CN104024498B - 伤口敷料以及可用于伤口敷料中的线 - Google Patents
伤口敷料以及可用于伤口敷料中的线 Download PDFInfo
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- CN104024498B CN104024498B CN201280060396.8A CN201280060396A CN104024498B CN 104024498 B CN104024498 B CN 104024498B CN 201280060396 A CN201280060396 A CN 201280060396A CN 104024498 B CN104024498 B CN 104024498B
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Classifications
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Abstract
伤口敷料、用于生产伤口敷料的方法以及在伤口敷料中使用的部件。编织结构包括凝胶纤维和非凝胶纤维的混合物,其中线包括重量比至少50%的凝胶纤维,三维织物材料包括凝胶纤维,线包括可用于生产线的凝胶纤维和非凝胶纤维的混合物,该编织结构和三维织物材料适于用作为伤口敷料或用作为复合伤口敷料的部件。伤口敷料可适于在负压伤口治疗(NPWT)中使用。已经发现,结合形成凝胶的纤维提供了这样一种材料,其具有较高的吸收能力以能够较好地将渗出物从伤口转移走,其保持结构完整性,并且其是非粘着性的并可容易地从伤口移除。
Description
技术领域
本发明涉及伤口敷料(dressing)。更具体地,本发明涉及包括线的伤口敷料,线由凝胶纤维形成,尤其是由凝胶纤维和非凝胶纤维的混合物形成,本发明还涉及这种线。
背景技术
为了满足不同的临床需求,需要不同类型的伤口敷料。然而,对于伤口敷料的共同要求是,它们能够吸收来自于伤口的渗出物,并且保留足够的结构,使得它们在使用后能够容易地从伤口上移除,而不撕裂或破裂。如果伤口敷料不能从伤口上完全移除,那么患者将遭受额外的痛苦。此外,如果伤口敷料在移除时裂开或破裂,那么敷料的碎片会留在伤口中,从而抑制康复。特别是对于一些伤口,例如凹处伤口,在更换伤口敷料时移除所有材料是必要的,这是因为已经报道了巨细胞异物反应的案例,其中藻酸盐敷料的碎片已残留在伤口中。
除了需要保持结构完整性,伤口敷料能够吸收大量液体对于许多应用也是很重要的。在康复过程中,伤口产生渗出物。为了保持伤口清洁并促进康复,由敷料吸收渗出物。敷料需要多久被更换的决定因素是敷料多快被渗出物浸透。不频繁的敷料更换是优选的,这是因为更换敷料会使伤口恶化,并且给患者导致疼痛和/或不适。
已知诸如藻酸盐的凝胶纤维或果胶纤维用于伤口敷料。这些纤维具有比标准织物纤维更好的吸收液体的性能,并且在吸收液体时,它们变得潮湿而易滑脱。这防止了敷料附着于伤口,因此更容易移除敷料。然而,这也导致凝胶纤维失去结构完整性,从而使得凝胶纤维更难以处理,且更难以从伤口上干净地移除。此外,凝胶纤维本身会是易碎的,从而使其难以在伤口敷料的生产中达到效果。因此,尽管具有优点,但在由无纺布形成伤口敷料时,通常只可能完全利用凝胶纤维生产伤口敷料。然而,无纺布通常具有较低的抗拉强度,从而导致当敷料被液体浸透时缺失完整性。此外,无纺布会使纤维脱落,这在伤口敷料中是非常不希望出现的特性。已通过生产由凝胶纤维和非凝胶纤维的组合形成的伤口敷料而进行了努力,以克服这些限制。
EP0925396考虑了提供一种伤口敷料,其是易吸水但非粘着性的。所描述的伤口敷料包括编织的支持线(其基本不含凝胶纤维)和含有凝胶纤维的内嵌线。支持线典型为纤维素纤维,诸如粘胶人造丝或棉线,凝胶纤维优选为羧甲基纤维素钠纤维。
