CN102481209B - 上皮再形成创伤敷料和系统 - Google Patents

上皮再形成创伤敷料和系统 Download PDF

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CN102481209B
CN102481209B CN201080037769.0A CN201080037769A CN102481209B CN 102481209 B CN102481209 B CN 102481209B CN 201080037769 A CN201080037769 A CN 201080037769A CN 102481209 B CN102481209 B CN 102481209B
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克里斯托佛·布赖恩·洛克
蒂莫西·马克·罗宾逊
理查德·丹尼尔·约翰·库特哈德
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Abstract

提出了用于促进作为创伤愈合的一个方面的上皮再形成的方法、装置和系统。用于与减压共同使用的上皮再形成敷料具有潮湿组织界面层、歧管构件和密封构件。潮湿组织界面层具有多个孔。潮湿组织界面层用于布置为毗邻创伤并且提供湿气平衡(即，在创伤是干燥的时提供湿气并且在创伤部位是实质上湿润的时接收湿气)。减压、孔和潮湿组织界面层帮助液体管理并且以其他方式促进上皮再形成。提出了其他的系统、装置和方法。

Description

上皮再形成创伤敷料和系统
相关申请
本发明根据35 USC§119(e)要求于2009年8月27日提交的名称为“Re-Epithelialization Wound Dressings and Systems(上皮再形成创伤敷料和系统)”的美国临时专利申请序列号61/237,486的权益，该美国临时专利申请为了所有目的通过引用并入本文。
背景
本公开内容大体上涉及医学治疗系统，并且更具体地但是不作为限制地涉及上皮再形成创伤敷料和系统。
创伤愈合的生理过程涉及可以同时或顺序发生的不同阶段。如本文所使用的，“或”不要求相互排他。创伤愈合过程的两个阶段涉及肉芽发生(增殖)和上皮再形成。
概述
本发明提出了对创伤护理敷料、方法和系统的某些方面的改进，如在本文的多种例证性的非限制性的实施方案中示出和描述的。根据一个例证性的非限制性的实施方案，用于与减压共同使用的上皮再形成敷料包括潮湿组织界面层(moist tissue-interface layer)、歧管构件和密封构件。潮湿组织界面层适于向组织提供湿气平衡并且形成有多个孔。歧管可操作以分布减压并且布置在密封构件和潮湿组织界面层之间。
根据另一个例证性的非限制性的实施方案，用于促进创伤的上皮再形成的系统包括上皮再形成创伤敷料。上皮再形成创伤敷料包括潮湿组织界面层、歧管构件和密封构件。潮湿组织界面层适于向组织提供湿气平衡并且形成有多个孔。歧管可操作以分布减压并且布置在密封构件和潮湿组织界面层之间。系统还包括减压连接器、减压递送导管和减压源，以将减压提供至上皮再形成创伤敷料。减压递送导管可操作以将减压源流体地耦合到减压连接器。
根据另一个例证性的非限制性的实施方案，用于促进创伤的上皮再形成的方法包括以下步骤：将上皮再形成敷料布置在邻近创伤处；将减压递送导管流体地耦合到上皮再形成敷料；以及将减压提供至减压递送导管。上皮再形成敷料包括可操作以提供湿气平衡的潮湿组织界面层。潮湿组织界面层具有第一侧和面向组织的第二侧并且形成有多个孔。上皮再形成敷料还包括用于分布减压的歧管构件。歧管构件具有第一侧和面向组织的第二侧。上皮再形成敷料还包括密封构件，密封构件具有第一侧和面向组织的第二侧。歧管构件布置在密封构件和潮湿组织界面层之间。
参照下文的附图和详细描述，例证性的实施方案的其他特点和优点将变得明显。
附图简述
图1是用于治疗创伤的系统的例证性的非限制性的实施方案的示意图，其中一部分是横截面形式；
图2是图1的用于治疗创伤的系统的例证性的非限制性的实施方案的一部分的示意性细节，显示未施加减压的情况；
