CN106535842B - 具有流体获取和分配特征的敷料 - Google Patents
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Abstract
描述了用于治疗组织部位的系统、方法和设备。在一些实施例中，该系统可以包括一个小袋，该小袋具有一个上游层、一个下游层、以及被封闭在该上游层与该下游层之间的一个吸收构件。该上游层和该下游层可以各自包括一个疏水侧和一个亲水侧。该上游层和该下游层二者的亲水侧可以被定位成面向该吸收构件。该上游层和该下游层二者的疏水侧可以形成该小袋的外表面的一部分，这样使得流入到该小袋上的流体在被该吸收构件吸收之前沿着该小袋的该外表面横向分配。
Description
相关申请
本申请根据35USC§119(e)要求于2014年6月5日提交的标题为“具有流体获取和分配特征的敷料(Dressing With Fluid Acquisition And DistributionCharacteristics)”的美国临时专利申请序列号62/008,395的提交权益，出于所有目的将该临时专利申请通过引用结合在此。
技术领域
本披露总体上涉及用于治疗组织部位和处理流体的医学治疗系统。更具体地，但不是通过限制的方式，本披露涉及一种敷料，该敷料能够在其内横向和竖直地分配流体。该敷料可以在或不在减压下用于治疗组织部位。
背景
临床研究和实践已表明，降低在一个组织部位附近的压力可以增进并加速在该组织部位处的新组织的生长。这种现象的应用很多，但已经证明用于治疗伤口是特别有利的。不论伤口病因是外伤、手术或者其他的原因，伤口的适当护理对结果很重要。用减压治疗伤口通常可称为“减压伤口治疗，”但是也以其他的名称为人所知，例如包括“负压治疗”、“负压伤口治疗”、以及“真空治疗”。减压治疗可以提供许多益处，包括上皮和皮下组织的迁移、改善血流、以及在伤口部位处的组织的微变形。这些益处可以共同增加肉芽组织的发育并且减少愈合时间。
虽然减压治疗的临床益处是广泛已知的，但减压治疗的成本和复杂性可能是限制因素。减压系统、部件以及过程的开发和操作一直对制造商、医疗保健提供者以及患者提出重大挑战。具体地说，包括紧邻组织部位定位的吸收构件的减压敷料可能经历吸收性材料的损失或者无效的吸收，这将负面地影响减压系统向组织部位提供减压治疗的能力。
概述
根据一个说明性实施例，用于治疗组织部位的系统可以包括歧管(manifold)、密封构件、小袋和减压源。该歧管可以被适配成邻近该组织部位放置。该密封构件可以被适配成覆盖该组织部位和该歧管以便在该组织部位处提供流体密封。该小袋可以是用于定位在该歧管与该密封构件之间。该小袋可以包括一个上游层，该上游层具有一个亲水侧和一个疏水侧；和一个下游层，该下游层具有一个亲水侧和一个疏水侧。该小袋还可以包括一个吸收构件，该吸收构件被封闭在该上游层与该下游层之间。该上游层的亲水侧可以被定位成面向该吸收构件，并且该下游层的亲水侧可以被定位成面向该吸收构件。该减压源可以通过该密封构件与该歧管处于流体连通。
根据另一个说明性实施例，用于从组织部位收集流体的设备可包括一个上游层、一个下游层和一个吸收构件。该上游层可以具有一个亲水侧和一个疏水侧，并且该下游层可以具有一个亲水侧和一个疏水侧。该吸收构件可被定位在该上游层与该下游层之间。该上游层的亲水侧可以被定位成邻近并且面向该吸收构件，这样使得该上游层的疏水侧可以形成该设备的外部的一部分。该下游层的亲水侧可以被定位成邻近并且面向该吸收构件，这样使得该下游层的疏水侧可以形成该设备的外部的另一部分。流入到该设备的外部的流体可以在被该吸收构件吸收之前沿着该设备的外部横向地分配。
根据又另一个说明性实施例，用于从组织部位收集流体的设备可包括一个上游层、一个密封构件和一个吸收构件。该上游层可以具有一个亲水侧和一个疏水侧。该密封构件可以被适配成覆盖该组织部位和该上游层，并且该密封构件可以粘结到该上游层上。该上游层的亲水侧可被定位成面向该密封构件。该吸收构件可被定位在该上游层与该密封构件之间。
根据还另一个说明性实施例，用于从组织部位收集流体的设备可包括一个上游层、一个下游层、一个吸收构件、一个密封构件、以及一个非粘附界面。该上游层可以具有一个亲水侧和一个疏水侧，并且该下游层可以具有一个亲水侧和一个疏水侧。该吸收构件可被定位在该上游层与该下游层之间。该上游层的亲水侧可以被定位成面向该吸收构件，并且该下游层的亲水侧可以被定位成面向该吸收构件。该密封构件可以被定位成邻近该下游层。该非粘附界面可以被适配成定位在该上游层与该组织部位之间。该密封构件可以通过第一热熔网层粘结到该下游层上，并且该非粘附界面可以通过第二热熔网层粘结到该上游层上。
