CN104287893B - 伤口敷料端口和相关的伤口敷料 - Google Patents
伤口敷料端口和相关的伤口敷料 Download PDFInfo
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Abstract
本发明提供一种伤口敷料端口和相关的伤口敷料,该用于真空伤口疗法处理中的伤口敷料包括用于定位在伤口之上以限定蓄池的衬层,在所述蓄池中减小的压力可以被保持在伤口之上。附着到所述衬层的端口元件通过周围表面中的开口提供到减小的压力源的连接。主端口在所述开口与蓄池表面中的主开孔之间延伸以提供蓄池与减小的压力源之间的流体连通。至少一个补充端口在所述主端口与蓄池表面中的补充开孔之间建立流体连通,所述补充开孔与所述主开孔不同并且与该主开孔明显间隔开。
Description
本分案申请是基于中国发明专利申请号200910007971.8、发明名称“伤口敷料端口和相关的伤口敷料”、申请日2009年3月6日的专利申请的分案申请。
技术领域
本发明通常涉及用真空伤口疗法处理开放伤口的伤口敷料(wound dressing)。特别地,本发明涉及具有端口元件的敷料,所述端口元件提供至真空系统的连接使得在伤口之上的蓄池可以被排空。
背景技术
身体的自然伤口愈合过程是在损伤时开始的一系列复杂事件。初始身体的反应是将通过血流蛋白和其他因子输送到伤口以使损害最小化。血液凝结以防止血液损失,同时细胞吞噬细菌和碎屑以将携带它远离伤口部位。接着,身体开始在常常被称为增殖期的愈合阶段修复自身。该时期的特征在于肉芽组织沉淀在伤口创面中。肉芽组织提供基础结构,在该基础结构上细胞可以从外围向内迁移以闭合伤口。最后随着时间当胶原给予新组织足够的强度时该过程结束,常常形成疤痕。
特别地但非唯一地在增殖期期间用于促进自然愈合过程的一种技术被称为真空伤口疗法(VWT)。减小的压力例如次大气压施加到伤口之上的局部蓄池已被发现有助于闭合伤口。减小的压力可以有效地促进血液流动到该区域以通过自然过程刺激肉芽组织的形成和健康组织在伤口上的迁移。而且减小的压力可以帮助去除从伤口渗出的流体,这可以抑制细菌生长。该技术已证明对慢性或非愈合性伤口有效,但是也被用于其他目的,例如术后伤口护理。
一般VWT协议规定将吸收性填充材料例如非网状泡沫、无纺织物或纱布引入伤口中以吸收渗出液。伤口和吸收性填充材料然后可以由柔性覆盖层例如聚合物膜覆盖以在伤口之上建立真空蓄池,在那里减小的压力可以由单个或循环排空程序施加。为了允许随着时间保持减小的压力,覆盖层可以包括粘性周边,所述粘性周边与围绕伤口的健康皮肤形成基本不透流体密封。
尽管一些程序可以利用包含在真空蓄池内的微泵,多数VWT处理使用外部真空源施加减小的压力。因此,必须建立真空源与蓄池之间的流体连通。为此,覆盖层将常常包括连接器或端口元件,来自外部真空系统的空气软管可以连接到所述连接器或端口元件。
在VWT处理中的一个关注方面是当施加减小的压力时填充材料和伤口渗出液沿着气流的方向迁移。这些物质可能沉淀在例如端口元件内的表面上,并且随着时间导致这些端口元件的堵塞或完全闭塞。该现象可能限制来自伤口区域的渗出液流的水平,或者甚至禁止减小的压力施加到伤口区域,因此限制或阻碍了VWT处理的效率。因此,需要一种适合用于VWT程序中的敷料。
发明内容
本发明描述了一种用于真空伤口疗法处理中的伤口敷料。所述伤口敷料包括用于定位在伤口之上以限定蓄池的衬层,在所述蓄池中减小的压力可以被保持在伤口之上。端口元件被附着到所述衬层使得所述端口元件的周围表面可以与所述端口元件的蓄池表面流体隔离。当所述衬层被定位在伤口之上时所述衬层限定在所述周围表面与所述蓄池表面之间的边界。所述端口元件包括在所述周围表面中的开口与所述蓄池表面中的主开孔之间延伸的主端口。所述开口适于连接到抽吸装置并且所述主开孔适于建立与所述蓄池的流体连通。所述端口元件进一步包括在所述主端口与所述蓄池表面中的补充开孔之间建立流体连通的至少一个补充端口。所述补充开孔与所述主开孔不同并且基本与它间隔。
