CN102015007B - 用在真空伤口治疗中的抗剪伤口敷料 - Google Patents
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Abstract
本发明公开了一种用于真空伤口治疗敷料的覆盖层，其包括由柔性聚合膜形成的衬垫层和在伤口创面上方贴附至衬垫层以围绕伤口创面周边提供基本液密密封的粘性层。该覆盖层由加强层来加强，该加强层延伸到衬垫层的外周区域，以使与排空由覆盖层限定或位于覆盖层中的蓄积部相关联的力散布，从而刺激伤口创面的愈合。
Description
相关申请的交叉引用
本申请要求申请号为61/036,275、申请日为2008年3月13日、申请人为Vitaris的美国临时申请的优先权及其权益，将其全部内容通过引用结合于此。
技术领域
本发明总体涉及用于利用真空伤口治疗程序处理开放伤口的伤口敷料。尤其是，本发明涉及使用网状或者说网络状加强结构来在该程序的整个过程中保护伤口的伤口敷料。
背景技术
身体的自然的伤口愈合过程是在受到伤害的时刻开始的一系列复杂的作用情况。身体最初借助通过血流向伤口输送蛋白质和其它因子而做出反应，以将损伤降至最低。血液凝结以防止血液损失，同时细胞吞噬细菌和残骸以将其带离伤口点。接下来，身体开始在愈合阶段进行自我修复，该愈合阶段常常称为增殖期。增殖期的特征在于伤口创面(wound bed)中的沉积肉芽组织。肉芽组织提供基础结构，细胞可在该基础结构上方从外周向内迁移以封闭伤口。最后，由于随着时间的流逝胶原质向新组织提供了强度，该过程结束，并常常形成疤痕。
一种特别是但不限于在增殖期中用于促进自然的愈合过程的技术称为真空伤口治疗(VWT)。人们发现，将低压(例如亚大气压)施加于伤口上方的局部蓄积部(reservoir)有助于封闭伤口。该低压可有效地促进血液流向该区域，以刺激通过自然过程在伤口上方进行的肉芽组织形成和健康组织的迁移。低压也可有助于去除从伤口渗出的流体，这可抑制细菌增长。该技术已证明对慢性或难愈伤口是有效的，但也已用于其它用途，例如用在术后伤口护理中。
一般的VWT方案用于将填充物材料引入伤口以吸收渗出物并促进流体离开伤口创面输出。伤口填充物可包括如非网状泡沫、无纺加强物或纱布之类的材料。然后可用柔性覆盖层覆盖伤口和吸收性伤口填充物材料，该柔性覆盖层具有粘性外周，该粘性外周与伤口周围的健康皮肤形成基本液密密封。覆盖层因而在伤口上方限定了真空蓄积部，可在此处通过单独的或循环的排空程序长时间维持低压。
VWT处理中所关注的一个方面是对在施加低压时在敷料中产生的力的控制。这些力可能会不合希望地使柔性覆盖层变形，将伤口周围的边缘拉到伤口中以及使周围皮肤张紧。这些相同的力可能会显著地压缩吸收性填充物，以使得其形成硬块。在这样一种状态下，填充物粘附到伤口创面的趋势增强，限制可用于渗出物输出的流体通道并且抑制低压透过。因此，需要适于用在VWT程序中的敷料。
发明内容
本发明描述了一种用在促进伤口愈合的真空伤口治疗程序中的敷料。该敷料包括覆盖层，该覆盖层具有一体式的支撑结构以控制与VWT程序相关联的力。该覆盖层包括由柔性聚合膜形成的衬垫层、在伤口上方贴附衬垫层并且围绕伤口创面提供密封的粘性层以及贴附在衬垫层上并且延伸到覆盖层的外周区域的网状或者说网络状加强层。该网络状加强层使覆盖层变硬并且有助于提高覆盖层抵抗通常与VWT程序相关联的伤口区域中的变形的能力。因而，伤口填充物可被压缩到较小的程度，以使得它能够继续提供渗出物输出和真空渗透。网络状加强层的使用也可减轻伤口边缘塌陷的程度，并且可有助于使通过施加低压而产生的力显示为压缩力而非剪切力。众所周知，在伤口施加压缩力是有益的伤口处理方式。
