CN101530361B - 具有不同性能区域的真空伤口治疗伤口敷料 - Google Patents

具有不同性能区域的真空伤口治疗伤口敷料 Download PDF

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CN101530361B
CN101530361B CN2009101286185A CN200910128618A CN101530361B CN 101530361 B CN101530361 B CN 101530361B CN 2009101286185 A CN2009101286185 A CN 2009101286185A CN 200910128618 A CN200910128618 A CN 200910128618A CN 101530361 B CN101530361 B CN 101530361B
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R·F·维塔利斯
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Smith and Nephew Inc
Covidien LP
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Abstract

一种用于开放性伤口的敷料，包括尺寸设定为相对于伤口床定位的覆盖层。所述覆盖层允许排空伤口床周围的空间，从而可以形成负压以刺激愈合和利于从伤口移除流体。覆盖层中的多个性能区域允许在不在伤口床上施加过度张力的情况下通过重复的排空循环将敷料保持就位。外周边区域可以包括高抗剥强度的粘合剂，而中间区域可以包括抗剪力粘合剂。中心区域可以没有任何涂层，从而最大程度地通过覆盖层输送湿气。

Description

具有不同性能区域的真空伤口治疗伤口敷料
技术领域
本公开总体涉及一种用于使用真空伤口治疗来处理开放性伤口的伤口敷料。具体地，本公开涉及一种具有覆盖层的敷料，其中所述覆盖层采用多个具有不同性能特征的区域以促进伤口的愈合。
背景技术
身体的自然伤口愈合过程是始于受伤那一刻的一系列复杂的事件。最初身体做出反应，通过血流输送蛋白质和其它因子到伤口以将损伤降到最小。血液凝结以防止血液流失，同时细胞吞噬细菌和死细胞，以将其运离伤口部位。接下来，在通常被称为增殖阶段的愈合期，身体开始自行修复。该阶段的特征在于伤口床中肉芽组织的沉积。肉芽组织提供基本结构，细胞可以在所述基本结构上从周边向内迁移至伤口附近。最后，当胶原质给予新组织强度时所述过程结束，随着时间的过去通常会形成疤痕。
一种用于(尤其但不排除)在增殖阶段促进自然愈合过程的技术被称为真空伤口治疗(VWT)。已经发现对伤口上方的局部贮器施加减小的压力(即负压)有助于伤口的闭合。所述减小的压力可以有效地促进血液流到所述区域，从而在伤口自然愈合的过程中刺激肉芽组织的形成和健康组织在伤口上的迁移。减小的压力还可以帮助清除从伤口渗出的流体，这可以抑制细菌的生长。这一技术已经被证实对于慢性或不愈合的伤口是有效的，但是也已经被用于其它用途，例如术后伤口的护理。
通常的真空伤口治疗方案在伤口中引入填充材料，用以吸收渗出物。所述填充材料可以包括例如非网状泡沫、无纺织物或纱布之类的材料。然后可以用可透湿汽的覆盖层覆盖伤口和填充材料，所述覆盖层允许与环境交换氧气，这对伤口的愈合可能是必要的。所述覆盖层通常包括粘性的周边，所述周边与伤口周围的健康皮肤形成基本上不透流体的密封。于是所述覆盖层在伤口上限定真空贮器，在真空贮器中随着时间的过去可以通过单个或周期性的排空程序维持减小的压力。
