的在某些治疗方面有益的物质也相对较少。
本发明的一个目的是
a)避免已知的抽吸和/或冲洗治疗系统的上述缺点中的至少一些缺点，和
b)提供可从创伤渗出物除去对创伤愈合有害的物质，同时保留与创伤层接触的对促进创伤愈合有益的物质的治疗系统。
本发明的另一个目的是
a)避免已知的渗析系统的上述缺点中的至少一些缺点，和
b)提供可从创伤渗出物除去对创伤愈合有害的物质，同时保留与创伤层接触的对促进创伤愈合有益的物质治疗系统，
c)不全身性地影响身体。
本发明的又一个目的是
a)避免已知的渗析系统的上述缺点中的至少一些缺点，和
b)提供可从创伤渗出物除去对创伤愈合有害的物质，同时保留与创伤层接触的对促进创伤愈合有益的物质治疗系统，
c)便携式的。
对创伤下及创伤周围组织的血管供应及在所述组织中的循环经常受到损害。本发明的另一个目的是提供一种治疗系统，其保留和提供治疗活性量的如下物质，该物质对改变这种损害作用有益，同时除去有害物质，从而促进创伤愈合。
因此，本发明的第一方面提供抽吸、冲洗和/或净化创伤用装置，其特征在于该装置包括：
a)流体流路，其包括
i)共形性(conformable)创伤敷料，其具有
能够在创伤上形成相对不透流体的密封或封闭的背衬层，和
至少一个用于与流体供给管连接的入口管，其穿过面对创伤的面和/或在面对创伤的面之下，和
至少一个用于与流体排出管连接的出口管，其穿过面对创伤的面和/或在面对创伤的面之下，
该或每个入口管和该或每个出口管穿过面对创伤的面和/或在面对创伤的面之下的点，所述面对创伤的面在创伤上形成相对不透流体的密封或封闭，
至少一个与流体循环管连接的入口管，和
至少一个与流体排出管连接的出口管；以及
ii)流体净化机构，其具有至少一个与流体排出管连接的入口和至少一个与流体循环管连接的出口；
b)通过第二流体供给管与整个流路连接的流体储存器(选择性地或根据需要借助于在供给和循环之间的流动转换机构)；
c)用于使流体移动通过创伤敷料和流体净化机构、和选择性地或根据需要通过流体供给管的设备；和
d)选择性地用于泄放(bleeding)流路的机构，
使流体经由流体供给管(选择性地或根据需要借助于流动转换机构)从流体储存器被供应填充流路，并通过设备循环通过流路。
在供给和循环之间的流动转换机构可采取能够使创伤同时实现以下状态的形式：
a)与流体储存器相通，但是
b)对流体循环管关闭，和
c)反之亦然。
因此，如果只有一个入口管穿过创伤敷料的面对创伤的面和/或在面对创伤的面之下，则借助于根据需要使流体进入流体循环管或流体排出管中的流动转换机构通过流体供给管使流体储存器与流路连接。
在这种情况下，在供给和循环之间的流动转换机构可为调节器，如三通阀。其依次与流体循环管或流体排出管和流体供给管两部件连接，从而实现所需的在供给和循环之间的流动转换。
如果有两个或多个入口管，其可分别与流体供给管或流体循环管连接，流体供给管或流体循环管分别具有第一调节器和第二调节器如阀或其它允许流体进入创伤内的控制设备。
通过分别打开第一调节器同时关闭第二调节器实现所需的在供给和循环之间的流动转换，反之亦然。
用于泻放流路的机构可位于与冲洗液和/或创伤渗出物接触的装置的任何适当的部件中，但通常位于排出管和/或循环管中。然而，尽可能使其在储存器和流体供给管的下游并远离储存器和流体供给管，使得其可用于从流体储存器经由流体供给管灌注(prime)整个流路。
转动调节器如阀或其它控制设备如三通阀，在泻放和循环之间转换，用于从装置泻放流体到如废液储存器如收集袋中。
或者，可能不需要在供给和循环之间的流动转换，而是需要共存的泻放和/或循环。
当循环中冲洗液和/或创伤渗出物的量由于持续加入以下物质而增加时可能发生后者的情况
a)创伤渗出物，和/或
b)从清洗液穿过例如系统如渗析单元中的选择渗透性整体(integer)的流体。
然后可提供用于泻放排出管和/或循环管的机构，其可为调节器，如简单的阀或其它控制设备，允许或阻止冲洗液和/或渗出物穿过由循环通路分支出来的泻放管线的路径。
流体净化机构可根据需要为“单相系统”。
这其中，来自创伤和流体储存器的循环流体通过自备系统，在该自备系统中除去对创伤愈合有害的物质并使仍包含对促进创伤愈合有益的物质的净化流体经由循环管返回到创伤层。这种系统结合流体净化机构在下文中进一步详述。
或者，如果合适，可以提供两相系统的形式，如渗析单元、或二相液体提取单元。
这其中，来自创伤和流体储存器的循环流体穿过其中流体循环间接接触或(在较少情况下直接)接触第二流体(渗析液)相的系统，在更多情况下所述第二流体(渗析液)相为液体，在该系统中除去对创伤愈合有害的物质并使仍包含对促进创伤愈合有益的物质的净化过的流体经由循环管返回到创伤层。这种系统结合流体净化机构在下文中进一步详述。
通常，在使用中，在供给和循环管之间的流动转换机构设定为允许流体从流体储存器进入创伤中，使创伤对流体循环管封闭。
然后，打开用于泻放排出管和/或循环管的任何机构，并开动使流体移动通过创伤的设备和流体净化机构。
装置流路的容量和冲洗液和/或来自创伤的创伤渗出物的流量主要决定了是否适合运行设备以在装置流路的整个长度内灌注装置，即，从流体循环通路置换任何存在的流体储备(经常是空气)，和运行多久。通常，来自流体储存器的冲洗液比循环中的创伤渗出物多得多，因此使用使流体移动通过创伤的设备适合这种目的。
可以运行设备直到在装置流路的整个长度内灌注装置。
然后，通常关闭用于泻放排出管和/或循环管的机构，并设置在供给和循环管之间的流动转换机构使创伤对流体储存器关闭，而允许流体从流体循环管进入创伤中。
如果流体净化机构为两相系统如渗析单元、或两相提取单元，通常净化流体设置为与选择渗透性整体如聚合物膜、片或薄膜的表面运动接触。当然，在较少的情况下清洗液可能为静态的，那么则省略这个步骤。
如以下更具体的描述，在循环中，可通过连续加入以下物质而增加冲洗液和/或来自创伤的创伤渗出物的量
a)创伤渗出物，和/或
b)清洗液穿过两相系统如渗析单元的选择渗透性整体如聚合物膜、片或薄膜而得到的流体。
另外地或作为替换地，希望借助于使流体移动通过创伤和流体净化机构的设备对创伤施加负压力，所述设备作用于在创伤敷料下游并远离创伤敷料的流体循环管中循环的流体。
在这种情况中，希望提供其中可同时进行泻放和/或循环的系统，并希望进行必要的调整，以借助于用于泻放排出管和/或循环管的机构保持循环中所需的流体平衡。
在循环中，冲洗液和/或来自创伤的创伤渗出物的量可由于在清洗液穿过例如系统如渗析单元中的选择渗透性整体时流体持续损失而减少。
另外地或作为替换地，希望借助于用于使流体移动通过创伤和流体净化机构的设备对创伤施加正压力，所述设备作用于在创伤敷料上游并朝向创伤敷料的流体循环管中循环的流体。
可类似地以其中可同时进行供应和/或循环的形式提供在供给和循环之间的流动转换机构，并且进行必要的调整，以借助于流动转换机构保持循环中所需的流体平衡。
可以理解，当对创伤施加正压力或负压力时，在朝向和离开创伤层的循环流路中的至少一个空心体应具有足够对抗压力的回弹性，使得冲洗液能够发生任何显著的压缩或减压。
在装置的所有实施方案中，在本文中举例说明的适用于本发明的这种体(其由膜、片或薄膜限定)的类型和材料将在很大程度上具有这种功能。
因此，充满冲洗液并由膜、片或薄膜限定的体，如入口管或排出管和/或循环管，和如袋、室和小袋的结构，以及如创伤敷料的背衬层的物体的适当材料的例子为当以这种方式施加压力时可能发挥这种功能的适当地弹性回弹的热塑性材料。
在这个方面，本发明具有几个优点。
一个优点是对背衬层下的创伤施加正压力有可能使一种或多种生理学活性组分涌入创伤下的组织。
这可能在治疗活性量下起作用，与单独用流体生理学活性组分处理时相比，可促进更大的创伤愈合。
渗出物中这种有益于创伤愈合的生理学活性组分可为例如酶或其它物质，其可由流体净化用渗析机构的渗析液体提取供。
认为周期地使用本发明的抽吸、冲洗和/或净化创伤用装置可进一步增强作用。
创伤流体的循环有助于与创伤愈合有关的生物信号分子运动到有利于创伤愈合过程的创伤层中和/或运动到在例如高度渗出的创伤中所述分子不能与之接触的细胞中。
在本发明第一方面的抽吸、冲洗和/或净化创伤用装置的那些实施方案中尤其如此，其中有入口总管或出口总管，从这些总管，细管辐射并伸展到创伤层并以开口终止，这些细管在增大的面积范围内直接向创伤层递送流体和从创伤层收集流体。
这些物质包括细胞因子、酶、帮助创伤细胞增殖的营养物质、氧气和有利于创伤愈合的其它分子如生长因子、和有助于导致趋化性的有益作用(其可被进一步增强)的其它物质。
在本发明第一方面的抽吸、冲洗和/或净化创伤用装置的所有实施方案中，特别的优点在于创伤敷料具有与使用该创伤敷料的身体部分共形的倾向。
创伤敷料包括具有面对创伤的面的背衬层，所述面对创伤的面能够在创伤上形成相对不透流体的密封或封闭；和
至少一个用于与流体供给管或循环管连接的入口管，其穿过面对创伤的面和/或在面对创伤的面之下，和
至少一个用于与流体排出管连接的出口管，其穿过面对创伤的面和/或在面对创伤的面之下，
该或每个入口管和该或每个出口管穿过该形成相对不透流体的密封或封闭的面对创伤的面和/或在面对创伤的面之下的点。
本文中使用的术语“相对不透流体的密封或封闭”表示其为不透流体和不透微生物并允许最多50％大气压的正压力或负压力，更通常为最多15％大气压施加于创伤。本文中使用的术语“流体”包括凝胶类物质如浓稠的渗出物、液体如水、和气体如空气、氮气等。
使用的背衬层的形状可为任何适合在整个创伤区域内抽吸、冲洗和/或净化创伤的形状。
这种形状的例子包括基本上扁平的膜、片或薄膜，或袋、室、小袋、或背衬层的其它结构，如可以是包含流体的聚合物膜。
背衬层可为膜、片或薄膜，其厚度(通常是均一厚度)通常为最大100微米，优选最大50微米，更优选最大25微米，最小为10微米。
其最大跨越尺寸为最大500毫米(例如用于大的躯干创伤)、为最大100mm(例如用于腋窝和腹股沟的创伤)、和用于四肢为最大200毫米(例如用于长期创伤，如静脉性腿溃疡和糖尿病性足溃疡)。
希望敷料可为回弹性变形的，因为这可增加患者的舒适度，减少创伤发炎的危险。
用于此目的的材料包括不吸收含水流体的合成聚合物材料，如聚烯烃如聚乙烯如高密度聚乙烯、聚丙烯及其与例如乙酸乙烯酯和聚乙烯醇的共聚物、及其混合物；聚硅氧烷；聚酯，如聚碳酸酯；聚酰胺，如6-6和6-10，和疏水性聚氨酯。
它们可以是亲水性，因此还包括亲水性聚氨酯。
它们还包括热塑性弹性体和弹性体共混物，例如共聚物如醋酸乙基乙烯酯共聚物，该共聚物任选地或根据需要与高抗冲聚苯乙烯共混。
它们还包括聚氨酯弹性体，特别是通过溶液浇注形成的聚氨酯。
用于本发明的创伤敷料的优选材料包括热塑性弹性体和可固化系统。
背衬层能够在创伤上和/或在入口管和出口管周围形成相对不透流体的密封或封闭。
然而，特别是沿着创伤敷料的外围，在相对不透流体的密封的外侧，优选具有高湿气透过性的材料，以防止创伤周围皮肤发生浸渍。其还可是当与液体如水、血液或创伤渗出物接触时具有较高的湿气透过性的可转换材料。这可为例如在Smith & Nephew的AllevynTM、IV3000TM和OpSiteTM敷料中使用的材料。
背衬层面对创伤的面的外围可具有例如粘性膜，用于使背衬层附着于创伤周围的皮肤上。
可使用例如压敏粘合剂，条件是该粘合剂足够使创伤敷料沿着创伤敷料面对创伤的面的外围呈不透流体的密封地保持在适当位置。
作为替换地或另外地，适当时，可使用光转换粘合剂以确保敷料在适当位置上防止渗漏(光转换粘合剂是其粘性通过光固化而降低的粘合剂。使用该粘合剂可以有助于减少除去敷料时的损伤)。
因此，背衬层可具有在背衬层的最近面的周围延伸、由透明或半透明材料制成的凸缘或唇缘(可以理解，上述材料也属于适用于此目的的材料之中)。
其带有光转换粘合剂膜以确保敷料在适当位置上，防止在其最近面上渗漏，并在其远面上带有不透明材料层。
为了除去敷料而不在除去敷料时引起过度损伤，在对凸缘或唇缘施加适当波长的辐射之前，除去在邻近创伤的周围延伸的凸缘或唇缘的远面上的不透明材料层。
如果在相对不透流体的密封外侧、带有使其附着于创伤周围的皮肤上的粘性膜的创伤敷料的外围为具有高湿气透过性的材料或为可转换材料，那么，如果粘性膜为连续的，其也应为高湿气透过性或可转换湿气透过性，如用于Smith & Nephew的AllevynTM、IV3000TM和OpSiteTM敷料中的粘合剂。
当施加真空使创伤敷料沿着创伤敷料面对创伤的面的外围呈不透流体的密封地保持在适当位置时，创伤敷料可具有硅氧烷凸缘或唇缘，以密封创伤周围的敷料。其免去了对粘合剂的需要，也不会损伤患者的皮肤。
当敷料内部以及流到和通过敷料的冲洗液和/或创伤渗出物流处于任何显著的正压力下时，正压力倾向作用于外围点以升起并从创伤周围的皮肤除去敷料。
因此在装置的这种用法中，必须在创伤上提供用于形成并保持这种密封或封闭、对抗这种创伤上的正压力的机构，以便为此目的在周边点发挥作用。
这种机构的例子包括上述的光转换粘合剂，以确保敷料处于适当位置防止渗漏。
因为光转换粘合剂的粘性被光固化降低，因此减少了除去敷料时的损伤，如上所述，因而在例如凸缘上可使用侵蚀性更强的粘合剂的膜。