根据又另一个说明性实施例，用于治疗组织部位的方法可以包括邻近该组织部位定位一个歧管，提供一个小袋，将该小袋邻近该歧管定位，用一个密封构件覆盖该歧管和该小袋，从该组织部位提取流体，并且沿着该小袋的外部分配该流体。该小袋可以包括一个上游层，该上游层具有一个亲水侧和一个疏水侧；一个下游层，该下游层具有一个亲水侧和一个疏水侧；以及一个吸收构件，该吸收构件被封闭在该上游层与该下游层之间。该上游层的亲水侧可以被定位成面向该吸收构件，这样使得该上游层的疏水侧可以形成该小袋的外部的一部分。该下游层的亲水侧可以被定位成面向该吸收构件。该方法可以包括将该小袋邻近该歧管定位，这样使得该上游层的疏水侧可以邻近该歧管。该歧管和该小袋可以用一个密封构件覆盖，以提供该密封构件与该组织部位之间的流体密封。该方法还可以包括从该组织部位提取流体并且在将该流体吸收在该吸收构件中用于储存之前将该流体沿该小袋的外部横向分配。
根据另一个说明性实施例，用于制造流体储存设备的方法可以包括提供具有亲水侧和疏水侧的第一层，将吸收构件邻近该第一层的亲水侧定位，提供具有亲水侧和疏水侧的第二层，并且将该第二层的亲水侧邻近该吸收构件定位。该第二层可以被定位在该吸收构件的与该第一层相反的侧上。该方法还可以包括将该第一层和该第二层的周边部分联接以便封闭该吸收构件。
参考以下附图和详细说明，这些说明性实施例的其他方面、特征和优点将变得明显。
附图简要说明
图1是说明根据一个示例性实施例的减压治疗系统的截面视图；
图2是与在图1的减压治疗系统中描绘的伤口敷料相关的小袋的一个说明性实施例的截面视图；
图3是图2的小袋的分解截面视图；
图4是描绘伤口敷料的另一个说明性实施例的截面视图；
图5是描绘伤口敷料的另一个说明性实施例的截面视图；以及
图6是示出与根据本披露的伤口敷料相关的改善的吸收能力的曲线图。
说明性实施方式的详细说明
在以下非限制性的、说明性实施例的详细说明中，参考了形成本文的一部分的附图。可以利用其他实施例，并且可以作出合乎逻辑的、结构的、机械的、电的以及化学的改变而不脱离所附权利要求书的范围。为了避免对于使得本领域的技术人员能够实践在此所描述的这些实施例来说所不必要的细节，本说明可能省略了本领域的技术人员已知的某些信息。以下详细说明是非限制性的，并且这些说明性实施例的范围是由所附权利要求书限定。如在此使用的，除非另外指明，“或”不需要相互排除。
在此还可以在减压治疗应用的背景中描述这些示例性实施例，但是许多这些特征和优点对于其他环境和行业是易于应用的。例如，这些示例性实施例可以与或不与减压治疗一起使用。
参照图1，治疗系统100可以包括一个敷料102，该敷料与组织部位106处于流体连通；一个任选的减压源104，该减压源用于向流体联接到该减压源104上的一个管120提供减压；以及一个连接器122，该连接器将该管120流体联接到该敷料102上。
术语“组织部位”可以指的是位于组织上或组织内的伤口或缺损，该组织包括但不限于骨组织、脂肪组织、肌肉组织、神经组织、皮肤组织、血管组织、结缔组织、软骨、肌腱或韧带。组织部位可以包括例如慢性、急性、外伤性、亚急性、和裂开的伤口；部分皮层烧伤、溃疡(如糖尿病性溃疡、压力性溃疡、或静脉功能不全溃疡)、皮瓣、以及移植物。术语“组织部位”还可以指的是不一定受伤的或缺损的任何组织区域，但是为在其中可能希望增加或促进另外的组织生长的替代区域。例如，减压可以用于某些组织区域中以使可以被收获并且移植到另一个组织位置的另外的组织生长。
减压源，如减压源104，可以是一个处于减压的空气储存器，或者可以是一个可降低密封体积中的压力的手动或电力驱动装置，例如像真空泵、抽吸泵、可用于许多医疗保健设施中的壁吸端口、或微型泵。该减压源可以被收纳在其他部件内或者可以与这些其他部件结合使用，这些其他部件是例如传感器、处理单元、报警指示器、储存器、数据库、软件、显示装置、或进一步有助于减压治疗的用户界面。尽管施加到一个组织部位上的减压的量和性质可能根据治疗要求而变化，但是该压力可以是在约-5mm Hg(-667Pa)与约-500mm Hg(-66.7kPa)之间。在一些实施例中，该压力可以是在约-75mm Hg(-9.9kPa)与约-300mm Hg(-39.9kPa)之间。
一般来说，渗出物及其他流体可以沿着一个流体路径朝向更低的压力方向流动。进一步，流体可以被吸引到沿着增加材料之间的亲水性或吸收性的路径流动通过可渗透材料。因此，术语“下游”可以指的是比可被称为“上游”的部件沿着流体路径更远的部件。
“减压”可以指的是小于局部环境压力的压力，该局部环境压力如在密封的治疗环境外部的局部环境中的环境压力。该局部环境压力还可以是患者所处位置的大气压。进一步，该压力可以小于与组织部位处的组织相关的流体静压。除非另外说明，否则在此陈述的压力值是表压。类似地，提及减压的增加典型地指的是绝对压力的降低，而减压的降低典型地指的是绝对压力的增加。