EP0927013描述了使用改性纤维素凝胶纤维和另一种形式的凝胶纤维(例如,藻酸盐)的混合物形成伤口敷料。可将这两种类型的凝胶纤维纺在一起或缠绕在一起,以形成线,然后进行编织或纺织,以形成绷带或长筒。伤口敷料还可包括诸如织物纤维的其他纤维,例如,粘胶人造丝。
EP0740554描述了一种易吸水、非粘着性的伤口敷料,其包括织物纤维和凝胶形成的纤维的混合物,可将织物纤维和凝胶形成的纤维纺在一起或缠绕,以形成线,然后编织或纺织成绷带或长筒。所描述的伤口敷料优选包括重量比80%的织物纤维和重量比20%的凝胶纤维。
由于凝胶纤维在被液体浸透时损失其完整性的特性,在现有技术的伤口敷料中使用的凝胶纤维的比例已受到限制,并且其比例关系到这将导致不可接受地损失了伤口敷料作为整体的完整性。典型地,诸如以上所描述的伤口敷料所包括的凝胶纤维的重量比小于三分之一。这限制了伤口敷料吸收渗出物的能力,也意味着需要经常更换敷料。
除了损失完整性的预期问题,所提出的凝胶纤维的易碎特性关系到包含较高比例凝胶纤维的线将在生产伤口敷料的过程中破裂和破碎,特别是在涉及在纤维上施加应力的过程中,诸如编织和纺织。如果发生了这种现象,所生产的伤口敷料将较差并缺乏完整性,从而使其更容易在伤口中破碎。
发明内容
然而,现在惊讶地发现,当凝胶纤维与非凝胶纤维混合时,可以较高比例使用凝胶纤维,而只需要较低比例的非凝胶纤维,以保持敷料在使用中的结构完整性。
根据本发明的第一方面,提供了一种编织结构,用作为伤口敷料或伤口敷料的部件,所述编织结构由线编制而成,所述线包括凝胶纤维和非凝胶纤维的混合物,其中所述线包括重量比至少50%的凝胶纤维。
根据本发明的编织结构克服了或基本减轻了现有技术的一些或所有缺陷。有利地,其包括较大比例的凝胶纤维,从而提供了较高的吸收伤口渗出物的能力。这意味着,可更不频繁地更换伤口敷料,减轻患者的不适和疼痛。已惊讶地发现,在混合线中凝胶纤维和非凝胶纤维的结合生产出可被编织的牢固的柔性线,尽管非凝胶纤维的比例相对较低。编织材料在保持一些拉伸和移动时具有较高的抗拉强度。这些特性在伤口敷料中是有益的,已对其应用敷料的患者的运动会使敷料扭曲。编织结构的柔性特征允许扭曲,而不使敷料断裂或撕裂。
而且,还发现了,包括根据本发明的混合线的编织结构在用于伤口敷料后,保持其结构完整性。即使在浸透液体时,结构也保持足够的完整性,从而使其可被容易地从伤口移除,而只有少量或没有破损和破裂。在根据本发明制造时,该伤口敷料的保持结构使得,即使通常用于包裹凹处伤口类型的绳状敷料,也可被容易地移除,而没有破损。
相信用于本发明第一方面的编织结构中的混合线是新颖的,其表示了本发明的另一方面。因此,根据本发明,提供了一种线,包括凝胶纤维和非凝胶纤维的混合物,其中所述线包括重量比至少50%的凝胶纤维。
有利地,由本发明提供的混合线包含较高比例的凝胶纤维,使其可用于制造伤口敷料。此外,已惊讶地发现,在混合线中较高比例的凝胶纤维与较低比例的非凝胶纤维的结合生产出牢固的柔性线,该线可被编织,而基本没有破损和弱化,其在用液体浸透时保持其完整性。
根据本发明第一方面的编织结构自身用作为简单形式的伤口敷料,例如在常规使用的藻酸盐或羧甲基纤维素(CMC)的无纺敷料的应用中。对于这些应用,该结构采取简单的片状或带状的编织织物的形式。片可以是方形、矩形、圆形、卵形,或者可具有任何其他适当的形状。
然而,在其他应用中,编织结构式符合伤口敷料的部件。在一个这种应用中,将编织结构结合至泡沫敷料中,特别是凝胶泡沫敷料。已知由藻酸盐材料形成的这种敷料。在传统的这种敷料的生产中,将藻酸盐的水溶液注入模具中,并使其凝为胶体。然后,将水从所得到的水凝胶中去除,例如,通过加热,或者更常用地,通过冷冻干燥,以形成片状的泡沫。然后,可以与无纺藻酸盐敷料类似的方式使用泡沫,即,泡沫片被置于伤口上并吸收伤口渗出物,从而泡沫形成凝胶。