在真空伤口治疗处理中关心的一个方面是当应用真空时敷料中产生的力的控制。这些力可能导致敷料从皮肤上分离，由此限制了真空伤口治疗处理的效果并增大了微生物感染伤口的可能性。另外，这些力可能破坏新近形成的肉芽组织。真空的应用会使柔韧的覆盖层变形，使得覆盖层压缩填充物并增大其粘附在伤口床上的趋势。此外，覆盖层的变形会在伤口周围区域产生沿着皮肤-粘合剂接触面的横向剪力。这些剪力会导致敷料移位和/或离开皮肤，在那里可能逐渐形成裂口和皱纹。这种运动以及所提及的运动导致的后果会约束敷料提供适于维持真空和阻止污染物渗入的密封的能力。
施加到覆盖层以加强或增强敷料在皮肤上的附着性的粘合剂会减小敷料的可透湿汽性，从而影响敷料的允许与环境交换氧气的能力。降低的可透湿汽性还可能导致在皮肤-粘合剂的接触面处积聚湿气。允许这种积聚会破坏敷料对伤口周围区域皮肤的附着性，由此缩短了敷料的敷戴时间、降低了处理效果并且影响伤口周围区域的健康。因此需要一种适合在真空伤口治疗过程中使用的敷料。
发明内容
本公开描述了一种在真空伤口治疗过程中使用以促进伤口愈合的敷料。所述敷料包括覆盖层，所述覆盖层具有多个具有不同性能特性的区域。由一部分可透湿汽的膜限定的中心区域，所述膜没有任何阻止湿气通过所述膜输送的涂层。与覆盖层的周边邻近的周边区域适于围绕伤口的周边提供密封。至少一个中间区域设置在中心区域和周边区域之间，用于为伤口提供治疗效果或帮助。
所述周边区域可以包括高抗剥强度(peal-strength)的粘合剂，而第一中间区域可以包括抗剪力粘合剂(shear-resistant adhesive)。第二中间区域可以包括适于药剂输送的涂层，用于维持潮湿的伤口环境的水凝胶，或者抗感染剂、抗菌剂、抗生素、止痛剂、再生因子、维生素、生长因子、清创剂或营养素中的至少一种。
可透湿汽的膜可以延伸到覆盖层的周边从而构成背衬层，所述背衬层用于附着限定周边区域的粘合剂。所述周边区域和所述至少一个中间区域可以相对于中心区域同心布置。所述覆盖层还可以包括用于允许真空管进入在覆盖层下面限定的真空贮器的口。
根据本公开的另一个方面，一种在真空伤口治疗过程中使用的伤口敷料装置，包括接触层和定位在伤口床中并且由覆盖层覆盖的填充材料。所述覆盖层在伤口床上方限定真空贮器，并允许真空管进入真空贮器。所述覆盖层包括用于在伤口床周围提供密封的周边区域、至少一个用于为伤口床提供治疗效果或帮助的中间区域以及由可透湿汽的膜形成的中心区域。
所述接触层可以由带有锥形孔的膜形成，以促进伤口渗出物的单向流动。所述吸收性填充材料可以包括布置成多股丝束的聚烯烃细丝。另外，与真空贮器流体连通的真空系统可以包括真空源、收集罐和单向阀。
附图说明
结合在说明书的一部分中并且构成说明书的一部分的附图示出了本公开的实施例，并且和下文给出的实施例的详细描述一起，用来解释本公开的原理。
图1是根据本公开的真空伤口治疗系统的分解透视图；
图2A是用在患者身上的组装好的图1的真空伤口治疗系统的透视图；
图2B和2C示出所述真空伤口治疗系统的可供选择的组件。
图3A是图1的覆盖层的反面角度的透视图；
图3B示出了覆盖层的可供选择的实施例；
图4A是图1的真空伤口治疗系统在显现真空贮器的第一状态下的横截面视图；以及
图4B示出真空伤口治疗系统处于真空贮器被排空的第二状态下。
具体实施方式
本公开的伤口敷料通过在伤口上提供可以维持减小的压力的贮器来促进伤口的愈合。所述贮器使伤口受到负压，以在没有连续使用真空泵的情况下有效地从伤口吸取包括液体渗出物在内的伤口流体。因此，根据伤口的性质和严重程度可以应用一次真空压力或以可变间隔应用真空压力。已经发现以这种方式使用伤口敷料通过减小感染的可能性、刺激肉芽组织的沉积和其它有益过程来促进愈合。本公开的伤口敷料包括具有多个性能区域的覆盖层以提高真空伤口治疗处理的效果。
附图示出了本公开的示例性实施例并且参考附图来描述附图中所示的实施例。在下文中，将通过解释附图来详细描述本公开，其中在这几个视图中相同的附图标记表示相同的部件。