加强层可由如聚对苯二甲酸乙二醇酯纤维网、带孔膜和热塑性网。粘性层可贴附至衬垫层的外周区域并且可包括开口以使得粘性层不延伸到覆盖层的中央区域。粘性层可与加强层的一部分重叠以使得使加强层牢固地贴附至衬垫层。替代地，加强层可包括适当的粘性敷层，以使其更牢固地附着至衬垫层。衬垫层可由厚度为约0.8mil(千分之一英寸)到约1.0mil的聚亚安酯膜形成，并且其中可包括便于使真空端口与覆盖层连接的孔。该真空端口可结合有限定了多个开口的滤网。衬垫层可由湿气可渗透膜形成。
根据本发明的另一方面，伤口敷料系统包括放置在伤口创面中并由覆盖层覆盖的吸收性填充物和接触层。真空蓄积部限定在覆盖层和伤口创面之间。覆盖层包括由柔性聚合膜形成的衬垫层、在伤口上方贴附衬垫层并围绕伤口创面提供密封的粘性层以及贴附至衬垫层并延伸到覆盖层的外周区域的加强层。一真空系统与真空蓄积部处于流体连通。
接触层可由圆锥形带孔膜形成，以促进渗出物从伤口向外单向流动。吸收性填充物材料可包括单股的聚烯烃细丝。另外，真空系统可包括真空源、收集罐和单向阀。
附图说明
本发明的附图结合到本说明书中且构成本说明书的一部分，其示出了本发明的实施例，并与下面给出的对实施例的详细描述一起用于阐明本发明的原理。
图1是根据本发明的真空伤口治疗系统的分解透视图；
图2是图1所示覆盖层的面向伤口侧的正视图；
图3是沿图2中的3-3线剖开的分解剖视图；
图4A是在施加低压之前的安装在患者伤口上方的图1所示真空伤口治疗系统的剖视图；
图4B是在施加低压之后的安装在患者伤口上方的图1所示真空伤口治疗系统的剖视图；
图5是图1所示真空端口的俯视图；
图6是图5所示真空端口的透视图；
图7是真空端口的一个替代实施例的透视图；
图8是包括端口构件和独立滤网的真空端口组件的一个替代实施例的分解透视图；
图8A是图8所示滤网沿另一方向的透视图；
图8B是独立滤网的一个替代实施例的透视图；
图9是图8所示端口构件的底视图；
图10是组装在伤口敷料中的真空端口组件的局部剖视图；以及
图11是包括处理元件的真空端口组件的一个替代实施例的分解透视图。
具体实施方式
本发明的伤口敷料通过在伤口上方提供蓄积部来促进伤口的愈合，在该处可维持低压。蓄积部使伤口承受亚大气压压力，以在无需持续使用真空泵的情况下有效地从伤口抽取伤口流体，包括液体渗出物。从而，真空压力可一次施加，或者根据伤口的类型和严重程度以变化的间隔施加。为便于流体从伤口输出，蓄积部内可包括填充物材料，以促进处于低压下的伤口流体通过毛细作用输出。伤口敷料以这种方式的使用已被发现能够通过减少感染的可能性、刺激肉芽组织的沉积和其它有益的过程来促进愈合。本发明的伤口敷料包括覆盖层，该覆盖层具有增强真空伤口治疗处理效果的加强结构。
附图示出了本发明的示例性实施例并且作为参考来描述在此记述的实施例。在下文中，将通过解释附图来详细描述本发明，其中，贯穿若干视图，同样的附图标记表示同样的部件。
