CN101437479A - 设有可释放的保护层的、用于将医疗物品或其部粘附到皮肤上的医疗和技术性质的物品或构件 - Google Patents

设有可释放的保护层的、用于将医疗物品或其部粘附到皮肤上的医疗和技术性质的物品或构件 Download PDF

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CN101437479A
CN101437479A CNA2007800130018A CN200780013001A CN101437479A CN 101437479 A CN101437479 A CN 101437479A CN A2007800130018 A CNA2007800130018 A CN A2007800130018A CN 200780013001 A CN200780013001 A CN 200780013001A CN 101437479 A CN101437479 A CN 101437479A
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T·法博
A·斯文斯比
D·汉松
U·约翰尼松
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Molnycke Health Care AB
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Abstract

一种用于粘附在皮肤上的医疗和专业性质的物品(1)或者用于将医疗物品或其部分粘附在皮肤上的构件，其中该物品或构件包括载体材料层(2)和保护层(4)，该载体材料层(2)在一侧具有柔软的对皮肤无刺激的粘合剂层(3)，保护层(4)能在该物品或构件使用之前保护粘合剂层并以可释放的方式粘附在粘合剂层上。根据本发明，保护层(4)在面对粘合剂层(3)的一侧上设置有凸出物(6)的图案，在具有柔软的对皮肤无刺激的粘合剂层那一侧的对侧上，加强层(5)以可去除的方式布置在载体材料层(2)上。

Description

设有可释放的保护层的、用于将医疗物品或其部粘附到皮肤上的医疗和技术性质的物品或构件
技术领域
本发明涉及一种用于将医疗物品或其部分粘附到皮肤上的医疗和技术性质的物品或构件，其中该物品或构件包括载体材料层和保护层，该载体材料层在一侧具有柔软的对皮肤无刺激的粘合剂层，保护层能在敷料使用之前保护粘合剂层并以可释放的方式粘附在粘合剂层上。
背景技术
设有将敷料粘附到用户皮肤上的粘合剂层的用于伤口的敷料在使用之前在粘合剂层上设置有保护层，一方面是为了使敷料更易于处理，一方面是为了防止诸如粉尘附着在粘合剂层上，并因此减小了它的粘合。传统上，这样的保护层由硅树脂涂覆的纸(所谓的释放纸)构成，其对传统使用在敷料上的粘合剂具有较小的附着力。近来，柔软的对皮肤无刺激的粘合剂(主要是硅树脂基的粘合剂)的使用有所增加。对于这种粘合剂，硅树脂涂覆的纸并不能较好地使用，这是因为在硅树脂基的粘合剂和纸上的硅树脂涂层之间的附着力太强了。因此，经常使用塑料薄膜作为对设有柔软的对皮肤无刺激的粘合剂的敷料的保护层。硅树脂基的粘合剂也可以在其他产品中发现，用于将医疗物品等粘附到皮肤上。这类产品的实例如结肠瘘袋、用于管状物的固定带、手术帘或手术器械。
为了减少塑料薄膜对粘合剂层的附着力，例如在卫生巾上，一种已知的方法是提供具有凸出物图案的层，以使得薄膜和粘合剂层之间的接触表面被减小。JP2005-171030示出了一种接合带，其具有硅树脂基的粘合剂以及设有具有三角形或半球形横截面的凸出物图案的保护层。然而，令人吃惊的是，对于具有非常薄和柔性的载体材料层以及非常柔软的粘合剂的敷料，已经发现，在设有凸出物的保护层和粘合剂层之间的附着力随时间而大大地增加，有时甚至比不具有凸出物的保护层时的情况更强，而并非变弱，毕竟将其变弱是使用设有凸出物的保护层的意图。
