CN102784410A - 伤口敷料 - Google Patents
伤口敷料 Download PDFInfo
- Publication number
- CN102784410A CN102784410A CN2012101526833A CN201210152683A CN102784410A CN 102784410 A CN102784410 A CN 102784410A CN 2012101526833 A CN2012101526833 A CN 2012101526833A CN 201210152683 A CN201210152683 A CN 201210152683A CN 102784410 A CN102784410 A CN 102784410A
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- Prior art keywords
- wound dressing
- elastomer
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- polymer
- percentage
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- 229920001971 elastomer Polymers 0.000 claims abstract description 54
- 239000000806 elastomer Substances 0.000 claims abstract description 54
- 229920000642 polymer Polymers 0.000 claims abstract description 37
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- 229920002743 polystyrene-poly(ethylene-ethylene/propylene) block-polystyrene Polymers 0.000 claims abstract description 6
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- YXFVVABEGXRONW-UHFFFAOYSA-N Toluene Chemical compound CC1=CC=CC=C1 YXFVVABEGXRONW-UHFFFAOYSA-N 0.000 claims description 6
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- SMGTYJPMKXNQFY-UHFFFAOYSA-N octenidine dihydrochloride Chemical compound Cl.Cl.C1=CC(=NCCCCCCCC)C=CN1CCCCCCCCCCN1C=CC(=NCCCCCCCC)C=C1 SMGTYJPMKXNQFY-UHFFFAOYSA-N 0.000 claims description 3
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- SWSQBOPZIKWTGO-UHFFFAOYSA-N dimethylaminoamidine Natural products CN(C)C(N)=N SWSQBOPZIKWTGO-UHFFFAOYSA-N 0.000 claims description 2
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- BOXSVZNGTQTENJ-UHFFFAOYSA-L zinc dibutyldithiocarbamate Chemical compound [Zn+2].CCCCN(C([S-])=S)CCCC.CCCCN(C([S-])=S)CCCC BOXSVZNGTQTENJ-UHFFFAOYSA-L 0.000 description 2