首先参照图1，根据本发明的真空伤口治疗系统总体以10来表示，其用在由健康皮肤“s”所包围的伤口“w”上。真空伤口治疗系统10包括与真空蓄积部14(图4A)处于流体连通的真空系统12，真空蓄积部14由伤口敷料16限定或位于伤口敷料16中。真空系统12包括通过单向阀20和真空管24联接至敷料16的真空源18。可提供用于伤口排出物和残骸的收集罐28。真空系统12适于为适合刺激伤口“w”愈合的真空蓄积部14提供低压。对适当的真空系统12更为详细的描述可在属于共同受让人的美国专利申请公开文本2007/0066946中看到，其全部内容在此作为参考引入。
也可包括在图5和图6中更详细描述的真空端口30，以便于将真空系统12连接至敷料16。真空端口30可构造为适于以可释放和液密方式接收真空管24的刚性或半刚性的低轮廓(low-profile)部件。具空端口30可构造成包括绕其周边的宽柔性凸缘32。凸缘32容许粘合剂附着于凸缘32的下侧以固定至覆盖层44的外表面，或者附着于凸缘32的顶侧以保证安装至加强层46的下侧。任一构造都提供用于连接至敷料16的机构。真空端口30的中空内部在真空管24和由敷料16限定或位于其中的蓄积部14之间提供流体连通。连接器段33在凸缘32上方延伸，以方便与真空管24连接。可以想到，由于真空端口30可能与蓄积部14或伤口填充物38紧密接近，可通过加入如图6和图7所示的滤网58而增强真空端口30的性能。滤网58可抑制大颗粒的迁移，否则大颗粒可能会被抽吸到真空端口30中并且因而对真空管24产生限制或阻塞。滤网58可作为端口凸缘32的部分，与真空端口30的构造形成一体。滤网58可包括许多开口，每个都小于真空管24的或者真空端口30中适于接收真空管24的开口的横截面积，并且其合起来大于真空管24的或者真空端口30中适于接收真空管24的开口的横截面积。例如，真空端口30的滤网58可包括四个较大的开口，而图7所示真空端口30A的滤网58A可包括六个较小开口。滤网58、58A中的开口的尺寸被定为尽量减少经由相应真空端口30、30A通过的预定尺寸的组织颗粒。
真空端口的另一替代实施例在图8、9、10和11中总体以30B来表示。真空端口30B可构造成接受作为单独的或独立制造的部件的滤网59或60，如图8、10和11所示。如图9的以平面图所示出的和如图8中以虚线示出的、位于真空端口30B下侧上的开口或空穴31可适于容许滤网59永久性地结合在其中，以使得滤网59大致与真空端口30B的下侧平齐。替代地，滤网60可结合至真空端口30B下侧上的开口。滤网60可包括大致平坦的基部62，开口65通过该基部62延伸，一对唇缘64沿滤网60的相对边缘从基部62伸出。唇缘64的尺寸可定为能够使其在接收在空穴31中时与凸缘的面向患者的下表面平齐。替代地，唇缘64可延伸超过凸缘的下表面，以延伸超过图10所示端口构件30B中的空穴31。滤网60可具有可用于结合在真空端口30B的空穴31内的增加的表面面积。滤网60可通过粘结剂、接合剂、粘合剂等固定在空穴31内。在一个实施例中，将滤网62放置在空穴31内，其中唇缘64面向伤口(图8和10)。在另一实施例中，将滤网62放置在唇缘64内，其中唇缘64面向真空端口30B并背离伤口(图8A)。在另一实施例中，基部62如图8B所示没有唇缘64，并且大致是平坦的。