对于在其中对患者皮肤的损伤是可容许的更极端条件中使用的适当流体粘合剂的例子包括基本上由氰基丙烯酸酯等组织粘合剂组成的粘合剂，其施用于创伤边缘的周围和/或创伤敷料的背衬层的最近面，例如凸缘或唇缘上。
这种机构的其它适当例子包括粘性(如压敏粘合剂)和非粘性、弹性和非弹性的带、条、圈、窄条、结、绷带如压缩绷带、片、罩、套筒、夹套、鞘、包裹、袜子和管如弹性的长管或弹性的直统袜，当以这种方法进行治疗时将其压配到肢体创伤上，用于施加合适的压力；和可膨胀的封套、套筒、夹套、裤、鞘、包裹、袜子和管，当以这种方法进行治疗时将其压配到肢体创伤上，用于施加合适的压力。
这种机构各自布置于创伤敷料上，延伸超过创伤敷料的背衬层的周边，并视情况而定粘合或附着于创伤周围的皮肤和/或创伤本身，并视情况而定施加压缩(如使用弹性绷带、袜子)到足够使创伤敷料沿着创伤外围呈不透流体的密封地保持在适当位置。
这种机构各自可与敷料的其它组件特别是与背衬层成为一体。
或者，可使用例如粘性膜将这种机构永久性附着于或可拆卸地附着于敷料，特别是附着于背衬层，这些组件可为VelcroTM，彼此推动搭锁或扭锁配合。
机构和敷料可为单独的彼此未永久性附着的结构。
在用于创伤上的更高正压力的更适合的设计中，坚硬的凸缘或唇缘沿着如上定义的创伤敷料背衬层的最近面的周围延伸。
凸缘或唇缘在其最近面上为凹面，以限定周边的通道或管道。
其具有穿过凸缘或唇缘的吸力出口，以与通道或管道相通，并可连接于施加真空的设备上，如泵或真空管式输送供应装置。
可通过例如热封使背衬层与在其最近面周围延伸的凸缘或唇缘成为一体或将二者附着。
为在创伤上形成相对不透流体的密封或封闭，并防止冲洗液和/或渗出物从创伤敷料面对创伤的面的外围下方通过，在使用装置时，设置敷料在创伤周围的皮肤上。
然后设备对凸缘或唇缘内部施加真空，从而在创伤周围的外围点处形成并保持对抗创伤上的正压力的密封或封闭。
对于上述的附着机构、和在创伤周围外围点处形成并保持对抗创伤上的正压力或负压力的创伤上方的密封或封闭的机构，优选创伤敷料密封的外围为近似圆形，如椭圆形，特别是圆形。
为了在创伤上和在入口管和出口管穿过面对创伤的面和/或在面对创伤的面之下的点处的入口管和出口管周围形成相对不透流体的密封或封闭，可使背衬层与这些其它组件成为一体。
作为替换，组件只是彼此推动、搭锁或扭锁配合，或粘附或热封在一起。
该或每个入口管或出口管可为孔的形式，如漏斗、洞、开口、孔口、锁口、缝或气口，作为凹型部件分别与流体循环管和/或流体供给管的匹配端连接：
(任选地或根据需要，通过用于形成管子、导管或管、或管口、洞、开口、孔口、锁口、缝或气口的机构，作为凸出部件分别与流体循环管和/或流体供给管的匹配端连接(任选地或根据需要，通过在供给和循环之间的流动转换机构)或
流体排出管。
在组件成为一体的情况中，它们通常由同样的材料制成(可以理解，上述材料也包括在所适用的材料中)。
或者，在它们为推动、搭锁或扭锁配合的情况中，它们可为相同的材料或不同的材料。在两种情况中，上述材料包括在适用于所有组件的材料中。
该或每个管通常穿过背衬层而不是在背衬层下面。在这种情况中，背衬层通常可具有坚硬的和/或不可回弹性弯曲的或刚性的区域，以抵抗该或每个管与该或每个匹配管之间的任何巨大作用，或抵抗在压力下在任何方向上的变形。
通常可通过在用于将与流体循环管和/或流体供给管或流体排出管的匹配端连接的每个相关的管子、导管或管、或管口、洞、开口、孔口、锁口、缝或气孔的周围远侧(从创伤向外)凸出的凸起部使其增强、加强或强化。
作为替换地或另外地，在适当的情况下，背衬层可具有在背衬层最近面周围延伸的刚性凸缘或唇缘，以增强、加强或强化背衬层。
创伤敷料在创伤中使用的背衬层下可不包括任何整体。
然而，这不可能提供将冲洗液在足够的功能表面内分布、以便以实用的速率冲洗创伤的系统。为了适合使用，特别是在具有较高浓度的对创伤愈合有害的物质的长期创伤渗析中使用，可有利地提供其中创伤冲洗液和/或创伤渗出物能够更均匀地分布、或在创伤层上的敷料下以更盘旋的通路通过的系统。
因此，一种形式的敷料提供“树枝”状管、导管或细管，其从入口总管向创伤层辐射并以孔终止，通过孔直接将循环流体向创伤层递送。类似地，有其中细管向创伤层辐射并以开口终止并从创伤层直接收集流体的出口总管。
分别从入口总管或出口总管辐射出来的管等在使用中可规则地或不规则地通过创伤，但优选以规则方式通过创伤。用于较深创伤的更适合的设计为其中管等向创伤层以半球状同心辐射。
对于较浅的创伤，管等的这种设计的适合形式的例子包括其中管等向创伤层以扁平的半椭圆形同心辐射的设计。
管等的这种设计的适合形式的其它例子包括管、导管或细管在入口管和/或出口管穿过覆盖创伤层的背衬层面对创伤的面和/或在面对创伤的面之下的点从入口管和/或出口管伸出的那些。这些可具有沿着管等具有穿孔、孔、洞、开口、孔口、裂缝或缝的盲孔。
然后，这些管等有效地形成分别将循环流体直接向创伤层递送的入口总管或从创伤直接收集流体的出口总管。
其通过在背衬层下的大部分创伤层上的管、导管、细管等的洞、开口、孔口、裂缝或缝进行上述递送或收集。
可能希望管、导管或细管是在创伤中和在创伤敷料内部具有良好共形性的有回弹弹性的弹性体结构，优选柔软的结构。
当用这种方式进行治疗时，管、导管、细管等的设计可取决于创伤的深度和/或容积。
因此，对于较浅的创伤，管、导管、细管等的这种设计的适合形式的例子包括基本上由螺旋状的一个或多个管等形成的那些形式。
当用这种方式进行治疗时，对于较深创伤，更适合的设计可为包括螺旋体状或螺旋式螺旋体状的一个或多个管等的那些形式。
对于较浅创伤的其它适当的设计包括在使用敷料时在创伤中循环流体、具有盲孔的穿孔入口总管或出口总管的那种。
这其中的一种或两种都可为这种形式，另一种可为例如一个或多个直型盲孔、穿孔辐射管、导管或管口。
另一个适合的设计为其中
分别通过入口管、导管或细管和/或出口管、导管或细管，将循环流体直接向创伤层递送或直接从创伤收集流体的入口总管和/或出口总管，和
通过以层叠方式彼此永久性附着的层中的缝隙形成入口总管和/或出口总管，和
通过以层叠方式彼此永久性附着的层中的孔形成入口和/或出口管、导管或细管(在图10a中表示了这种层叠体的分解立体图，其是非限制性的)
如本文中提及的，使用的背衬层可以是适合本发明的治疗系统并允许对创伤施加最多50％大气压、通常为最多25％大气压的正压力或负压力的任何背衬层。
因此其通常为不透微生物的膜、片或薄膜，其基本上扁平的，取决于作用于其上的任何压差，其厚度(通常为均一厚度)通常类似于常规创伤敷料中所用的这种膜或片的厚度，即为最大100微米，优选为最大50微米，更优选为最大25微米，最小为10微米。
背衬层通常可具有坚硬的和/或不可回弹性弯曲的或刚性的区域，以抵抗没有互相成为一体的其它组件之间的任何巨大作用，其可通过例如凸出的凸起部而增强、加强或强化。
敷料的这种形式不会与创伤层非常共形，其可有效地形成由背衬层和背衬层下的创伤层限定的室、空穴或腔。
希望创伤敷料的内部与创伤层、尤其是与处于高度渗出状态下的创伤共形。因此，所提供的一种敷料形式在背衬层下具有创伤填充物。
其有利地为与创伤形状具有良好共形性的有回弹性的如弹性体的结构，并优选柔软的结构。
其通过其自身抵靠背衬层的回弹性推动，对创伤层施加温和的压力。
创伤填充物可以与敷料的其它组件成为一体，特别是与背衬层成为一体。
或者，可以使用例如粘性膜、或例如通过热封使创伤填充物与所述组件附着，例如与从最近面伸出的凸缘或唇缘永久性附着，从而使得所需创伤上相对不透流体的密封或封闭不会破裂。
在较少的情况中，使用例如粘性膜使创伤填充物可拆卸地附着于背衬层，或这些组件可彼此为推动、搭锁或扭锁配合。
创伤填充物和背衬层可以是彼此未永久性附着的单独的结构。
创伤填充物可以是或可以包括对创伤形状具有良好共形性的固体整体，优选有回弹弹性的如弹性体结构，并优选柔软的结构。
这种创伤填充物的适当形式的例子为由适当材料如弹性热塑塑料形成的泡沫。用于本发明的创伤敷料的优选材料包括具有小孔或微孔的网状过滤聚氨酯泡沫。
作为替换地或另外地，其可以是或可以包括一个或多个由膜、片或薄膜限定的共形性空心体，如袋、室、小袋或其它结构，其中充满了推动空心体使其与创伤形状共形的流体或固体。
膜、片或薄膜的厚度(通常为均一厚度)通常类似于常规创伤敷料背衬层所用的膜或片的厚度。
也就是说，厚度为最大100微米，优选为最大50微米，更优选为最大25微米，最小为10微米，并经常是有回弹弹性的如弹性体的，优选是柔软的。
这种填充物通常与敷料的其它组件成为一体，特别是与背衬层成为一体，或使用例如粘性膜或通过热封使其永久性附着于其它组件如凸缘上。
在由膜、片或薄膜限定的空心体中包含的适当流体的例子包括处于超过大气压的小的正压力下的气体如空气、氮气和氩气，更通常为空气；和液体如水、盐水。
例子还包括凝胶如硅氧烷凝胶，如CaviCareTM凝胶，或优选纤维素凝胶，例如亲水性交联纤维素凝胶，如IntrasiteTM交联的材料。例子还包括气溶胶泡沫，其中气溶胶系统的气相为出于超过大气压的小的正压力下的空气或惰性气体如氮气或氩气，更通常为空气，和固体粒子如塑料屑。
当然，如果背衬层具有充分的共形性和/或例如为凹陷的碟形片，则背衬层可位于创伤填充物下方，而不是在创伤填充物上方。
在上述设计类型中，为了使创伤填充物朝向创伤层推动创伤敷料，创伤填充物必须牢固地粘附或可拆卸地附着于创伤周围的皮肤。这在其中创伤填充物和背衬层为彼此未永久性附着的单独的结构的那些实施方案中尤其如此。
当用这种方法进行治疗时，在用于较深创伤的这种设计中，用于这种附着的机构也可在创伤上形成和保持密封或封闭。
当填充物在背衬层上面并且流体入口管和出口管穿过背衬层面对创伤的面时，入口管和出口管可贯穿背衬层上面的创伤填充物或在创伤填充物周围。
提供的一种敷料形式在背衬层下面具有创伤填充物，所述创伤填充物是或包括由膜、片或薄膜限定的有回弹弹性的如弹性空心体、优选柔软的空心体，如具有孔、洞、开口、孔口、裂缝或缝、或管、导管、细管或管口的袋、室、小袋或其它结构。空心体通过至少一个孔、洞、开口、孔口、裂缝或缝与至少一个入口管或出口管相通。
然后空心体中包含的流体可以是装置中的循环流体。
然后，空心体或每个空心体有效地形成入口总管或出口总管，该入口总管或出口总管经由膜、片或薄膜中的洞、开口、孔口、裂缝、或缝等，或管、导管或管子等分别直接将循环流体向创伤层递送或直接从创伤收集流体。
当用这种方法进行治疗时，填充物的类型也可能在很大程度上由创伤的深度和/或容量决定。
因此，对于较浅的创伤，作为创伤敷料的组件的适当创伤填充物的例子包括基本上由一个或多个共形空心体组成的那些，所述共形空心体限定了直接将循环流体向创伤层递送或直接从创伤收集流体的入口总管和/或出口总管。
当用这种方法进行治疗时，用于较深创伤的更适当的创伤填充物可为包括一个或多个共形空心体的创伤填充物，所述空心体由例如聚合物膜、片或薄膜限定，其至少部分地围绕固体整体。这可能提供处理方便、刚性较好的系统。
除非背衬层下面的创伤填充物有效地形成具有在入口管和出口管穿过面对创伤的面和/或在面对创伤的面之下的点的入口管或出口管之间的直接连接的入口总管或出口总管，并且存在创伤层，为了进行创伤层的抽吸和/或冲洗，适合使一个或多个孔、通道、管道、通路、导管、管、细管和/或间隙等在流体入口管和出口管穿过背衬层面对创伤的面和/或在面对创伤的面之下的点开始通过背衬层下面的创伤填充物或在创伤填充物周围走行。
在较少的情况中，创伤填充物为开孔泡沫，开孔泡沫具有可形成这种通过背衬层下面的创伤填充物的孔、通道、管道、通路和/或间隙。
在填充物是或包括一个或多个由例如聚合物膜、片或薄膜限定的共形空心体时，该填充物可具有允许流体到达创伤敷料下面的创伤层的机构。
这些机构可以是从流体入口管和出口管穿过背衬层面对创伤的面和/或在面对创伤的面之下的点开始通过背衬层下面的创伤填充物或在创伤填充物周围走行的导管、管、细管、或管口的形式。
所有用于较浅创伤的适当设计可在背衬层下面的创伤填充物下使用，所述设计包括盲孔、上文所述当使用敷料时在创伤内循环流体的穿孔入口总管或出口总管。
总之，适合的设计包括其中一个或两个总管
为环状或环形(规则环，如椭圆形或圆形，或不规则环)，任选地具有从环或圆环分支出来的盲孔、穿孔的辐射状管、导管或管口，和/或
为曲折的、弯曲的、卷曲的、锯齿形的、蛇形的或由左而右/又由右而左交互成行(即像犁沟一样的)图案，或
由彼此附着为层叠体的层中的缝和通过层的孔限定。
入口管和/或出口管、流体循环管和流体供给管等可为常规的类型，如椭圆或圆形截面类型，并可适当地在其整个长度上具有均匀的柱状孔、通道、管道或通路。
取决于冲洗液和/或来自创伤的创伤渗出物的所需的流体体积流量和在循环中所需的量，孔的最大跨越尺寸可适当地为最大10毫米用于大的躯干创伤，和为最大2毫米用于肢体创伤。