凝胶泡沫敷料的已知形式的一个缺点是,敷料在使用中倾向于完全丧失其完整性,导致难以或不可能完全移除敷料。
根据本发明的另一方面,用包括凝胶纤维和非凝胶纤维的稀松布加固凝胶泡沫敷料。因此,本发明还提供了一种凝胶泡沫敷料,其包括凝胶泡沫片,所述凝胶泡沫片与稀松布层压,所述稀松布包括凝胶纤维和非凝胶纤维。该稀松布可以是根据本发明第一方面的编织结构,即,编织结构由包括凝胶纤维和非凝胶纤维的混合物的线编织而成,其中线包括重量比至少50%的凝胶纤维。在其他实施方式中,稀松布可以是编织的。
根据本发明的凝胶泡沫敷料的主要优点是,稀松布加固了泡沫并保持敷料的完整性,足以使得敷料从伤口位置被容易地且基本完全移除,甚至在敷料已吸收了大量的伤口渗出物并已变成凝胶状之后,也是如此。
本发明还提供了包括凝胶纤维的三维织物材料,该织物材料可用作为伤口敷料或作为伤口敷料的部件。一种形式的伤口治疗是负压伤口治疗(NPWT),其中这样的敷料可具有特定用途,NPWT技术旨在促进健康肉芽组织的形成,从而促进伤口康复,这也被称为真空辅助愈合。本文中的“负压”是指低于环境气压的压力。NPWT可用于促进慢性伤口、急性伤口和难治愈伤口的康复。在较大的开放性伤口中,需要装填物填充伤口腔并支撑和帮助排放管的定位。封闭的敷料用于覆盖伤口床,并形成封条或密封圈,真空在封条或密封圈之下形成。敷料必须附着于伤口周围的活的皮肤组织,并在排放管周围扎紧,以保证适当的密封。然后,施加负压并收集伤口流体。如果未使用适当的装填物,那么敷料将被吸入伤口腔内,并因此而没有形成有效的密封。
伤口装填物必须是非粘着性的且多孔的,并且伤口装填物必须接触整个伤口。传统上,将开放单元泡沫或纱布用于装填伤口腔。
当使用纱布时,其被典型地用为单层。将引流管置于纱布上,然后在引流管之上放置第二片纱布,产生“纱布三明治”。纱布可浸渍有例如抗微生物剂。
更普通地,诸如聚氨酯泡沫和聚乙烯醇(PVA)泡沫的泡沫用作为负压伤口治疗中的装填材料。由于密度更大,PVA泡沫具有比聚氨酯泡沫更小的孔,PVA泡沫需要比PVA更大的负压,从而有效地起作用。通常将泡沫切割为适于伤口的尺寸和形状,如果需要,可使用多于一片的泡沫。然而,每片泡沫必须与另一片泡沫接触,以在施加负压时得到均匀的压缩。
然而,当前可用的所有装填材料均具有相关的困难和风险。具体地,装填材料会粘至伤口,导致在贴敷的过程中给患者造成疼痛。还有一个风险是,一段泡沫或纱布纤维将分离并保留在伤口中,导致外来物反应或形成脓肿。装填材料还会发生阻塞,阻挡了伤口渗出物的通路和/或妨碍了对伤口施加负压。
现在发现,三维织物材料和结合了三维织物材料的伤口敷料(其中织物材料包括凝胶纤维)克服了或基本减轻了上述现有技术的一些或所有缺点和/或其他缺点。
因此,根据本发明的另一方面,提供了包括凝胶纤维的三维织物材料。
在本发明的上下文中,使用“三维织物材料”的意思是,具有这样一种结构的织物材料,该结构使得织物材料具有实质的厚度,即,与平面的织物材料不同,该织物材料在维度上是有体积的。通常,这种织物材料将是可压缩的,从而使其厚度基本上可通过施加机械力而减小,例如,减小两倍或更多(例如五倍、十倍、二十倍或更多)。
关于本发明的所有方面,使用“凝胶纤维”的意思是,能够吸收诸如伤口渗出物的水状流体的纤维,其在吸收液体后,变成凝胶状、潮湿且易滑脱。凝胶纤维可具有对于0.9%的盐溶液每克纤维至少2克的吸收率,正如通过自由膨胀吸收率测试所测量的(即,将已知干重量的纤维分散在测试液体(盐水)中足够的时间,以用于纤维吸收液体,通过真空过滤去除多余的液体,测量纤维重量的增加)。吸收率可以相当高,例如,至少5g/g、至少10g/g、至少15g/g、或者至少25g/g。