治疗系统100的这些部件可以直接或间接地联接。部件可以彼此流体联接，以便提供用于在这些部件之间传递流体(例如，液体和/或气体)的路径。在一些示例性实施例中，部件可以与一个导管例如像管120流体联接。如在此所用的“管”可以指的是管道、软管、导管或具有被适配用于在两个末端之间传送流体的一个或多个管腔的细长结构。在一些示例性实施例中，部件可以另外地或者可替代地凭借物理接近而联接，在整体上成为单一结构，或者由同一件材料形成。在一些情形下，联接还可以包括机械联接、热联接、电联接、或化学联接(如化学结合)。
由减压源104产生的减压可以通过管120递送至连接器122。连接器122可以是被配置成将减压源104流体联接到敷料102上的一个装置。例如，减压可以通过布置在连接器122中的端口提供到敷料102。在一些示例性实施例中，连接器122可包括联接到敷料102用于将连接器122固定到敷料102上的凸缘部分123。连接器122还可以包括被流体连通地定位在敷料102与连接器122之间的主过滤器121。主过滤器121可以包括被适配成限制液体穿过连接器122进入管120中的疏水性材料。在一个示例性实施例中，连接器122可以是可获自德克萨斯州圣安东尼奥市的动力学概念公司(Kinetic Concepts,Inc.of San Antonio,Texas)的
衬垫或Sensa
衬垫。在其他示例性实施例中，连接器122还可以是插入敷料102中的一个导管。
敷料102可以包括一个任选的歧管110，该歧管被适配成与组织部位106处于流体联通；一个小袋112，该小袋被适配成在组织部位106或歧管110与连接器122之间处于流体联通；以及一个盖布108，该盖布覆盖在组织部位106处的任选的歧管110和小袋112。歧管110可置于组织部位106之内、上方、之上、或以别的方式紧邻该组织部位。小袋112可以被邻近歧管110放置，并且盖布108可以被置于歧管110上方并且密封到紧邻组织部位106的组织上。该紧邻组织部位106的组织可以是在组织部位106周围的完整无损的表皮。因此，敷料102可以提供紧邻组织部位106的密封治疗环境，从而基本上将组织部位106与外部环境相隔离。减压源104可以降低该密封治疗环境中的压力。通过歧管110均匀地施加在该密封治疗环境中的减压可以诱导组织部位106中的宏应变和微应变、并且从组织部位106移除渗出物和其他流体，这些渗出物和其他流体可被收集在小袋112中并予以适当处置。
在图1中说明的示例性实施例中，歧管110可以接触组织部位106。歧管110可以与组织部位106部分或完全接触。例如，如果组织部位106从一个组织表面延伸到组织中，则歧管110可以部分或完全地填充组织部位106。在其他示例性实施例中，歧管110可以被放置在组织部位106的上方。歧管110可以采取多种形式，并且可以具有多种大小、形状或厚度，这取决于多种因素，如正在实施的治疗的类型或组织部位106的性质和大小。例如，歧管110的大小和形状可以适合于深的且形状不规则的组织部位的轮廓。
歧管110可以包括被适配用于向组织部位分配减压、从组织部位去除流体、或者向组织部位分配减压并从该组织部位去除流体的一种物质或结构。在一些示例性实施例中，例如如果流体路径是相反的或者提供了第二流体路径，歧管110还可有助于将流体递送到组织部位。歧管110可以包括多个流动通道或通路，这些流动通道或通路将提供到组织部位和从该组织部位移除的流体分配到歧管110周围。在一个示例性实施例中，这些流动通道或通路可以相互连接以便改善提供到一个组织部位或从该组织部位移除的流体的分配。例如，蜂窝状泡沫、开孔泡沫、多孔组织集合、以及其他多孔材料如纱布或毡垫可以包括被安排为形成流动通道的结构元件。液体、凝胶、以及其他泡沫也可以包括或被固化成包括流动通道。
在一个示例性实施例中，歧管110可以是具有相互连接的孔(cell)或孔隙(pore)的多孔泡沫材料，这些孔或孔隙被适配成用于将减压以基本上均匀的方式分配到组织部位106。该泡沫材料可以是疏水性的抑或亲水性的。在一个非限制性的实例中，歧管110可以是一种开孔网状聚氨酯泡沫，如可获自德克萨斯州圣安东尼奥市的动力学概念公司的
敷料。
在其中歧管110可由一种亲水性材料制成的实例中，歧管110还可芯吸流体离开组织部位106，同时继续将减压分配到组织部位106上。歧管110的这些芯吸特性可以通过毛细流动或其他芯吸机制来汲取流体离开组织部位106。亲水性泡沫的一个实例是一种聚乙烯醇开孔泡沫，诸如可获自德克萨斯州圣安东尼奥市的动力学概念公司的V.A.C.