所述端口元件可以包括从所述主端口径向向外延伸的多个补充端口。所述主和补充开孔可以基本分布在整个蓄池表面上。所述端口元件可以由柔性聚合物或弹性体材料模制并且可以包括适于连接粘性涂层薄膜的附连凸缘。
伤口敷料的所述衬层可以包括柔性聚合物薄膜。所述衬层可以包括粘性涂层,所述粘性涂层适于附着到伤口之上的所述衬层并且提供围绕伤口的周围的基本不透流体密封。所述粘性涂层可以被中断使得所述衬层的中间部分保持无涂层。
根据本发明的进一步方面,一种真空伤口疗法系统包括定位在伤口创面中的接触层和吸收性填充物,和附着到定位在伤口创面之上的衬层以限定真空蓄池的端口元件。所述端口元件包括在周围表面中的开口与蓄池表面中的主开孔之间延伸的主端口,和在所述主端口与补充开孔之间延伸的至少一个补充端口,所述补充开孔与所述主开孔不同并且基本与它间隔。
所述接触层可以由带圆锥形开孔的薄膜形成以促进渗出液从伤口单向流动。吸收性填充材料可以包括单股聚烯烃细丝。而且,与所述真空蓄池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
结合在该说明书中并且作为它的一部分的附图示出了本发明的实施例,并且与下面给出的实施例的详细描述一起用于解释本发明的原理。
图1是根据本发明的真空伤口疗法系统的分解透视图;
图2是图1的端口元件的面对伤口侧的正视图;
图3是沿着图2的线3-3获得的横截面图;
图4是安装在患者上的伤口之上的图1的真空伤口疗法系统的横截面图;和
图5是类似于图4的视图,其描绘了真空伤口疗法系统的一个备选实施例。
具体实施方式
本发明的伤口敷料通过提供在伤口之上的蓄池促进伤口的愈合,在所述蓄池中可以保持减小的压力。所述蓄池使伤口受到次大气压以在不连续使用真空泵的情况下从伤口有效地抽吸包括渗出液的伤口流体。因此,可以取决于伤口的性质和严重性一次或以不同的时间间隔施加真空压力。以该方式使用伤口敷料已被发现通过减小感染的概率、刺激肉芽组织的沉淀和其他有益处理促进了愈合。本发明的伤口敷料包括附着到端口元件的衬层以用于增强真空伤口疗法系统的效果。
附图示出了本发明的典型实施例并且被参考以描述这里所述的实施例。在下文中,通过解释附图将详细描述本发明,其中在全部几个视图中相似的参考数字表示相似的部分。
首先参考图1,根据本发明的真空伤口疗法系统一般被显示成10,用于由健康组织“s”围绕的伤口“w”上。真空伤口疗法系统10包括真空系统12,该真空系统与由伤口敷料16限定或在伤口敷料16内的真空蓄池14(图4)流体连通。真空系统12包括真空源18,该真空源通过单向阀20和抽吸装置例如真空管24耦联到敷料16。收集罐28可以被提供用于伤口引流物和碎屑。真空系统12适于将减小的压力提供给真空蓄池14以适合刺激伤口“w”的愈合。合适的真空系统12的更详细描述可以在共同转让的美国专利申请公开2007/0066946中找到,该专利的全部内容被引用于此作为参考。
伤口敷料16通常包括接触层34,填充物38和覆盖层40。覆盖层40包括衬层44和端口元件46。端口元件46被构造成通过提供用于抽吸装置例如真空管24的接口在真空蓄池14与真空系统12之间建立流体连通。下面更详细地描述伤口敷料16的每一层。
接触层34可以足够舒服地被定位成与伤口创面“w”的不规则成形表面直接接触。聚乙烯或其他合适的非粘连材料的薄膜可以形成接触层34以限制填充物38和其他物质粘连到伤口“w”。薄膜中的开孔或穿孔允许流体穿过接触层34,允许次大气压透入伤口“w”并且允许渗出液自由流出伤口“w”。通过选择合适的薄膜材料,可以控制伤口渗出液基本单向地通过接触层34以防止伤口渗出液流回伤口中。为了促进单向流动,可以被选择带圆锥形开孔的薄膜,例如由Kendall公司,Covidien公司的一个分公司生产的VENTEXTM,或由弗吉尼亚州里士满的Tredegar Film Products公司生产的开孔薄膜来形成接触层34。渗出液的单向流动也可以通过选择其他材料促进,包括具有可变吸收特性的叠层。可以用作接触层的一种典型材料由Kendall公司,Covidien公司的一个分公司以商标销售。
