CN101836918B - 合形的创伤敷料 - Google Patents
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Abstract
本发明公开了一种合形的创伤敷料，包含吸附剂衬片、粘附层，和背衬层，还有敷料支承层，构形用于向伤口保持和发放创伤敷料，所述敷料支具有径向的构形，所述径向构形沿创伤敷料的粘性周边形成多个交替覆盖和不覆盖的背衬层部分。
Description
本申请是中国专利申请200480004519.1(PCT/US2004/003688)的分案申请。
技术领域
本发明涉及创伤敷料，并且更加特别地涉及一种薄膜复合敷料和一种径向支承发放系统。
技术背景
公知创伤敷料使用由较大的粘附膜包围的吸附剂中心区域。例如，美国专利5,738,642号(`642专利)说明了一种包含置于薄背衬中心的厚吸收剂衬垫的创伤敷料和发放系统。载体框架包围创伤敷料的周边，对背衬提供足够支承(例如刚性)以在向创伤施用时方便操作敷料。`642专利中教导的敷料可以用于包敷各种各样的创伤。然而还需要一种可以较有效地敷用于诸如足跟或者肩膀之类的不规则表面上的创伤敷料。当前，有时向其中心切割创伤敷料以制造一种圆锥形敷料，但是这些敷料具有显著的局限，包括沿切割线感染的风险、难于单手敷用，以及沿切割线从伤口渗漏液体。
因此还需要有一种配置用于圆形或者其它不规则形身体部位的改进的创伤敷料。
发明内容
本发明提供一种具有薄的、挠性周边的创伤敷料，和方便创伤敷料操作的发放系统。所述创伤敷料构成得具有对诸如足跟之类的不规则形状的表面具有提高的粘性，并且使之能够方便地敷用于不规则的表面上。所述创伤敷料和发放系统非常适用于在凹的或者凸的表面上定位吸附剂衬片。例如，创伤敷料和发放系统适用于向脚的足跟敷放吸附剂衬片，同时保持环绕创伤敷料的完善的消毒周边。
在一些实施方式中，创伤敷料和发放系统包括在背衬层上包含粘贴附层的创伤敷料。可供选择地，在贴附层上施加或者附着吸附剂衬片或者吸附材料。敷料支承层定位在背衬层顶部，并且构成向创伤持定和发放所述创伤敷料。特别地，所述敷料支承层具有径向的延伸构形，所述径向延伸构形沿创伤敷料的周边支承背衬层，同时还允许把敷料方便地敷放到凸的或者其它非平坦的表面上。
表征本发明的这些优点和其它优点和特征用本文所附并且形成其一部分的权利要求书中所述的特点指出。然而，为了较好地理解本发明、其优点以及其使用中得到的目标，应当参阅附图及说明，其中示出并且阐述了本发明的具体实施方式。
附图说明
下面参照附图对本发明进一步地加以描述，其中相应的标号指代各个视角的对应的部分，在附图中：
图1是根据本发明的实施方式构形和安排的创伤敷料的顶视透视图。
图2是图1的敷料的顶视平面图。
图3是实质上沿图2的线3-3取的图1和图2的敷料的侧视示意图。
图4是图3的敷料的放大的侧视横截面图，横截面沿图5的线4-4取。
图5是根据本发明制造的创伤敷料的变通实施方式的顶视平面图。
图6是根据本发明制造的创伤敷料的另一个变通实施方式的顶视平面图。
图7是根据本发明制造的创伤敷料的又一个变通实施方式的顶视平面图。
本发明可以有各种修改和变通的形式，本说明书以附图中示例的方式向本领域内普通技术人员示出并且详细地进行了说明。然而应当理解，本发明不以所述的特定实施方式为限制。相反，本发明覆盖本落入本发明范畴内的所有修改、等同和变通方式。
具体实施方式
本发明针对一种创伤敷料和发放系统以及向患者敷用创伤敷料和发放系统的方法。所述创伤敷料和发放系统特别地非常适用于敷用在患者足跟之类的凸表面上。所述创伤敷料能够对创口布置高度吸附性的材料，同时所述发放系统有助于形成围绕创口凸的或者不规则形状的区域四周的密封。