此外还发现的是，难以利用乙撑氧气体完成对设有柔软的对皮肤无刺激的粘合剂和塑料薄膜保护层的敷料和其他医疗物品的有效杀菌，而不论其保护层是否设有凸出物。
本发明的目的在于，获得一种用于粘附到皮肤上的医疗和技术性质的物品、或用于将医疗物品或其部分粘附到皮肤上的构件，其设有保护层，在保护层和该物品或构件之间的附着力在经受压力时不会发生任何显著的变化，同时其能通过乙撑氧气体的方式进行有效的杀菌。
发明内容
根据本发明，上述目的可以通过以下获得：一种用于粘附在皮肤上的医疗和技术性质的物品或者用于将医疗物品或其部分粘附在皮肤上的构件，其中该物品或构件包括载体材料层和保护层，该载体材料层在一侧具有柔软的对皮肤无刺激的粘合剂层，该保护层能在该物品或构件使用之前保护粘合剂层并以可释放的方式粘附在粘合剂层上，其特征在于，保护层在面对粘合剂层的一侧上设置有凸出物图案，加强层以可释放的方式布置在载体材料层上、在具有柔软的对皮肤无刺激的粘合剂层那一侧的对侧上。通过加强层的施加，已经发现，在压力施加前后，在粘合剂层和保护层之间的附着力差异很小。加强层此外也有助于防止载体材料层和粘合剂层的边缘由于外力而被卷起。
在优选实施例中，加强层至少在载体材料层的周边区域延伸，但其也可以基本在整个载体材料层上延伸。粘合剂具有优选8-22mm的柔度，保护层上的凸出物图案的凸出物具有等于或大于粘合剂层厚度的高度。保护层优选由聚乙烯构成。
加强层可以由纸层构成或可以包括纸层，或者可以由完全的塑料薄膜或塑料层片构成。载体材料层可以有塑料薄膜构成。
附图说明
现在将要参照附图来描述本发明，其中：
图1示意性地示出了根据本发明第一实施例的敷料的横截面图。
图2示出了一种测量附着力的方法。
图3和4示出了一种测量柔度的方法。
图5a、5b示意性地示出了边缘卷起的开始。
图6和7示出了对于具有不同厚度的粘合剂层以及具有不同释放材料的试样，在释放材料和粘合剂之间的剥离力的柱形图。
具体实施方式
图1示出了敷料1的一部分，其由载体材料层2构成，在该载体材料层2上施加有柔软的对皮肤无刺激的粘合剂的层3。此外，保护层4以可释放的方式粘附在粘合剂层3上。此外，加强层5粘附在载体材料层2上、在柔软的对皮肤无刺激的粘合剂的相对一侧上。这一层由塑料薄膜(例如聚丙烯或聚乙烯)、纸或塑料涂覆的纸(例如聚乙烯涂覆的纸)构成。根据需要，加强层可以由透明塑料层构成。
如图1所示，保护层4包括面向粘合剂层3并略微凹进粘合剂层3的凸出物6的图案。被粘合剂围绕的这些凸出物表面的总和构成了与粘合剂接触并确定在使用之前去除保护层所需力的全部表面。保护层4在面对粘合剂层3的一侧上应具有塑料层。保护层4其整体可以由聚烯烃塑料适当地构成，例如聚丙烯或聚乙烯，但其也可以具有塑料和另一材料的叠层，例如也可以是纸与其他塑料，如PVC。
载体材料由薄的塑料薄膜构成，优选为具有小于50微米，优选10-30微米厚度的聚氨酯塑料构成。
此外，涂层上的粘合剂必须对皮肤无刺激，并且必须能够在不损伤皮肤的情况下将敷料去除。由于当前用于伤口敷料的粘合涂层的压敏粘合剂的种类，这些要求是一个显著的问题。这样的粘合剂经常牢固地粘附在皮肤上，使得在去除敷料时，一部分角质层即皮肤的顶层，粘附在粘合剂上并从皮肤上脱离。这将引起发炎并损伤皮肤，尤其是对于具有敏感皮肤的患者，特别是上了年纪的患者、小于3岁的儿童以及具有某些疾病(例如湿疹)或正在进行某些治疗(例如可的松治疗)的患者。
柔软的对皮肤无刺激的粘合剂的一个实例是来自WackerChemie GmbH，Germany股份有限公司的硅树脂弹性体Silgel 612。硅树脂弹性体是非常柔软的并具有低的表面张力，使得其能流入皮肤的不规则处并在皮肤和硅树脂弹性体之间产生较大的接触面积。虽然硅树脂弹性体对皮肤的附着力不是非常强，但该较大的接触表面使得硅树脂弹性体能够很好地附着在皮肤上。该附着力构成了从皮肤上分离/去除粘合剂层所需的能量的量度(measurement)。虽然其附着力相对较弱，但导致大量能量并因此需要较大拉力以将硅树脂弹性体从皮肤上去除的影响因素在于，在将柔软的硅树脂弹性体从皮肤上松开之前，需要大量能量来伸展柔软的硅树脂弹性体。硅树脂弹性体层越柔软、越厚，越需要更多的能量/力来将弹性体从皮肤上去除。