图3是图1的用于治疗创伤的系统的例证性的非限制性的实施方案的一部分的示意性细节，显示施加减压的情况；以及
图4是图1的用于治疗创伤的系统的例证性的非限制性的实施方案的一部分的示意性细节，显示加入吸收体层的情况。
详细描述
在以下的对例证性的非限制性的实施方案的详细描述中，参照了附图，附图形成例证性的非限制性的实施方案的一部分。这些实施方案被足够详细地描述以使本领域的技术人员能够实践本发明，并且应当理解，可以利用其他的实施方案并且可以做出逻辑结构的、机械的、电的以及化学的变化而不偏离本发明的精神或范围。为了避免对于使本领域的技术人员能够实践本文描述的实施方案来说不必要的细节，描述可能省略了本领域的技术人员已知的某些信息。因此，以下的详细描述不应在限制的意义上理解，并且例证性的实施方案的范围仅被所附的权利要求限定。
主要参照图1，呈现了创伤治疗系统100的例证性的非限制性的实施方案，其包括上皮再形成敷料102。上皮再形成敷料102显示为被布置以用于在组织部位104并且特别是创伤106或创伤部位上的治疗。创伤106显示为延伸穿过表皮108并且进入皮下组织110中。组织部位104可以是任何人类、动物或其他生物体的身体组织，包括骨组织、脂肪组织、肌肉组织、皮组织、维管组织、结缔组织、软骨、腱、韧带或任何其他组织。具有上皮再形成敷料102的创伤治疗系统100促进创伤106的上皮再形成并且可以促进创伤边缘112的迁移。
急性创伤愈合的上皮再形成或上皮形成阶段涉及创伤106的表面重修以及创伤边缘112的变化。该过程保护患者的身体不被外部有机体侵入并且可以与其他的阶段同时发生(如果没有限制的话)。表面重修方面涉及角质形成细胞。
此外，角质形成细胞形成真皮和表皮的层。角质形成细胞来源于位于毛囊的隆突区域中的表皮干细胞并且从该位置迁移入表皮的基底层中。角质形成细胞增殖和分化以产生表皮并且由此补充表皮。角质形成细胞可以响应由可能在创伤渗出液中的生长因子释放的信号、通过在层中推进以对区间表面重修。因为这种迁移，潮湿创伤环境可以加速或以其他方式帮助角质形成细胞的从创伤边缘112朝向彼此的迁移。创伤治疗系统100促进这种上皮再形成阶段或过程。
创伤治疗系统100包括减压连接器114，减压连接器114可以与上皮再形成敷料102相关联以将减压提供至上皮再形成敷料102的至少一部分。减压递送导管116可以在第一端118处流体地耦合到减压连接器114并且在第二端122处流体地耦合到减压源120。一个或多个装置124可以流体地耦合在减压连接器114和减压源120之间，例如在减压递送导管116上。
可以流体地耦合到减压递送导管116的一个或多个装置124包括例如但不限于流体储存器(或收集构件，用于容纳被除去的渗出液和其他流体)、压力反馈装置、体积检测系统、血液检测系统、感染检测系统、流量监测系统、温度监测系统、或其他装置。
减压源120作为创伤治疗系统100的一部分提供减压。如本文所使用的术语“减压”通常是指小于在正在经受治疗的组织部位104处的环境压力的压力。在大多数情况下，此减压将小于患者所处之处的大气压力。可选择地，减压可以小于在组织部位104处的组织的流体静压。虽然可以使用术语“真空”和“负压”描述施加于组织部位的压力，但是施加于组织部位的实际压力可以显著地大于通常与绝对真空相关联的压力。除非另外指明，否则本文陈述的压力值是表压。
通过减压源120递送的减压可以是恒定的或变化的(有规律的或随机的)并且可以被连续地或间歇地递送。为了最大程度地使患者活动和方便患者，减压源120可以是电池供电的减压发生器。这有利于在手术室中的应用并且在康复阶段期间向患者提供活动性和便利。可以利用其他的减压源，例如可从德克萨斯州的圣安东尼奥的KCI获得的V.A.C.治疗单元、墙壁吸入器(wall suction)或机械单元。
由减压源120产生的减压通过减压递送导管116或医疗导管或管递送至减压连接器114。插入的疏水膜过滤器可以散置在减压递送导管116和减压源120之间。在另一个例证性的非限制性的实施方案(未示出)中，减压源可以容纳在上皮再形成敷料102内并且可以是例如微型泵。