在一些实施方式中，所述创伤敷料包含吸附剂衬片、背衬层和在背衬层上面对吸附剂衬片的贴附层。贴附层和背衬层形成围绕吸附剂衬片的周边并且把吸附剂衬片在创口上持定在位。由贴附层形成的周边和背衬层保持吸附剂衬片正确地定位，并且围绕创口还帮助保持消毒的环境。贴附层和背衬层典型地极薄，并且通常是非常挠性的。如果敷放过程中贴附层和背衬层没有被正确地支承就容易使之折叠和自相粘贴，有碍于在创口上正确地敷放。本发明的发放系统提供一种方便和有效的方式向患者敷放创伤敷料同时有效地支承敷料的周边以防止过度的不利折叠，同时使得背衬层有控制的和有限的折叠，足以正确地接触患者的不平坦的皮肤表面。
图1和图2示出一种根据本发明制造的创伤敷料和发放系统的例子。创伤敷料10包括位于中心的吸附剂衬片12。吸附剂衬片12由向创伤敷料10的周边15超出的背衬层14上的贴附层17覆盖。所述背衬层14典型地是极薄的、挠性的，并且既可以是半透明的，也可以是透明的，使吸附剂衬片12可以经之观察。本发明的发放系统特别适于与置于高度舒适的背衬层14上的具有相对较重或者刚性的吸附剂衬片12的创伤敷料10配合使用，所述背衬层14相对衬片12轻而且可挠。
在创伤敷料10上布置至少一个敷料支承层16。在本发明的一些实施方式中，敷料支承层16具有实质上径向的构形，带有许多总体上从敷料10的中心辐射出的延伸18。支承层16形成贴附性背衬层14上多个交替的不覆盖部分，由沿创伤敷料的贴附性周边15的延伸18彼此分开。支承层16可以是单件材料，诸如多聚体膜，也可以是两个或者多个相异的件。图1和图2中示出的支承层16是由连接件28相异的两个单独件。
在多数实施方式中，支承层16包含许多从敷料10的内部向其边缘辐射的延伸18。敷料支承层16的径向构形使得围绕凸的表面压住敷料10的周边15。在敷放过程中，在延伸18之间的背衬层14的不受覆盖的部分20可以收缩以围绕创口的边缘保持良好的密封。所述收缩典型地定位使各个部分20将本身收缩甚至折叠。然而，部分20之间的折叠和收缩是最小化的。以此方式，创伤敷料10可以具有相对均匀的、平坦的边缘，而没有折叠在本身上的背衬层14的大飘摆。
在一些实施方式中，譬如在图1和图2中所示实施方式中，许多延伸18的至少一些在它们抵达敷料10的周边15处变窄。同样，在实施方式中，敷料支承层16的至少一部分超出创伤敷料10的背衬层14的边缘形成接片22。在布置创伤敷料10的过程中可以持定接片22。
另外，创伤敷料10典型地包括载体膜24，它也具有接片26。载体膜24覆盖敷入到患者身上的创伤敷料的表面，总体上造成与吸附剂衬片12和贴附层17的周边接触。直到使用者准备敷放敷料以前载体膜24保持附着在创伤敷料10上。载体膜24可以是单件或者多件释放衬里，并且可以是含有敷料的包装(未示出)的部分或与该包装层压，也可以只是与随同敷料一起封闭在包装内。载体膜24在存储和运输创伤敷料10的期间保持粘胶清洁。
在图1和2所示的实施方式中，延伸18会聚到创伤敷料10的中心却不覆盖中心19。总体上，敷料支承层16的周边可释放地附着在背衬层14上，然而敷料支承层16中心部分19的至少一部分不附着到背衬层14上。这样就形成许多中心定位的接片23，构形用于在把敷料10敷放到患者身上以后从背衬层去掉敷料支承层。在一些实施方式中，借助于面对背衬层14的敷料支承层16侧面上的衬里23a防止敷料支承层16的至少部分中心粘附到背衬层14上。该衬里23还辅助取走支承层，并且在一些实施方式中在向创口敷放敷料10时帮助提起接片23。
参见图3和图4，在图3中示出图1和图2所示敷料10的侧视图，而在图4中示出根据本发明制造的敷料10沿图3的线4-4取横截面图。该横截面示出由薄的挠性背衬层14覆盖的吸附剂衬片12，所述背衬层14转而部分地由支承层16和贴附层17覆盖。图3示出本发明的一个实施方式的重要方面。然而为了补充或者取消图4所示的方面也可以有各种其它的实施方式。例如，背衬层14可以是多重膜或者是涂层而不偏离本发明或者脱离本文中使用的术语“膜”的意义。类似地，吸附剂衬片12可以包括多个亚层，包括膜、织物、片材等待。还有可以在本文说明的材料之间添加其它材料的附加的层和膜而不偏离本发明。