首先参考图1，根据本公开的真空伤口治疗系统整体示出为10，所述真空伤口治疗系统用在健康皮肤s围绕的伤口w上。真空伤口治疗系统10包括与真空贮器14(图4A)流体连通的真空系统12，真空贮器14由伤口敷料16限定或限定在伤口敷料16内。真空系统12包括通过单向阀20和真空管24与敷料16连接的真空源18。收集罐28设置用于收集伤口排出物和死细胞。真空系统12适于给适于刺激伤口愈合的真空贮器14提供减小的压力。适当的真空系统12的更详细描述可以在公开号为2007/0066946的共同转让的美国专利申请中找到，该专利申请的整个内容以引用的方式并入本文中。
伤口敷料16主要包括接触层34、填充物38和限定多个性能区域的覆盖层40。背衬层44可以以并置关系涂敷各种材料，从而限定周边区域48、第一中间区域52、第二中间区域56和中心区域58(图3A)。作为选择，每个区域可以包括邻近伤口床w定位的单独层。下面更详细地描述每个层。
接触层34可以是十分适应的(conformable)，以定位成与伤口床w的不规则成形表面直接接触。聚乙烯或其它适合的非粘附材料制成的薄膜可以形成接触层34以限制填充物38和其它物质粘附在伤口w上。所述膜中的孔或穿孔允许流体穿过接触层34，从而允许负压透入伤口w并且允许渗出物自由流出伤口w。通过选择适当的膜材料，可以将伤口渗出物穿过接触层34的通道控制成基本上为单向的，从而防止伤口渗出物倒流回伤口中。为了促进单向流动，可以选择例如由梵地冈的Tredegar Film Products of Richmond提供的带有锥形孔的膜用于形成接触层20。这种类型的膜布置有孔，所述孔位于膜材料中的锥形形成物的顶点处，以便渗出物接触在一个方向上为微型漏斗阵列而在另一个方向为集液池阵列的膜。渗出物的单向流动还可以通过选择其它材料促进，其它材料包括具有变化的吸收特性的层的层压材料。可以用作接触层的一种示例性的材料是由Covidien的分公司，即Kendall Corp.公司出售的商标为XEROFLO
Figure G2009101286185D00051
的材料。
填充物38可以布置在接触层34上，以填充伤口w至围绕健康皮肤s的程度，或者作为选择，填充物38可以过度填充伤口w。吸收材料(例如无纺纱布或网状泡沫)可以用作填充物38以俘获通过接触层34迁移的任何渗出物。Covidien的分公司，即Kendall Corp.公司出售的商标为KERLIXTM AMDTM的抗菌敷料可适于用作填充物38。为了防止粘附在伤口w上，填充物38还可以包括构造成其纤维不易穿过接触层34的孔而伸出的材料，在这些孔处纤维会被新近形成的肉芽组织吞没。表现出这种特性的一种特殊类型的材料通常被称为“丝束(tow)”。合成纤维的制造过程通常包括挤压不确定长度的连续细丝，这些连续细丝被纺在一起形成纤维。连续长度的非纺细丝可以布置成被称为丝束的多股丝束。可以在伤口床w中放置由疏水材料(例如聚烯烃)形成的单个长度的丝束，以形成填充物38。这种布置允许在不会再次损伤伤口w的情况下更换敷料16时完全移除填充物50。
覆盖层40可以放置在伤口w上，以将接触层和填充物封闭在其中。覆盖层40的周边横向延伸超出伤口床w的周边，以便接触健康皮肤s，从而在伤口w上形成密封。如图2A中所示，可以穿过覆盖层40设置或形成开口60，以提供用于真空管44的入口，从而与真空贮器14连通，或者如图2B中所示，真空管44可以密封在覆盖层40的周边的下面。作为选择，如图2C中所示，可以设置不同的入口元件或口62，以促进真空系统12和真空贮器14之间的流体连通。口62可以构造成适于以可释放和流体密封的方式容纳真空管24的刚性或半刚性的矮外形元件。真空口62可以构造成包括围绕其周界的宽挠性凸缘64。凸缘64允许粘合剂附着在凸缘64的下侧以固定到覆盖层40的外表面，或者附着在凸缘64的上侧以安装到覆盖层40的下侧。