敷料。其他亲水性泡沫可以包括由聚醚制成的那些。可表现出亲水性特征的其他泡沫包括已被处理或被涂覆以提供亲水性的疏水性泡沫。
当该密封治疗环境内的压力被降低时，歧管110可以进一步促进组织部位106处的肉芽形成。例如，当通过歧管110向组织部位106施加减压时，歧管110的任何或所有表面都可以具有不均匀的、粗糙的、或锯齿形的轮廓，该轮廓可诱导在组织部位106处的微应变和应力。
在一个示例性实施例中，歧管110可由生物可再吸收材料构成。适合的生物可再吸收材料可以包括但不限于聚乳酸(PLA)和聚乙醇酸(PGA)的聚合物共混物。该聚合物共混物还可以包括但不限于聚碳酸酯、聚延胡索酸酯、以及己内酯(capralactone)。歧管110可以进一步用作用于新细胞生长的支架，或一种支架材料可以与歧管110结合使用以促进细胞生长。支架通常是用于增强或促进细胞生长或组织形成的一种物质或结构，诸如提供用于细胞生长的模板的一种三维多孔结构。支架材料的说明性实例包括磷酸钙、胶原、PLA/PGA、珊瑚羟基磷灰石、碳酸盐或者经加工的同种异体移植材料。
盖布108或密封构件可由能提供两个部件或两个环境之间如在该密封治疗环境与局部周围环境之间的流体密封的材料构成。盖布108可以是，例如，一种不可渗透的或半渗透性的弹性体材料，其可针对给定的减压源提供足以在组织部位处维持减压的密封。对于半渗透性材料，渗透性总体上应当足够低，使得可以维持所希望的减压，同时允许湿蒸汽通过。盖布108可以进一步包括一个附接装置，该附接装置可以用于将盖布108附接到一个附接表面上，该附接表面如完整无损的表皮、衬片、或另一个密封构件。该附接装置可以采取多种形式。例如，附接装置可以是一种围绕盖布108的周边、一部分或整体延伸的在医学上可接受的压敏粘合剂。附接装置的其他示例性实施例可包括双面胶带、浆糊、水胶体、水凝胶、硅酮凝胶、有机凝胶、或一种丙烯酸粘合剂。
参考图2，小袋112可以包括吸收构件124、第一外层如上游层126、以及第二外层如下游层128。上游层126和下游层128包封或封闭吸收构件124。例如，吸收构件124可以吸收通过上游层126传输的流体。
吸收构件124可由一种吸收性材料形成或者包括一种吸收性材料。该吸收性材料可容纳、稳定、和/或凝固可以从组织部位106收集的流体。该吸收性材料可以具有被称为“水凝胶”、“超级吸收剂”、或“水胶体”的类型。该吸收性材料可以包括能够分支(manifolding)减压的纤维或球体。在这些纤维或球体之间的空间或空隙可以允许被施加到敷料102上的减压在吸收构件124内传递并通过吸收构件124被传递至歧管110和组织部位106。在一些示例性实施例中，该吸收性材料可以是具有800克/平方米(gsm)的材料密度的Texsus FP2325，或Texsus CCBSL130LL。在其他示例性实施例中，该吸收性材料可以是BASF Luquafleece 402C、可从技术吸收剂公司(Technical Absorbents)(www.techabsorbents.com)获得的Technical Absorbents 2317、聚丙烯酸钠超吸收体、纤维素材料(羧甲基纤维素及盐，如CMC钠)、或海藻酸盐。
在一些示例性实施例中，上游层126和下游层128具有大于吸收构件124的周边尺寸的周边尺寸，这样使得当吸收构件124被定位在上游层126与下游层128之间时，上游层126和下游层128延伸超过吸收构件124的周边。在一些示例性实施例中，上游层126和下游层128包围吸收构件124。上游层126和下游层128的周边部分可以被联接，这样使得上游层126和下游层128封闭吸收构件124。上游层126和下游层128可以通过例如高频焊接、超声波焊接、热焊接、或者脉冲焊接联接。在其他示例性实施例中，上游层126和下游层128可以通过例如粘结或折叠联接。
参考图2和图3，上游层126可以包括第一侧，如疏水侧130；和第二侧，如亲水侧132。亲水侧132可被定位成邻近并面向吸收构件124。疏水侧130可被定位成面向组织部位106。以这种方式，上游层126的疏水侧130可以是小袋112的上游侧。上游层126可以由具有厚度138的非织造材料形成。在一些示例性实施例中，上游层126可以具有一种聚酯纤维多孔结构。上游层126可以不是穿孔的。在一些实施例中，上游层126可以由Libeltex TDL2或Libeltex TL4形成，并且可以具有在约80gsm至约150gsm之间的材料密度。在其他示例性实施例中，该材料密度可以取决于小袋112的具体应用而更低或更高。进一步，在一些实施例中，多层材料可以被用来实现上游层126的所需厚度。