用于由混合纤维生产线的方法是本领域已知的,可通过利用任何适当的方法混合凝胶纤维和非凝胶纤维来制备根据本发明的线。通常,长度较短的纤维(短纤维)在纺至线中之前就混合到一起。优选地,用于生产线的短纤维具有大于30mm的长度。更优选地,其具有大于40mm的长度。短纤维的长度可小于100mm,例如,可以是30-100mm或40-100mm。短纤维的长度可以是可变的,在这种情况下,平均长度可以在上述范围内。
凝胶纤维可以是本领域已知的任何适当的凝胶纤维,包括果胶纤维、藻酸盐纤维、由藻酸盐和另一种多糖制成的纤维、壳聚糖纤维、透明质酸纤维、其他多糖的纤维或由树胶衍生的纤维、或者以化学方法改性的纤维素纤维,例如羧甲基纤维素(CMC)。凝胶纤维可以是不同凝胶纤维的组合或混合。
当前对于本发明所有方面优选的凝胶纤维是藻酸盐纤维和果胶纤维。
藻酸盐具有较大分子量,是亲水聚合物,其由海藻衍生,并在与水流体接触时形成凝胶。其亲水特性促进对诸如伤口渗出物的液体的吸收,这使其在伤口敷料中非常有用。
藻酸盐聚合物由两种基础单体单元(甘露糖醛酸和古罗糖醛酸)形成。使聚合物中这些单元的比例不同将改变藻酸盐的性质。除此之外,藻酸盐聚合物还与阳离子相关联,其通常以藻酸钠、藻酸钙或藻酸钠/藻酸钙混合物的形式产生。诸如藻酸钾的其他形式也是已知的。
与藻酸盐聚合物相关联的阳离子的性质使藻酸盐的特性改变。例如,藻酸钠是水溶性的,而藻酸钙不是。因此,通过改变伤口敷料中所使用的藻酸盐,可确保最终的敷料表现出所需的特性。
以多种形式生产藻酸盐纤维,但最常见的是以藻酸钠、藻酸钙或藻酸钠/藻酸钙混合物的形式。诸如藻酸钾的其他形式也是已知的。不同的藻酸盐具有不同的性质,因此,为了得到线所需的性质,可改变所使用的不同藻酸盐的相对比例。例如,藻酸钠是水溶性的,因此当用水浸渍时,利用较高比例藻酸钠生产的线会失去其一部分结构完整性。与此相比较,藻酸钙不是水溶性的。在与伤口渗出物接触时,伤口渗出物中的钠离子与藻酸盐中的钙离子交换,藻酸盐中将出现钠离子,这随后导致凝胶的形成。在根据本发明的混合线中使用的藻酸盐纤维可以是藻酸钙、藻酸钠或混合的藻酸钙/藻酸钠。优选地,在本发明中使用的藻酸盐纤维是藻酸钙。
果胶是包括1,4链α-D-半乳糖醛残留物的络合多糖的族,其首先在陆生植物的细胞壁中发现。果胶可被分为具有不同凝胶性质的两个主基团:低甲氧基果胶和高甲氧基果胶。低甲氧基果胶是这样一种果胶,其中用甲醇酯化半乳糖醛酸残留物链中少于一半的羰基。低甲氧基果胶可在存在二价阳离子(例如,钙)时形成凝胶,这是由于半乳糖醛酸残留物团块和二价离子之间的非共价离子相互作用。高甲氧基果胶是这样的果胶,其中已用甲醇酯化了多于一半的羰基。这种果胶可在存在糖或酸时凝胶,形成果胶分子的二维网,其中用糖和酸溶质固定溶剂(水)。
已知可用于吸收性伤口敷料的另一种凝胶纤维由化学改性的纤维素制成。具体地,可使用羧甲基纤维素纤维,例如羧甲基纤维素钠的形式。这种纤维优选地具有每个葡萄糖单元至少0.2个羧甲基基团的取代程度,或者至少0.3,或者至少0.5。
在本领域中已知生产凝胶纤维的方法,可采用任意适当的方法生产用于本发明的纤维。例如,可利用通过钙离子溶液对藻酸钠溶液进行溶剂纺丝来生产藻酸钙纤维。类似地,可通过在水混有机溶剂浴中对果胶聚合物溶液进行溶剂纺丝来生产果胶纤维。可通过本领域已知的适当方法对纤维进行进一步处理,包括洗涤、压皱、梳理、纺制和/或切割。
根据本发明第一方面的编织结构可具有各种形式,例如,片状、带状、管形带状、绳状或适于用作为伤口敷料的任何其他形状。许多这种结构将基本上是二维的,具有远小于其他维度的厚度。这些结构典型为片状,具有方形或矩形形状,或者成形为与身体的特定区域一致。根据本发明的其他结构可形成为三维形状,如管状敷料。