填充物38被布置在接触层34上以将伤口“w”填充到周围健康皮肤“s”的水平。吸收性材料例如无纺纱布或网状泡沫可以用于填充物38以俘获迁移通过接触层34的任何渗出液。由Kendall公司,Covidien公司的一个分公司以商标销售的抗菌敷料可以适合于用作填充物38。为了防止粘连到伤口“w”,填充物38也可以包括这样的材料,所述材料被构造成使得任何杂散纤维不会倾向于通过接触层34的开孔突出,在突出的情况下它们可能被新形成的肉芽组织吞没。具有该特性的一种特殊类型的材料常常被称为“落纤(tow)”。用于合成纤维的制造过程常常包括挤出未定长度的连续细丝,将所述连续细丝捻在一起形成纤维。正是连续长度的未捻细丝被称为落纤。由疏水材料例如聚烯烃形成的单一长度的落纤可以被放置在伤口创面“w”中以形成填充物38。该布置允许当敷料16被更换时完全去除填充物38而不会再损伤伤口“w”。
覆盖层40可以作为包括衬层44和端口元件46的单个单元被提供,或者备选地,这些部件可以单独被提供并且在安装时被组装到伤口“w”之上。覆盖层40可以被放置在伤口“w”之上,在其中封闭接触层34和填充物38。
衬层44可以由柔性聚合物膜片或薄膜形成以用作流体屏障从而允许在真空蓄池14中建立次大气压,并且也用作防止污染物进入伤口区域的微生物屏障。例如,衬层44可以包括具有从大约0.8密耳到大约1.0密耳的厚度的聚氨酯薄膜。优选地,衬层44由湿蒸汽可渗透薄膜形成以促进伤口部位与大气之间的氧气和湿蒸汽的交换。一种典型材料是由Kendall公司,Covidien公司的一个分公司以商标销售的透明薄膜。可以适合用在衬层中的其他材料包括由明尼苏达州圣保罗的3M公司以商标TEGADERMTM和由英国伦敦的Smith and Nephew PLC公司以商标OPSITETM销售的薄膜。
覆盖层40的衬层44适于侧向延伸超过伤口创面“w”的周围以接触健康组织“s”从而与之形成密封。为了形成密封,衬层44可以在面对伤口侧的全部或任何合适部分上配备有粘性涂层。粘性涂层可以包括例如适于提供围绕伤口“w”的不透流体和防菌的密封的医用级、压敏粘合剂。因此渗出液不能通过敷料16的边缘漏出并且外部空气和污染物不会进入伤口区域。为了提供这样的密封,粘性涂层例如可以在从大约1密耳到大约10密耳的厚度范围内。一般而言,高皮尔强度粘合剂可以用于在覆盖层40的边缘阻止意外升高、卷起或“下垂”,即,敷料未能粘连到自身。粘合剂可以包括例如包括在由Kendall公司,Covidien公司的一个分公司以商标销售的敷料中的水状胶体的那些粘合剂。
衬层44包括连接区域50以允许连接端口元件46。连接区域50接收端口元件46的蓄池表面54以除了通的端口元件46以外与端口元件46上的周围表面56流体隔离蓄池表面54。如图1和4中所示,连接区域50可以适于直接接收蓄池表面54使得蓄池表面54或连接区域50上的粘性涂层将端口元件46附着到衬层44。衬层44限定蓄池表面54和周围表面56之间的边界。该布置允许蓄池表面54与蓄池14隔离,即,蓄池表面54可以布置在蓄池14的外部。穿孔58可以通过连接区域50形成以允许从蓄池14抽吸流体。备选地,如图5中所示,衬层44a可以包括入口50a,该入口尺寸被确定成使得端口元件46a的一部分通过衬层44a突出。合适定位的粘性涂层可以在衬层44a的面对伤口侧与凸缘60a的相反定向表面之间形成密封。该布置允许蓄池表面54a定位在蓄池14a内,使蓄池表面54a与周围表面56a流体隔离。可以预见用于将端口元件46,46a附着到衬层44,44a的其他布置,其可以包括其他部分,例如密封圈(未显示)。
衬层44可以包括中断粘性涂层,例如仅仅形成密封的衬层44的部分被涂覆。例如,衬层44可以包括围绕周边以与皮肤“s”形成密封的粘性涂层的带,或靠近连接区域50以与端口元件46形成密封的另一个带。衬层44的中间部分可以保持没有被涂覆以限制衬层44粘连到填充物38、接触层34或其他表面。这样的布置可以便于敷料16的去除而不会再损伤伤口“w”。