疏水侧130可以被配置成将流体沿着小袋112的上游侧分配。疏水侧130还可以被称为芯吸侧、芯吸表面、分配表面、分配侧、或者流体分配表面。疏水侧130可以是一个平滑的分配表面，该分配表面被配置成使流体沿着上游层126的纹理移动通过上游层126，从而将流体分配到整个上游层126上。亲水侧132可以被配置成从疏水侧130获得流体，以便帮助流体移动到吸收构件124中。亲水侧132还可以被称为流体获取表面、流体获取侧、亲水性获取表面、或者亲水性获取侧。亲水侧132可以是一个纤维表面并且可以被配置成将流体汲取到上游层126中。虽然在图3中作为单独的部件说明，但上游层126的亲水侧132和疏水侧130是上游层126的相反侧，并且被示出为单独的部件以便帮助解释所描述的示例性实施例。
下游层128可以包括可以邻近并面向吸收构件124的第一侧，如亲水侧134；和第二侧，如疏水侧136。下游层128的疏水侧136也可以是小袋112的下游侧。下游层128可以由具有厚度140的一种非织造材料形成。在一些示例性实施例中，下游层128可以具有一种聚酯纤维多孔结构。下游层128可以不是穿孔的。在一些实施例中，下游层128可以由LibeltexTDL2或Libeltex TL4形成，并且可以具有在约80gsm至约150gsm之间的材料密度。在其他示例性实施例中，该材料密度可以取决于小袋112的具体应用而更低或更高。下游层128的材料密度可以大于上游层126的材料密度。进一步，在一些实施例中，多层材料可以被用来实现下游层128的所需厚度。在一些实施例中，下游层128的厚度140可以大于上游层126的厚度138。在图2和图3中说明的示例性实施例中，例如，厚度140可以是大于厚度138大约三倍。
在一些实施例中，上游层126和/或下游层128可以部分地由抗菌材料形成。在这样的示例实施例中，上游层126和/或下游层128可以在结构内包括聚己缩胍或聚六亚甲基双胍(PHMB)抗微生物材料，以提供更长的敷料寿命。其他材料可以与上游层126和/或下游层128结合。例如，胶原或胶原ORC(氧化的再生纤维素)可以粘结到或者上游层126或下游层128以调节在组织部位106处的基质金属蛋白酶(MMP)。胶原ORC已经显示出改善慢性伤口的上皮再形成时间。
下游层128的亲水侧134可以邻近并且面向吸收构件124被布置在吸收构件124的与上游层126的亲水侧132的相反侧上。下游层128的亲水侧134可以被配置成获得未被吸收构件124吸收的过量的流体。下游层128的亲水侧134还可以被称为流体获取表面、流体获取侧、亲水性获取表面、或者亲水性获取侧。下游层128的亲水侧134可以是一个纤维表面并且可以被配置成将流体汲取到下游层128中。下游层128的疏水侧136可以被配置成分配未由吸收构件124和下游层128的亲水侧134包含的流体。疏水侧136还可以被称为芯吸侧、芯吸表面、分配表面、分配侧、或者流体分配表面。疏水侧136可以是一个平滑的分配表面，该分配表面被配置成使流体沿着下游层128的纹理移动通过下游层128，从而将流体分配到整个下游层128上。虽然在图3中作为单独的部件说明，但亲水侧134和疏水侧136是下游层128的相反侧，并且被示出为单独的部件以便帮助解释所描述的示例性实施例。
当流体被吸收时，一些吸收性材料可能在流体进入该吸收构件本身的点处变得饱和。当一个区域中的吸收性材料在其他区域中的该吸收性材料饱和之前变得饱和时，该吸收性材料可能经历使流体从进入点移动到该吸收性材料是未饱和的区域的降低的能力。此外，如果施加减压，则分配至该组织部位的减压的量可能被减少，从而降低使用减压的治疗益处。当如上所述降低吸收性和流体管理时，需要更频繁的敷料更换，从而增加成本。
如在此所披露的，治疗系统100可以克服这些缺点和其他缺点。例如，通过将上游层126的疏水侧130面向组织部位106邻近歧管110放置，疏水侧130的疏水性质可以使流体沿着疏水侧130的纹理(未示出)沿着上游层126的宽度横向移动。以这种方式，该流体可以平行于歧管110和组织部位106移动。该流体的横向移动可以相对于离开组织部位106朝向盖布108的该流体的竖直或下游移动是基本上垂直的。这种芯吸作用可以在流体进入亲水侧132和吸收构件124之前将从组织部位106汲取的流体横向散布到更宽的区域上。当流体从疏水侧130朝向吸收构件124移动通过上游层126时，亲水侧132变得被该流体润湿，允许该流体被汲取到吸收构件124中。亲水性或吸收性梯度从疏水侧130至亲水侧132增加，并且因此，流体离开组织部位106并且朝向吸收构件124向下游移动。向敷料102施加减压可进一步增强流体的下游移动。
在操作中，下游层128的增加的厚度140和增加的材料密度可以帮助减压分配到上游层126和歧管110上。在一个示例性实施例中，上游层126可以具有大约80gsm的密度，并且下游层128可以具有大约150gsm的密度，这样使得下游层128对上游层126的相对厚度是大约1.875。在其他示例性实施例中，对于其他应用，下游层128与上游层126的相对厚度可以落在从大约1.5至大约3.0的范围中。通过下游层128分配减压可以帮助上游层126的疏水侧130的芯吸作用，这样使得从组织部位106汲取的流体可以被更均匀地分配在敷料102中。反过来，从组织部位106汲取的这些流体的更均匀的分配可以提供吸收构件124的更有效的使用，从而增加更换敷料102之间的时间，并且降低成本，因为需要更少的敷料来吸收等量的流体。