还可以适于用作为伤口包裹材料(即,不用于覆盖伤口而用于填充空腔或凹处伤口的材料)的形式生产编织结构。对于这种应用,可将编织结构生产为相对较小、生产为离散伤口包裹元件或生产为带或条。
非凝胶纤维可以是本领域已知的任何适当的纤维,或者可以是两种或多种非凝胶纤维的混合物。非凝胶纤维可以是织物纤维,并且可以是天然的,例如,棉花,非凝胶纤维可以是已改性的天然纤维,例如,诸如粘胶纤维或莱赛尔纤维(lyocell)(以商标名出售)的纤维素纤维,或者其可以是合成的,例如,聚酯、聚丙烯或聚酰胺。不同的纤维在抗拉强度和吸收能力方面具有不同的特性,可根据伤口敷料所需的特性选择适当的非凝胶纤维。此外,可使用两种或多种非凝胶纤维的组合,以获得所需的特性。优选地,非凝胶纤维是已改性的自然纤维。更优选地,非凝胶纤维是纤维素纤维。
因此,在本发明的一些实施方式中,线可包括藻酸盐纤维和纤维素纤维的组合。在这些情况中,线优选地包括藻酸钙纤维和纤维素纤维的组合。更优选地,线包括藻酸钙和粘胶纤维,或者包括藻酸钙和莱赛尔纤维。
在本发明的其他实施方式中,线可包括果胶纤维和纤维素纤维的组合。在这些情况中,线优选地包括果胶纤维和粘胶纤维的组合,或者包括果胶纤维和莱赛尔纤维的组合。
线中凝胶纤维与非凝胶纤维的比率可以在很宽的范围内改变,只要混合物中凝胶纤维的比例(重量比)至少为50%。优选地,凝胶纤维包括混合物的重量比50-98%。凝胶纤维可包括混合物的重量比60-98%或者混合物的重量比70-98%。优选地,非凝胶纤维包括混合物的重量比2-49%。非凝胶纤维可包括混合物的重量比5-49%或者混合物的10-30%。因此,凝胶纤维与非凝胶纤维的比率可从98:2至51:49。凝胶纤维与非凝胶纤维的比率可从98:2至60:40,更优选地,从98:2至70:30。例如,凝胶纤维与非凝胶纤维的比率可约为60:40、65:35、70:30、75:25、80:20、85:15、90:10、95:5或98:2。
在之前的段落所列出的比例和比率通常可应用于凝胶纤维和非凝胶纤维的任意组合,例如凝胶纤维是藻酸盐纤维、果胶纤维或改性的纤维素纤维的组合,再例如,非凝胶纤维是自然纤维或合成纤维(例如,聚酯、聚丙烯或聚酰胺)的组合,自然的非凝胶纤维诸如棉花、已改性的自然纤维(例如,诸如粘胶纤维或莱赛尔纤维的纤维素纤维)。对于如上所述的短纤维长度和吸收能力也是如此。
根据本发明第一方面的结构是编织的。编织是一种过程,而织物是通过对线的环进行互锁而形成的。多种编织技术在本领域中已知,并适于用于本发明中。
优选地,利用双针床对结构进行编织。双针床生产比由其他方法生产的编织织物更大且强度更高的编织织物。这保证了该结构具有较高的结构完整性,并有助于保持完整性,即使在使用后。
可对编织织物进行经编或纬编。在经编的织物中,沿着织物的长度(经线)制作成行的线圈。实现此过程的普通方法是,同时对成行的独立针提供多种长度的线。在纬编的织物中,跨越织物(纬线)水平地制作线圈(通常使用单根线),通过将上下行线圈与线圈进行互锁,形成针迹。优选地,根据本发明的编织结构是经编的。
在本领域中已知用于由混合纤维生产线的方法,可通过以任意适当的方法混合凝胶纤维和非凝胶纤维来制作根据本发明的线。
线可以是本领域已知的任意适合类型的线。特别地,可期望利用该线生产的产品具有结构,从而使其保持其形状和形式。这种产品可通过使用有纹理的线来生产,例如,空气混纺(air-intermingled)线、假捻线、多股线、KDK线(假编变形线)或其他类似的线。因此,根据本发明的线可以是有纹理的线。
本发明的凝胶泡沫敷料可包括单片泡沫,将稀松布层压至该单片泡沫的一面。可通过以下步骤制造这些实施方式:
a)将诸如藻酸盐的凝胶材料的溶液注入模具中;
b)使所述溶液部分固化;
c)将稀松布置于部分固化的溶液的顶部上;
d)使所述溶液进一步固化,以形成水凝胶;以及
e)从所述水凝胶去除水,以形成结合至所述稀松布的泡沫片。
在其他实施方式中,稀松布夹在泡沫层之间,例如,通过以下步骤:
a)将第一量的凝胶材料(诸如,藻酸盐)的溶液注入模具中;
b)使所述溶液部分固化;
c)将稀松布置于部分固化的溶液的顶部上;
d)将额外量的凝胶材料的溶液注入到所述稀松布上;
e)使所述溶液进一步固化,以形成水凝胶;以及
f)从所述水凝胶去除水,以形成结合至所述稀松布的两侧的泡沫片。
凝胶泡沫敷料中所使用的凝胶材料可以是上述材料中的任一种。然而,当前最优选的凝胶材料是藻酸盐。
所使用的藻酸盐的溶液将典型地包括藻酸钠和钙离子(或者其他金属离子,如锌、铝、银或铜),从而与藻酸盐进行反应,以致使形成水凝胶。为了使溶液注入模具中而不可溶的藻酸钙不会过早沉淀,在溶液中可期望或必须包括螯合剂,例如,乙二胺四乙酸(EDTA)或柠檬酸钠(柠檬酸三钠盐二水合物),从而使不可溶的金属离子藻酸盐凝胶的沉淀延迟允许包含藻酸钠和Ca2+离子的溶液流入模具的时间周期,从而使凝胶化在适当的时间周期之后发生,并且不可溶的藻酸盐凝胶保持其流入的模具的形式。可使用的另一种方法是向藻酸钠的溶液添加不可溶的钙盐,诸如碳酸钙,然后使藻酸钠的溶液流入模具。钙离子与藻酸盐的一部分非常缓慢地反应,因此藻酸钙凝胶的沉淀延迟,从而发生凝胶化,并使所形成的水凝胶是模具的形式。
可通过传统方法(例如,通过冷冻干燥或通过加热)从泡沫片除去水。
在凝胶泡沫和稀松布中使用的加固泡沫的凝胶材料尽管不是必须的,但是同类产品中最方便得到的。例如,泡沫可以是藻酸盐泡沫,稀松布可由包括藻酸盐纤维和非凝胶纤维的线形成。稀松布的非凝胶纤维成分提供能够从伤口除去敷料所必须的完整性,即使在发生凝胶之后,凝胶纤维成分有助于稀松布结合至泡沫。
本发明的三维织物材料优选为“双面的”或“衬垫”织物。衬垫织物包括由连接层结合在一起的、织物的两个不同的表面层。连接层最普通地具有在两个外表面层之间延伸的连接绒头丝的形式。两个外表面层可以是相同的或不同的。最优选地,每个表面层将具有编织结构,该结构具有开口的规则阵列。两个表面层中开口的大小和/或排列可以是相同的或不同的。
该连接层包括丝,例如,单丝或线,其连接两个表面层。典型地,衬垫织物被编织为使得连接丝与两个表面层基本垂直排列。两个表面层之间的距离(即,衬垫织物的厚度)由连接丝的长度决定。也可通过适当选择连接丝的类型和通过改变连接丝的密度而改变衬垫织物的性质。
该材料的结构使其特别有利于在伤口护理领域使用。三维织物材料的开放结构允许空气快速流过该材料,并意味着被伤口渗出物阻塞的可能性小于传统敷料和包裹材料;这在负压伤口治疗中特别重要。在该材料中使用凝胶纤维导致较好的吸收流体(特别是伤口渗出物)的能力。这与材料的开放结构共同使得能够较好地从伤口将渗出物转移走。织物的高吸收性和不吸附性意味着,包括该材料的伤口敷料将需要较小频率的更换,并将易于从伤口移除,以减少患者的损伤和疼痛。凝胶纤维还帮助保持潮湿的伤口环境,这有利于康复。
利用如上所述的线,即,包括凝胶纤维和非凝胶纤维的混合物的线,在编织操作中可形成三维织物材料,其中,线包括重量比至少50%的凝胶纤维。非凝胶纤维的比例可小于织物材料重量比的40%,优选地,小于织物材料重量比的约20%,更优选地,非凝胶纤维的比例小于重量比的约15%,或者小于织物材料的重量比的约10%或小于织物材料的重量比的约5%。因此,凝胶纤维的比例可在织物材料的重量比50%至100%之间,或在织物材料的重量比80%至100%之间,或在织物材料的重量比90%至100%之间,或在织物材料的重量比50%至95%之间,或在织物材料的重量比80%至95%之间,或在织物材料的重量比85%至95%之间。可替换地,在本发明的该方面中,三维织物材料可完全由凝胶纤维组成,即,凝胶纤维包括三维织物材料100%的重量比。