现在主要参照图1和2，上皮再形成敷料102可以包括多个层或材料。例如，上皮再形成敷料102可以包括潮湿组织界面层126、支持层(supportlayer)128、歧管构件130和密封构件132。密封构件132可以形成有连接器孔134，减压连接器114的至少一部分延伸穿过连接器孔134。在图1的例证性的非限制性的实施方案中，减压连接器114显示为部分地布置在密封构件132和歧管构件130之间并且一部分延伸穿过连接器孔134。在某些实施方案中，上皮再形成敷料102可以具有另外的层或较少的层，并且层可以以不同组合来放置。
潮湿组织界面层126具有第一侧136和面向组织的第二侧138。潮湿组织界面层126形成有第一多个孔140，第一多个孔140可以采用任何形状。第一多个孔140延伸穿过潮湿组织界面层126。第一多个孔140可以使用激光、穿孔、钻孔形成，或通过浇铸或任何其他的技术形成。第一多个孔140可以形成为具有统一的模式或可以是随机的并且可以具有相同的或变化的直径。
在一个例证性的非限制性的实施方案中，第一多个孔140形成为具有统一的模式，且孔中心141形成为具有在毗邻的孔中心141之间的距离142。在某些例证性的非限制性的实施方案中，距离142是约二毫米、三毫米、四毫米、五毫米、六毫米、七毫米、八毫米、九毫米、十毫米或更多。距离142可以选择成用于期望的穿过潮湿组织界面层126的液体传输。第一多个孔140的直径还可以选择成使得当施加减压并且发生饱和(至少在某些实施方案中)时，第一多个孔140不会坚实地塌缩和密封，但是将变成受限制以允许液体通过但是受限制以大体上限制气体穿过第一多个孔140。在其他的实施方案中，第一多个孔140可以定制尺寸以允许第一多个孔140在减压的影响下完全地和紧紧地关闭。
潮湿组织界面层126可以由多种材料制造。潮湿组织界面层126可以是例如水基材料，例如水凝胶或水解胶体。形成潮湿组织界面层126的材料提供与期望的潮湿条件相关的流体平衡或均衡。因此，例如，材料可以在需要(即组织部位104是干燥的)时提供湿气并且将在需要(即在组织部位104处存在过量的湿气或组织部位104是实质上湿润的)时吸收湿气。面向组织的第二侧138可以是与微应变诱导材料相比相对平滑的表面，例如开孔泡沫。面向组织的第二侧138的相对平滑的表面帮助促进(或至少不阻碍)细胞迁移。面向组织的第二侧138的相对平滑的表面可以很少产生或不产生局部微应变。由潮湿组织界面层126提供的潮湿环境、第一多个孔140的流体管理以及面向组织的第二侧138的相对平滑的表面可以促进创伤106的上皮再形成。
在其他的例证性的非限制性的实施方案中，其他的材料可以用于潮湿组织界面层126，例如密度非常大的亲水泡沫(例如亲水闭孔泡沫)；薄膜涂布的穿孔的无纺材料；水凝胶浸渍的泡沫；水活性的(hydroactive)敷料材料，或其他的材料。水凝胶浸渍的泡沫可以特别适合于较深的创伤或困难的形状。潮湿组织界面层126可以被穿孔或切割为允许潮湿组织界面层126的一个或多个部分的去除的节段，以便向一部分或整个组织部位104提供减压。由被去除的节段所产生的开口可以帮助高度渗出的创伤或如果需要的话可以促进创伤106的区域中的肉芽发生。
在使用时，当潮湿组织界面层126在减压下接收流体时潮湿组织界面层126通常将溶胀。当有足够的流体时，潮湿组织界面层126可以变成饱和的。如图3中所示的，与图2的打开位置或状态相比，第一多个孔140可以实质上溶胀至受限位置或状态。受限位置在潮湿组织界面层126被实质上饱和时发生。在受限位置中，第一多个孔140将允许液体从组织部位104穿过第一多个孔140，但是将不能通过第一多个孔140实质上连通减压。一旦潮湿组织界面层126变成饱和的或实质上饱和的，那么上皮再形成敷料102的其他部分将把流体从潮湿组织界面层126的第一侧136除去。某些液体或湿气例如渗出液将保留在创伤106处并且可能通过提供信号辅助愈合过程。