沿创伤敷料10的周边15，背衬层14的暴露区域20的数量、形状和尺寸上可以不同。然而，典型地，有至少六个相异的暴露区域，一般地至少八个，并且更加普通地有十二个或者更多的相异的区域。在一些实施方式中，背衬层14的周边(在吸附剂外侧的部分)的80％以下由支承层16覆盖，而在其它的实施方式中，背衬层14的周边的60％以下由支承层16覆盖，而在又一些实施方式中，背衬层14的周边的40％以下由支承层16覆盖。
在一些实施方式中，延伸18的分开由划分延伸18的预切割的路径或者线条提供，譬如在图1和图2中所示的连接件28。在另一些实施方式中，如图7所示，线条或者说路径29包括在延伸18之间。路径29在向患者敷用敷料10的过程中或者其后提起接片23去掉敷料支承层16时提供受控制地撕开敷料支承层16。然而还可以有替代的构形，包括但是不限于直线的、钩形的、Y形的、双钩形偏移的、圆形的孔，以及其交替的组合。在图7中示出路径29在窄的构形中带有多个穿孔。
创伤敷料10典型地通过首先清创并且确保包绕创口的区域准备好接受敷料而敷放到患者身上。然后从敷料上取走载体膜24，暴露出吸附垫片12的底部和贴附层17和背衬层14的周边。通过支承层16中的数个延伸18，背衬层14的该周边保持成总体上平面或者伸展开的取向。吸附剂衬片12的中心被带入与创口接触，并且然后对患者身体轻轻地和平稳地压住敷料10的边缘，从而把背衬层14的暴露的粘性周边带入与患者身体的接触。一般地，居于延伸18之间的背衬层14的区域20收缩以合形周围皮肤表面。当施加到凸表面上时，所述收缩可以导致接片23从背衬层14的表面隆起。在正确地布置敷料10并且附着到患者的皮肤上以后，可以去掉支承层16。总体上，取走支承层16通过抓握接片23然后向敷料10的边缘使用剥离运动以去掉支承层16而完成。
在背衬层14的一个主表面上一般地设有压敏胶层17，以使之有粘附性，并且在背衬层14的另一个主表面与支承层16接触的侧面上设有低粘性涂层(低粘性护层或者说LAB)。当在敷料10上安放其它的带或者装置并且然后去掉时，所述低粘性涂层减少了由于多余的敷料取下而改变敷料10的需要，并且降低敷料10在亚麻布或者其它织物上的表面磨擦力，从而对意外去掉敷料10提供附加的防护。适用于本发明的低粘性背衬材料的说明可以在美国专利5,531,855和6,264,976中找到，所述材料与下文说明的热封缚带兼容。
当从背衬层14上取走支承层16时，施加在背衬层14的边缘上的力一般地垂直于敷料10的周边。该力与常规支承层的剥离边相反，后者平行于创伤敷料的周边，并且后者常常把所述周边抬离患者的皮肤，潜在地松开敷料或者说产生液体从创口泄露的路径。
敷料10的吸附剂衬片12有时称为“小岛衬片”，因为背衬层14实质上延伸超过吸附剂衬片12，典型地超过吸附剂衬片12的整个周边。例如，吸附剂衬片的长度和宽度可以是6cm乘6cm，而该衬片的背衬可以是9m乘9cm。从而背衬层14的周边部分上的压敏胶层17不被相对地厚而刚性的吸附剂衬片12支承或者加强，并且缺少支承层16的好处可能在敷放前或者敷放时难于不折叠、邹缩或者自身粘附而不是粘附到皮肤上地操作。
支承层16优选地附加到背衬层14的第二主表面上(在低粘性背衬上方)。在支承层16与背衬层14之间的缚带较压敏胶17与载体层24之间的缚带强，从而当从敷料10上取走载体层24时背衬层14保留附着在支承层16上。一旦载体层24与敷料10分开，只有支承层16和吸附剂衬片12对背衬层14提供显著的刚性。