如果使用了较硬的粘合剂，为了使去除力如同使用较柔软的粘合剂时一样大，则需要更大的附着力。在皮肤和粘合剂之间的强附着力易于导致在去除粘合剂时将皮肤细胞从皮肤上去除。
较硬的粘合剂的另一个不利之处在于，随时间推移，其能流动从而增加与皮肤的接触面积，这意味着去除力随时间而增加，这将导致随时间推移这样的粘合剂将变得越难以从皮肤上去除。与较硬的粘合剂相反，较柔软的粘合剂(例如硅树脂弹性体)直接达到它们的全部附着力，使得去除它们所需的力在时间上保持恒定。
由于人和人之间的皮肤特征各不相同，粘合涂层对对不同患者皮肤的附着力也自然地发生变化。附着力此外还取决于柔软粘合剂的厚度以及取决于载体材料层的机械特性。现今使用的测量附着力的标准方法利用不同类型的板，例如钢的或者玻璃的，并没有给出对于测量与皮肤附着力相关的数值。下面规定的粘合剂对皮肤附着力的数值将通过图2示出的并且由申请人所发展的方法进行测量。
自粘合敷料带(其对皮肤的附着力将被测量)被切成25×125mm大小。应注意的是，所有的带在敷料背面也都设置有载体材料层。(载体材料层的作用为，在应用到皮肤上期间使带变硬)。之后，带被施加到健康志愿者背部的皮肤上。这些带利用手指柔软地进行敷贴，然后带背面的载体材料层被去除。最后，通过由胶合在钢板(50×200mm，厚度＝1mm)上的泡沫塑料(42×182mm，厚度＝48mm)制成的海绵使带压靠皮肤3秒钟。压力估计等于6kN/m2。带在皮肤上保持2分钟。之后，带以25mm/s的速度去除，对去除力F1进行测量。去除角度，即在皮肤表面和带的去除部分之间形成的钝角为135°。带对皮肤的附着力由力F1的平均值构成。
根据本发明，能用于伤口敷料的粘合剂必须具有根据该方法的至少0.2-4N/25mm的附着力。该附着力优选为1-2.5N/25mm。
根据本发明的粘合剂必须具有超过根据基于ASTM D 937和ASTM D 51580的方法进行测量的8mm的柔度。下面的说明已经给出了一些改进。图3和4示出通过将具有62.5g重量的锥体B通过重力刺入待定柔度的粘合剂的30mm厚度的试样C中，用于测量粘合剂柔度的改进的方法。试样是通过将粘合剂填充具有60mm内径和35-40mm内部高度的圆柱形玻璃容器直至30mm的深度而制得的。对于硅树脂弹性体，非固化的硅树脂预聚物被注入容器中，然后在玻璃容器中被交联成弹性体。使用的锥体如图3所示，并具有以下尺寸：a＝65mm，b＝30mm，c＝15mm，d＝8.5mm。在进行柔度的测量方法时，锥体B首先被降低至如图4虚线所示的位置I，其中锥体的顶端仅仅轻触试样C的表面。然后，锥体B被释放，使得其能依靠重力刺入样品C。5秒钟后，对锥体B的顶端刺入样品C的mm数进行测量，其构成穿透值P，该值越大，样品越柔软。刺入值P构成了在本发明中使用的柔度的量度。来自Sommer & Runge KG，德国的针入度计PNR 10被用于执行该方法。
根据图1的敷料中的粘合剂层3由添加-固化的RTV(室温硫化)硅树脂系统构成，即在混合后，交联并形成粘合弹性体。RTV添加-固化的硅树脂系统的实例在EP0300620A1中给出，其描述了所谓的凝胶形成成分，该凝胶形成成分由链烯基取代的聚二有机硅氧烷、包含联接到一些硅树脂原子的氢原子的有机硅氧烷以及铂催化剂构成。
Wacker SilGel 612是一种市场上可得到的RTV硅树脂系统。它是一种二元物系。所形成的弹性体的柔度和粘合度可以通过将两种组分的比例A:B从1.0:0.7改变至1.0:1.3而发生变化。