上皮再形成敷料102可以包括可选择的支持层128。支持层128具有第一侧144和面向组织的第二侧146。面向组织的第二侧146布置为毗邻潮湿组织界面层126的第一侧136。潮湿组织界面层126和支持层128可以被耦合。如本文所使用的，术语“耦合”包括经由另外的物体的耦合并且包括直接耦合。术语“耦合”还包括借助于由相同的材料片形成的部件中的每一个而彼此连续的两个或更多个部件。此外，术语“耦合”可以包括化学的(例如通过化学键)、机械的、热的或电的耦合。术语“耦合”可以包括任何已知的技术，包括但不限于焊接(例如超声波或射频焊接)、键合、粘合剂、胶接剂或其他的技术或装置。流体耦合意指流体在所指定的部分或位置之间连通。
支持层128是可选择的但是可以被加入以提供对潮湿组织界面层126的支持。如通过比较图2和3极好地示出的，支持层128可以帮助将第一多个孔140的第一端148保持为在打开位置中或在其他部分作为受限状态的一部分可以被进一步限制时具有设定的直径。支持层128可以由多种材料例如闭塞的膜材料形成。支持层128可以是例如聚氨酯层、聚乙烯层或其他的支持材料。支持层128可以帮助引导流体流和提供支持，特别是对于第一多个孔140，如上文提到的。支持层128可以形成有第二多个孔150。第二多个孔150可以与第一多个孔140对准和相对应。第二多个孔150可以以与第一多个孔140相同或相似的方式形成。
上皮再形成敷料102包括歧管构件130。歧管构件130具有第一侧152和面向组织的第二侧154。歧管构件130可以由任何分布流体(包括减压)的材料形成。如本文所使用的术语“歧管”大体上是指被提供以辅助向组织部位104施加减压、向组织部位104递送流体或从组织部位104除去流体的物质或结构。歧管构件130通常包括多个流动通道或路径，多个流动通道或路径分布提供至歧管构件130周围的组织部位104的流体以及从歧管构件130周围的组织部位104除去的流体。在一个例证性的非限制性的实施方案中，流动通道或路径互相连接以改进提供至组织部位104的流体以及从组织部位104除去的流体的分布。
歧管构件130可以包括例如但不限于具有配置为形成流动通道的结构元件的装置，例如多孔状泡沫、开孔泡沫、多孔的组织结缔、包括或固化以包括流动通道的液体、凝胶和泡沫。歧管构件130可以是多孔的并且可以由泡沫、纱布、毡制垫或适合于具体的生物应用的任何其他的材料制造。在一个例证性的非限制性的实施方案中，歧管构件130是多孔泡沫并且包括作为流动通道的多个互相连接的小室或孔。多孔泡沫可以是聚氨酯开孔网状泡沫，例如由德克萨斯州的圣安东尼奥的Kinetic Concepts，Incorporated制造的材料。其他的实施方案可以包括“闭孔”。在一个非限制性的例证中，歧管构件130由无纺材料形成，例如从比利时的Libeltex BVBA可获得的无纺材料。歧管构件130的面向组织的第二侧154在一个例证性的非限制性的实施方案中被布置为毗邻支持层128的第一侧144或在另一个例证性的非限制性的实施方案中被布置为毗邻潮湿组织界面层126的第一侧136。
上皮再形成敷料102包括密封构件132。密封构件132具有第一侧158和面向组织的第二侧160。密封构件132在组织部位104或创伤106上形成密封空间。面向组织的第二侧160被布置为毗邻歧管构件130的第一侧152或另一个层并且可以被耦合到歧管构件130的第一侧152或另一个层。密封构件132可以由任何提供流体密封的材料形成。“流体密封”或“密封”意指在考虑到所涉及的具体的减压源或子系统时足以在所需部位处保持减压的密封。密封构件可以例如是不可渗透的或半渗透的弹性体型材料。“弹性体的”意指具有弹性体的性质。弹性体的通常是指具有类似橡胶的性质的聚合物材料。更具体地，大多数弹性体具有大于100％的极限伸长和显著量的回弹性。材料的回弹性是指材料从弹性形变恢复的能力。弹性体的实例可以包括但不限于天然橡胶、聚异戊二烯、丁苯橡胶、氯丁橡胶、聚丁二烯、丁腈橡胶、丁基橡胶、乙丙橡胶、三元乙丙橡胶、氯磺化聚乙烯、聚硫橡胶、聚氨酯、EVA膜、共聚酯以及硅树脂。密封构件材料的另外的实例包括硅树脂盖布、3M盖布、丙烯酸盖布例如从Avery Dennison可获得的丙烯酸盖布、或切口盖布(incise drape)。