- JECYNCQXXKQDJN-UHFFFAOYSA-N 2-(2-methylhexan-2-yloxymethyl)oxirane Chemical compound CCCCC(C)(C)OCC1CO1 JECYNCQXXKQDJN-UHFFFAOYSA-N 0.000 description 1
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical class [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 1
- VGGSQFUCUMXWEO-UHFFFAOYSA-N Ethene Chemical compound C=C VGGSQFUCUMXWEO-UHFFFAOYSA-N 0.000 description 1
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- BUGBHKTXTAQXES-UHFFFAOYSA-N Selenium Chemical class [Se] BUGBHKTXTAQXES-UHFFFAOYSA-N 0.000 description 1
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- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 description 1
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- BGYHLZZASRKEJE-UHFFFAOYSA-N [3-[3-(3,5-ditert-butyl-4-hydroxyphenyl)propanoyloxy]-2,2-bis[3-(3,5-ditert-butyl-4-hydroxyphenyl)propanoyloxymethyl]propyl] 3-(3,5-ditert-butyl-4-hydroxyphenyl)propanoate Chemical compound CC(C)(C)C1=C(O)C(C(C)(C)C)=CC(CCC(=O)OCC(COC(=O)CCC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)(COC(=O)CCC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)COC(=O)CCC=2C=C(C(O)=C(C=2)C(C)(C)C)C(C)(C)C)=C1 BGYHLZZASRKEJE-UHFFFAOYSA-N 0.000 description 1
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Classifications
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- A61L15/24—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
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Abstract
本发明涉及一种无菌的伤口敷料,该伤口敷料具有承载体和非吸收性的弹性体伤口接触层,该弹性体基层由合成的三嵌段弹性体组成并通过非极性的油和/或凡士林塑化加工而成,特别是由主要为聚苯乙烯嵌段和聚烯烃嵌段的共聚物(SEPS,SEBS,SEEPS,等等)所构成的,或者是由其混合物构成的,其中总的聚合物含量低于3.2重量百分比,特别是3.0重量百分比或者更少,优选的是2.6重量百分比或者更少。本发明的无菌的伤口敷料除了有经济上的好处以外还能获得较好的组织相容性。
Description
技术领域
本发明涉及一种无菌伤口敷料,其具有由承载体和弹性体聚合物基层构成的伤口接触层。
背景技术
含油脂的伤口敷料已经多年来成功地被应用于创伤性伤口的局部治疗,例如某些刀伤和擦伤,以及慢性伤口,例如某些褥疮、下肢溃疡等这一类伤口,还有人和动物的烧伤性伤口的治疗。