现在参见图3A，覆盖层40包括多个含有不同材料的性能区域48、52、56和58。背衬层44可以延伸到覆盖层40的周边，以为限定不同性能区域48、52、56和58的不同涂层或材料提供衬底。如所示出的，每个性能区域48、52、56和58是相对于其它性能区域同心布置的连续带。但是，这些区域的尺寸、形状和位置可以根据特殊伤口或处理的需要变化。例如，如图3B中所示的覆盖层40A可以设置成包括第一中间区域52，该第一中间区域52由被第二中间区域56A围绕的具有不同形状的图案形成。不同的涂层可以层压在背衬层44上或者通过其它适当的方式固定。形成层40的不同材料在下文作更详细的描述。
背衬层44可以由柔韧的聚合物膜形成，以作为允许在真空贮器14中形成负压的流体屏障。所述材料的柔韧性适应与真空伤口治疗过程中的排出循环相关的压力变化。背衬层44还作为防止污染物进入伤口区域的微生物屏障。优选的是，背衬层44由可透湿汽的膜形成，以促进伤口部位与大气之间的氧气和湿气的交换。可以选择提供足够的湿汽传输率(MVTR)同时又不透液体的膜用作背衬层44。另一个优选的膜特性是伸展并与被压缩的伤口填充物或伤口床顺应的能力。膜在受到真空时的伸长趋势减小了传递给伤口周围区域的剪切力。在背衬层44中使用的一种示例性的材料是一家Bayer Material ScienceCompany(拜耳材料科技公司)，即Deerfield Urethan出售的商标为DURAFLEX
Figure G2009101286185D00071
的透明膜。适于在背衬层中使用的其它材料包括Covidien的分公司，即Kendall Corp.公司出售的商标为POLYSKIN
Figure G2009101286185D00072
II的薄膜、蒙古Paul大街的3M出售的商标为TEGADERMTM的薄膜、英国伦敦的Smith and Nephew PLC出售的商标为OPSITETM的薄膜。覆盖层的中心区域58由背衬层44上没有覆盖任何易于减小湿汽传输率的材料的区域限定。
覆盖层40的周边是周边区域48，所述周边区域48由高抗剥强度的压敏粘合剂的连续层限定。所述粘合剂围绕覆盖层周边与皮肤形成密封，以便在贮器14中形成减小的压力时防止大气流体从覆盖层40的边缘下面进入。限定周边区域48的粘合剂适于即使是在受到环境因素，例如伤口w的渗出物或患者身体的运动的影响时防止对皮肤的附着力的降低。通常，高抗剥强度的粘合剂适于防止在覆盖层的边缘处无意中的升起(lift-off)、卷起或松弛(flogging)，即敷料不能粘附到自身。限定周边区域48的粘合剂可以包括例如那些包含在CYTECSurface Specialties Inc.公司出售的商标为GELVA
Figure G2009101286185D00073
 MultipolymerSolutions的敷料内的粘合剂。
限定周边区域48的高抗剥强度的粘合剂可以粘合在背衬层44上，或者直接施加在伤口床w周围的皮肤s上。所述粘合剂应当优选对所接触的皮肤是不刺激且不致敏的，并且可以渗透湿汽以允许所接触的皮肤输送湿气。优选的是，如图4A和4B中所示，周边区域48和第一中间区域52定位成不与接触层34重叠。这种布置有助于在不移除整个敷料16的情况下更换敷料的某些独立元件，例如填充物38。
设置在周边区域48和中心区域58之间的分别是第一和第二中间区域52和56。第一和第二中间区域52、56由一层用于给伤口w提供治疗效果或帮助的物质限定。如上面所指出的，第一和第二中间区域52、56可以布置成如图3A中所示的与中心区域58同心的连续带，如图3B中所示的具有不同形状的图案，或是任何其它传统布置。