现在主要参照图4，上皮再形成敷料102可以具有布置在密封构件132和歧管构件130或其他的层之间的可选择的吸收层162或吸收体。吸收层162具有第一侧164和面向组织的第二侧166。第一侧164可以耦合到密封构件132的面向组织的第二侧160，并且吸收层162的面向组织的第二侧166可以耦合到歧管构件130的第一侧152。吸收层162主要起储存或保持流体的作用。吸收层162可以由高吸水性聚合物(SAP)或适合于将流体保留在上皮再形成敷料102内的其他材料形成。可以基于所需的要保留的流体的量来选择形成吸收层162的材料以及材料的厚度。吸收层162可以由一个或多个组成层(constituent layer)形成。
在操作中，根据例证性的非限制性的实施方案，组织部位104，并且特别是创伤106，可以通过布置上皮再形成敷料102来用创伤治疗系统100治疗。上皮再形成敷料102被放置为毗邻患者的完整的表皮108的一部分以及创伤106。如果尚未被安装，那么将减压连接器114流体地耦合到上皮再形成敷料102以提供减压，并且如果尚未被布置，那么将密封构件132布置在上皮再形成敷料102的其他的部分上。潮湿组织界面层126的面向组织的第二侧138因此被布置为毗邻完整的表皮108的一部分以及创伤106，如图1所示的。面向组织的第二侧138向创伤106和创伤边缘112呈现出潮湿的平滑的表面。
如果尚未被安装，那么将减压递送导管116流体地耦合到减压连接器114并且流体地耦合到减压源120。减压源120被激活并且由此减压被供应至上皮再形成敷料102。减压可以帮助使上皮再形成敷料102保持在原位，可以帮助避免从上皮再形成敷料102的任何流体泄漏，可以帮助避免感染，并且可以帮助管理流体。
典型地，提供至上皮再形成敷料102的减压在-10mm Hg至-100mmHg的范围内，并且更典型地在-25mm Hg至-75mm Hg的范围内。减压足以引起流体的流，但是通常不是高至足以引起在组织部位104处的大量的微应变。在其他的例证性的非限制性的实施方案中，减压可以在-10mm Hg至-200mm Hg的范围之间。在其他的例证性的非限制性的实施方案中，减压可以是对于初始时间时期在-100mm Hg至-200mm Hg的范围内，并且然后对于第二时间时期在-25mm Hg至-100mm Hg的范围内。如果需要，其他的变化形式是可能的。
当减压被提供至上皮再形成敷料102时，第一多个孔140可以由于饱和而立即地或随时间推移从打开位置(图2)运动至受限位置或状态(图3)。在受限状态中，第一多个孔140可以允许液体通过，但是防止或限制气体(以及气态压力)被传输。上皮再形成敷料102可以由此将力施加在组织部位104上，而不连通气态压力。如果包括的话，支持层128可以使第一多个孔140的第一端148保持为实质上打开或具有恒定的直径。
被递送至上皮再形成敷料102的减压帮助从组织部位104除去过量的流体，并且在潮湿组织界面层126变成实质上饱和的时帮助从潮湿组织界面层126除去流体。潮湿组织界面层126的流体平衡或均衡还帮助管理流体，因为潮湿组织界面层126在组织部位104是干燥的时提供流体或在组织部位104是湿润的时帮助吸收流体。可以缓慢地实现通过潮湿组织界面层126的流体去除以允许某些渗出液(但是不是渗出液的聚集)保留在组织部位104处以帮助愈合过程。渗出液可以通过允许发送信号(例如从生长因子)来帮助激活角质形成细胞，如上文提到的。
潮湿组织界面层126还提供可以帮助(或至少不抑制)细胞迁移的紧靠组织部位104的相对平滑的表面。除了提供相对平滑的潮湿表面外，潮湿组织界面层126可以紧靠组织部位104保留延长的时间段，而没有肉芽向内生长、感染，或对于频繁的敷料更换的需要。
虽然已经在某些例证性的非限制性的实施方案的内容中公开了本发明以及其优点，但是应当理解，可以作出各种改变、代替、置换和变化，而不偏离本发明的由所附的权利要求限定的范围。应认识到，关于任何一个实施方案所描述的任何特征也可以适用于任何其他实施方案。

Claims (15)

1.一种上皮再形成敷料，其用于与减压共同使用以治疗创伤部位，所述敷料包括：