现在参考图2和3,端口元件46可以形成为刚性部件,或者备选地端口元件46可以由柔性聚合物或弹性体材料模制。端口元件46的柔性便于伤口敷料16放置到患者的皮肤“s”的弧形区域上。端口元件46包括蓄池表面54和周围表面56。蓄池表面54适于被定位成使得其中的主开孔64可以通过例如穿孔58与真空蓄池14流体连通。周围表面56可以被定位在围绕敷料16的环境中并且包括适于连接到抽吸装置例如真空系统12的真空管24的开口68。主端口70在主开孔64和开口68之间被限定以允许蓄池14与真空系统12之间的流体连通。
从主端口70分叉的是延伸到蓄池表面54的补充端口72的径向阵列。每个补充端口70终止于补充开孔74,所述补充开孔与主开孔64不同并且与主开孔64明显间隔开。补充端口72的任何数量、分布和布置可以被包括以将补充开口74分布在蓄池表面54上。如图2所示补充开孔74可以靠近蓄池表面54的周边定位使得流体可以从蓄池14被抽吸到收集区域之上,所述收集区域跨越由端口元件46覆盖的整个区域。对于特殊应用可以预见主开孔64和补充开孔74的任何数量、尺寸和布置以有效地抽吸流体。
现在参考图4,伤口敷料16可以安装在患者上以覆盖伤口“w”。当应用到皮肤“s”时蓄池14由伤口敷料16限定或在伤口敷料16内。接触层34被定位成与伤口“w”直接接触并且填充物38被定位成达到健康皮肤“s”的水平。端口元件46可以被定位在衬层44的连接区域50之上使得主和补充开孔64,74与穿孔58对准。这将允许流体从蓄池14被抽吸到主和补充端口70,72中。周围表面56除了通过主和补充端口70,72以外与蓄池14流体隔离。周围表面56中的开口68接收真空管24,因此流体连接真空系统12与蓄池14。
排空蓄池14可以给予填充材料38和伤口渗出液沿着气流的方向迁移的趋势。该迁移趋势可能导致一个或多个主和补充端口70,72的堵塞或闭塞。然而,由于端口元件46可以包括分布在由端口元件46覆盖的整个区域上的许多开孔64,74,VWT程序的有效性可以持续。如果开孔64,74中的一个被阻塞,流体将被抽吸到与被阻塞的开孔64,74不同并且与被阻塞的开孔64,74明显间隔开的另一个开孔64,74。
现在参考图5,真空伤口疗法系统的一个备选实施例一般被显示成10a。伤口敷料16a包括通过覆盖层40a的入口50a突出的端口元件46a。衬层44a粘连到端口元件46a的凸缘60a并且也粘连到皮肤“s”使得蓄池表面54a和周围表面56a除了通过主和补充端口70a,72a以外被流体隔离。周围表面56a在其中具有开口68a以用于连接抽吸装置例如真空管24。因此通过主端口70a和主开口64a建立蓄池14a与真空系统12之间的流体连通。补充端口72a在主端口70a与蓄池表面54a中的补充开孔74a之间建立流体连通。补充开孔74a与主开孔64a不同并且基本与它间隔。在该布置中,蓄池表面54a由蓄池14a封闭。
端口元件46a包括补充端口72a的径向阵列使得开孔64a,74a可以基本分布在整个蓄池表面54a之上。该布置提供了保持端口46a的收集区域暴露于尽可能多的敷料16a的手段。
尽管为了清楚或理解起见作为图解和例子在某些细节上描述了前面的公开,将显而易见可以在附带权利要求的范围内实施的某些变化和修改。
Claims (16)
1.一种负压伤口疗法敷料,其包括:
构造成放置在伤口之上的衬层;以及
端口,所述端口具有面对伤口的表面并且被构造成附着至衬层,所述端口包括:
开口,所述开口被构造成与负压源流体连通;
主开孔,所述主开孔被构造成与伤口流体连通,主开孔定位在面对伤口的表面上;
在开口与主开孔之间延伸的主端口,主端口被构造成将负压从负压源连通到伤口;以及
多个补充端口和多个补充开孔,所述多个补充端口与主端口流体连通,并且所述多个补充开孔被定位在面对伤口的表面上并且被构造成与伤口流体连通,其中,所述多个补充开孔在面对伤口的表面之上分布,从而补充开孔与主开孔不同且与主开孔间隔开。
2.根据权利要求1所述的敷料,其中所述端口由柔性聚合物模制。
3.根据权利要求1所述的敷料,其中端口还包括适于连接到衬层的附连凸缘。
4.根据权利要求1所述的敷料,其中所述衬层包括柔性聚合物膜。