例如，第一中间区域52可以由一层粘合剂限定，所述粘合剂在利用减小的压力排空贮器时横向固定敷料。如图4B中所示，当贮器被排空时，覆盖层可能趋向于紧贴在伤口w上。这会在敷料16中形成指向外的力，所述力趋向于将覆盖层40从皮肤s上分离。同样，覆盖层40中的剪切力会传递给皮肤s，撕开新近形成的肉芽组织并再次损伤伤口w。为了消除这些趋势，可以选择抗剪力粘合剂用于第一中间区域52。因为很多高抗剥强度的粘合剂主要适于抵抗指向上的力，即那些趋向于将覆盖层从皮肤上提起的力，所以限定周边区域48的高抗剥强度的粘合剂可以用尤其适于抵抗限定第一中间区域52的横向力的粘合剂补充。可以使用抗剪力粘合剂(例如CYTEC SurfaceSpecialties Inc.公司制造的可透湿汽且适合在皮肤上使用的GMS1753)来限定第一中间区域52。
第二中间区域56可以由一层不同的材料限定，所述材料用于给伤口提供治疗效果或帮助。例如，第二中间区域56可以适于输送通过皮肤起作用的药剂。可以在背衬层108的一些部分上涂覆例如抗感染剂、抗菌剂、抗生素、止痛剂、再生因子、维生素、生长因子、清创剂或营养素之类的物质，以限定第二中间区域56。作为选择，可以选择水凝胶用于第二中间区域56，以维持潮湿的伤口环境。如图4B中所示，当贮器14被排空以允许向其中输送有益药剂时，第二中间区域56可以与填充物38接触。如果适当地允许第二中间区域56直接接触伤口床，则可以去掉填充物38和接触层34。另外可以想到的是，在第二中间区域56中使用额外的附着粘合剂可能是有利的。
尽管出于澄清或理解的目的，已经通过图示和举例的方式对上述公开进行了较详细的描述，但是显然可以在所附权利要求的范围内实施某些变化和修改。

Claims (14)

1.一种用于在真空伤口治疗中使用的伤口敷料的覆盖层，所述覆盖层包括：
由一部分可透湿汽的膜限定的中心区域，所述膜没有任何阻止湿气通过所述膜输送的涂层；
同心地围绕所述中心区域的周边区域，所述周边区域适于围绕伤口床的周边提供密封；和
至少部分地设置在中心区域和周边区域之间的至少一个中间区域，所述至少一个中间区域包括用于为伤口床提供治疗效果的物质。
2.根据权利要求1所述的覆盖层，其中所述周边区域包括高抗剥强度的粘合剂。
3.根据权利要求1所述的覆盖层，其中所述至少一个中间区域包括第一中间区域，所述第一中间区域包括抗剪力粘合剂。
4.根据权利要求3所述的覆盖层，其中所述至少一个中间区域进一步包括第二中间区域，所述第二中间区域包括药剂输送涂层。
5.根据权利要求3所述的覆盖层，其中所述至少一个中间区域进一步包括第二中间区域，所述第二中间区域包括水凝胶。
6.根据权利要求3所述的覆盖层，其中所述至少一个中间区域进一步包括第二中间区域，所述第二中间区域包括抗感染剂、抗菌剂、抗生素、止痛剂、再生因子、维生素、生长因子、清创剂或营养素中的至少一种。
7.根据权利要求1所述的覆盖层，其中所述可透湿汽的膜延伸到覆盖层的周边以构成背衬层，所述周边区域由粘合在背衬层上的一层粘合剂限定。
8.根据权利要求1所述的覆盖层，其中所述周边区域和所述至少一个中间区域相对于中心区域同心设置。
9.根据权利要求1所述的覆盖层，进一步包括允许真空管进入在覆盖层下面限定的真空贮器的口。
10.一种在真空伤口治疗过程中使用的伤口敷料装置，包括：
接触层，其适于邻近伤口床定位；
吸收性填充物，其在伤口床内邻近接触层定位，以用于收集从伤口床渗出的液体；
覆盖层，其定位在伤口床上、与伤口床之间限定真空贮器并且允许真空管进入真空贮器，所述覆盖层包括在伤口床周围提供密封的周边区域、至少一个用于为伤口床提供治疗效果的中间区域以及由可透湿汽的膜形成的中心区域。
11.根据权利要求10所述的伤口敷料装置，其中所述接触层由带锥形孔的膜形成。
12.根据权利要求10所述的伤口敷料装置，其中所述吸收性填充材料包括布置成多股丝束的聚烯烃细丝。
13.根据权利要求10所述的伤口敷料装置，进一步包括与真空贮器流体连通的真空系统。
14.根据权利要求13所述的伤口敷料装置，其中所述真空系统包括真空源、收集罐和单向阀。
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