管壁应适当地足够厚，以经受作用于其上面的任何正压力或负压力，特别是如果在循环中冲洗液和/或来自创伤的创伤渗出物的量由于持续向其中加入创伤渗出物，和/或清洗液通过选择渗透性整体如两相系统如渗析单元的聚合物膜、板或薄膜得到的流体而增加。然而，如以下关于泵的描述，这种管的主要目的是将流体冲洗液和渗出物运输到整个装置流路的长度，而不是作为压力容器。管壁的厚度可适当地为至少25微米。
沿着导管等或在空心体或每个空心体中的孔或任何穿孔、孔洞、洞、开口、孔口、裂缝或缝可具有小的跨越尺寸。
它们可有效地形成宏观和/或微观过滤器，用于过滤包括细胞碎片和微生物的微粒，而允许蛋白质和营养物质通过。
无论填充物为固体整体和/或一个或多个有回弹弹性的空心体或共形空心体，这种通过填充物和/或在填充物周围的管、导管或管子等在以上关于入口管和出口管中有进一步详细的描述。
一旦创伤敷料在使用中位于创伤上面，抽吸、冲洗和/或净化创伤用装置的整个长度应是不透微生物的。
希望本发明的创伤敷料和抽吸、冲洗和/或净化创伤用装置内部为无菌的。
流体可在流体储存器中和/或其中流体循环所在系统的其余部分包括流体净化机构中，通过紫外线照射、γ辐射或电子束辐射消毒。如此消毒特别地减少或排除了内表面和流体与任何杀菌剂的接触。
流体消毒的其它方法的例子还包括例如使用：
通过选择性地不透过微生物、跨越尺寸例如为最大0.22到0.45微米的微孔进行的超滤；和
流体防腐剂，如化学品溶液，如洗必太和聚乙烯吡酮碘；金属离子源如银盐如硝酸银；和
过氧化氢；
但后面的方法涉及使内表面和流体与杀菌剂接触。
流体在流体储存器中经过消毒之后，希望创伤敷料的内部、其中流体循环所在系统的其余部分、和/或创伤层、甚至对于处于高度渗出状态下创伤的创伤层保持无菌状态，或希望至少抑制了天然存在的微生物生长。
因此，可在最初向冲洗液中加入在这方面可能有益或实际上有益的物质，并且根据需要通过持续加入而增加其在循环中的量。
这种物质的例子包括抗菌剂(其中一些如以上所列)、和抗真菌药。
适合的那些为例如三氯生、碘、甲硝哒唑、溴化十六烷基三甲铵、醋酸洗必泰、十一碳烯酸钠、洗必太和碘。
可加入缓冲剂如磷酸二氢钾/磷酸氢二钠调整pH，也可加入局部镇痛药/麻醉剂，如利多卡因/利诺卡因盐酸盐、昔罗卡因(adrenoline、利多卡因)和/或抗炎药，以减少创伤疼痛或发炎或与敷料有关的疼痛。
还希望提供一种系统，其中在实施流体净化前后，没有除去有益于创伤愈合的渗出物的生理学活性组分。
这可通过例如有益于促进创伤愈合的物质如蛋白质如生长因子的被动沉淀实现。
这可在流路中的任一点进行，如在至少一个入口管和出口管中进行。
有益于促进创伤愈合的物质的沉淀可如下对抗：
a)最初向冲洗液中加入额外的物质，并且根据需要通过持续加入而增加额外物质在循环中的量，或
b)在循环通路中直接与流体接触的任一点或任何整体上使用拒斥性涂料，例如在流体净化机构上或任何所需的管或导管上。
用于循环流体通过的表面上的涂覆材料的例子包括
抗凝血剂如肝素，和
高表面张力材料如PTFE、和聚酰胺，
其对生长因子、酶和其它蛋白质和衍生物有用。
本发明的抽吸、冲洗和/或净化创伤用装置具有这样的机构，该机构允许流体以与流体储存器连接的流体供给管的形式直接或间接进入创伤敷料下的创伤。
流体储存器可为任何常规的类型，如可包含冲洗液、由聚合物膜制得的管、袋(如通常用于血液或血液制品如血浆的袋，或用于如营养物质的灌输的袋)、室、小袋或其它结构。
流体储存器可由膜、片或薄膜制成，其厚度(通常为均一厚度)通常类似于常规创伤敷料背衬层中所用的膜或片的厚度，即为最大100微米，优选为最大50微米，更优选为最大25微米，最小为10微米，并且其通常是有回弹弹性的如弹性空心体，优选为柔软的空心体。
在装置的所有实施方案中，本发明的抽吸、冲洗和/或净化创伤用装置使用的全部管和流体储存器的类型和材料主要取决于它们的功能。
为了适合应用，特别适用于长期时程，材料应无毒且生物相容、对任何活性组分为惰性的，并适合装置流路中的来自流体储存器的冲洗液和/或创伤渗出物，并适合移动到装置中循环流体内的在两相系统渗析单元的任何应用中的渗析液。
在使用装置时，当材料与冲洗液接触时，该材料不应允许显著量的可提取物自由扩散。
其应可以通过紫外线辐射、γ辐射或电子束辐射和/或流体防腐剂如化学品溶液消毒，一旦使用，其应为不透过流体和不透过微生物的，并且是柔性的。
用于流体储存器的适当材料的例子包括合成聚合物材料，如聚烯烃，如聚乙烯如高密度聚乙烯、和聚丙烯。
用于此目的的适当材料还包括其共聚物，例如与乙酸乙烯酯的共聚物及其混合物。用于此目的的适当材料还包括医学级的聚氯乙烯。
尽管使用这种聚合物材料，流体储存器通常具有坚硬的区域，以抵抗其与未互相成为一体的组件如朝向创伤敷料的流体供给管之间的任何巨大作用，并且其可能通过例如凸出的凸起部得到增强、加强、或强化。
使流体移动通过创伤和流体净化机构的设备可以是适合此目的的任何一种设备，并且可在任何适当的点为此目的而起作用。
其可对创伤施加正压力或负压力，虽然其主要目的是使流体(来自流体储存器的冲洗液和/或创伤渗出物)移动通过装置流路的总长，而不是对创伤施加正压力或负压力。
如果对创伤敷料上游并朝向创伤敷料的流体循环管中循环的流体施用该设备和/或对朝向创伤敷料的流体供给管中的流体施用该设备(任选地或根据需要借助于供给和循环之间的流动转换机构)，该设备通常对创伤层施加正压力(即，超过大气压的压力)。
通常流体净化机构在创伤敷料的下游(为此目的，大多数情况下是这样)，并在流路中提供最高的阻力。这对于其中流体净化机构为单相系统时更是这样，如通过小孔或微孔进行的超滤作用，从而增强了作用于创伤的正压力。
当将设备施用于在流体循环管中循环的流体和/或在创伤敷料下游并远离创伤敷料的排出管中的流体时，其通常对创伤层施加负压力(即低于大气压的压力或真空)。
此外，流体净化机构通常(为此目的，大多数情况是这样)在创伤敷料的下游并在流路中提供最高的阻力，从而增强作用于创伤的负压力。
根据需要，可使用以下类型的泵：
往复式泵，例如
往返梭式泵-具有摆梭机构，用于以2到50ml/分钟的速率移动流体；
隔膜泵-由一个和两个柔性膜片的脉动移动液体，同时止回阀控制流体流动的方向；
活塞泵-其中活塞泵送流体通过止回阀，特别适用于在创伤层上产生正压力和/或负压力；
回转泵，如：离心泵
柔性叶轮泵-其中弹性叶轮将流体夹带在叶轮叶片和模制外壳之间并使流体掠过泵的外壳。
容积递进式泵-具有配合的螺杆转子和定子，特别适用于较高粘度和填充有颗粒的渗出物；
转动叶片泵-通过旋转连接于主动轴的带叶片的盘推动流体，而在其旋转时没有脉动。可以限制出口而不破坏泵。
蠕动泵-使用转子臂上的外围辊作用于柔性的流体循环管，迫使管内的流体流以转子的方向流动。
真空泵-具有压力调节器。
设备的类型和/或容量主要取决于
a)适当的或所需的冲洗液和/或来自创伤的创伤渗出物的流体体积流量，和
b)是否适合或是否希望对创伤层施加正压力或负压力，和对创伤层施加的这种压力的水平，
以取得创伤愈合过程的最佳性能，还取决于诸如便携性、耗电量和与污物的分离性的因素。
这种设备也可适当地为能够实现脉冲的、连续的、可变的、可逆的和/或自动的和/或程序可控的流体运动的设备。其可特别是这些类型的泵中的任一种。
在实践中，甚至是从高度渗出状态的创伤中，渗出物流动的流量最大仅为75微升/cm2/小时(其中cm2表示创伤面积)，并且流体可为高度流动的(由于存在蛋白酶)。当创伤愈合时渗出物水平下降并且稠度改变，例如对于同样的创伤，水平下降到12.5-25微升/cm2/小时。
在其中通过如渗析单元的两相系统(见下文)除去对创伤愈合有害的物质的情况中，流体还可能通过流体净化机构从系统中失去。
这可能通过例如渗析聚合物膜、片或薄膜发生，它们除了可透过对创伤愈合有害的物质之外，所述聚合物膜、片或薄膜还可以透过水。
因此循环中流体的平衡可进一步降低，但可通过上述常规的方式调节以使这种不希望的损失减小。
因此，可以看出，来自创伤的循环流体通常包含比循环中的创伤渗出物多得多的来自流体储存器的冲洗液。
因此，设备的类型和/或容量在这个方面主要取决于适当的或所需的冲洗液的流体体积流量，而不是来自创伤的渗出物的流量。
在实践中，总的冲洗液和/或创伤渗出物流量为1到1000毫升/cm2/24小时的水平，如3到300毫升/cm2/24小时，次之为1到10毫升/cm2/24小时，其中cm2是指创伤面积。
在用这种方法进行治疗时，循环中的冲洗液和/或创伤渗出物的量可在宽的范围内改变，但通常为例如1到8升(例如对于大的躯干创伤)，200到1500ml(例如对于腋窝的和腹股沟的创伤)，和0.3到300ml用于肢体创伤。
在实践中，适合的压力为在创伤层上最大25％大气压如最大10％大气压的正压力或负压力，装置作为密闭循环系统操作。
这些范围的较高端点可能更适合医院应用，在那里可在专业管理下安全地使用较高百分数的压力和/或真空。
较低的端点可能更适合家用，或用于野战医院，其中没有专业管理，不能安全地使用较高百分数的压力和/或真空。
设备可为蠕动泵或隔膜泵，例如优选小型便携式隔膜泵或蠕动泵。这些是优选的泵类型，特别是为了减少或排除泵的内表面和活动部件与(长期的)创伤渗出物接触，并便于净化。
可能适当地是对创伤和/或流体净化机构施加正压力的泵。当外加压力为正压力时，优选泵为蠕动泵，如安装在流体净化机构上游的小型便携式蠕动泵。
在泵为蠕动泵的情况中，其可为例如Instech Model P720型微型蠕动泵，流量为0.2-180ml/小时，重量＜0.5千克。其可用于家用和野战医院。
泵可适当地为对创伤和/或流体净化机构施加负压力的那种。
当外加压力为负压力时，优选泵为隔膜泵，例如安装在敷料或流体净化机构下游的小型便携式隔膜泵。
当泵为隔膜泵并优选小型便携式隔膜泵时，移动液体的一个或两个柔性膜片可为例如与产生脉冲的机构连接的聚合物膜、片、或薄膜。其可以以任何方便的形式提供，特别是作为压电式换能器、其中电流方向交替变换的螺线管芯或铁磁体和芯，旋转式凸轮和随动器，等等。
敷料的出口物通到流体净化机构，用于从创伤渗出物除去对创伤愈合有害的物质，并又传递到流体循环管中。
本发明的抽吸、冲洗和/或净化创伤用装置具有流体净化机构，其可为
a)单相系统，如超滤单元、或化学吸附和/或吸附单元；或
b)两相系统，如渗析单元、或两相提取单元。
在前者中，来自创伤和流体储存器的循环流体通过自备系统，在该系统中除去对创伤愈合有害的物质而使仍包含对促进创伤愈合有益的物质的净化流体返回到创伤。
单相系统可以是常规类型中的任一种。
在这种系统中的流体净化机构的例子包括粗滤单元和微滤单元，其适当地包括一个或多个宏观和/或微观过滤器。
这些用于保留微粒如细胞碎片和微生物，而允许蛋白质和营养物质通过。
或者，它们还包括超滤单元，如其中净化整体为用于对创伤愈合有害的物质过滤的过滤器，例如高通量的低蛋白结合性聚合物膜、片或薄膜的那种，其可选择性地不透过并除去对创伤愈合有害的物质，而透过仍包含对促进创伤愈合有益的物质的净化过的流体。
薄膜可优选为亲水性聚合物材料的，如乙酸-硝酸纤维素混合物、聚偏氯乙烯、和例如亲水性聚氨酯。
次优选的材料的例子包括疏水性材料，其还包括聚酯如聚碳酸酯、PTFE、和聚酰胺如6-6和6-10，和疏水性聚氨酯，以及石英和玻璃纤维。
其具有微孔，微孔的最大跨越尺寸主要取决于用这种方法选择性除去的物质及其可透过的物质。
前者可由例如通常具有20到700微米的最大跨越尺寸的微孔除去，如20到50纳米(例如除去不希望有的蛋白质)、50到100纳米、100到250纳米、250到500、和500到700纳米。
过滤器整体可为处于更多回旋形式的聚合物材料的扁平的片或薄膜，如为细长结构的形式，如导管、细管等。
系统可为化学吸附单元，例如其中颗粒如沸石、或层如官能化聚合物的层在它们的表面上具有能够从经过的来自创伤和流体储存器的循环流体除去对创伤愈合有害的物质的位点。
所述物质可由例如螯合剂和/或离子交换剂、降解剂破坏或结合而除去对创伤愈合有害的物质，所述降解剂可为酶。
这种例子还包括具有特异性较差的化学吸收单元和/或吸附单元，例如其中物理吸收剂如活性碳或沸石在其表面上具有非特异性位点，这些位点能够从经过的来自创伤和流体储存器的循环流体除去对创伤愈合有害的物质。
对于给定的装置流路的容量和冲洗液的流量，净化整体，例如聚合物膜、片或其它化学吸收机构和/或吸附机构等理所当然能够以实用的速率除去对创伤愈合有害的物质。
在两相系统中，来自创伤和流体储存器的循环流体间接或(较少通常地直接)接触第二流体(渗析液)相，第二流体更通常为液体。
因此，在一种形式的二相液体提取单元中，第二流体相(通常)为这样的液体，其在循环流体直接通过与清洗液接触的表面上，与来自敷料的循环流体不混溶。对创伤愈合有害的物质被移到渗析液中，而使仍包含对促进创伤愈合有益的物质的净化过的流体经由循环管返回到创伤层。
这种流体净化机构的例子包括其中第二流体(渗析液)相为全氟萘烷等材料的那些。
或者，适当时，可提供两种流体(循环流体和渗析液)由显著的二维整体进行分离的形式，例如在装置中循环流体内的物质能够渗透的聚合物膜、片或薄膜或中空纤维或细丝。
仍然如此，对创伤愈合有害的物质被移到渗析液中，而使仍包含对促进创伤愈合有益的物质的净化过的流体经由循环管返回到创伤层。