吸附剂衬片12可以包含厚度至少为1mm(例如，最优选地3-9mm)的水状胶体(hydrocolloid)和水凝胶衬片，并且背衬层14可以包含厚度不大于0.1mm(例如，最优选地0.021-0.051mm)的半透明弹性多聚体膜(例如聚氨酯)。应当理解在该实施方式中，吸附剂衬片12比背衬层14厚得多、硬得多和重得多。
现在参照图5、图6和图7，图中示出替代的创伤敷料的实施方式。在图5和图6中示出创伤敷料的不同形状。在图5中所示的实施方式是卵形创伤敷料50，带有吸附剂衬片52、粘性背衬54和支承56。在图6中所示的实施方式是方形创伤敷料60，带有吸附剂衬片62、粘性背衬64和支承66。在图7中示出支承层的各个部分由穿孔的撕开路径连接。
下面较详细地说明本发明的各个部件的其它方面。
吸附剂垫片
吸附剂垫片12可以各种材料制造，包括但是不限于，有纺或者无纺的绵或者人造丝。吸附剂衬片12有用于包含数种物质，可供选择地包括杀菌剂、经皮给药的药品、监视患者体内激素或者其它物质的化学指示剂等等。
吸附剂可以包括水状胶体成分，包括在美国专利5,622,711和5,633,010中所述的水状胶体成分。例如水状胶体吸附剂可以包含例如，天然水状胶体，譬如果胶、明胶或者羧甲基纤维素(CMC)(Aqualon公司，Wimington，del)，半合成水状胶体，譬如交联的羧甲基纤维素(X4inkCMC)(例如Ac-Di-Sol；FMC公司，Philadelphia，Pa)，合成水状胶体，譬如交联的聚丙烯酸(PAA)(例如，CARBOPOLTMNo.974p；B.F.Goodrich，Breckville，Ohio)，或者其组合。总体上，水状胶体吸附剂成分占吸附剂组合物的约5％至约69％重量。当制备用于创伤敷料的吸附剂组合物时，水状胶体吸附剂优选地占所述组合物的约20％至约40％重量。还可以从其它合成和天然的亲水材料，包括多聚体凝胶和泡沫中选择吸附材料。
背衬材料
适用于背衬层14的背衬材料例如包括无纺织物、纺织物、编织物、针织物、膜或者其它熟悉的背衬材料。背衬材料典型地是半透明或透明聚合物弹性膜。背衬可以是高水蒸汽可通透的膜背衬。美国专利3,645,835说明了制造这种膜的方法和检测其通透性的方法。
所述背衬有利地应当以等于或者大于人类皮肤的速率通透水蒸汽。在一些实施方式中，涂覆背衬层的胶以至少300g/m2/24小时/37℃/100-10％RH的速率通透水蒸汽，往往以至少700g/m2/24小时/37℃/100-10％RH的速率通透水蒸汽，并且使用颠倒杯方法最典型地以至少2000g/m2/24小时/37℃/100-10％RH的速率通透水蒸汽。
背衬层14总体上对解剖表面合形。如此，当把背衬层14施加到解剖表面上时，即使当移出该表面时它对该表面也是合形的。背衬层14还对动物的解剖关节合形。当弯曲关节并且然后恢复到其未弯曲过的位置时，可以使得背衬层14延伸以适应关节的弯曲，但是它的弹性足以在关节恢复到其未弯曲状态时连续地合形关节。
适用于本发明这种背衬层14的特征的说明可以在授权美国专利5,088,483和5,160,315中找到。特别适用的背衬材料是弹性聚氨酯、共聚酯或者聚醚嵌段酰胺膜。这些膜结合了背衬中所希望的弹性、高水蒸汽通透性和半透明性的特性。
支承层
用于形成支承层16的材料一般基本上较背衬层14更加有刚性以防止在敷放到患者身体上时背衬层14不适当地邹缩。支承层16可以热封到背衬层14上，不论是否有上述的低粘性涂层。总体上，支承层材料可以包括，但是不限于聚乙烯/乙烯乙酸共聚物涂布的纸和聚酯膜。适用的支承层材料的一个例子是聚乙烯/乙烯乙酸共聚物涂布的超级压延牛皮纸(1-80BKG-157PE；Dixon的DCP-Lohya，Ill.)。