还可想到，滤网59和60可与如图11所示的包括治疗材料的处理元件61组合设置。处理元件61可插在滤网59、60之间并且可通过适当的粘性结合剂固定至真空端口30B。处理元件61和滤网59、60可限定用于接收到端口构件30B下侧上的空穴或开口31中的插入物。该布置可提供在伤口渗出物从伤口“w”抽出时处理伤口渗出物的便利方法。处理元件61可包括容纳在多孔容器或包裹物中的含纤维或颗粒状材料，以便于在滤网59和60之间放置。处理元件61可包括如活性炭或其它抑臭或中和物质的材料。处理元件61可包括抗菌物质，比如聚六亚甲基双胍(PHMB)。另外，也可包括抗微生物物质，比如离子金属或双胍，以在渗出物被抽到收集罐28中时减少渗出物的生物负载或渗出物内的微生物。在一个替代实施例中，滤网59、60可包括木炭、抗微生物物质、抗臭物质。
真空管30可构造成能够接受各种管状几何形状，比如圆形、长方形或椭圆形。真空端口30可作为敷料16的预贴附部件、作为真空系统12的部分或作为完全独立的部件来提供。真空端口30也可不必依赖于敷料16的构造。
伤口敷料16大体包括接触层34、填充物38和加强覆盖层40。加强覆盖层40可由包括衬垫层44、加强层46和粘性层48的复合物形成。伤口敷料16的每一层都将在下面得到更详细的描述。
接触层34可具有充分顺应性以与伤口创面“w”的不规则形状表面直接接触地放置。聚乙烯或其它合适的非粘着性材料的薄膜可形成接触层34，以限制填充物38及其它物质粘着至伤口“w”。该膜中的洞或孔容许流体经过接触层34，允许亚大气压压力渗入伤口“w”并允许渗出物自由流出伤口“w”。通过选择适当的膜材料，可控制伤口渗出物通过接触层34的情况以使其大致是单向的，从而防止伤口渗出物回流到伤口。为促进单向流动，可选择圆锥形带孔膜，比如由Tredegar FilmProducts of Richmond，VA提供的那些，来形成接触层34。这种类型的膜布置有设置在膜材料中的锥形结构的顶部处的孔，以使得渗出物所遇到的膜在一个方向上是一系列微漏斗，而在另一方向上是一系列收集盆。尽管是以正方形构造进行描述的，但接触层34的形状能够被定制成更适合伤口几何形状。渗出物的单向流动也可通过选择其它材料来促进，所述其它材料包括具有变化的吸收特性的叠积层。一种可用作接触层的示例性材料是由Covidien的一个分公司Kendall Corp.出售的商标为XEROFLO
的材料。
填充物38可布置在接触层34上方，将伤口“w”填充到围绕健康皮肤“s”的水平，或可将伤口“w”填充过满，如图4A所示。吸收性材料，比如无纺纱布或网状泡沫，可用于填充物38，以截获或传输通过接触层34迁移的任何渗出物。由Covidien的一个分公司Kendall Corp.出售的商标为KERLIX
的抗微生物敷料可适于用作填充物38。为防止粘附至伤口“w”，填充物38也可包括一种材料，这种材料使得任何偏离的纤维不会通过接触层34的孔突出，在此处它们被新形成肉芽组织吞没。一种具有这种特性的特殊类型的材料常常被称作“丝束(tow)”。合成纤维的制造过程常常包括不确定长度的连续细丝的挤出，它们被纺在一起形成纤维。称作丝束的是连续长度的非纺成细丝。由疏水材料比如聚烯烃形成的单一长度的丝束可放置在伤口创面“w”中以形成填充物38。这种布置允许在没有再伤害伤口“w”的情况下，在改换敷料16时完全除去填充物38。