在其中提供两相系统如渗析单元的任何形式中，在使用状态中，通常使渗析液以顺流或优选的逆流方向移动通过装置中的循环流体。
泵如蠕动泵和/或阀门控制两种流体流动的方向。
然而，清洗液在很少情况下可能是静态的，虽然其提供的系统可能不具有充分的(动力)表面以便以实用的速率从创伤渗出物除去对创伤愈合有害的物质。
在本发明的抽吸、冲洗和/或净化创伤用装置中，用于流体净化的渗析机构的典型的渗析液流量为常规类型的两相系统如用于全身治疗的渗析单元中所用的流量。
整体可为膜、片或薄膜，其通常为同样类型而且具有同样的(通常为均一的)厚度，如同常规两相系统如用于全身治疗的渗析单元中所用的。
膜、片或薄膜可基本上是扁平的，并取决于跨越它的任何压差，在其上面或其中可能需要其它材料使其得以增强、加强或强化。
然而，这不能提供具有充分的功能表面区域以便以实用的速率从创伤渗出物除去对创伤愈合有害的物质。
为了适合使用，特别是用于具有较高浓度的对创伤愈合有害的物质的长期创伤渗析，可能有利地是提供其中聚合物材料的膜、片或薄膜处于更多回旋的形式的系统。
其可为细长结构的形式，如圆形截面，如椭圆或圆形的导管、管、中空纤维或细丝或细管，如在其间具有间隙的平行排列。
创伤冲洗液和/或创伤渗出物可反复循环通过内部，而清洗液可进入顺流或优选逆流方向的相邻导管、管或细管之间的间隙，或反之亦然。
仍然如此，对创伤愈合有害的物质被移入渗析液中，而仍包含对促进创伤愈合有益的物质的净化过的流体经由循环管返回到创伤。
在流体净化机构为两相系统如渗析单元的形式，或两相提取单元时，来自创伤和流体储存器的循环流体通过显著的两维整体的表面，例如聚合物膜、片或薄膜，其选择性地透过对创伤愈合有害的物质。
通过使清洗液通过该整体的其它表面除去这些。整体可为选择性渗透上述对创伤愈合有害的物质的膜、片或薄膜。
上述这些的例子包括
氧化剂，如自由基，如过氧化物和超氧化物；
铁II和铁III；
创伤层的氧化应激中所涉及的所有物质；
蛋白酶，如丝氨酸蛋白酶类，如弹性蛋白酶和凝血因子；半胱氨酸蛋白酶类；基质金属蛋白酶，如胶原蛋白酶；和羧基(羧酸)蛋白酶；
内毒素，如脂多糖；
自体诱导信号分子，如高丝氨酸内酯衍生物，如氧代烷基衍生物；
血管生成抑制剂如凝血栓蛋白-1(TSP-1)、血纤维蛋白溶酶原激活剂抑制剂、或制管张素(血纤维蛋白溶酶原碎片)
促炎细胞因子如肿瘤坏死因子α(TNFα)和白细胞介素1β(IL-1β)，
和
炎性物质如脂多糖，和如组胺。
用于膜、片或薄膜(通常为由膜、片或薄膜限定的共形空心体的形式，如上述结构)的适当材料的例子包括天然聚合物材料和合成聚合物材料。
薄膜可由一种或多种亲水性聚合物材料制成，如纤维素衍生物，如再生纤维素、纤维素单、二或三酯，如纤维素单、二或三乙酸酯、苄基纤维素和Hemophan，及其混合物。
其它材料的例子包括疏水性材料，如芳香族聚砜、聚醚砜、聚醚醚砜、聚酮、聚醚酮和聚醚醚酮、及其磺化衍生物，及其混合物。
其它材料的例子包括疏水性材料，如聚酯，如聚碳酸酯；和聚酰胺如6-6和6-10；聚丙烯酸酯，包括如聚(甲基丙烯酸甲酯)；聚丙烯腈及其共聚物，如丙烯腈-金属磺酸钠共聚物；和聚(偏二氯乙烯)。
用于本发明的薄膜的适当材料包括热塑性聚烯烃，如聚乙烯如高密度聚乙烯、聚丙烯、及其与乙酸乙烯酯和聚乙烯醇的共聚物，及其混合物。
应选择渗析膜的截留分子量(MWCO)，使得能够选择性地灌注要从创伤除去的对创伤愈合有害的物质。例如，丝氨酸蛋白酶弹性蛋白酶(分子量25900道尔顿)的灌注需要MWCO＞25900道尔顿的薄膜。可改变MWCO的阈值以适合分子量在1到3000000道尔顿之间的每种应用。
优选地，MWCO应尽可能靠近这一分子量，以排除更大的竞争者的干扰。
例如，这种MWCO＞25900道尔顿的薄膜不允许任何显著量的、在创伤制自然产生的弹性蛋白酶拮抗剂a-1抗胰蛋白酶(AAT)(分子量54000道尔顿)自由扩散离开创伤流体进入渗析液。对促进长期创伤愈合有益的这种抑制剂保持与创伤层接触，并对创伤层产生有益的作用，同时除去对创伤愈合有害的弹性蛋白酶。
本发明的装置的这种应用可有利于例如长期创伤如糖尿病性足溃疡、特别是褥疮压力溃疡的愈合过程。
如下文所述，可使用在薄膜的渗析液一侧上的拮抗剂如降解酶或弹性蛋白酶的螯合剂，以促进从创伤渗出物除去这些蛋白酶。
在希望除去几种不同的对创伤愈合有害的物质时，可有利地提供串联模块的系统，其中每个模块除去不同的物质。这使得不相容的净化材料能在同一流体和/或创伤渗出物上使用。
优选任何这种系统为常规自动的程序可控系统，可使用最少的管理净化创伤冲洗液和/或创伤渗出物。
如以上的详述，流体从清洗液通过选择渗透性整体。
这可为两相系统如渗析单元的典型的渗透性聚合物膜、片或薄膜。
另外，溶质或分散相从渗析液通过渗析聚合物膜、片或薄膜进入冲洗液和/或创伤渗出物。
这种性能可用于将对创伤愈合有益的物质从渗析液灌注到冲洗液和/或渗出物中。
在这种较不常规的灌注供应类型中，通常使多种物质从渗析液进入渗出物和/或冲洗液中。
这些包括
离子类物质，如碳酸氢盐；
维生素，如抗坏血酸(维生素C)和维生素E，及其稳定的衍生物，及其混合物；以减轻创伤层的氧化应激；
pH缓冲剂，如磷酸二氢钾/磷酸氢二钠，
局部镇痛药/麻醉剂，如利多卡因/利诺卡因盐酸盐和昔罗卡因(adrenoline、利多卡因)和/或抗炎剂，以减少创伤疼痛或发炎或与敷料有关的疼痛，
帮助创伤细胞增殖的营养物质如氨基酸、糖、低分子量组织砌块和微量元素；以及其它细胞培养物质；和
气体，如空气、氮气、氧气和/或一氧化氮。
为了在本发明的装置中净化流体，单相系统如超滤单元和两相系统如渗析单元都可具有如以下的(稳定的、不溶解的和/或固定的)捕获物质，其结合于不溶解的和/或固定的底物，来自创伤敷料的冲洗液和/或创伤渗出物流经和/或通过该底物，随后进入流体循环管：
抗氧化剂和自由基清除剂，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、及其稳定的衍生物、及其混合物；以减轻创伤层的氧化应激；
金属离子螯合剂和/或离子交换剂，如过渡金属离子螯合剂，如铁III螯合剂(FeIII参予了创伤层的氧化应激)，如去铁草酰胺(DFO)、3-羟基酪胺(多巴胺)；
铁III还原剂；
蛋白酶抑制剂，如TIMP和α1-抗胰蛋白酶(AAT)；丝氨酸蛋白酶抑制剂，如4-(2-氨乙基)-苯磺酰氟(AEBSF，PefaBloc)和Nα-对甲苯磺酰基-L-赖氨酸氯甲基酮(TLCK)和ε-氨基己酰基-对氯苄基酰胺；半胱氨酸蛋白酶抑制剂；基质金属蛋白酶抑制剂；和羧基(羧酸)蛋白酶抑制剂；
通过除去引发对创伤愈合有害的氧化还原敏感基因在创伤渗出物中表达的物质，可能或实际上对促进创伤愈合有益的牺牲氧化还原物质；
自体诱导信号分子降解剂，其可为酶；和
结合或破坏脂多糖的抗炎物质，如peptidomimetics。
用这种方法可除去对创伤愈合有害的渗出物的其它生理学活性组分。
这些可用适当螯合剂和/或离子交换剂、降解剂(其可以是酶)、或其它物质排除。
以下类型的官能化底物在其表面上具有当来自创伤和流体储存器的循环流体通过它们时能够除去对创伤愈合有害的物质的位点：
异质的树脂，例如二氧化硅负载的试剂，如
金属清除剂，
3-(二乙三胺基)丙基官能化的硅胶
2-(4-(乙二胺基)苯)乙基官能化的硅胶
3-(巯基)丙基官能化的硅胶
3-(硫脲基)丙基官能化的硅胶
三胺四乙酸盐官能化的硅胶
或亲电子的清除剂，
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-(马来酰亚胺基)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-(乙二胺基)官能化的硅胶
2-(4-乙二胺基)丙基官能化的硅胶
3-(二乙三胺基)丙基官能化的硅胶
4-乙基苯磺酰胺官能化的硅胶
2-(4-甲苯磺酰肼基)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
或除碱剂或除酸剂，
3-(二甲氨基)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
或以下试剂，
3-(1-环己基碳二酰亚胺基)丙基官能化的硅胶
TEMPO-官能化的硅胶
2-(二苯基膦)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-(甲氧甲酰基)丙基官能化的硅胶
3-(4-硝基苯甲酰胺基)丙基官能化的硅胶
3-(脲基)丙基官能化的硅胶
或上述的任何组合。
使用如上所述的这种结合于不溶解底物和/或固定底物上的捕获(稳定的、不溶解的和/或固定的)物质被作为适用的流体净化机构进行了描述，其中来自创伤敷料的冲洗液和/或创伤渗出物流经和/或通过该底物。
然而，在适当的情况下，它们可另外用于装置中与冲洗液和/或创伤渗出物接触的任何部分，但经常在敷料内，用于从创伤除去对创伤愈合有害的物质。
在适当的情况下，流体净化机构可另外包括一个或多个宏观的和/或微观的过滤器。
这些用于保留微粒，如细胞碎片和微生物，允许蛋白质和营养物质通过。
或者，可使用较不常见类型的两相系统(参见上面)如渗析单元用作流体净化机构。在这种类型中，渗析聚合物膜、片或薄膜不是选择性地透过对创伤愈合有害的物质的整体，所述物质如
蛋白酶，如丝氨酸蛋白酶类，如弹性蛋白酶和凝血因子；半胱氨酸蛋白酶类；基质金属蛋白酶，如胶原蛋白酶；和羧基(羧酸)蛋白酶；
内毒素，如脂多糖；
血管生成抑制剂如凝血栓蛋白-1(TSP-1)、血纤维蛋白溶酶原激活剂抑制剂、或制管张素(血纤维蛋白溶酶原碎片)；
前炎细胞因子如肿瘤坏死因子α(TNFα)和白细胞介素1β(IL-1β)，
氧化剂，如自由基，如过氧化物和超氧化物；和
金属离子，如铁II和铁III，它们都参与了创伤层的氧化应激。
然而，其还允许创伤和/或冲洗液的，可以是大分子或小分子、但有利于创伤愈合的组分进入并通过。
在流体净化机构中，在渗析液中，或优选在具有与渗析液接触的至少一个表面的一个或多个固体结构整体中，有一种或多种可除去来自创伤渗出物、对创伤愈合有害的物质的物质，其为
上述有害物质的拮抗剂，如酶或其它物质，如蛋白酶抑制剂，如丝氨酸蛋白酶抑制剂，如4-(2-氨乙基)苯磺酰氟(AEBSF，PefaBloc)和Nα-对甲苯磺酰-L-赖氨酸氯甲基酮(TLCK)和ε-氨基己酰基-对氯苄基酰胺；半胱氨酸蛋白酶抑制剂；基质金属蛋白酶抑制剂；和羧基(羧酸)蛋白酶抑制剂；
粘合剂和/或降解剂，如结合或破坏脂多糖的抗炎物质，如peptidomimetics；
抗氧化剂，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、及其稳定的衍生物、及其混合物；以减轻创伤层的氧化应激；和
螯合剂和/或离子交换剂，如去铁草酰胺(DFO)、3-羟基酪胺(多巴胺)。
它们另外还包括肽(包括细胞因子，如细菌细胞因子，如α-氨基-γ-丁内酯和L-高肌肽)；和
可能或实际上对促进创伤愈合有益的牺牲氧化还原物质，如铁III还原剂；和/或这种类型的可再生物质，如谷胱甘肽氧化还原系统；和
其它生理学活性组分。
在使用这种较不常见类型的两相系统渗析单元中，通常使多种物质从渗出物进入渗析液。
一些(主要是离子型)物质可通过对对创伤愈合有害的物质的选择性透过能力不太强的渗析聚合物膜、片或薄膜，从渗析液进入冲洗液和/或创伤渗出物。
创伤渗出物和/或冲洗液的组分可自由地扩散，来回通过。
如果(优选地)没有渗析液作为废液被排泄到如收集袋中，则最终在渗析液和冲洗液和/或创伤渗出物之间建立稳态的浓度平衡，其为由创伤敷料“装满”(topped up)。
循环创伤流体有助于更快地达到对促进创伤愈合有益的物质的这种平衡。
循环创伤流体还使对促进创伤愈合有益的物质返回到它们可能最有用的位置，即创伤层。
对创伤愈合有害的目标物质也通过对创伤愈合有害的物质选择性透过不太强的渗析聚合物膜、片或薄膜，从渗出物进入渗析液。
与来自创伤渗出物和/或冲洗液的其它组分不同，对创伤愈合有害的目标物质接触到渗析液，或优选接触在渗析液中具有至少一个表面的一个或多个固体结构整体，并通过适当的拮抗剂、粘合剂和/或降解剂、螯合剂和/或离子交换剂和氧化还原剂等除去。仍包含一些对促进创伤愈合有益的物质的净化过的流体回到循环管中。
与来自创伤渗出物和/或冲洗液的其它组分不同，上述目标物质被不断地从渗析液除去，极少的这些物质从渗析液通过进入冲洗液和/或创伤渗出物，其不建立稳态的浓度平衡，即使是该物质不断地从创伤敷料“装满”。
人们认为循环创伤流体有助于从循环中除去来自创伤渗出物的对创伤愈合有害的物质，同时保留与创伤接触时对促进创伤愈合有益的物质。
这种两相系统形式的特别优点在于，其中可以从创伤渗出物除去对创伤愈合有害的物质的材料为(细胞)毒性的或生物不相容的、或对促进创伤愈合有益的任何组分为惰性的的情况下，该系统不允许任何显著量的拮抗剂从渗析液中自由扩散出来进入冲洗液。然而，这些活性物质可有利地作用于流体。
膜、片或薄膜优选是选择了截留分子量(MWCO)以便能够灌注要被螯合或破坏的物质的渗析膜。