支承层16可以包括穿孔以在把敷料10敷入到患者身上后辅助相异的支承层16的部分。调节穿孔的间隔和形状以给予支承层在从敷放的敷料上取走支承层时相对易于撕开的性能。所述穿孔可以根据可接受的穿孔图案成形，包括直线的，有钩的、Y字形、V字形的、双钩形偏移的，正弦形的等。
压敏胶
可以在背衬层14上使用各种压敏胶以形成压敏胶层17以使之有粘性。压敏胶通常是合理地对皮肤兼容的并且是“低过敏性的”，譬如在美国专利RE 24,906中说明的丙烯酸共聚物。特别适用的是97∶3异辛基丙烯酸∶丙烯酰胺共聚物，美国专利4,737,410中说明的70∶15∶15异辛基丙烯酸∶环氧乙烷丙烯酸∶丙烯酸三聚体是适用的。另外可用的粘胶在美国专利3,389,827、4,112,213、4,310,509和4,323,557中说明。还设想在胶中包括药物或者杀菌剂，如在美国专利4,310,509和4,323,557所说明。
载体膜
适用于本发明的载体膜24可以用牛皮纸、聚乙烯、聚丙烯、聚酯或者任何这些材料的复合物制造。所述膜优选地涂覆以释放剂，譬如氟化学品或者硅酮。例如，美国专利4,472,480号说明了低表面能过氟化物衬里。所述衬里是涂覆以硅酮释放材料的纸、聚烯烃膜，或者聚酯膜。市售硅酮涂覆的释放纸的例子是POLYSILKTM，可以从RexamRelease公司(BedfordPark，Ill)购买的硅酮释放纸和由DCP-Lohya公司(Dixon，Ill)提供的硅酮释放纸。
在上述的结构、组合物和方法中可以做出各种改变而不偏离权利要求书中定义的本发明的范畴，以上说明或者附图中所示的所有事物都应当解释为示例性的而不是限制性的意义。
Claims (13)
1.一种创伤敷料发放系统，该系统包含：
创伤敷料，其包含背衬层；以及
创伤敷料支承层；
其中所述敷料支承层的周边可释放地附着于背衬层，但所述敷料支承层的与所述敷料的中心接近的中心部分的至少一部分未附着于所述背衬层，
其中所述支承层的中心部分不覆盖创伤敷料的中心，
所述支承层的中心部分包含多个中心定位的接片，所述接片构形用于在把敷料敷放到患者身上以后从背衬层去掉敷料支承层。
2.如权利要求1所述的创伤敷料发放系统，其中所述敷料支承层的中心部分的至少一部分借助于在敷料支承层的面向背衬层的一侧上的衬垫防止附着于所述背衬层。
3.如权利要求2所述的创伤敷料发放系统，其中所述敷料支承层包含至少一个延伸出所述创伤敷料的背衬层的边缘的部分。
4.如权利要求3所述的创伤敷料发放系统，其中延伸出所述背衬层的边缘的部分被构造为在放置所述创伤敷料的过程中用于持定。
5.如权利要求1所述的创伤敷料发放系统，其中所述中心部分包含多个中心定位的接片，所述接片被构造用于在已经向患者施加敷料以后将所述敷料支承层从所述背衬层移除。
6.一种创伤敷料发放系统，该系统包含：
创伤敷料，其包含背衬层；以及
创伤敷料支承层；
其中所述支承层的周边可逆地附着于背衬层，但所述敷料支承层的覆盖与所述敷料的中心接近的背衬层的中心部分的至少一部分未附着于所述背衬层；
其中所述中心部分包含多个中心定位的接片，所述接片被构造用于在已经向患者施加敷料以后将所述敷料支承层从所述背衬层移除，
其中所述支承层的中心部分不覆盖创伤敷料的中心。
7.如权利要求6所述的创伤敷料发放系统，其中所述敷料支承层包含至少一个延伸出所述创伤敷料的背衬层的边缘的部分。
8.如权利要求7所述的创伤敷料发放系统，其中延伸出所述背衬层的边缘的部分被构造为在放置所述创伤敷料的过程中用于持定。
9.如权利要求1或6所述的创伤敷料发放系统，其中所述创伤敷料的周边包含沿着所述创伤敷料周边的未被所述支承层覆盖的至少六个不同的所述背衬层的未覆盖部分。
10.一种创伤敷料发放系统，该系统包含：
创伤敷料，其包含背衬层；以及
创伤敷料支承层；