覆盖层40可放置在伤口“w”上方，在其中包围接触层34和填充物38。覆盖层40的外周横向延伸超过伤口创面“w”的周边，以便接触健康皮肤“s”，从而在伤口“w”上方形成密封。如图2所示，粘性层48可延伸到覆盖层40的外周，以利用医学等级的压敏粘合剂提供密封。粘性层48可适于围绕敷料16的外周区域提供液密和菌密密封，以使得渗出物不能通过敷料16的边缘溢出并且外部空气和污染物不会进入伤口区域。为提供这种屏障，根据使用的粘合剂情况，粘性层48的厚度可例如是在1.0-10mil的范围内。通常，高抗剥强度(peal-strength)粘合剂可用于抵抗在覆盖层40边缘处的无意中的升起、卷起或“扬起(flagging)”(即，敷料不能粘附至其自身或患者)。限定粘性层48的粘合剂可包括但不限于医学等级丙烯酸树脂、橡胶基或硅树脂粘合剂。优选的是，可以使用Covidien的一个分公司KendallCorp.出售的商标为Polyskin II Transparent Dressings的敷料所包括的那些粘合剂。粘性层48在覆盖层40的外周区域周围形成连续的带，但包括开口以使得粘性层不向内延伸到覆盖层40的中央区域。
如图3所示，加强层46可在外边缘与粘性层48重叠，以使得加强层46的外周牢固地贴附至衬垫层44。加强层46延伸到覆盖层40的外周区域，但不必到覆盖层40的外周边。加强层46，尤其是未与粘性层48重叠的任何部分，可利用涂敷于加强层46或衬垫层44的适当侧上的薄层粘合剂57贴附至衬垫层44。加强层46的面向伤口侧52的一部分不带有粘合剂，以防止覆盖层40粘附至填充物38。孔54通过加强层46延伸，以容许蓄积部14和真空系统12之间的流体连通。
加强层46可包括聚对苯二甲酸乙二醇酯(PET)纤维网，其提供良好的液阻，使得它适于用在潮湿的伤口环境中。PET纤维可用于形成具有大孔径的纺织或无纺加强物。一些PET加强物制造方法互连纤维接合点以生产在多个方向上是柔性的且在切隔时也不会被拆开的网。一种这种方法被称作高压射流缠结。由此制造的PET加强物倾向于具有在加强覆盖层40中有用的高剪切刚度。可适于结合到加强层46中的一种示例性材料是DuPont出售的商标为Sontara
的材料。替代地，加强层46可由具有合适的剪切刚度的另一加强或网结构形成。合适结构的例子包括挤出网和带孔膜。用在这种替代结构中的合适的材料包括PET、聚乙烯、尼龙和聚丙烯。另外，纺织结构可用于加强层46。可接受的纺织材料可包括棉纱布、纺织醋酸纤维素和尼龙。
衬垫层44延伸到覆盖层40外周。衬垫层44提供可供加强层46和粘性层48贴附的基底。孔56延伸通过衬垫层44，以容许蓄积部14和真空系统12之间的流体连通。衬垫层44可由柔性聚合膜形成，以用作流体屏障从而允许在真空蓄积部14中形成亚大气压压力，并且还用作抗微生物屏障从而防止污染物进入伤口区域。例如，衬垫层44可包括厚度为约0.8mil-约1.0mil的聚亚安酯膜。优选的是，衬垫层44由湿气可渗透的膜形成，以促进氧气和湿气在伤口位置与大气之间的交换。一种示例性的材料是Covidien的一个分公司Kendall Corp.出售的商标为POLYSKIN
II的透明膜。可适于用在衬垫层中的其它材料包括3M of St.Paul，MN出售的名为TEGADERMTM的薄膜以及英国伦敦的Smith and Nephew PLC出售的OPSITETM薄膜。加强层46可通过例如包括大孔径而构造成不阻碍湿气的传送。
如图4A所示，当伤口敷料16应用到皮肤上时，蓄积部14由伤口敷料16限定或位于伤口敷料16中。可包括填充物38以用于填充蓄积部14。从蓄积部14排出大气压气体可使得覆盖层40具有平靠在伤口“w”上的趋势，如图4B所示。覆盖层40的这一变形趋势可将伤口周围的边缘拉到伤口“w”中并且使周围皮肤“s”张紧。该趋势可由加强层46中的剪切刚度抵消或抵抗，以使得覆盖层40可更好地保持其形状。因为加强层46延伸到锚固至健康皮肤“s”的衬垫层44和覆盖层40的外周区域，所以与排空蓄积部14相关联的力可被转移到伤口“w”的周边之外，并且可显现为压缩力。加强层46因此加强了覆盖层40和真空蓄积部14。