通过在小袋112的顶侧用疏水侧136配置下游层128，在一个区域中，当吸收构件124变得饱和、或凝胶阻塞时，敷料102可从吸收构件124获得游离流体。敷料102然后可以芯吸并在敷料102的顶部之上重新分配流体，这样使得流体芯吸发生在小袋112的两侧上。例如，当吸收性材料124的区域变得饱和时，下游层128的亲水侧134可以从吸收性材料124汲取和获得过量的流体进入亲水侧134的相邻部分。此过量的流体然后可迁移到下游层128的疏水侧136中。疏水侧136的疏水性质可以使该流体沿着疏水侧136的纹理(未示出)沿着下游层128的宽度横向移动。当该流体到达其中下游层128的在下面的亲水侧134和吸收构件124是不饱和的位置时，该流体可以从疏水侧136的外表面汲取回到亲水侧134和吸收构件124。因为亲水性从疏水侧136到亲水侧134并进一步到吸收构件124的增加的梯度，流体将朝向吸收构件124被汲取回上游，现在进入不饱和的吸收构件124的区域中。这提供了在小袋112中的最佳流体分配和吸收，并且此外可以防止吸收性材料124的过早饱和或凝胶阻塞。
如在此所描述，上游层126和下游层128的定位可以定向上游层126和下游层128的纹理，其方式为使得增加吸收构件124的有效使用。通过使用提供芯吸功能的材料，可以改善可获得的吸收性材料的有效使用。
芯吸流体并增多减压的层的使用允许可获得的吸收性材料的控制使用。如以上描述安排的这些层将减压分配成使得流体可以被更均匀地分配到该小袋的吸收构件上，从而当更多的流体通路被用于分配该流体时，增加使该吸收构件的吸收性材料饱和所需的总时间。使用形成具有不同亲水性结构的小袋的多个层允许对进入该小袋的吸收构件的这些流体的更好的控制。使用具有不同涂覆重量的多个层允许小袋的特性以一种技术上更好且成本有效的解决方案来匹配于应用。所披露的解决方案将产生在达到容量之前更高水平的吸收，而不需要另外的吸收性材料。
参照图4，描绘了适合于与治疗系统100一起使用的敷料400的另一个说明性实施例。敷料400可包括上游层126、吸收构件124和盖布108。类似于图2-3的实施例，上游层126可包括疏水侧130和亲水侧132。亲水侧132可以被定位成邻近并且面向吸收构件124，这样使得上游层126的疏水侧130也是敷料400的一个上游侧。以这种方式，疏水侧130可以被适配成定位成面向组织部位106和歧管110，如在图1中所示的。类似于图1-3的实施例，疏水侧130可以被配置成沿着上游层126分配流体，而亲水侧132可以被配置成从疏水侧130获得液体并协助流体移动进入吸收构件124中。上游层126可以由具有厚度138的非织造材料形成。在一些示例性实施例中，上游层126可以具有一种聚酯纤维多孔结构。上游层126可以不是穿孔的。在一些实施例中，上游层126可以由Libeltex TDL2或Libeltex TL4形成，并且可以具有在约80gsm至约150gsm之间的材料密度。在其他示例性实施例中，该材料密度可以取决于小袋112的具体应用而更低或更高。
继续参考图4，敷料400的盖布108可覆盖上游层126和吸收构件124二者。盖布108可邻近吸收构件124放置并且延伸超过吸收构件124的边缘以附接到上游层126。盖布108可以进一步包括一个附接装置，该附接装置可以用于将盖布108附接到上游层126的表面上。以这种方式，吸收构件124可以被封闭在敷料400的盖布108和上游层126内或被敷料400的盖布108和上游层126包围。
参照图5，描绘了适合于与治疗系统100一起使用的敷料500的另一个说明性实施例。类似于图2-3中所描绘的实施例，敷料500可以包括小袋112和盖布108。小袋112可以包括上游层126、吸收构件124和下游层128。如对于图2-3描述的，小袋112的上游层126可包括疏水侧130和亲水侧132。亲水侧132可被定位成邻近并面向吸收构件124。疏水侧130可以被适配成面向组织部位106和歧管110。疏水侧130可以被配置成沿着上游层126分配流体，而亲水侧132可以被配置成从疏水侧130获得液体并协助该流体移动进入吸收构件124中。
小袋112的下游层128可以包括邻近并面向吸收构件124的亲水侧134。如上所述，下游层128的疏水侧136可以是小袋112的下游侧。下游层128的亲水侧134可以邻近吸收构件124被布置在吸收构件124的与上游层126的亲水侧132的相反侧上。类似于先前的实施例，亲水侧134可以被配置成获得未被吸收构件124包含的流体用于由下游层128的疏水侧136分配。疏水侧136可以被配置成沿下游层128的纹理横向移动流体用于通过吸收构件124吸收。