例如，丝氨酸蛋白酶弹性蛋白酶(分子量25900道尔顿)的螯合需要MWCO＞25900道尔顿的薄膜。
可改变MWCO阈值以适合分子量在1到3000000道尔顿之间的每种应用。优选地，MWCO应尽可能靠近这一分子量，以排除更大的竞争物质的螯合干扰。
单相系统如超滤单元和两相系统如渗析单元都可以是相对容易地从本发明的装置上拆卸的模块形式。系统可适当地包括一个或多个这种模块。
a)来自创伤敷料的冲洗液和/或创伤渗出物，和
b)仍包含对促进创伤愈合有益的物质的净化过的流体返回到循环管，和
c)(在其中提供两相系统如渗析单元形式的机构的情况下)清洗液进入或离开该机构
分别通过的管道在模块断开和模块撤销上具有机构，用于
i)断开流动，和
ii)在如此暴露的本发明装置的其余部分的管道和配合管的端部提供紧密的不透流体的密封或封闭，
以防止冲洗液和/或渗出物和净化过的流体和清洗液持续通过。
本发明的抽吸、冲洗和/或净化创伤用装置具有用于泻放排出管和/或循环管的机构，如调节器，如阀或其它控制设备，用于从创伤泻放流体。
使用使流动流体移动通过创伤和流体净化机构的设备使冲洗液移动到创伤敷料并在创伤层上施加所需的正压力或负压力。
如果适合，所需的循环管中流体的平衡通常根据情况通过以下调节
a)用于泻放排出管和/或循环管的机构，
b)在供给和循环之间的流动转换机构，和/或
c)使流体流动移动通过创伤层和流体净化机构的机构。
因此，例如，如果
a)抽吸、冲洗和/或净化创伤用装置为单相系统，如超滤单元，
b)创伤没有处于高度渗出的状态，和
c)不适合或不希望使流体从流体储存器进入创伤中，
则循环中流体的平衡没有或只有很小的变化。
一旦其已经灌注达到例如所需的创伤层上的正压力或负压力，则装置可作为密闭循环系统进行操作。
在供给和循环管之间的流动转换机构设置为关闭创伤通过流体供给管与流体储存器的通路，而用于泻放排出管和/或循环管的机构也被关闭。
如果
a)抽吸、冲洗和/或净化创伤用装置为单相系统，如超滤单元，
b)创伤处于高度渗出的状态，和/或
c)适合或希望流体从流体储存器进入创伤，
则循环中流体的平衡有正的变化。
一旦已经灌注达到例如所需的创伤层上的正压力或负压力，则装置不能作为密闭循环系统操作，对创伤层的压力不增加，这可能是不希望的。
用于泻放排出管和/或循环管的机构必须以某种程度开放，以减轻创伤层上的正压力。泻放物可作为废液排泄到如收集袋中。
当以这种方式进行治疗时，对促进创伤愈合有益的物质可能离开它们可能最有用的位置，即创伤层。
然而，可常规地调节循环中流体的平衡，使这种不需要的损失最小化。
以上结合装置的操作详细地说明了决定循环中流体平衡的因素，所述循环在具有渗析单元形式或两相提取单元形式的用于流体净化的两相系统机构的装置中进行。值得注意的是，如果来自渗析液的流动使整个流体水平增加到不希望的程度，则在装置流路的整个长度范围内建立稳态循环之后的某一点上，有必要打开任何泄放阀。
其它组合，以及为在循环管中保持所需的流体平衡而通过
a)用于泻放排出管和/或循环管的机构，
b)在供给和循环之间的流动转换机构，和/或
c)使流体移动的机构
进行的必要调整对于本领域技术人员来说是显而易见的。
可收集和监测用于泻放排出管和/或循环管的机构的出口物，并用于判断创伤和/或其渗出物的状况。
废液储存器可为任何常规的类型，如聚合物膜的管、袋(如通常用作造口术袋的袋)、室、小袋、或其它结构，其可包含已经泄放的冲洗液。在装置的所有实施方案中，废液储存器的类型和材料主要取决于其功能。为了适合使用，只需要材料为在使用中不能透过流体的，并且是柔性的。
用于流体储存器的适当材料的例子包括合成聚合物材料，如聚烯烃，如聚(偏二氯乙烯)。
用于此目的的适当材料还包括聚乙烯如高密度聚乙烯、聚丙烯、及其与例如乙酸乙烯酯的共聚物、及其混合物。
本发明的第二方面中提供一种共形性创伤敷料，其特征在于该创伤敷料包括背衬层，背衬层具有能够在创伤上形成相对不透流体的密封或封闭的面对创伤的面；并具有
至少一个用于与流体供给管连接的入口管，其穿过面对创伤的面和/或在面对创伤的面之下；和
至少一个用于与流体排出管连接的出口管，其穿过面对创伤的面和/或在面对创伤的面之下；
该或每个入口管和该或每个出口管通过在创伤上形成相对不透流体的密封或封闭的面对创伤的面和/或在面对创伤的面之下的点。
有利地，敷料在不透细菌的小袋中使用。
这种创伤敷料的适当形式如上举例所述。
本发明的目的是
a)避免已知的抽吸和/或冲洗治疗的缺点中的至少一些缺点，和
b)提供一种治疗系统，所述治疗系统
i)能够从创伤渗出物除去对创伤愈合有害的物质，同时保持对促进创伤愈合有益的物质与创伤层接触，和/或
ii)使包含活性量的对促进创伤愈合有益的物质的流体进入和/或通过创伤与创伤层接触。
因此，本发明的第三方面提供使用本发明的抽吸、冲洗和/或净化创伤用装置处理创伤以促进创伤愈合的方法。
以下参考附图说明本发明，其中：
图1为本发明第一方面的抽吸、冲洗和/或净化创伤用装置的示意图。
其具有超滤单元形式的流体净化用的单相系统机构。
图2为本发明第一方面的抽吸、冲洗和/或净化创伤用装置的示意图。
其具有渗析单元或两相提取单元形式的流体净化用的两相系统机构。
图3到图7为本发明第二方面的用于抽吸和/或冲洗创伤的共形性创伤敷料的剖面图。
这其中，图3a到图6a为创伤敷料的剖面俯视图，图3b到图6b为创伤敷料的剖面侧视图。
图8到图10为本发明第二方面的创伤敷料使用的分别用于递送流体到创伤和从创伤收集流体的入口总管和出口总管设计的不同视图。
图11为本发明第一方面的抽吸、冲洗和/或净化创伤用装置的示意图。
其具有超滤单元形式的流体净化用的单相系统机构。
图12为本发明第一方面的抽吸、冲洗和/或净化创伤用装置的示意图。
其具有渗析单元或两相提取单元形式的流体净化用的两相系统机构。
图13到图26为本发明第二方面的用于抽吸和/或冲洗创伤的共形性创伤敷料的剖视图。
图27为本发明第一方面的另一个抽吸、冲洗和/或净化创伤用装置的示意图。
其具有超滤单元形式的流体净化用的单相系统机构。
参考图1，抽吸、冲洗和/或净化创伤用装置(1)包括：
共形性创伤敷料(2)，其具有
背衬层(3)，其能够在创伤(5)上形成相对不透流体的密封或封闭(4)，和
一个用于与流体供给管(7)连接的入口管(6)，其在(8)处穿过背衬层面对创伤的面(5)，和
一个用于与流体排出管(10)连接的出口管(9)，其在(11)处穿过背衬层面对创伤的面(5)，
入口管和出口管穿过在创伤上形成相对不透流体的密封或封闭的面对创伤的面和/或在面对创伤的面之下的点(8)、(11)，
入口管借助于在供给和循环之间的流动转换机构，在这里借助于三通阀(14)，通过流体供给管(7)与流体储存器(12)和流体循环管(13)连接，流体循环管(13)具有泄放该管的机构，在这里是三通阀(16)，以便泄放废液到收集袋(未示出)中，
与流体排出管(10)连接的出口管(9)，其又连接到
流体净化机构(17)，在这里为超滤单元的形式，其通过流体循环管(13)和三通阀(14)与入口管(6)连接，和
使流体移动通过创伤和流体净化机构(17)的设备，在这里为蠕动泵(18)，如优选为小型便携式蠕动泵，蠕动泵使用其转子上的外周辊(未示出)作用于流体循环管(13)，以在创伤上施加低的负压力。
超滤单元(17)为单相系统。在这里，来自创伤和流体储存器的循环流体穿过一个自备系统，在该自备系统中除去对创伤愈合有害的物质而使仍包含对促进创伤愈合有益的物质的净化过的流体经由循环管返回到创伤层。
(在这种装置的一个变体中，有两个入口管(6)，其分别与分别具有第一阀(19)和第二阀(20)的流体供给管(7)和流体循环管(13)连接，第一阀(19)允许流体从流体储存器(12)进入创伤，第二阀(20)允许流体从循环管进入创伤。
通常在使用装置时，当第一阀(19)打开时，第二阀(20)关闭，反之亦然。)
在使用装置(1)时，阀(16)对收集袋(未示出)打开，转动三通阀(14)允许流体从流体储存器通过流体供给管(7)和入口管(6)到达创伤敷料。  (在这种装置的具有两个入口管(6)的变体中，两个入口管(6)分别与流体供给管(7)和流体循环管(13)连接，打开允许流体从流体储存器(12)进入创伤的第一阀(19)而关闭第二阀(20)，反之亦然)。
开动泵(18)，该泵使用其转子上的外周辊(未示出)压缩流体循环管(13)，对创伤施加低的正压力。运行该泵直到装置在装置流路的整个长度内被完全灌注并且过量的流体借助于泄放三通阀(16)作为废液进入收集袋(未示出)。
然后转动三通阀(14)，从供给转换到循环，即创伤对流体储存器(12)关闭，而允许流体从流体循环管(13)进入创伤，并且同时关闭泄放三通阀(16)。
(在这种装置的变体中，其中有两个入口管(6)，它们分别与流体供给管(7)和流体循环管(13)连接，关闭第一阀(19)并通过打开允许流体从循环管(13)进入创伤的第二阀(20)而建立循环系统。
来自创伤和流体储存器(12)的循环流体穿过超滤单元(17)。对创伤愈合有害的物质被除去，并使仍包含对促进创伤愈合有益的物质的净化流体经由循环管(13)返回到创伤层。
流体的循环可根据需要持续进行。
然后通过转动三通阀(14)，反转供给和循环之间的转换，允许流体从流体储存器通过流体供给管(7)和入口管(6)到达创伤敷料。
(在这种装置的具有两个入口管(6)的变体中，两个入口管(6)分别与流体供给管(7)和流体循环管(13)连接，打开允许流体从流体储存器(12)进入创伤的第一阀(19)而关闭第二阀(20)，反之亦然)。
同时打开泄放阀(16)，使新鲜的流体涌入循环系统。
可继续运行泵(18)直到装置被灌注，此时停止泵和流体循环。
如果，例如创伤处于高度渗出状态，循环中的流体平衡有正的改变。有必要使流体从循环中泄放，通过打开泄放三通阀(16)使流体从循环管(13)泄放。
参考图2，装置(21)为图1装置的变体，其具有相同且编号相同的组件，不同的是流体净化机构，该结构为两相系统形式，在这里为渗析单元(23)。
这其中，有一个系统，来自创伤和流体储存器的循环流体穿过该系统，通过与其中穿过净化液的第二系统进行选择性渗透接触，从该系统中除去有害的物质。
因此，渗析单元(23)具有内部聚合物膜、片或薄膜(24)，所述聚合物膜、片或薄膜(24)可选择性地渗透对创伤愈合有害的物质并将渗析单元(23)分成
a)第一室(25)，清洗液跨越聚合物膜、片或薄膜的一个表面穿过第一室，和
b)第二室(26)，来自创伤和流体储存器(12)的循环流体穿过该室，并从该室除去有害物质。
因此渗析单元(23)具有渗析液入口管(28)，其与通到蠕动泵(38)如优选小型便携式蠕动泵的渗析液供给管(29)连接，所述泵使用其转子上的外周辊(未示出)作用于渗析液供给管(29)，使来自渗析液储存器(未示出)的清洗液经由阀(34)供给穿过第一室(25)中的聚合物膜、片或薄膜(28)的表面。
渗析单元(23)还有渗析液出口导管(30)，其与经由第二泄放三通阀(36)通到废液的渗析液出口管(31)连接，使废液泄放到如收集袋(未示出)中。
这种装置的操作类似于图1的装置，除了渗析单元(23)的操作，其中在冲洗系统被灌注并且在装置流路的整个长度内完全建立了稳态循环之后的某一点，打开阀(34)和第二泄放阀(36)。
开动泵(38)，该泵使用其转子上的外周辊(未示出)压缩流体渗析液管(29)，将清洗液从渗析液储存器(未示出)泵送到第一室并经由泄放阀(36)作为废液泵送到收集袋(未示出)中。
渗析单元(23)为具有一种基底的模块(或洗涤筒)，所述基底改变颜色指示净化过的流体中存在有害因子，并且洗涤筒已经耗尽，应该更新。
参考图3到图6，每个敷料(41)为共形体形式，由25微米均匀厚度的不透过微生物的膜式背衬层(42)限定，该敷料具有能够在创伤上形成相对不透过流体的密封或封闭的面对创伤的面(43)。
在使用中，背衬层(42)在创伤上的创伤周围的皮肤范围内延伸。在重叠部分(44)上的背衬层的最近面(43)上，带有粘性膜(45)，使该面充分地附着于皮肤，使创伤敷料借助于创伤敷料的面对创伤的面(43)的周边周围的不透过流体的密封保持在适当的位置。
有一个入口管(46)用于与流体供给管(未示出)连接，其穿过面对创伤的面(43)和/或在面对创伤的面之下，有一个出口管(47)用于与流体排出管(未示出)连接，其穿过面对创伤的面(43)和/或在面对创伤的面之下。
参考图3a和图3b，提供的一种形式的敷料在圆形背衬层(42)下面具有创伤填充物(48)。
其包括通常为截头圆锥、环形共形性空心体，其由充满流体的薄膜(49)限定，在这里上述流体为空气或氮气，该流体促使膜与创伤形状共形。
可使用粘性膜(未示出)或热封使填充物(48)永久性附着于背衬层。
入口管(46)和出口管(47)安装在环形空心体(48)中心孔道(50)上的背衬层(42)内的中心，并且各自穿过背衬层(42)，并各自分别以导管(51)和(52)的形式延伸通过环形空心体(48)的孔道(50)，然后在空心体(48)下面以直径相反方向辐射延伸。