适用于本发明的三维织物材料优选地具有至少1mm的厚度,更优选地,至少1.5mm,更优选地,至少2mm。适用于本发明的三维织物材料优选地具有高达60mm的厚度,更优选地,具有高达20mm的厚度,更优选地,具有高达15mm的厚度,最优选地,具有高达10mm的厚度。因此,适用于本发明的三维织物材料优选地具有1mm至60mm范围内的厚度,更优选地,具有1.5mm至20mm范围内的厚度,更优选地,具有2mm至15mm范围内的厚度,最优选地,具有2mm至10mm范围内的厚度。
凝胶纤维和非凝胶纤维可在生产三维织物材料之前混合在一起。可将已混合的纤维用于全部材料的生产,从而使得凝胶纤维和非凝胶纤维均匀地分部于整个材料中。可替换地,非凝胶纤维可仅结合至织物的一部分中。例如,非凝胶纤维可包括衬垫织物的第一外表面层、第二外表面层和/或连接丝中的所有或一部分。
在本发明的其他方面中时,非凝胶纤维可以是本领域中已知的任意适合的纤维,或者可以是两种或多种非凝胶纤维的掺合物或混合物。非凝胶纤维可以是织物纤维,也可以是诸如棉花的自然纤维或者诸如的纤维素纤维(如粘胶纤维或莱赛尔纤维)的已被改性的自然纤维,或者其可以是诸如聚酯、聚丙烯或聚酰胺的合成纤维。不同的纤维在抗拉强度和吸收能力方面具有不同的特性,可根据材料所需的特性选择适当的非凝胶纤维。此外,两种或多种非凝胶纤维的组合可用于获得所需的特性。优选地,非凝胶纤维是已改性的自然纤维。更优选地,非凝胶纤维是纤维素纤维。最优选地,非凝胶纤维是莱赛尔纤维(lyocell),其以商标名出售。
当凝胶纤维吸收液体和凝胶时,凝胶纤维会失去其结构完整性。向三维织物材料添加一定比例的非凝胶纤维有助于保持织物的结构完整性,并仍保持凝胶纤维的较高吸收能力和不吸附特性。这使得敷料能够被容易地从伤口移除,而没有将纤维的碎片留在伤口内的风险。
上述三维织物材料在伤口敷料中具有特别应用。
因此,根据本发明的进一方面,提供了一种伤口敷料,该伤口敷料包括三维织物材料,所述三维织物材料包括凝胶纤维。
包括根据本发明的三维织物材料的伤口敷料可具有多种形式。作为原则,三维织物材料将构成敷料的伤口接触部分。
在一些实施方式中,伤口敷料可完全由或基本由该三维织物材料构成。换言之,敷料可主要由或完全由织物材料部件(例如,方形、矩形或其他适于成形的材料部件)制成。在这种情况下,可以与传统凝胶敷料类似的方式使用该敷料,传统凝胶敷料诸如藻酸盐敷料或羧甲基纤维素纤维敷料,其典型地具有无纺垫的形式。与这些传统敷料相比,根据本发明的敷料可表现出具有更大的转移伤口渗出物的能力,因此,这种敷料可有利地与位于敷料上与伤口的相对侧的吸收体(如,泡沫或纱布垫)结合使用。还可将三维织物材料用作为伤口包裹材料,因此,可将三维织物材料生产为相对较小的形式、离散伤口包裹元件或者带状或条状。
在其他实施方式中,伤口敷料是复合敷料,其包括三维织物材料和其他部件。
根据本发明该方面的复合伤口敷料典型地包括背衬层,背衬层形成伤口和周围大气之间的屏障。本领域中任何已知的材料均可用于背衬层。
通常,背衬层对于伤口渗出物和其他液体是不可渗透的,但优选地,背衬层对于空气和水蒸气是可透过的。特别地,背衬层优选地表现出相对较高的水蒸气传输率(MVTR)。背衬层的MVTR在37℃100%至10%的相对湿度差可以至少为300g/m2/24h,更适合地,至少为500g/m2/24h,优选地,至少为700g/m2/24h。
背衬层最优选为具有所需特性的塑料膜。背衬层可以是聚氨酯膜。