粘附到干皮肤上的其他柔软的硅树脂弹性体的实例为：来自NuSilTechnology Carpintieria，GA，USA的NuSil MED-6340、NuSilMED3-6300和NuSil MED 12-6300以及来自Dow CorningCorporation，Midland，USA的Dow Corning 7-9800的热粘合剂。
其他可用于本发明的柔软的对皮肤无刺激的粘合剂，例如，来自National Starch and Chemical Company，Bridgewater，NJ，USA的
Figure A200780013001D00091
 70-4647。
令人惊奇的是，对于设有载体材料的柔性层和柔软的对皮肤无刺激的粘合剂层以及设有具有凸出物图案的聚乙烯薄膜作为保护层的敷料，已经发现，将保护层从敷料上去除所需的力随时间而增大，甚至可以大于使用并没有凸出物的平坦的保护层时的情况。对于保护层和伤口敷料之间的增大的附着力的唯一合理解释就是，设有凸出物图案的层的总接触表面必须大于平坦的层的接触表面。由于载体单元和粘合剂形成了与凸出物图案相互补的形状，这有可能发生。对载体材料层和粘合层单元的形状的上述变化在制造之后的伤口敷料的处理期间完全或局部地出现，即在敷料的包装、存储和运输期间和/或在利用环氧乙烷气体对敷料杀菌期间，在上述期间敷料经受压力的极端变化。根据在处理、储存、运输和杀菌期间对所受外力的程度，形状的上述变化可发生较大或较小的程度。
因此，由上述形状变化带来的保护层和粘合剂层之间的附着力的增大取决于外力，由此在不同的敷料之间可有很大不同。这种在不同敷料之间的去除保护层所需力的差异并不是所希望的。即使它保持在最大去除力的极限之下，不同敷料之间的去除力应不会发生很大程度的变化。此外，除了杀菌压力之外，敷料上的外力是局部性的，这将使得在敷料之内去除力也会局部地变化。
为了防止上述伤口敷料的形状变化去匹配设有凸出物6的层4的形状，加强层5以可释放的方式被布置在载体材料层2上并粘附在与具有粘合剂层3的那一侧的相对侧上。这就意味着，由于附接在载体材料层2上的层5的刚性，使得在具有外部局部力的情况下，载体材料层2的形状被防止发生局部变化以匹配设有凸出物的层4形状，但是在具有局部力的情况下，其只能与更加刚性的层5一起移动并遵循层5的任何曲率或弯曲，而当力消失时，其也随其恢复到平坦形状。
已经发现，加强层5并不需要在整个载体材料层2上延伸，层5只需绕载体材料层2的周边区域延伸就足以满足，即形成围绕并不具有加强层的中心区域的边框。这样的设计确实意味着，在受局部力时，位于中心区域的载体材料和粘合剂层单元可以被局部弯曲和伸展以形成与保护层4互补的形状，但一旦该局部力消失，载体材料和粘合剂层单元将恢复到平坦形状以校平载体材料和粘合剂层的上述弯曲和伸展所引起的在载体材料中出现的应力。如果没有添加加强层5，载体材料和粘合剂层的局部凹限所引起的应力将通过载体材料和粘合剂相对于保护层的局部移动直接得到补偿。作为加强层5附着在载体材料上的结果，上述的局部移动被阻止了，并且在粘合剂层上以及在载体材料中的残余应力在力消失之后通过该层重新恢复其平坦形状而得到补偿。
施加加强层5的一个附加优点在于，它能防止敷料边缘被卷起。图5a、5b示意性地示出了不具有加强层而具有载体材料层2′、粘合剂层3′和保护层4′的敷料，其经受一个朝向敷料边缘的力F。力F可能源于包装的摇动、弯曲、摩擦力等等。结果，载体材料层2′和粘合剂3′的边缘将不被附接在更加刚性的保护层4′上，层2′、3′的“自由边缘”将被力F弯曲，并从而附接在周围上，即周围的包装上。上述情况发生，尤其是如果凸出物由纵向范围上的垂直于纸面的线性凸脊构成。如果加强层5被布置在层2′之上，则敷料能在很大程度上承受边缘卷起的力。