一种用油脂浸渍的网眼纱布(Lomatuell H,来自L&R公司),被用来制造用于皮肤表面伤口的医学治疗中最常用的一种产品。这种具有大网眼的并由经凡士林基底的油脂体浸渍后的棉织物构成的产品被证实还是有缺点的,例如油脂体在处理工具(例如手套)上和在伤口及伤口周围的损失。在接触伤口时凡士林由于在温度升高时软化的原因而容易被挤到绷带的边缘上。
这种现象经常会导致承载体的暴露并和伤口形成直接接触。承载体和伤口的粘连会导致医药绷带的需要经常更换并且会阻碍伤口的愈合过程。
其他商业化的治疗产品,例如Johnson公司的绷带和Johnson AD APTIC,一种用水包油型乳剂浸渍的粘胶纤维针织材料;或者治疗产品JELONET(Smith和Nephew公司),一种用石蜡浸渍的棉纱布,它们和Lomatuell H一样具有相同的用途,同样也被证实了具有类似的有关油脂体损失的不良特性。
另外也发现,在实际使用中这些常用的用油脂浸渍过的网眼纱布类型的绷带的疏水性过高,造成了伤口一种不希望发生的变干燥现象。
根据常识,少量的来自于水性胶质基团的亲水性物质,例如CMC,作为附加成分被分散到疏水性的弹性体基层中,基质的亲水特性使得其在接触到伤口渗出液时通过在表面上形成凝胶被局部地扩大。这种基层表面的疏水性和亲水性的混合特性,使得其和伤口直接接触时,形成了对于伤口的治疗过程极其有利的结果:最佳的表面持久湿度,以及现场的油脂体隔离了绷带结构和伤口,促进了更快速的伤口治疗以及敷布可以完全不粘附在伤口上。
在EP 1 691 851 B1中描述了一种伤口绷带,其包含具有细孔的液体可渗透性衬底和一种吸附性(至少50%的干量)的非粘附性聚合物,疏水性的有机聚合物基层,软化剂和亲水性有机微粒以及必要时加入的生物活性剂。在这篇文献中描述了合成的和天然的生物活性 剂。当使用这些药剂时会发生以下问题,即、吸收剂(高亲水性树脂)在绷带中和液体形成凝胶状。在浸涨的过程中使得那些用于伤口渗出液(如粘稠状液体)的细孔变得几乎不能通过。这样可能导致伤口渗出液被排出到吸入性的第二层绷带中这一原本通畅的过程受到阻碍。这样可能造成伤口浸渍的问题。
对于绷带和伤口的粘连可以通过使用根据EP 1 143 895 B1中所描述的一种无菌的,不粘连的敷布来防止。这种敷布包含由热塑性弹性体形成的聚合物组合物、油质的软化剂、凡士林和水凝胶(CMC,藻酸盐)的亲水颗粒以及必要时含有的作用药物。根据在这篇文献所述发明的一种优选的实施方式中弹性体基层包括有三嵌段的弹性体,在这里弹性体的浓度至少应该为3.2%到8.8%之间,由此可以保证一个聚合的,弹性的,在潮湿介质中稳定的聚合物基层的使用。
这是被期望的,在弹性体聚合物和伤口之间只允许有非常受限制的直接接触,这时的接触主要是通过油性的连接方式来实现的,相比使用的弹性体这样能够和伤口的活性组织更好的相处。另一方面,聚合物的使用是必不可少的,这时根据EP 1 143 895所述总聚合物的比例至少为3.2%,这样可以保证整个基层有足够的聚合力和弹性。
在EP 127 229 B1中描述了一种抗菌敷布,其伤口接触层由弹性体基层、非极性油、作为分散剂的水凝胶(羧甲基纤维素钠)和至少一种表面活性剂(吐温80),必要时还具有至少一种抗菌剂(磺胺嘧啶银)构成。在上述文献中所述发明的一种优选的实施方式中敷布具有高的总体浓度为大于4.6重量百分含量的合成三嵌段弹性体。这是考虑到理想化的避免弹性体和伤口之间的直接接触是有问题的。此外,表面活性剂的使用也不是没有问题的,因为它们具有一定的潜在细胞毒性。
EP 0 521 761中描述了一种不粘连的疏水性的封闭绷带,其由一种和基层表面相连接的承载体构成,其中弹性体基层含有至少10-30重量百分含量的嵌段聚合物和70-90重量百分含量的软化剂,首选的是凡士林。
由此,所有可以被用于促进无微生物污染风险的治疗的这些伤口敷料,必须在使用之前进行消毒。已被证实伤口感染会延缓治疗过程。这是由于病原体细菌作用所造成的影响,其渗入到伤口里(也许还可能穿过伤口敷料),在伤口处繁殖并产生毒素,这不仅作用在伤口组织上而且也作用到整个生物体。
有不同的技术用于消灭感染性的微生物。除了通过用饱和蒸汽或者通过干热来消毒外,常用的消毒方法是通过气体(环氧乙烷,甲醛),或者通过辐射来实现的。然而这些技术中没有一种能够无条件地适用于产品的生产,特别是那些制药学应用和特别包含有含脂肪类弹 性体基层的产品的生产。针对这些产品通过饱和蒸汽或者干热的消毒方法几乎不能应用,因为弹性体基层和水凝胶在高温和/或升高的空气湿度的状况下只有很差的耐受性。