加强层46的中央区域可没有粘性敷层，以使得加强层46不会趋于粘着于或弄乱填充物38(特别是在从蓄积部14中除去低压时)。加强层46因而进一步保护了伤口“w”，以在VWT程序的排空循环的整个过程中促进愈合。
尽管为了清楚或理解起见，已通过图解和示例比较详细地对前述公开内容进行了描述，但显而易见的是，在后附权利要求范围内的某些改变和变型也是可行的。
Claims (12)
1.一种用于真空伤口治疗敷料的覆盖层，其包括：
衬垫层，该衬垫层包括柔性聚合膜，该衬垫层包括面向伤口内侧和与面向伤口内侧相反的外侧；
粘性层，该粘性层布置在该衬垫层的面向伤口内侧上，该粘性层适于在伤口创面上方贴附衬垫层并围绕伤口创面周边提供基本液密密封；以及
加强层，该加强层贴附至衬垫层并且布置在该衬垫层的面向伤口内侧上，该加强层包括延伸横跨衬垫层的中央区域且延伸到在衬垫层的相对横向侧上的衬垫层的外周区域的互连纤维的网络以便在伤口创面上方加强真空蓄积部。
2.如权利要求1所述的覆盖层，其中该互连纤维的网络包括由聚对苯二甲酸乙二醇酯纤维形成的网。
3.如权利要求1所述的覆盖层，其中该粘性层贴附至衬垫层的外周区域并且包括开口以使得该粘性层不延伸到覆盖层的中央区域。
4.如权利要求3所述的覆盖层，其中该粘性层与加强层的一部分重叠，以使得加强层牢固地贴附至衬垫层。
5.如权利要求1所述的覆盖层，其中该衬垫层包括厚度为约0.8mil-约1.0mil的聚亚安酯膜。
6.如权利要求1所述的覆盖层，其中该衬垫层中还包括便于将真空端口与覆盖层连接的孔。
7.如权利要求6所述的覆盖层，其中该真空端口贴附至衬垫层，该真空端口中具有限定多个开口的滤网。
8.如权利要求1所述的覆盖层，其中该衬垫层由湿气可渗透的膜形成。
9.一种伤口敷料系统，其包括：
适于邻近伤口创面放置的接触层；
在伤口创面内邻近接触层设置的吸收性填充物，用于收集从伤口创面渗出的液体；
放置在伤口创面上方并且在其间限定真空蓄积部的覆盖层，该覆盖层包括由柔性聚合膜形成并且包括面向伤口内侧和与面向伤口内侧相反的外侧的衬垫层、布置在该衬垫层的面向伤口内侧上以围绕伤口创面提供密封的粘性层、以及布置在该衬垫层的面向伤口内侧上且贴附至衬垫层的包括互连纤维的网络的加强层，该互连纤维的网络延伸横跨衬垫层的中央区域且延伸到在衬垫层的相对横向侧上的衬垫层的外周区域；以及
与真空蓄积部处于流体连通的真空系统。
10.如权利要求9所述的伤口敷料系统，其中该接触层由圆锥形带孔膜形成。
11.如权利要求9所述的伤口敷料系统，其中吸收性填充物材料包括单股聚烯烃细丝。
12.如权利要求9所述的伤口敷料系统，其中该真空系统包括真空源、收集罐和单向阀。
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Effective date of registration: 20140102 Address after: Tennessee Patentee after: Smith & Nephew, Inc. Address before: Massachusetts, USA Patentee before: Covidien L.P. |