当然，在使用时加强层5并不保持在敷料上，而是在敷料施加在患者上之前或者与敷料施加同时将其去除。因此，层5和载体材料层2之间的附着力必须小于粘合剂3对皮肤的附着力，以便在施加敷料之后在去除加强层5时使敷料保持附着在皮肤上。在载体材料层2和加强层5之间的附接可以由粘合剂附接构成，但也可以由其他方式完成，例如，如果两层都由塑料材料构成则通过复合挤压或通过将其中一层或两层加热至半熔化状态，例如通过热叠层经过辊而完成。
因此，加强层5的使用可以保证敷料1(即载体材料层2和粘合剂层3的单元)与保护层4的基部相距一段距离，凸出物6从该基部向敷料凸出。结果，在利用环氧乙烷气体或其他气体杀菌期间，通过形成在凸出物图案中的凸出物之间的通道系统，气体对粘合剂层表面具有自由入口。这意味着，杀菌工艺将比没有凸出物图案的敷料更加有效，于是，能够更加快速地进行。加强层还能保证：不论在生产过程期间、包括包装，在杀菌、运输、存储和与施加有关期间的外力如何，在保护层和粘合剂层之间的附着力都保持在预定水平。
还可以识别的是，一旦有外力时，粘合剂越软，凸出物可以嵌入粘合剂层的程度越大。为了保证敷料的处理不导致凸出物被完全压入粘合剂层3，可以对凸出物6给定一个高度h，即凸出物伸出超过保护层4的程度，其超过粘合剂层3的厚度。
为了测量加强层的效果，对四种不同的样品A-D进行剥离试验，其中，A由构造有载体材料层和设有保护层的粘合剂层的试样构成，其中的保护层具有凸出物图案，B由在其上侧设有加强层的类似材料构成，C由根据A但具有平坦保护层的试样构成，而D由根据B但具有平坦保护层的试样构成。不同的保护层或释放层手动进行施加，试验在施加释放层的一周后进行。
试验以以下方式进行。首先，25×200mm尺寸的试样从上述的材料A-D中切下。材料A-D中的载体材料层由20μm的聚氨酯薄膜4200 Z-T(Epurex Films GmbH，Walsrode，Germany)构成，粘合剂层由具有14-15mm柔度的SilGel 612构成。对于试样A和B，来自Huthamaki，Forchheim，Germany的90μm厚度的压印LDPE 16000以及压印124被作为保护层或释放层，对于试样C和D，来自相同公司的100μm厚度的平滑LDPE 16000被作为保护层或释放层。试样B和D在载体材料层上也将设有加强层，该加强层由涂覆15g/m2 PE(Polyguard E MG 120/PE15 Treat 30+，Amcor Flexibles，Lund，Sweden)的120g/m2的纸构成。
在第一组试验循环(A1-D1)中，剥离试验直接进行，如下所述。
试验按以下方式进行。在叠层的一端，一张释放层从粘合剂涂覆的表面上去除。释放层被保持在拉力试验机(Alliance RT/1或等效物)的上夹具中，粘合剂涂覆的叠层被保持在拉力试验机的下夹具中。启动拉力试验机，记录将释放层从试样的硅树脂涂覆表面拉开所需的平均力。拉力试验机以42mm/s的速度移动。在力的测量期间，叠层的非剥离部分被保持直线，使得形成在两个夹紧部分和叠层的非剥离部分之间的角度都为大约90°。
在第二组循环(A2-D2)中，剥离试验在两个25＊200mm大小的切片试样经受下面描述的滚压方法的载荷之后进行。试样被放置于平坦的底部上，在试样上具有一张聚氨酯泡沫塑料(1.6mm L00562-5，来自Rynel Inc.Boothbay，ME，USA)。然后试样经受辊(45mm宽，重量＝2kg，r＝47mm)的载荷，该辊以5mm/s的速度向前和向后对上述泡沫进行一次碾压。在滚压之后，试样不经过等候而是立即进行试验。
对于每种材料A-D，对粘合剂层的两种不同的表面重量：60和100g/m2进行试验。
试验结果显示在图6和7以及表格1和2中。
表格1
Figure A200780013001D00121
表格2
Figure A200780013001D00122