这种形式的敷料是更适合较深创伤的设计。
参考图4a和图4b，所示为更适合较浅创伤的形式。其包括圆形背衬层(42)和具有孔(62)的凹陷圆碟形第一薄膜(61)，该薄膜通过热封永久性附着于背衬层(42)形成圆形小袋(63)。
小袋(63)通过洞(64)与入口管(46)相通，从而有效地形成入口总管，在使用敷料时，该总管将循环流体直接递送到创伤。
具有开口(66)的环状第二薄膜(65)通过热封永久性附着于背衬层(42)，与该层(42)形成环形室(67)。
室(67)通过孔口(68)与出口管(47)相通，从而有效地形成出口总管，当使用敷料时，该总管从创伤直接收集流体。
参考图5a和5b，所示为图4a和4b的敷料的变体，是更适合较深创伤的形式。
其包括圆形背衬层(42)和填充物(69)，填充物为翻转的截头圆锥固体整体，在这里是有回弹弹性的弹性泡沫材料，由热塑性泡沫或优选交联塑料泡沫形成。
该填充物可通过粘性膜(未示出)或通过热封永久性附着于背衬层(42)。
凹陷的圆碟形片(70)位于背衬层(42)和固体整体(69)下并与背衬层(42)和固体整体(69)共形，该凹陷的圆碟形片是未永久性附着于背衬层(42)和固体整体(69)的独立结构。
具有孔(72)的凹陷的圆碟形第一薄膜(71)通过热封永久性附着于片(70)，与片(70)形成圆形小袋(73)。
小袋(73)通过洞(74)与入口管(46)相通，从而有效地形成入口总管，当使用敷料时，该总管将循环流体直接递送到创伤。
具有开口(76)的环状第二薄膜(75)通过热封永久性附着于片(70)，与片(70)形成环状室(77)。
室(77)通过孔口(78)与出口管(47)相通，从而有效地形成出口总管，当使用敷料时，该总管从创伤直接收集流体。
或者，当适当时，敷料的形式可以是：其中凹陷的圆碟形片(70)起背衬层的作用，固体填充物(69)置于作为背衬层的片(70)上，而不是在片(70)下。通过粘性膜或粘性带将填充物(69)而不是背衬层(42)固定就位。
参考图6a和6b，所示敷料是更适合较深创伤的形式。
其包括圆形背衬层(42)和填充物(79)，填充物(79)是翻转的近似半球形整体，在这里是有回弹弹性的弹性泡沫材料或是充满流体的空心体，所述流体是凝胶，其使空心体与创伤的形状相适合，填充物(79)通过粘性膜(未示出)或通过热封永久性附着于背衬层。
入口管(46)和出口管(47)安装在背衬层(42)的外围。
凹陷的圆碟形片(80)置于背衬层(42)和填充物(79)的下面并与背衬层(42)和填充物(79)共形，但该凹陷的圆碟形片是未永久性附着于背衬层(42)和填充物(79)的独立结构。
凹陷的圆碟形双薄片薄膜(81)在其薄片组件之间具有封闭孔道(82)，沿着由薄膜(81)形成的碟的外表面(84)上的长度具有穿孔(83)，在其螺旋体外端具有开口(85)，孔道(82)通过开口(85)与入口管(46)相通，从而有效地形成入口总管，当使用敷料时，该总管将循环流体直接递送到创伤。
薄膜(81)在孔道(82)圈之间并沿其长度还有孔(86)。
由薄膜(81)形成的碟的的内表面(87)在其最内部点(88)通过粘性膜(未示出)或通过热封永久性附着于片(80)。这限定了配合的密封螺旋状管道(89)。
在螺旋体最外端处，管道(89)通过开口(90)与出口管(47)相通，从而有效地形成出口总管，该总管借助于孔(86)从创伤直接收集流体。
参考图7a和7b，提供了一种具有圆形背衬层(42)的敷料的形式。第一(较大)倒置半球形薄膜(92)通过热封永久性附着于层(42)的中心，与层(42)形成半球形室(94)。在第一半球形薄膜(92)内的第二(较小)同心半球形薄膜(93)通过热封永久性附着于层(42)，形成半球形小袋(95)。小袋(95)与入口管(46)相通，从而有效地形成入口总管，导管(97)从入口总管呈半球形辐射并伸展到创伤层，以孔(98)终止。导管(97)通过孔(98)将循环流体直接向创伤层递送。
室(94)与出口管(47)相通，并由此有效地形成出口总管，细管(99)从出口总管呈半球形辐射并伸展到创伤层，以开口(100)终止。细管(99)借助于开口(100)从创伤直接收集流体。
参考图8a到8d，提供了一种敷料形式，其具有方形背衬层(42)和从入口管(46)自某点延伸的第一管(101)和从出口管(47)自某点延伸的第二管(102)，第一管和第二管在创伤层上方延伸，所述点是入口管(46)和出口管(47)穿过背衬层的点。
这些导管(101)、(102)沿着导管(101)、(102)具有带有孔口(103)、(104)的盲孔。这些导管(101)、(102)分别形成入口总管或出口总管，该总管分别借助于孔口将循环流体直接向创伤层递送或从创伤直接收集流体。
在图8a和8d中，各个导管(101)、(102)作为入口总管和出口总管的一种设计是螺旋形的。
在图8b中，该设计是图8a和8b的设计的变体，入口总管(101)的设计是完全的环或部分的环，出口总管(102)是辐射状导管。
参考图8c，所示为另一种适当的设计，其中入口总管(101)和出口总管(102)以由左而右/又由右而左交互成行的图形即犁沟形在创伤层上相互并排。
参考图9a到9d，所示为其它用于较深创伤的适当设计，其与图8a到8d所示设计相同。然而，方形背衬层(42)在背衬层(42)下具有创伤填充物(110)，其可通过粘性膜(未示出)或通过热封永久性附着于背衬层(42)，所述创伤填充物(110)是倒置半球形固体整体，在这里是有回弹弹性的弹性泡沫材料，由热塑性泡沫优选交联塑料泡沫形成。
在创伤填充物(110)下面是凹陷的圆碟形片(111)，其与固体填充物(110)共形，但是为未永久性附着于固体填充物(110)的独立结构。入口管(46)和出口管(47)穿过片(111)，在创伤层上方延伸。此外，这些导管(101)、(102)沿着导管(101)和(102)具有带孔口(103)、(104)的盲孔。
或者，(如图5a和5b所示)，当适当时，可提供以下形式的敷料：其中凹陷的圆碟形片(111)起背衬层的作用，固体填充物(110)置于作为背衬层的片(42)的上方，而不是在片(42)的下方。通过粘性膜或粘性带将填充物(110)而不是背衬层(42)固定就位。
在图10a到10c中，创伤敷料的用于分别将流体递送到创伤和从创伤收集流体的入口总管和出口总管通过以层叠方式彼此永久性附着的层中的缝和孔形成。
因此，在图10a中，所示为由五层方形相连的热塑性聚合物层组成的入口总管和出口总管层叠体(120)的分解立体图，所述聚合物层为第一层到第五层(121)到(125)，各层通过粘性膜(未示出)或通过热封以层叠(120)方式附着于相邻层上。
最上(第一)层(121)(其为敷料在使用时的最远侧)是空白的正方形封盖层。
下一个(第二)层(122)，如出自总管层叠体(120)的图10b所示，是正方形的层，通过该层具有入口总管缝(126)。缝(126)沿着层(122)的一个边缘(127)走行，用于与流体入口管(未示出)的配合端连接，并分散成四个平行排列、彼此之间具有间隙的相邻支路(128)。
下一个(第三)层(123)是另一个正方形层，通过该层(123)具有入口总管孔(129)，孔排列为阵列从而使孔(129)对准通过第二层(122)的入口总管缝(126)(如图10b所示)。
下一个(第四)层(124)，如出自总管层叠体(120)的图10c所示，为另一个正方形层，通过该层(124)具有入口总管孔(130)，孔排列为阵列从而使孔(130)对准通过第三层(123)的孔(129)。
通过层(124)还有出口总管缝(131)。
缝(131)沿着层(124)的一个边缘(132)走行，用于与流体出口管(未示出)的配合端连接，所述边缘位于总管层叠体(120)的与层(122)的边缘(127)相对一侧上。
缝(131)在层(124)内的孔(130)之间的空间中分散成三个平行排列的相邻支路(133)并对准层(122)内的孔(129)之间的空间。
最后(第五)层(125)是另一个正方形层，通过层(125)具有入口总管孔(134)，孔(134)排列为阵列从而使孔(134)对准通过第四层(124)的入口总管孔(130)(又对准通过第三层(123)的孔(129))。在层(125)中还具有出口总管孔(135)，其排列为阵列从而使孔(135)对准第四层(124)中的出口总管缝(131)。
可见，当层(121)到(125)附着在一起形成层叠体(120)时，最上(第一)层(121)，通过第二层(122)的入口总管缝(126)和第三层(123)合作形成第二层(122)内的入口总管，其在使用时与流体入口管(未示出)的配合端连接。
通过第二层(122)的入口总管缝(126)、通过层(123)、(124)、(125)的入口总管孔(129)、(130)、(134)全部互相对准，在第二层(122)内的入口总管和层叠体(120)的最近面(136)之间，合作形成贯穿第三层到第五层(123)、(124)和(125)的入口总管管道。
第三层(121)、通过第四层(124)的出口总管缝(131)和第五层(125)合作形成第四层(124)内的出口总管，其在使用时与流体出口管(未示出)的配合端连接。
通过第四层(124)的出口总管缝(131)和通过第五层(125)的出口总管孔(135)互相对准，在第四层(124)内的出口总管和层叠体(120)的最近面(136)之间，合作形成通过第五层(125)的出口总管管道。
参考图11，所示抽吸、冲洗和/或净化创伤用装置是图1装置(1)的变体。
其在泵(17)的周围有弯路(711)，保护泵抵抗系统内的任何故障。
泵通过适当手段自动启动，如，其通常被防爆盘(未示出)或压力启动电动阀阻断。
旁路(711)的另一种替代方案是系统内的压力传感器，其将监测过载或过压力，并关闭泵。
参考12，所示抽吸、冲洗和/或净化创伤用装置(1)是图2的装置(1)的变体。
图2的装置是具有渗析单元(21)的两相系统，但是渗析单元(21)是其中渗析液仅从渗析液储存器(未示出)穿过第一室(25)内的渗析膜(28)表面一次，经由第二泄放三通阀(36)作为废液进入如收集袋(未示出)中。
图12的变体具有在渗析泵(23)入口侧上的第一三通阀(816)和第二三通阀(817)之间走行的渗析循环管(811)，当管路被多次灌注时，允许泵(23)使渗析液穿过渗析单元(21)重复循环。
系统的这一操作对于本领域的技术人员将是显而易见的。
参考图13到15，提供了以下形式的敷料：敷料在圆形背衬层(342)下具有创伤填充物(348)。
创伤填充物(348)分别包括通常向下的圆顶形或圆环或扁圆球状共形性空心体，空心体由充满流体(在这里是空气或氮气)的薄膜(349)限定，该流体促使空心体与创伤形状相适合。
填充物(348)借助于凸起部(351)永久性附着于背衬层，例如其通过热封附着于背衬层(342)上。
充气入口导管(350)、入口管(346)和出口管(347)安装在空心体(348)上的背衬层(342)内的凸起部(351)的中心。充气入口导管(350)与空心体(348)的内部相通，使空心体(348)膨胀。入口管(346)以导管(352)的形式有效地延伸通过空心体(348)。出口管(347)在背衬层(342)下紧密地辐射延伸。
在图13中，导管(352)与入口总管(353)相通，入口总管(353)由带有孔(362)的薄膜(361)形成，薄膜(361)通过热封永久性附着于填充物(348)。入口总管(353)充满由适当材料如有回弹弹性的热塑性塑料形成的泡沫(363)。优选的材料包括带有小孔或气孔的网状过滤聚氨酯泡沫。
在图14中，出口管(347)与由适当材料如有回弹弹性的热塑性塑料形成的泡沫(364)的层相通。并且，优选的材料包括带有小孔或气孔的网状过滤聚氨酯泡沫。
在图13、14和15中，当使用敷料时，导管(346)以一个或多个开口终止，所述开口在增大的面积范围内将冲洗液直接从创伤层递送。
类似地，在使用敷料时，出口管(347)从创伤外围有效地径向收集流体。
参考图16，敷料还在圆形背衬层(342)下具有创伤填充物(348)。
创伤填充物(348)也包括由充满流体(这里是空气或氮气)的薄膜(349)限定的通常为环形的共形性空心体，所述流体促使空心体与创伤形状相适合。
填充物(348)可能借助于第一凸起部(351)和由适当材料如有回弹性的热塑性塑料形成的泡沫层(364)永久性附着于背衬层(342)。并且，优选的材料包括带有小孔或气孔的网状过滤聚氨酯泡沫。
第一凸起部(351)和泡沫层(364)分别热封于背衬层(342)和凸起部(351)上。
充气入口导管(350)、入口管(346)和出口管(347)居中安装在环形空心体(348)上的背衬层(342)内的第一凸起部(351)内。
充气入口导管(350)、入口管(346)和出口管(347)各自分别以导管(353)、(354)和(355)的形式延伸通过空心体(348)内的中心孔道(356)到达附着于环形空心体(348)的第二凸起部(357)。