5.根据权利要求1所述的敷料,其中所述衬层被构造成围绕伤口的周围形成基本不透流体密封,以限定被构造成保持负压的蓄池。
6.根据权利要求1所述的敷料,其中所述衬层包括围绕其周边的粘性涂层,所述粘性涂层适于附着到伤口之上的所述衬层并且提供围绕伤口的周围的基本不透流体密封。
7.根据权利要求6所述的敷料,其中所述粘性涂层被中断,使得所述衬层的中间部分保持没有涂覆。
8.根据权利要求1所述的敷料,其中所述端口预先附着到衬层。
9.根据权利要求1所述的敷料,还包括被构造为定位成与伤口直接接触的伤口接触层,伤口接触层被构造成允许流体基本单向地流动,从而防止从伤口移出的渗出物流回到伤口中。
10.一种真空伤口疗法系统,所述真空伤口疗法系统包括:
被构造为定位成与伤口直接接触的伤口接触层,伤口接触层被构造成允许流体基本单向地流动,从而防止从伤口移出的渗出物流回到伤口中;
覆盖伤口接触层的吸收性填充材料;
覆盖吸收性填充材料的衬层,所述衬层被构造成定位在伤口之上,以限定伤口之上的真空蓄池;和
端口,所述端口具有面对伤口的表面并且被构造成附着至真空蓄池外的衬层,所述端口包括:
开口,所述开口被构造成与负压源流体连通;
主开孔,所述主开孔被构造成与伤口流体连通,主开孔定位在面对伤口的表面上;
在开口与主开孔之间延伸的主端口,主端口被构造成将负压从负压源连通到伤口;以及
多个补充端口和多个补充开孔,所述多个补充端口与主端口流体连通,并且所述多个补充开孔被定位在面对伤口的表面上并且被构造成与伤口流体连通,其中,所述多个补充开孔在面对伤口的表面之上分布,从而补充开孔与主开孔不同且与主开孔间隔开。
11.根据权利要求10所述的真空伤口疗法系统,其中吸收性填充材料包括非网状泡沫、无纺织物、或纱布。
12.根据权利要求10所述的真空伤口疗法系统,包括与真空蓄池流体连通的真空系统。
13.根据权利要求12所述的真空伤口疗法系统,其中真空伤口疗法系统包括真空源、收集罐和单向阀。
14.根据权利要求10所述的真空伤口疗法系统,其中主开孔和多个补充开孔定位在吸收性填充材料之上。
15.根据权利要求10所述的真空伤口疗法系统,其中端口还包括适于连接至衬层的附连凸缘。
16.根据权利要求10所述的真空伤口疗法系统,其中所述端口预先附着到衬层。
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IL197030A0 (en) | 2009-12-24 |
US20150314052A1 (en) | 2015-11-05 |
ZA200901339B (en) | 2010-02-24 |
MX2009002051A (es) | 2009-09-28 |
AU2009200607A1 (en) | 2009-09-24 |
AU2009200607B2 (en) | 2014-08-14 |
EP2810667A1 (en) | 2014-12-10 |
JP2009213889A (ja) | 2009-09-24 |
CN104287893A (zh) | 2015-01-21 |
CA2653146C (en) | 2018-03-06 |
US9033942B2 (en) | 2015-05-19 |
CO6200101A1 (es) | 2010-09-20 |
CL2009000543A1 (es) | 2009-12-18 |
EP2098257B1 (en) | 2014-08-27 |
EP2098257A1 (en) | 2009-09-09 |
CA2653146A1 (en) | 2009-09-07 |
CN101536950B (zh) | 2014-12-10 |
US9956329B2 (en) | 2018-05-01 |
US20090227968A1 (en) | 2009-09-10 |
IL197030A (en) | 2015-10-29 |
CN101536950A (zh) | 2009-09-23 |
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