仍参照图5，敷料500可以此外包括一个任选的非粘附层502。非粘附层502可以被定位成邻近上游层126的疏水侧130。非粘附层502可以被放置在上游层126的疏水侧130与组织部位106之间，并且可以被适配成防止组织部位106粘附到上游层126。非粘附层502还可以起到保持敷料500适当地抵靠组织部位106的作用。非粘附层502可以是穿孔的硅酮片材或具有丙烯酸粘合剂的对齐的“点”(registered“dots”)的图案涂覆的硅酮片材。例如，穿孔504可提供组织部位106与小袋112之间的流体连通。该丙烯酸粘合剂可防止敷料500在剪切应力下移动，诸如与骶骨伤口相关的那些。
在另一个说明性实施例(未示出)中，根据本披露的敷料的部件可以被配置为一个无边界的、层压结构。例如，参照图1-3的实施例，盖布108、下游层128、吸收构件124和上游层126的相邻表面可以被层压或联接在一起。热熔融的聚酯材料或其他粘结剂，例如，可以被定位在这些部件的相邻表面之间用于将这些部件联接在一起作为层压结构。将敷料部件的相邻表面彼此联接可以提供具有暴露的边缘的无边界结构。以这种方式，部件的周边部分可能不能彼此联接，从而允许每个组件具有暴露的边缘。在一些实施例中，亲水性泡沫界面可以被包括在该层压件中用于作为非粘附界面定位邻近组织部位。
图6示出了与根据本披露的敷料相关的改善的吸收和芯吸能力。吸收对比曲线图600比较了对于50ml盐水溶液被由曲线602标识的根据本披露的敷料和由曲线604和606标识的现有技术的敷料递送和在其之间吸收的时间。吸收对比曲线图600示出了曲线602的敷料比曲线604和606的现有技术的敷料在获取和吸收在4英寸的流体压头下的0.9％盐水溶液方面表现的更好。
在此描述的这些系统和方法可以提供显著的优点，其中一些已经提到。例如，该治疗系统可以提供改善的效率、更低的成本、以及增强的减压分支。所披露的示例性实施例还可以与多个串联式储罐一起使用，例如，布置在敷料外部的多个流体吸收小袋或多个流体吸收储罐。
尽管已经呈现某些说明性、非限制性示例性实施例，可以在不脱离所附权利要求书的范围的情况下进行不同的改变、替代、排列和变更。结合任何一个示例性实施例所描述的任何特征也可以应用于任何其他示例性实施例。进一步，在此所述的方法的步骤可以按任何适合的顺序进行，或在适当情况下同时进行。
Claims (35)
1.一种用于治疗组织部位的系统，该系统包括：
一个歧管，该歧管被适配成邻近该组织部位放置；
一个密封构件，该密封构件被适配成覆盖该组织部位和该歧管以便在该组织部位处提供流体密封；
一个小袋，该小袋被适配成定位在该歧管与该密封构件之间，该小袋包括：
一个上游层，该上游层具有一个亲水侧和一个疏水侧，
一个下游层，该下游层具有一个亲水侧和一个疏水侧，以及
一个吸收构件，该吸收构件被封闭在该上游层与该下游层之间，该上游层的该亲水侧被定位成面向该吸收构件，并且该下游层的该亲水侧被定位成面向该吸收构件，其中该上游层的该疏水侧被适配成沿着该上游层的该疏水侧的外表面横向分配流体；以及
一个减压源，该减压源被适配成定位成通过该密封构件与该歧管处于流体连通。
2.如权利要求1所述的系统，其中该上游层具有第一厚度并且该下游层具有第二厚度，该第二厚度大于该第一厚度。
3.如权利要求1所述的系统，其中该上游层具有大约80gsm的材料密度。
4.如权利要求1所述的系统，其中该下游层具有大约150gsm的材料密度。
5.如权利要求1所述的系统，进一步包括被适配成定位在该上游层与该组织部位之间的非粘附层。
6.如权利要求5所述的系统，其中该非粘附层包括穿孔的硅酮片材。
7.如权利要求6所述的系统，其中该穿孔的硅酮片材被图案涂覆有丙烯酸粘合剂，该丙烯酸粘合剂被适配成面向该组织部位。
8.如权利要求1所述的系统，进一步包括一个连接器，该连接器被联接到该密封构件上并且被适配成将该减压源流体联接到该歧管上。
9.如权利要求8所述的系统，进一步包括一个管，该管被流体联接在该减压源与该连接器之间。
10.如权利要求1所述的系统，其中该上游层的该亲水侧与该上游层的该疏水侧相反，并且其中该下游层的该亲水侧与该下游层的该疏水侧相反。
11.如权利要求1所述的系统，其中该下游层被适配成定位在该吸收构件与该密封构件之间。
12.如权利要求1所述的系统，其中该上游层和该下游层各自包括延伸超过该吸收构件的周边部分，该上游层的该周边部分被联接到该下游层的该周边部分上并且包封该吸收构件。
13.如权利要求1所述的系统，其中该密封构件被联接到该下游层上。
14.如权利要求1所述的系统，其中该上游层的该疏水侧和该下游层的该疏水侧限定该小袋的外表面的至少一部分，该小袋的该外表面被适配成在流体被该吸收构件吸收之前沿着该外表面横向分配这些流体。