导管(353)与空心体(348)的内部相通，使空心体(348)膨胀。导管(354)径向延伸通过第二凸起部(357)与入口总管(352)相通，入口总管(352)由通过热封永久性附着于填充物(348)的薄膜(361)形成，薄膜(361)的形式为带有将冲洗液在增大的面积范围内直接向创伤层递送的开口(362)的网状蜂窝。当使用敷料时，导管(355)从创伤中心收集径向流动的流体。
这种形式的敷料是更适合较深创伤的设计。
在图17中，敷料类似于图16的敷料，不同之处在于由薄膜(349)限定的环形共形性空心体充满了流体(这里为固体粒子)，如塑料屑或塑料珠，而不是气体如空气或惰性气体，诸如氮气或氩气，并从中心孔道(356)省去了充气入口导管(350)和导管(353)。
空心体(348)的内容物的例子还包括凝胶，如硅氧烷凝胶或优选纤维素凝胶，例如亲水性交联纤维素凝胶，如IntrasiteTM交联材料。例子还包括气溶胶泡沫、和定型气溶胶泡沫，如CaviCareTM泡沫。
参考图18和19，所示为另一种用于较深创伤的形式。该敷料包括圆形背衬层(342)和室(363)，室(363)的形式为深陷的碟形，非常像多个马尔他十字或固定样式的玫瑰。
室(363)由上面的防渗薄膜(361)和下面的带有孔(364)的多孔性膜(362)限定，孔(364)在增大的面积范围内将冲洗液直接从创伤层递送。示出了各种室(363)的形状，所有这些室(363)都能通过插入到创伤内的封闭并可能重叠的臂与创伤层充分的共形。
在室(363)的具体设计中，如最下面的图形所示，臂之一延伸并在延伸臂的末端具有入口。这在使用中提供了一个用于使远离敷料和创伤的冲洗液供应结合和分离的机会。
入口管(346)和出口管(347)安装在室(363)上的背衬层(342)内的凸起部(351)内的中心上。入口管(346)永久性附着于室(363)并与室(363)的内部相通，因此有效地形成入口总管。室(363)上的间间充满疏松的网状填充物(364)。
在图18中，出口管(347)从背衬层(342)的面对创伤的面(343)的正下方从敷料内部收集流体。
图18的敷料的变体如图19所示。出口管(347)安装为进入泡沫块(374)中，在室(363)上空间的最低点开口。
在图20中，敷料类似于图13的敷料，不同之处在于入口管(352)与入口总管(353)相通，入口总管(353)由带有孔(362)的薄膜(361)形成，入口管(352)位于通常为向下的圆顶形创伤空心填充物(348)的上表面的上方，而不是穿过空心填充物。
在图22中，敷料类似于图14的敷料，多了入口总管(353)，其由带有孔(362)的薄膜(361)形成，入口总管在通常为向下的圆顶形环状创伤空心填充物的下部表面的上方。
在图21中，省去了通常为向下的圆顶形环状创伤空心填充物。
参考图23，所示为另一种用于较深创伤的形式。入口管(346)和出口管(347)安装在封锁泡沫填充物(348)上的背衬层(342)内的凸起部(351)内的中心。入口管(346)永久性附着于填充物(348)并穿过填充物(348)到达创伤层。出口管(347)附着于室(363)并与室(363)的内部相通，室(363)由附着于填充物(348)上部外周的多孔性泡沫限定。室(363)因此有效地形成出口总管。
在图24中，泡沫填充物(348)只是部分封锁(sealed-off)。入口管(346)永久性附着于填充物(348)并穿过填充物(348)到达创伤层。出口管(347)附着于填充物(348)的泡沫并与填充物(348)泡沫的内部相通。流体穿过泡沫进入靠近填充物(348)上部外周的环形隙(349)，环形隙(349)有效地形成出口总管。
图25和26示出了其中入口管(346)和出口管(347)穿过背衬层(342)的敷料。
在图25中，它们与多孔性袋状填充物(348)的内部相通，多孔性袋状填充物(348)由多孔性膜(369)限定并充满了有弹性的塑料珠或塑料屑。
在图26中，它们与泡沫填充物(348)正下方的创伤空间相通。泡沫(348)可为注入到导管(346)和(347)的周围并就地形成的CaviCareTM泡沫。
参考图27，抽吸、冲洗和/或净化创伤用装置(1)是图1所示装置的大部分变体。
图1中用于使流体移动通过创伤和流体净化机构(17)的设备是蠕动泵(18)，如优选为小型便携式蠕动泵，其作用于敷料(2)下游的流体循环管(13)，对创伤施加低的负压力。
在图27所示的装置(1)中，蠕动泵(18)被以下泵代替，以对创伤施加低的负压力：
a)作用于敷料(2)上游的流体供给管(7)的蠕动泵，和
b)具有调压机构的真空泵机组，作用于敷料(2)下游的流体循环管(13)。
上述真空泵机组包括槽(911)，槽(911)带有：
与流体循环管(13)连接并与槽(911)的上部相通的入口管(912)，
与带有废液袋(915)的废液泵(914)连接并与槽(911)的下部相通的废液管(913)，
与真空泵(918)连接并与槽(911)的上部相通的泵管(916)，和
与到达净化机构(17)的流体循环管(13)连接并与槽(911)的下部相通的出口管(917)。
真空泵(918)通过压力反馈调节器(919)通过输电线(920)控制，调节器分别借助于线(923)和(924)接收来自槽(911)上部的槽传感器(921)的信号，和创伤空间内的敷料传感器(922)的信号。
装置(1)的操作类似于图1中装置的操作，加以必要的变更。
压力反馈调节器(919)调节创伤和/或槽(911)处的压力。
如果循环中流体的量过大，如因为创伤持续地大量渗出，则废液泵(914)可启动，将来自槽(911)下部的流体转移到废液袋(915)中。
本发明的装置的使用将通过以下以举例方式表示的实施例来说明。
实施例1-从单相系统微过滤除去生物负荷(bioburden)，包括微生物
通过γ辐射消毒单相线路，所述单相线路基本上如图1中所示，但在创伤敷料和泵之间有样品端口S1，和在作为净化机构的无菌的0.22μm过滤器过滤设备下游有样品端口S2。
在接种试验生物(S.aureus NCTC10788)之前，用45ml无菌MRD(最大回收率稀释剂)充满创伤储存器，然后用试验生物接种MRD，得到最终的浓度104cfu/ml。
在使培养物在过滤设备中循环之前，使其围绕线路预循环(绕过无菌的0.22μm过滤器)。在30和60分钟从端口S1取出预循环流体的样品(0.5ml)。将其在MRD中连续稀释到10-3并根据标准验证规程从每个稀释物制备双份1ml胰化蛋白胨大豆琼脂(TSA)片。在计数之前将片在32℃培养至少72小时。
在1小时之后，使流体循环通过过滤设备。在T＝10、30、50和70分钟从端口S1和在T＝0、20、40、60和80分钟从端口S2取出0.5ml样品，所有的样品如上所述计数。
结果
表1：得自单相系统的预循环流体的细菌计数
取样时间(分钟)  平均计数(cfu/ml)  Log10计数(cfu/ml)
30  2.31×104  4.36
60  1.87×104  4.27
表2：得自单相Exudialysis系统的通过创伤储存器(端口S1)后的流体的细菌计数
 取样时间(分钟)  平均计数(cfu/ml)  Log10计数(cfu/ml)
 10  6.30×103  3.80
 30  4.10×103  3.61
 50  1.77×103  3.25
 70  1.23×103  3.09
表3：得自单相Exudialysis系统的通过创伤储存器(端口S2)后的流体的细菌计数
 取样时间(分钟) 平均计数(cfu/ml) Log10计数(cfu/ml)
 0 ＜1.0×101 ＜1.00
 20 ＜1.0×101 ＜1.00
 40 ＜1.0×101 ＜1.00
 60 1.0×101 1.00
 80 ＜1.0×101 ＜1.00
结论
在通过0.22μm过滤器之后，单相系统能够立即以大约3个数量级从创伤线路除去细菌细胞并引起循环细菌总数的逐渐减少。
实施例2-在两相系统(静态第二相)中对弹性蛋白酶的抑制
a)固定化弹性蛋白酶拮抗剂的制备-4-(2-氨乙基)苯磺酰氟(AEBSF)与聚(马来酸酐-alt-甲基乙烯基醚)、和与1％的5-(2-氨乙基氨基)-1-萘磺酸(EDANS)荧光标记物的共轭物(抑制剂)的制备
向磁力搅拌的MAMVE(1.646g，10.5mmol单位)在DMF(100ml)中的溶液中加入EDANS(30.4mg，0.1mmol)在DMF(2ml)中的溶液。15分钟之后，滴加AEBSF盐酸盐(2.502g，10.4mmol)和三乙胺(1.056g，10.4mmol)在DMF(20ml)中的溶液。在5小时之后，将该溶液逐滴沉淀到0.5M HCl(2000ml)中，Buchner过滤并用0.5M HCl洗。产物真空烘干，并在-4℃贮存。收率3.702g，98％。
向磁力搅拌的MAMVE(2.000g，12.8mmol单位)在DMF(100ml)中的溶液中加入EDANS(37.0mg，0.1mmol)在DMF(2ml)中的溶液。在15分钟之后，逐滴加入苯乙胺(1.537g，12.7mmol)在DMF(10ml)中的溶液。在5小时之后，将该溶液逐滴沉淀到0.5M HCl(2000ml)中，Buchner过滤并用0.5M HCl洗。产物真空烘干到干燥，并在室温下贮存。收率3.426g，97％。
b)弹性蛋白酶抑制
使用基本上如图1所示的二相线路，具有静态第二相的双相净化机构，在净化机构的下游具有样品端口。
净化机构为MiCroKros Cross Flow Syringe Filter(SpectrumLabs Inc)PS/400K MWCO 8cm2，具有两个独立的室，保持室外的任何流体为静态的。
用2mg/ml抑制剂溶液(～1ml的TRIS溶液)充满外室并将其连接于管线。入口管和出口管置于TRIS溶液中，并使TRIS涌入通过MiCoKros注射器的内室和管线5分钟。然后清空管线，将2ml的弹性蛋白酶(0.311mg/ml)滴加到创伤循环中。
将管置于储存器中并同时开动泵和计时器。
在6小时内每小时从创伤线路取出10微升样品并在取样后立即用下列方式分析。在每个时间点分析静态弹性蛋白酶对照，以测定在6小时内活性的降低。
c)弹性蛋白酶活性分析
制备弹性蛋白酶底物N-Succ-(Ala)3-nitronilide(10mg/ml的DMSO溶液)。将25微升的N-Succ-(Ala)3-nitronilide(10mg/ml的DMSO溶液)加入到4.5ml容量的一次性比色杯中的2.475ml的TRIS中。在预计要加入到比色杯的弹性蛋白酶溶液失效之前10分钟完成混合(以保证底物充分混合)。然后将10微升样品加入到每个比色杯中并充分混合。在室温下培养样品40分钟并记录在405nm的吸光度。
结果和结论
 TRIS
 时间/小时  试验1  试验2  试验3  弹性蛋白酶对照
 0  0.266  0.284
 1  0.255  0.258  0.239  0.283
 2  0.271  0.242  0.225  0.284
 3  0.219  0.218  0.209  0.291
 4  0.208  0.203  0.203  0.277
 5  0.197  0.17  0.194  0.304
 6  0.198  0.161  0.182  0.288
 弹性蛋白酶最终 0.267 0.289 0.281
表1：在培养40分钟之后检测弹性蛋白酶+TRIS的吸光度(405nm)。每个试验重复三次并且每小时记录静态弹性蛋白酶对照。
 MAMVE-AEB SF
 时间/小时  试验1  试验2  试验3  弹性蛋白酶对照
 0  0.362  0.39  0.371
 1  0.234  0.308  0.267  0.4
 2  0.158  0.215  0.193  0.374
 3  0.081  0.161  0.128  0.363
 4  0.064  0.12  0.083  0.366
 5  0.046  0.073  0.048  0.375
 6  0.025  0.061  0.034  0.348
表2：在培养40分钟之后检测弹性蛋白酶+MAMVE-AEBSF的吸光度(405nm)。每个试验重复三次并且每小时记录静态弹性蛋白酶对照。
所有弹性蛋白酶对照试验的平均值用于计算0小时的100％活性。
 平均百分数  SD
 时间/小时  TRIS  AEBSF  时间/小时  TRIS  AEBSF
 0  100.00  100.00  0
 1  88.55  72.47  1  3.61  9.96
 2  86.90  50.70  2  8.22  7.73
 3  76.07  33.14  3  1.95  10.80
 4  72.30  23.92  4  1.02  7.65
 5  66.06  14.96  5  5.23  4.04
 6  63.70  1075  6  6.55  5.03
表3：3个变量的弹性蛋白酶活性平均百分数，带有SD数据
结果表明，对于弹性蛋白酶+Tris溶液，活性下降60-70％。这可解释为由于在外室中2ml弹性蛋白酶与1ml的TRIS混合的稀释效应(2/3)。这表明系统对于弹性蛋白酶为惰性的，在3小时内发生完全混合/通过薄膜扩散。