其中所述敷料支承层的周边可逆地附着于背衬层，但敷料支承层的覆盖与所述敷料的中心接近的背衬层的中心部分的至少一部分未附着于所述背衬层；
其中所述创伤敷料的周边包含沿着所述创伤敷料周边的未被所述支承层覆盖的至少六个不同的所述背衬层的未覆盖部分，
其中所述支承层的中心部分不覆盖创伤敷料的中心，
所述支承层的中心部分包含多个中心定位的接片，所述接片构形用于在把敷料敷放到患者身上以后从背衬层去掉敷料支承层。
11.如权利要求1、6或10所述的创伤敷料发放系统，其中所述背衬层包含透明的或半透明的聚合物膜。
12.如权利要求1、6或10所述的创伤敷料发放系统，其中所述支承层覆盖所述创伤敷料的周边的不到80％。
13.如权利要求1、6或10所述的创伤敷料发放系统，其中所述敷料支承层是两个或更多个不同的材料片。
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| US10/370,249 | 2003-02-19 | ||
| US10/370,249 US6838589B2 (en) | 2003-02-19 | 2003-02-19 | Conformable wound dressing |
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| CN2004800045191A Division CN1750800B (zh) | 2003-02-19 | 2004-02-09 | 合形的创伤敷料 |
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| CN101836918B true CN101836918B (zh) | 2013-07-17 |
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| CN2004800045191A Expired - Lifetime CN1750800B (zh) | 2003-02-19 | 2004-02-09 | 合形的创伤敷料 |
| CN201010156944XA Expired - Lifetime CN101836918B (zh) | 2003-02-19 | 2004-02-09 | 合形的创伤敷料 |
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| CN2004800045191A Expired - Lifetime CN1750800B (zh) | 2003-02-19 | 2004-02-09 | 合形的创伤敷料 |
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| US (4) | US6838589B2 (zh) |
| EP (5) | EP2353558A3 (zh) |
| JP (1) | JP4795933B2 (zh) |
| KR (1) | KR20050107434A (zh) |
| CN (2) | CN1750800B (zh) |
| AT (2) | ATE520380T1 (zh) |
| AU (2) | AU2004212904B2 (zh) |
| BR (1) | BRPI0407542B1 (zh) |
| CA (1) | CA2515031C (zh) |
| MX (1) | MX283859B (zh) |
| NO (1) | NO20054281L (zh) |
| WO (1) | WO2004073567A1 (zh) |
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