同样地,由于会出现固有的残余气体滞留在这种类型的伤口敷料中的风险从而通常情况下避免使用气体的消毒方法。另外应用这些消毒技术时,通常不可能使得消毒剂分布到弹性体聚合物团的整个体积中。由此使得消毒的效果受到限制。
通常情况下无菌隔离材料(原始包装材料)的使用也会阻碍大多数如上所述的消毒过程的应用,这些无菌隔离材料用于保护产品从市场到病人使用过程中的无菌性,因为包装材料选用了不透气的材料,用于阻止空气中氧气的氧化作用以及空气湿度对于散布在基层中的吸湿性水凝胶的影响。
因此在一般情况下针对这种类型的伤口绷带应用的技术是通过辐射来灭菌。由此来确保一个深入到产品内部的非常有效的灭菌过程。它可以使用两种类型的辐射,即β-和γ-辐射。
灭菌剂量将按照最初的微生物负载(生物负荷)函数,即灭菌前的产品上/内所具有的病菌数量,在剂量规定的范围内适量采用。
为了获得有效的并具有足够安全范围的消毒作用,通常情况下在需要灭菌的产品上使用从25千戈瑞(kGray)以上的中等剂量。在实验中得到了产品的灭菌剂量,按照所使用的方法差异使用25到40千戈瑞(kGray)的剂量。
这两种已知的辐射灭菌的技术在处理弹性体基层的过程中也会产生不希望发生的副作用。特别是通过辐射进入到基层中的能量已经足够高,而打破所应用的弹性体上的碳-碳和碳-氢链,并且可能会打破这类聚合的高分子的分子链并由此造成它们的平均分子量的减少。这会对其特性,特别是其聚合力产生影响甚至降低聚合力。
于是要么是由于在操作中放置或取下绷带时有困难,要么是由于相对较高的聚合物价格,要么是因为某些弹性体聚合物的组织不相容性,要么就是因为辐射灭菌后的聚合力损失,导致了上述的产品不能完全令人满意。
发明内容
面对以上所述的现有技术中存在的问题,本发明的目的是:基于一种含有油脂和水凝胶的弹性体基层,提供一种具有生物相容性,不粘连(必要时轻度粘附)的伤口敷料,其相对辐射灭菌具有更好的耐久性,用于创伤性和慢性伤口以及烧伤的治疗。
根据本发明,上述目的将通过对已知的伤口敷料的进一步改进来实现的,其主要的特征是:伤口接触层包含下述弹性体基层,其含有聚合物含量少于3.2重量百分比,尤其是3.0 重量百分比或更少,最好是少于2.7重量百分比的弹性体,这样除了有经济上的好处以外还能获得较好的组织相容性。
在本发明的一种特别优选的实施方式中将采用热塑性弹性体(TPE)或者具有超高分子量的弹性体混合物,以此来抵消辐射灭菌对于基层聚合力的负面影响。令人惊讶的发现是,在添加/使用优选的超高分子量的弹性体时,例如Septon 4077,基层聚合力在灭菌以后有显著的改进。
受制于基层内所含的对温度敏感的成分,如凡士林或者CMC,使得加工温度的上限受到限制。(优选的最高为大致140-145℃)。在使用超高分子弹性体的情况下所期望的加工温度的提高也只能是轻微的并且是在可接受的范围内。
根据本发明所述的一种伤口敷料的伤口接触层主要包括除了有机聚合物的基层之外还有软化剂(增塑剂)以及亲水有机的或者无机的微粒,其在和含水性溶液接触的时候会形成一种凝胶。
根据本发明所述的一种特征,伤口敷料具有一种灵活的开放式网眼织物,其中所述织物包括纤维,用一种弹性的,聚合的并且不粘连的凝胶/基层包裹,其网眼基本上保持不阻塞以及可渗透性。
这种聚合物的基层可以包含一种合成的热塑性的疏水性的三嵌段共聚物A-B-A。这种情况下聚合物基层主要含有不超过3.2重量份额,特别的不超过2.6重量份额的嵌段聚合物,其中末端嵌段A可以是聚苯乙烯类型,且中心嵌段B可以是饱和聚烯烃类型,其中苯乙烯含量在25%和40%之间。
为了使本发明所述的疏水性的基层在辐射灭菌后也具有的足够的聚合力,三嵌段弹性体将使用具有高和超高分子量的SEBS或SEPS和/或SEEPS类型。
相应的氢化共聚物可为聚苯乙烯-聚乙烯-聚丁烯-聚苯乙烯(SEBS,如G1651,MD9633,Kraton)。在本发明中氢化共聚物优选的是聚苯乙烯-b-聚(乙烯/丙烯)-b-聚苯乙烯(SEEPS,Septon 4055和Septon 4077,Kuraray)。
为了获得本发明所述的疏水性基层,将至少选择一种来自SEBS或SEPS,特别是SEEPS类型的具有非常高分子量(至少200.000道尔顿,优选的至少400.000道尔顿)且布氏粘度至少为5000mPas(10%的甲苯溶液在30℃时)的三嵌段弹性体。