在6小时内弹性蛋白酶+MAMVE-AEBSF表现出弹性蛋白酶活性有90％的下降。
实施例3：从两相系统(静态第二相)螯合铁离子
使用基本上如图1中所示的两相系统，具有静态第二相的二相净化机构，在净化机构的下游有样品端口，净化机构为在Slide-A-Lyzer室中的透析盒(Pierce，10,000 MWCO，3-15ml容量，产品号#66410)。
在透析盒中装载以下物质：
a)5ml的磷酸盐缓冲液盐水(PBS)，
b)淀粉对照(40、120和200mg/ml)或
c)淀粉-去铁草酰胺(DFO)共轭物(由Biomedical Frontiers Inc.提供)的溶液(40、120和200mg/ml)。
每个透析盒置于Slide-A-Lyzer室中。在这种布置中，由以上所述的10,000MWCO薄膜从循环第一流体中分离透析盒中的装载物。
将转铁蛋白(10mg/ml，35体积)注入到样品端口中，并通过Masterflex泵(型号7523-37)使其以不同的流量(0.54、0.82、1.08和1.35ml/min)在流动系统中循环8小时。
在0、2、4、6和8小时收集样品。
使用菲咯嗪(ferrozine)分析如下测量样品的铁含量：将样品与pH4.8的50mM乙酸盐缓冲液混合，以从转铁蛋白释放铁。向样品加入抗坏血酸(30mM)以将释放的Fe(III)离子还原为Fe(II)离子。将菲咯嗪(5mM)与样品混合，与Fe(II)离子形成显色络合物。使用UNICAM UV4-100 UV-Vis分光光度计V3.32(序列号022405)测量吸光度。
结果和结论
在8小时内淀粉-DFO以剂量依赖性方式从转铁蛋白捕获铁。在200mg/ml的淀粉-DFO存在下在循环8小时之后除去大约20-25％的铁。
在不同浓度的淀粉对照或PBS存在下，转铁蛋白的铁含量由于稀释效应而轻微下降，但是慢慢地又恢复正常，表明由淀粉-DFO捕获的铁由DFO单独调解。
不同流量下转铁蛋白的铁捕获曲线类似，表明流量对通过透析膜的铁转移没有影响。
实施例4-从两相系统的第二相(动态第二相)灌注抗生素
使用基本上如图1中所示的二相循环系统，其具有基本上如图2中所示的第二(渗析液)线路。泵蠕动作用于硅氧烷管。第二线路具有渗析液储存器(50ml Falcon离心管)，用于改变创伤流体。将创伤线路连接到锁口接合空心纤维切向薄膜透析单元(SpectrumMicroKrosX14S-100-04N，表面积8cm2，摩尔分子量截留值400KD)的端部中。将透析线路连接到同一透析单元的侧孔，从而使创伤线路与透析线路的流动为逆流方向。
根据制造商的说明书，首先用乙醇灌注创伤线路，然后用无菌水灌注。用20ml无菌水充满创伤储存器。以设定为100的速度运行创伤泵，其产生在创伤线路中测量得到的2.09ml/min的流量。根据制造商的说明书，首先用乙醇灌注透析线路，然后用无菌水灌注。用20ml无菌水充满透析储存器。以设定为100的速度运行透析泵，其产生在透析线路中测量得到的1.93ml/min的流量。通过一段硅胶管从创伤和渗析液取得样品(1ml)，该硅胶管具有与2ml注射器连接的锁口接合。
在试验开始时，从渗析液储存器除去5ml无菌水并加入5ml的5mg/ml庆大霉素硫酸盐溶液(EP标准庆大霉素硫酸盐，CRS；(活性616IU/mg))。同时开动创伤泵和透析泵。在230分钟内每隔一段时间从透析线路和创伤线路取得样品。在试验过程中没有容积被置换。
用2ml无菌水稀释样品(1ml)并测量在190nm的UV吸光度，使用预先生成的标准曲线得到从透析线路运动到创伤线路的庆大霉素的近似测量结果。
随后根据使用表皮葡萄球菌(Staphylococcus epidermidis)作为指示剂细菌的分析方法，随后用庆大霉素活性抑制分析的定量区域对样品进行分析。
结果和结论
抑制分析中的流体的抗微生物活性区域的结果表明，创伤线路中的庆大霉素的水平在230分钟内稳定增加，其增加的速率随着两个线路中药物水平彼此接近而减慢。透析线路中的庆大霉素水平表现出稳定的降低，正如期望的如果药物从透析线路移动到创伤线路中那样。在临床实践中可用的压力和流量下，可以以可接受的量和可接受的时程递送用于创伤愈合的药物。
实施例5-谷胱甘肽的再生(在两相系统(静态第二相)中由局部化的谷胱甘肽还原酶(GR)和辅助因子NADP(还原形式)将氧化的谷胱甘肽(GSSG)还原为谷胱甘肽(GSH))
使用基本上如图1中所示的二相循环，使用具有静态第二相的二相机构，在净化机构的下游具有样品端口，所述净化机构为在Slide-A-Lyzer室中的透析盒(Pierce，10,000 MWCO，3-15ml容量，产品号#66410)。
向单独的15ml容量的Slide-A-Lyzer盒的内腔中注入5ml的以下每种储备溶液：
a)在蒸馏水中制备的2mg/ml的NADP(NADP)
b)在NADP储备溶液中制备的2mg/ml的谷胱甘肽还原酶(GR+NADP)
c)在蒸馏水中制备的2mg/ml的谷胱甘肽还原酶(GR)
每种储备溶液制备三份。
将透析盒平置并向盒上部的外腔中加入分成小份的15ml GSSG储备溶液(在蒸馏水制备的50μm GSSG(30.6ml/l)。使其绕第一相线路循环。在总计6小时内从第一相线路中每小时取样(1ml)，并加入1.5ml容量的一次性UV比色杯中。在这段时间的末期，用谷胱甘肽分析试剂盒(得自Calbiochem)分析每个小份。将三个数值平均并测定每个数据点的SD。用这些数据绘制成三个对照系统中每个系统的GSSG浓度对时间的曲线。
结果和结论
通过GR与其辅助因子NADP的结合消耗的GSSG显著地比单独使用GR或NADP消耗的程度更大。因此，消耗不能归因于非特异性结合。在所述酶和辅助因子浓度下，在6小时内消耗大约40％的GSSG。
实施例6-从单相系统降解除去细菌自诱导体
称为自诱导体的胞外信号分子的交换被细菌利用，并且其对于在临界细菌细胞密度下活化的关键细菌毒力基因表达的协同是必不可少的，并从而实现成功的细菌集群和组织侵害。该系统称为QuorumSensing。相反地，自诱导体的(通常为酶促)降解或螯合是破坏必要的交通和帮助预防创伤感染的一种方法。
AiiA酶为3-氧代十二烷基高丝氨酸内酯信号分子的降解剂，所述信号分子被S.aureus用作自诱导体。
使用的AiiA酶由University of Nottingham生产，并且其结合于麦芽糖结合蛋白。
a)与聚合物载体结合的AiiA酶的制备
在1mM盐酸中洗涤溴化氰活化的琼脂糖凝胶6MB(得自Sigma)(200-300μm直径，用于较高通过流量)并将其浸泡并膨胀30分钟。用大量的蒸馏水洗凝胶，然后用NaHCO3/NaCl(pH8.5)洗，并立即使用。
向聚合物载体小珠中加入AiiA酶溶液(约1mg/ml)并使其在4℃静置过夜。用pH8.5的NaHCO3/NaCl洗涤偶联的小珠并将其作为淤浆储存。收集小珠的洗液以测定未偶联的酶的量，并由此测定偶联效率。
使用空白的未偶联小珠作为对照。
在由柱状玻璃筒的两个玻璃烧结体(该柱状玻璃筒具有用于流体通过的轴向入口和出口)限定的室中截留1mg、10mg和100mg的不同量的酶偶联小珠，其形成单相系统中的净化机构，在净化机构的下游还有样品端口。用6小时在37℃下泵送10μm的3-氧代十二烷基高丝氨酸内酯(ODHSL)的储备溶液以1.93ml/min通过室。
在总计6小时内，每小时从循环流体取样(1ml)，加入1.5ml容量的一次性UV比色杯中。
在此阶段的末期，使用Swift等人1997，J.Bacteriol.，179：5271-5281中的分析方法分析每个小份，所述分析方法使用基于生物荧光的大肠杆菌中的质粒报告系统。在6小时内100mg样品表现出ODHSL浓度有86％的降低。

Claims (10)

1.一种抽吸、冲洗和/或净化创伤用装置，特征在于该装置包括：
a)流体流路，其包括
i)共形性创伤敷料，其具有
能够在创伤上形成相对不透过流体的密封或封闭的背衬层，和
至少一个用于与流体供给管连接的入口管，其穿过面对创伤的面和/或在面对创伤的面之下，和
至少一个用于与流体排出管连接的出口管，其穿过面对创伤的面和/或在面对创伤的面之下，
该或每个入口管和该或每个出口管穿过面对创伤的面和/或在面对创伤的面之下的点，所述面对创伤的面在创伤上形成相对不透流体的密封或封闭，
至少一个与流体循环管连接的入口管，和
至少一个与流体排出管连接的出口管；以及
ii)流体净化机构，其具有至少一个与流体排出管连接的入口和至少一个与流体循环管连接的出口；
b)通过第二流体供给管与整个流路连接的流体储存器(任选地或根据需要借助于在供给和循环之间的流动转换机构)；
c)用于使流体移动通过创伤敷料和流体净化机构、和任选地或根据需要的流体供给管的设备；和
d)任选用于泄放流路的机构，
使流体经由流体供给管(任选地或根据需要借助于流动转换机构)从流体储存器被供应来填充流路，并由设备循环通过流路。
2.权利要求1的装置，特征在于其包括流体净化机构，该流体净化机构为单相系统，其中来自创伤的循环流体通过该流体净化机构，而对创伤愈合有害的物质被除去，从而不使循环流体与流体净化机构中的另一种流体直接或间接接触。
3.权利要求1的装置，特征在于其包括流体净化机构，该流体净化机构为两相系统，其中通过循环流体与流体净化机构中的另一种流体直接或间接接触，来自创伤的循环流体穿过该流体净化机构，而对创伤愈合有害的物质被除去。
4.权利要求3的装置，特征在于在流体净化机构中，来自创伤的循环流体和流体净化机构内的另一种流体通过能选择性渗透对创伤愈合有害的物质的整体而被分离。
5.权利要求3的装置，特征在于在流体净化机构中，来自创伤的循环流体和流体净化机构内的另一种流体通过不能选择性渗透对创伤愈合有害的物质的整体而被分离，所述另一种流体包括和/或与除去对创伤愈合有害的物质的物质接触。
6.权利要求3的装置，特征在于除去对创伤愈合有害的物质的物质是用于这些有害物质的拮抗剂、粘合剂和/或降解剂、螯合剂和/或离子交换剂，或是抗氧化剂。
7.权利要求3的装置，特征在于除去对创伤愈合有害的物质的物质是
4-(2-氨乙基)-苯磺酰氟(AEBSF，PefaBloc)，Nα-对甲苯磺酰基-L-赖氨酸氯甲基酮(TLCK)，ε-氨基己酰基-对氯苄基酰胺；半胱氨酸蛋白酶抑制剂；基质金属蛋白酶抑制剂；和羧基(羧酸)蛋白酶抑制剂；
抗炎物质peptidomimetics；
3羟基酪胺(多巴胺)，抗坏血酸(维生素C)，维生素E，谷胱甘肽；
去铁草酰胺(DFO)和/或3羟基酪胺(多巴胺)。
8.权利要求1的装置，特征在于对创伤愈合有害的物质是氧化剂、蛋白酶、内毒素、自体诱导信号分子、血管生成抑制剂、前炎性细胞因子、和炎性物质。
9.一种在权利要求1的装置中使用的共形性创伤敷料，特征在于该创伤敷料包括带有能够在创伤上形成相对不透过流体的密封或封闭的面对创伤的面的背衬层，并且该创伤敷料具有
至少一个用于与流体供给管连接的入口管，其穿过面对创伤的面和/或在面对创伤的面之下，和
至少一个用于与流体排出管连接的出口管，其穿过面对创伤的面和/或在面对创伤的面之下，
该或每个入口管和该或每个出口管穿过面对创伤的面和/或在面对创伤的面之下的点，面对创伤的面在创伤上形成相对不透过流体的密封或封闭。
10.一种使用权利要求1的抽吸、冲洗和/或净化创伤用装置来治疗创伤以促进创伤愈合的方法。
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ATE512689T1 (de) 2011-07-15
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AU2008229716A1 (en) 2008-11-06
CN101785726A (zh) 2010-07-28
CN1732028B (zh) 2010-04-21
US9844474B2 (en) 2017-12-19
US20190046360A1 (en) 2019-02-14
EP1994954B1 (en) 2011-06-15
US20130096519A1 (en) 2013-04-18
US9387126B2 (en) 2016-07-12
EP2902068B2 (en) 2022-09-07
US9844473B2 (en) 2017-12-19
US8535296B2 (en) 2013-09-17
AU2008229716B2 (en) 2011-12-15
CA2503897A1 (en) 2004-05-06
US20200022844A1 (en) 2020-01-23
AU2003276408B2 (en) 2009-01-22
EP1994954A1 (en) 2008-11-26
US20090254054A1 (en) 2009-10-08
US20110087176A2 (en) 2011-04-14

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