15.如权利要求1所述的系统，其中该上游层被适配成定位在该吸收构件与该歧管之间。
16.一种用于从组织部位收集流体的设备，该设备包括：
一个上游层，该上游层具有一个亲水侧和一个疏水侧；
一个下游层，该下游层具有一个亲水侧和一个疏水侧；以及
一个吸收构件，该吸收构件被定位在该上游层与该下游层之间，该上游层的该亲水侧被定位成邻近并且面向该吸收构件，这样使得该上游层的该疏水侧形成该设备的外部的一部分，并且该下游层的该亲水侧被定位成邻近并且面向该吸收构件，这样使得该下游层的该疏水侧形成该设备的该外部的另一部分；
其中该设备的该外部被适配成在流体被该吸收构件吸收之前沿着该外部的该疏水侧的外表面横向分配这些流体。
17.如权利要求16所述的设备，其中该上游层具有第一厚度并且该下游层具有第二厚度，该第二厚度大于该第一厚度。
18.如权利要求16所述的设备，其中该上游层具有大约80gsm的材料密度。
19.如权利要求16所述的设备，其中该上游层和该下游层各自包括延伸超过该吸收构件的周边部分，该上游层的该周边部分被联接到该下游层的该周边部分上并且包封该吸收构件。
20.如权利要求16所述的设备，其中该下游层具有大约150gsm的材料密度。
21.如权利要求16所述的设备，其中该上游层被适配成邻近该组织部位定位。
22.如权利要求16所述的设备，其中该上游层和该下游层包括一种抗微生物材料。
23.如权利要求22所述的设备，其中该抗微生物材料包含聚己缩胍或聚六亚甲基双胍。
24.如权利要求16所述的设备，进一步包括联接到该下游层上的密封构件。
25.如权利要求16所述的设备，进一步包括粘结到该上游层上的胶原或胶原氧化再生纤维素。
26.如权利要求16所述的设备，进一步包括联接到该上游层上的密封构件。
27.一种用于从组织部位收集流体的设备，该设备包括：
一个上游层，该上游层具有一个亲水侧和一个疏水侧；
一个密封构件，该密封构件被适配成覆盖该组织部位和该上游层，该密封构件被粘结到该上游层上，该上游层的该亲水侧被定位成面向该密封构件；以及
一个吸收构件，该吸收构件被定位在该上游层与该密封构件之间，
其中该上游层的该疏水侧被适配成沿着该上游层的该疏水侧的外表面横向分配流体。
28.一种用于从组织部位收集流体的设备，该设备包括：
一个上游层，该上游层具有一个亲水侧和一个疏水侧；
一个下游层，该下游层具有一个亲水侧和一个疏水侧；
一个吸收构件，该吸收构件被定位在该上游层与该下游层之间，该上游层的该亲水侧被定位成面向该吸收构件，并且该下游层的该亲水侧被定位成面向该吸收构件，其中该上游层的该疏水侧被适配成沿着该上游层的该疏水侧的外表面横向分配流体；
一个密封构件，该密封构件被邻近该下游层定位；
一个非粘附界面，该非粘附界面被适配成定位在该上游层与该组织部位之间；并且
其中该密封构件通过第一热熔融的聚酯材料粘结到该下游层上，并且该非粘附界面通过第二热熔融的聚酯材料粘结到该上游层上。
29.如权利要求28所述的设备，其中该非粘附界面包括亲水性泡沫。
30.一种用于制造流体储存设备的方法，该方法包括：
提供第一层，该第一层具有一个亲水侧和一个疏水侧；
将一个吸收构件邻近该第一层的该亲水侧定位；
提供第二层，该第二层具有一个亲水侧和一个疏水侧；
将该第二层的该亲水侧邻近该吸收构件定位，该第二层被定位在该吸收构件的与该第一层相反的侧上；并且
将该第一层和该第二层的周边部分联接以便将该吸收构件封闭在该第一层与该第二层之间；
其中该第一层和该第二层的该疏水侧被适配成在吸收到该吸收构件中之前沿着该第一层和该第二层的该疏水侧的外表面横向分配流体。
31.如权利要求30所述的方法，其中将该第一层和该第二层的周边部分联接包括将该第一层和该第二层的这些周边部分彼此焊接。
32.如权利要求30所述的方法，其中将该第一层和该第二层的周边部分联接包括将该第一层和该第二层的这些周边部分彼此粘结。
33.如权利要求30所述的方法，其中将该第一层和该第二层的周边部分联接包括将该第一层和该第二层的这些周边部分彼此折叠。
34.如权利要求30所述的方法，其中该第一层具有大约80gsm的材料密度。
35.如权利要求30所述的方法，其中该第二层具有大约150gsm的材料密度。
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- 2015-06-04 JP JP2016570333A patent/JP6640748B2/ja active Active
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| EP3854361B8 (en) | 2024-03-27 |
| CN106535842A (zh) | 2017-03-22 |
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