这种类型的聚合物组合物允许用织物对纤维的好的包围作为承载体,其和伤口保持长期的完全的隔离;这样就在任何时候也不会发生纤维和再生组织之间直接接触的风险,在伤口中的纤维夹杂可能导致在取下绷带时破坏组织而产生痛苦的结果。
通过使用高分子类和超高分子类的热塑性弹性体(TPE)的混合物,一方面可以获得非常柔软的敷布,其和所需保护的表面能够非常好的贴合,另一方面,由于基层具有的强大的聚合力和弹性力,在根据本发明所述的应用中,在灭菌消毒以后也不会对伤口形成这样的损害,即纤维松开并和伤口形成直接接触。在此,为了保持足够的可加工性,分子量超过300.000道尔顿的超高分子聚合物的含量占总聚合物含量少于50重量百分比,甚至少于25重量百分比。当分子量高于300.000道尔顿,特别是大约400.000到450.000道尔顿的超高分子聚合物的含量,占总聚合物含量超过5%,特别是超过10%,特别优选的是20%或者更高的时候,在辐射灭菌时就能够实现理想的灭菌耐久力的提升。
通过高含量的油性增塑剂,主要是含有矿物油和凡士林的一种混合物,其和一种含有非常低含量的聚合物/弹性体相组合形成的基层也作为一种纯的油脂体,通过它可以来确保一种非常好的组织相容性和在敷布表面上的不粘连的特性。
关于产品/增塑剂,其对于弹性体的增塑作用非常合适的,可以特别是在常温下为液态或者固态的油脂体,尤其是石蜡油,药用白油,矿物油,膏状石蜡,凡士林,硅油或硅脂或者蜡,以及它们的混合物。优选的增塑剂,例如凡士林,它的油滴点在35到70℃之间。医用白油也是优选的,其符合欧洲药典的纯度要求。
基层也可以含有抗氧化剂。作为合适的抗氧化剂可以为含硫抗氧化剂,例如来自于Akzo Nobel化学品公司以商品名称为PERKACIT ZDBC销售的二丁基二硫代氨基甲酸锌,和/或酚类抗氧化剂,如来自巴斯夫公司(BASF)以商品名称 销售的产品。
一种根据本发明所述的伤口敷料的伤口接触层此外还可以含有添加剂,其选自由另外的稳定剂,挤出助剂,填充剂,色素,着色剂,聚合剂,气味抑制剂,增粘剂,相容剂及其组合所构成的组。
作为亲水的有机或无机的微粒,其和水接触并凝胶化,可以使用例如众所周知的水凝胶(CMC,藻酸盐,明胶,黄原胶,果胶),也可以是硅酸盐,如皂土,硅溶胶或者高亲水性树脂。微粒的直径优选为50到300μm(假设为球状的),特别是直径为50到200μm。
在弹性体基层中以相对少量分散的水凝胶可以获得一种轻度的亲水特性,其足够用于保持对于伤口愈合有利的湿润的伤口环境,然而并不足以吸收非常多的水分而形成凝胶。事实上,这种吸收能力是不希望的,因为凝胶的浸涨会导致在敷布结构中保持的开孔被部分地阻塞。敷布之后将被闭塞,这样可能会抑制会导致浸渍危险的伤口渗出液的排出可能性。
根据本发明提供一种聚合物组合物,其包括非吸收性的弹性体基层/伤口接触层。
关于弹性体聚合物基层的“非吸收性”意思为:疏水性基层在24小时后,相对于基层的干量,吸收少于35%,尤其是少于25%的生理盐水溶液(0.8%氯化钠水溶液)。
在热塑性弹性体化合物中的聚合力表示为一种力量,它会影响化合物的凝聚力。这种凝聚力一方面是对于弹性体基层在加工时的粘滞性(粘度)和流动特性(流变学),另一方面是对于基层在它的应变时的强度负有责任。凝聚力在这样的系统中将通过参数例如弹性模数,断裂伸长率,抗拉和抗断强度/抗断力或者邵氏硬度来描述。
具体实施方式
抗拉和抗断强度测试:
抗断强度是断裂瞬间所测量到的力FR(抗断力)和测试样体在最薄点所测量到的初始横截面A0的商。
抗拉强度是测量到的最大力(最大的力量)和测试样体在最薄点所测量到的初始横截面的商。对于弹性体体来说抗断力通常就是最大力。
弹性体基层的抗断强度和断裂伸长率将用灭菌过的和未灭菌的测试样体,其初始横截面A0为100mm2,在一个Zwick-拉力测试机器上进行测量。断裂伸长率的测量将通过一个具有初始长度为8mm的测试样体在达到抗断力时的长度来确定。
表1.灭菌和未灭菌的样本的抗断强度和断裂伸长率
通过用很少量(约0.6%)的超高分子量的弹性体(例如在实施例2)来代替高分子量的 弹性体体(例如在实施例1)完全补偿了抗断强度和聚合力的下降;由此提升了聚合弹性体基层对辐射灭菌的耐久力。(样本实施例1,未灭菌2.86cN/mm2;样本实施例2,灭菌2.97cN/mm2)。同样对辐射灭菌对于断裂伸长率的负面影响也有部分补偿。