潮湿组织界面层，其用于布置为紧靠所述创伤部位，所述潮湿组织界面层提供湿气平衡，所述潮湿组织界面层包括水凝胶且具有第一侧和面向组织的第二侧，其中形成有穿过所述潮湿组织界面层的多个孔，其中所述孔的每一个在所述潮湿组织界面层的所述第一侧和所述面向组织的第二侧之间延伸，并且其中所述孔被配置成在增加的湿气的影响下溶胀至实质上受限位置；
歧管构件，其用于分布减压，所述歧管构件包括网状开孔泡沫且具有第一侧和面向组织的第二侧；
密封构件，所述密封构件具有第一侧和面向组织的第二侧；并且
其中所述歧管构件布置在所述密封构件和所述潮湿组织界面层之间。
2.根据权利要求1所述的上皮再形成敷料，
其中所述多个孔是从打开位置可运动至所述受限位置的，并且
其中，在所述受限位置中，所述多个孔允许液体通过并且限制气体通过。
3.根据权利要求1所述的上皮再形成敷料，其中所述潮湿组织界面层是水凝胶层。
4.根据权利要求1所述的上皮再形成敷料，其中所述潮湿组织界面层是用水凝胶浸渍的泡沫层。
5.根据权利要求1所述的上皮再形成敷料，还包括具有第一侧和面向组织的第二侧的支持层，其中所述支持层的所述面向组织的第二侧布置为毗邻所述潮湿组织界面层的所述第一侧并且在所述歧管构件和所述潮湿组织界面层之间，所述支持层具有多个孔，所述支持层的所述孔的每一个实质上对应于所述潮湿组织界面层的所述孔中的一个，其中所述支持层耦合于所述潮湿组织界面层，并且适合于将所述潮湿组织界面层的所述多个孔的至少一个的一端保持为在打开位置中，并且其中所述支持层包括闭塞的膜材料。
6.根据权利要求1所述的上皮再形成敷料，还包括布置在所述歧管构件和所述密封构件之间的吸收层。
7.根据权利要求1所述的上皮再形成敷料，
其中所述潮湿组织界面层的所述面向组织的第二侧用于布置为紧靠所述创伤部位；
其中所述歧管的所述面向组织的第二侧布置为毗邻所述潮湿组织界面层的所述第一侧；
其中所述密封构件的所述面向组织的第二侧布置为毗邻所述歧管构件的所述第一侧；并且
其中所述潮湿组织界面层中的所述多个孔以中心之间至少一毫米间隔开。
8.根据权利要求1所述的上皮再形成敷料，其中所述潮湿组织界面层的所述面向组织的第二侧是平滑的，并且适合于基本上防止所述创伤部位的微应变。
9.根据权利要求1所述的上皮再形成敷料，其中提供至所述上皮再形成敷料的减压在-25mm Hg至-75mm Hg之间，并且适合于基本上防止所述创伤部位的微应变。
10.一种用于促进创伤的上皮再形成的系统，所述系统包括：
上皮再形成创伤敷料，其包括：
潮湿组织界面层，其用于布置为紧靠所述创伤并且可操作以提供湿气平衡，所述潮湿组织界面层包括水凝胶且具有第一侧和面向组织的第二侧，其中形成有穿过所述潮湿组织界面层的多个孔，其中所述孔的每一个在所述潮湿组织界面层的所述第一侧和所述面向组织的第二侧之间延伸，并且其中所述孔被配置成在增加的湿气的影响下溶胀至实质上受限位置，
歧管构件，其用于分布减压，所述歧管构件包括网状开孔泡沫且具有第一侧和面向组织的第二侧，
密封构件，所述密封构件具有第一侧和面向组织的第二侧，并且
其中所述歧管构件布置在所述密封构件和所述潮湿组织界面层之间；以及
减压源，其流体地耦合到所述歧管构件。
11.根据权利要求10所述的系统，
其中所述多个孔是从打开位置可运动至所述受限位置的，并且
其中，在所述受限位置中，所述多个孔允许液体通过并且限制气体通过。
12.根据权利要求10所述的系统，其中所述潮湿组织界面层是水凝胶层。
13.根据权利要求10所述的系统，其中所述潮湿组织界面层是用水凝胶浸渍的泡沫层。
14.根据权利要求10所述的系统，还包括具有第一侧和面向组织的第二侧的支持层，其中所述支持层的所述面向组织的第二侧布置为毗邻所述潮湿组织界面层的所述第一侧并且在所述歧管构件和所述潮湿组织界面层之间，所述支持层具有多个孔，所述支持层的所述孔的每一个实质上对应于所述潮湿组织界面层的所述孔中的一个，其中所述支持层耦合于所述潮湿组织界面层，并且适合于将所述潮湿组织界面层的所述多个孔的至少一个的一端保持为在打开位置中，并且其中所述支持层包括闭塞的膜材料。
15.根据权利要求10所述的系统，还包括布置在所述歧管构件和所述密封构件之间的吸收层。
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