如表格和图所示，对于不同材料A-D在它们经受载荷前后，对于材料A的试样，其材料上的压印保护层没有加强层，剥离力之间存在相当大的差异，而对于材料B和C，则存在较小的差异。难以解释材料D在经受载荷之后的图6中的数值，图6中的值D1和D2之间的差异可以归因于材料D1上的保护层并没有正确地施加到粘合剂层上。然而材料C和D在试验中仅作为参考材料，因为其差异不需要进行进一步研究。
对于材料A表格1中的剥离力的增加A2-A1＝0.39，即给出了390％的增加，而材料B的增加B2-B1＝-0.1，即完全没有增加。
对于材料A表格2中的剥离力的增加0.55，即给出了大约149％的增加。对于材料B，增加为0.09，即为大约16％的增加。
为了保证材料功能完好，在其经受载荷之后的增加应不超过50％，优选不超过30％。此外，为了使敷料良好工作，剥离力应优选小于0.8N、更优选0.7N。
此外，通过给定凸出物顶部圆形甚至平坦的形状，可以减小凸出物刺入粘合剂层的能力。也可以将凸出物顶部设计为具有可轻易刺入粘合剂的尖端，该尖端被对刺入具有较大阻力的圆形表面所围绕。
上述实施例在本发明的范围内自然可以作出改进。例如，保护层上的凸出物图案可以是不均匀的；例如，它们可以疏散在保护层的去除的开始部分上。此外，凸出物的形状可以不同，例如，它们可以是圆柱形、半球形、立方形等等。凸出物并非必须是单独点的形式，也可以是线的形式。线性凸出物可以具有任何曲线形状，例如它们可以是正弦波形状。加强层并不是必须在载体材料层的周边全部延伸，周边区域的一部分甚至全部可以没有加强层。因此，本发明仅仅由附加权利要求的内容所限定。

Claims (13)

1、一种用于粘附在皮肤上的医疗和专业性质的物品(1)或者一种用于将医疗物品或其部分粘附在皮肤上的构件，其中该物品或构件包括载体材料层(2)和保护层(4)，该载体材料层(2)在一侧具有柔软的对皮肤无刺激的粘合剂层(3)，保护层(4)能在该物品或构件使用之前保护粘合剂层并以可释放的方式粘附在粘合剂层上，其特征在于，所述保护层(4)在面向粘合剂层(3)的一侧上设置有凸出物(6)的图案，一加强层(5)以可去除的方式布置在载体材料层(2)上、在具有柔软的对皮肤无刺激的粘合剂层的那一侧的相对侧上。
2、根据权利要求1所述的物品或构件，其特征在于，所述加强层(5)至少在所述载体材料层(2)的周边区域延伸。
3、根据权利要求2所述的物品或构件，其特征在于，所述加强层(5)基本上在整个载体材料层(2)上延伸。
4、根据权利要求1、2或3所述的物品或构件，其特征在于，所述粘合剂层(3)中的粘合剂具有8-22mm的柔度。
5、根据权利要求4所述的物品或构件，其特征在于，通过滚压方法在构件上施加2kg的载荷之后，去除力(B2-B1)的增大小于50％，优选小于30％。
6、根据权利要求5所述的物品或构件，其特征在于，去除所述保护层所需的力小于或等于0.8N/25mm，优选小于0.7N/25mm，最优选小于0.2N/25mm。
7、根据权利要求6所示的物品或构件，其特征在于，所述保护层(4)上在凸出物图案中的所述凸出物(6)具有大于或等于粘合剂层(3)厚度的高度。
8、根据权利要求1-7中任一项所述的物品或构件，其特征在于，所述保护层(4)由聚烯烃塑料构成。
9、根据权利要求8所述的物品或构件，其特征在于，所述保护层(4)由聚乙烯构成。
10、根据权利要求8或9所述的物品或构件，其特征在于，所述加强层(5)由纸层构成或者包括纸层。
11、根据权利要求8或9所述的物品或构件，其特征在于，所述加强层(5)由塑料材料构成。
12、根据权利要求8、9、10或11所述的物品或构件，其特征在于，所述载体材料层(2)由塑料薄膜构成。
13、根据权利要求8、9或10所述的物品或构件，其特征在于，所述载体材料层(2)由柔性塑料薄膜构成，该塑料薄膜具有小于50μm的厚度，优选具有10-30μm的厚度。
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