伤口敷料对于盐水溶液(NaCl 0,8%)在2小时,4小时和24小时接触时间后的吸收性
一个10cm2大的样本将用一个分析天平来称重(w1)。在烧杯中倒入盐水溶液,仅用少量的测试溶液完全覆盖样本,它的上面没有气泡。在确定的时间点将样本从溶液中取出并用软的纸巾小心地擦干,直到上面所有的水滴去除为止。擦干的样本用分析天平来称重(w2)。
相对于聚合物基层重量的吸收百分比(Pg)(吸收率),将按照下面的公式来计算:
为此必须把承载体重量(43g/m2)从样本重量中减去。
吸收率(Pg)=(w2-w1)/(w1-0.043)×100
表2.在2,4和24小时后对生理盐水的吸收率
根据表2中的吸收率数据非常清楚地表明,在本发明的一个特别优选的实施方式中,弹性体类的伤口接触层不能容纳显著量的生理盐水溶液而因此不能大量吸收。这些少量容纳的水将用于一种和伤口不粘连的含油脂类和水凝胶的边界层的形成。
本发明所述的伤口敷料可以按照以下方法来获得:
实施例1:
重量[g] | 重量百分含量[%] | |
石蜡油 | 1110 | 72.2 |
共聚物 | 40 | 2.6 |
抗氧化剂 | 1.5 | 0.1 |
凡士林 | 154 | 10.0 |
CMC | 231 | 15.0 |
敷料主体将在实验室溶解器中制备。加入1110g石蜡油以及40g弹性体共聚物SEEPS(Septon 4055,Kuraray公司)和1.5g抗氧化剂(Irganox 1010)并在135℃左右温度下搅 拌直到获得均一的澄清的弹性体主体。在添入154g凡士林(Vara AB,Sasol公司)后再加入231g羧甲基纤维素钠(CMC,Blanose 7H4XF,Aqualon公司)。用这样方法获得的弹性体主体还要再继续搅拌约30分钟直至得到均一的敷料主体为止。
敷料主体同样还可以在一个捏合机中或者相似的用于加工热熔胶主体的常规已知的设备/机器中制备。
敷料主体可以通过在大约140-145℃浸渗处理被涂在织布(织物)上,如此织物结构将被完全包围上,但是其中的间隙/孔尽可能保持开放,用于保障伤口渗出液能够流过。
实施例2:
类似实施例1,但是要使用由2% Septon 4055和0.6% Septon 4077组成的聚合物混料。
实施例3:
类似实施例1,但是要使用15%的非离子的纤维素-衍生物(HPMC,Bonucel D15000)。
在本发明的框架中,这可能是特别重要的,即弹性体的伤口接触层仅吸附5%到30%范围的干量。由此使得凝胶和浸涨作用(通过水凝胶溶液)受到限制,这样伤口渗出液的排液通过绷带的细孔进入第二层绷带的过程就不会受到阻碍。
在本发明的框架中,这可能是特别重要的观点,即承载体是网眼状的,这样在承载体用弹性体物质涂装/覆盖之后形成的纤维体还能保证伤口渗出液流过。
本发明并不仅仅局限于上述所说明的实施例。而且还考虑了承载体材料可采用形状为网格状的针织物和编织物和/或聚氨酯泡沫如Vivo MCF 03(AMS公司)。根据本发明所述的伤口敷料也可以具有一种溶化/分散/分布在弹性体基层中的金属基类的作用物质,如银、铜、硒和/或金属化合物类的基,特别是金属盐类(Ag2O、AgCl、ZnO、MgO)。
在本发明的一种特别优选的实施方式中作用物质包括低聚体/多聚体的双胍特别是疏水性的PHMB(例如Cosmocil PQ,Arch)和/或是低聚体/多聚体的胍,和/或类似的广谱灭菌剂,如癸双辛胺啶(奥替尼啶)。
Claims (15)
1.一种无菌的伤口敷料,包括承载体和非吸收性的弹性体伤口接触层,弹性体伤口接触层的弹性体基层由合成的三嵌段弹性体组成并通过非极性的油和/或凡士林塑化加工而成,特别是所述三嵌段弹性体由主要为聚苯乙烯嵌段和聚烯烃嵌段的共聚物(SEPS,SEBS,SEEPS,等等)所构成的,或者是由其混合物构成的,其中总的聚合物含量低于3.2重量百分比,特别是3.0重量百分比或者更少,优选的是2.6重量百分比或者更少。
2.根据权利要求1所述的伤口敷料,其特征在于,所述弹性体基层含有至少一种具有高分子量以及至少5.000mPas的布氏粘度(对于10%的甲苯溶液在30℃时)的合成的三嵌段弹性体。
3.根据权利要求1或2所述的伤口敷料,其特征在于,所述三嵌段弹性体的分子量为150.000道尔顿或者更高,特别为200.000道尔顿或者更高,优选的为300.000道尔顿或者更高,特别优选的为400.000到450.000道尔顿或者更高,但是低于600.000道尔顿,特别是低于550.000道尔顿。
4.根据权利要求3所述的伤口敷料,其特征在于,所述弹性体基层具有分子量为300.000道尔顿或者更低的高分子的聚合物,以及分子量大于300.000道尔顿的超高分子的聚合物。
5.根据权利要求4所述的伤口敷料,其特征在于,所述超高分子的聚合物的含量在整个聚合物的含量中为少于50重量百分比,特别是少于25重量百分比。
6.根据权利要求4或5所述的伤口敷料,其特征在于,所述超高分子的聚合物的含量在整个聚合物的含量中为多于5重量百分比,特别是多于10重量百分比,优选的为多于20重量百分比或更多。
7.根据上述权利要求中的任一项权利要求所述的伤口敷料,其特征在于,所述弹性体基层包含离子或者非离子的水凝胶,其均匀地分散在基层中。
8.根据上述权利要求中的任一项权利要求所述的伤口敷料,其特征在于,所述承载体主要是网眼状的针织物、编织物和/或纤维网和/或聚氨酯-泡沫。
9.根据上述权利要求中的任一项权利要求所述的伤口敷料,其特征在于,在所述伤口敷料的弹性体基层中另外还包含具有治疗性作用剂量的作用药物。
10.根据上述权利要求中的任一项权利要求所述的伤口敷料,其特征在于,所述作用药物均匀地溶解/分散/散布在所述弹性体基层中。
11.根据上述权利要求中的任一项权利要求所述的伤口敷料,其特征在于,所述弹性体基层在局部区域不包含所述作用药物。
12.根据上述权利要求中的任一项权利要求所述的伤口敷料,其特征在于,所述作用药物包含金属和/或金属化合物,特别是金属盐类。
13.根据上述权利要求中的任一项权利要求所述的伤口敷料,其特征在于,所述作用药物具有低聚的/聚合双胍,特别是PHMB,和/或低聚的/聚合胍,和/或类似的广谱杀菌剂,如癸双辛胺啶。
14.根据上述权利要求中的任一项权利要求所述的伤口敷料,其特征在于,所述弹性体基层含有一种增粘剂,其用于增加粘附力。
15.一种用于制备根据上述权利要求中的任一项权利要求所述的伤口敷料的伤口接触层的材料。
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CN109475655B (zh) * | 2016-05-04 | 2021-09-21 | Hcp医疗保健亚洲私人有限公司 | 用于交界面敷料的经优化的组合物 |
CN109475656A (zh) * | 2016-07-12 | 2019-03-15 | 优格创新与发展研究 | 允许二甲双胍的受控的延长释放的敷料 |
CN114057982A (zh) * | 2021-12-07 | 2022-02-18 | 广东粤港澳大湾区黄埔材料研究院 | 水基聚氨酯液体敷料及其制备方法、抗菌膜层 |
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RU2012118564A (ru) | 2013-12-20 |
PL2524706T3 (pl) | 2014-12-31 |
US9649402B2 (en) | 2017-05-16 |
EP2524706B1 (de) | 2014-07-23 |
CA2776663A1 (en) | 2012-11-19 |
RU2508127C2 (ru) | 2014-02-27 |
US20140341969A1 (en) | 2014-11-20 |
CN102784410B (zh) | 2015-01-21 |
EP2524706A1 (de) | 2012-11-21 |
US20120294927A1 (en) | 2012-11-22 |
BR102012012026A2 (pt) | 2014-07-08 |
CA2776663C (en) | 2015-03-31 |
HK1176025A1 (zh) | 2013-07-19 |
ES2489890T3 (es) | 2014-09-02 |
BR102012012026B1 (pt) | 2019-10-22 |
DK2524706T3 (da) | 2014-10-06 |
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