背衬层的尺寸可比三维织物材料大,从而使背衬层在一侧或多侧延伸超过三维织物材料的边缘。优选地,背衬层在所有侧均延伸超过三维织物材料的边缘,形成绕三维织物材料的边沿。
背衬层可在其下侧承载粘合剂。在背衬层在三维织物材料周围形成边沿的情况下,粘合剂可用于将伤口敷料粘着于患者伤口周围的皮肤。通常,敷料的尺寸将选择为使得三维织物材料置于伤口上且边沿与伤口周围的健康皮肤接触。用于伤口敷料的适合的皮肤接触粘合剂是已知的,本领域中已知的任何适当的粘合剂均可用于本发明。例如,粘合剂可以是丙烯酸粘合剂、水状胶体粘合剂、聚氨酯粘合剂、水凝胶或者软硅酮粘合剂。
软硅酮粘合剂提供了许多优点。最优选地,软硅酮粘合剂是硅酮凝胶的形式。
软硅酮粘合剂特别适于用作为伤口敷料中的皮肤接触层。软硅酮粘合剂是软的、可触摸的且适合的,其表现出对干燥皮肤较好的粘附性,而对下层伤口表现出较低的附着。因此,可将敷料应用于伤口,并在随后移除,而不会导致使伤口损伤。硅酮凝胶是粘合性的,但不会在被移除时在表面/衬底上留下纤维或残留物。
本发明中适于用作为皮肤接触材料的硅酮凝胶可承载在熔喷无纺材料的层上,例如,在如WO2007/113597所描述的熔喷聚氨酯(MBPU)片上。MBPU的相对侧可涂覆有粘合剂,例如丙烯酸粘合剂,从而将硅酮凝胶/MBPU层压物粘贴于敷料的放置部件,例如,三维织物材料和/或背衬层。
粘合剂可仅设置在敷料的边沿,即,在背衬层的下侧上,在三维织物材料周围或与三维织物材料有较小范围的交叠。然而,可替换地,粘合剂可跨越伤口敷料的下侧的整个范围延伸,覆盖三维织物材料。在这种情况下,粘合剂层通常设置有开口,例如相对较大的穿孔,以允许通过粘合剂层将伤口渗出物传输至三维织物材料中。在这些情况下,粘合剂层置于伤口本身,并与伤口本身接触,而不是仅仅围绕健康皮肤,因此通常优选的是,所使用的粘合剂是这样一种粘合剂,其是非粘着性的,且允许伤口敷料相对容易地移除并不会导致伤口损伤。因此,粘合剂可以是例如水状胶体粘合剂、聚氨酯粘合剂或水凝胶或者最优选为软硅酮粘合剂,特别是硅凝胶。硅凝胶可承载在MBPU片上,在这种情况下,MBPU/硅层压物可形成有相对较大的穿孔的规则阵列,例如,具有2-10mm或更大的直径(如,4-10mm)的穿孔。穿孔还可设置在仅存在于敷料的边沿处的粘合剂层中。在这种情况下,穿孔将相对较小,并设置为增大敷料的透气性。
伤口敷料还可包括吸收体。典型地,吸收体将位于三维织物材料之上,即,位于三维织物材料上的伤口的相对侧上,从而吸收通过三维织物材料的伤口渗出物。吸收体可具有任何适合的形式,并可由本领域中已知的任何适当的材料制成。例如,吸收体可以是泡沫垫(例如,开放单元聚氨酯泡沫),或者可以是纱布的垫或其他纺织材料或无纺材料。其他形式的吸收体包括聚合吸收材料。适当的聚合吸收材料包括多糖或多糖衍生物,并且可以是与适于生产三维织物材料相类似的材料。例如,吸收材料可以是藻酸盐(即,海藻酸的盐),特别是藻酸钠或藻酸钙,或者是两者的混合物。其他适当的吸收材料包括纤维素或纤维素衍生物(例如,羟乙基纤维素或羟基丙基纤维素)以及果胶或果胶衍生物(例如酰胺化果胶)。
可选地,吸收材料可以是通常称为“超级吸收物”或“超级吸收材料”的类型。这些材料典型地能够吸收数倍于它们自身质量的水(例如,高达200、300、400、500或更高倍它们自身质量的水)。优选的超级吸收材料是超级吸收聚合材料,包括聚丙烯酸酯(即,聚丙烯酸的盐)、聚丙烯酰胺共聚物、乙烯马来酸酐共聚物、羧甲基纤维素、聚乙烯醇共聚物、聚乙烯氧化物和聚丙烯腈的淀粉接枝的共聚物。
在敷料包括具有多个部件的复合结构(例如,三维织物、吸收垫和背衬层)的情况下,在必须或期望时,这些部件可通过传统的方式通过例如适当的粘合剂粘贴在一起。
在伤口敷料包括皮肤接触粘合剂的情况下,通常敷料将在其下侧上提供有可释放垫片。可释放垫片可在使用前覆盖伤口敷料的粘合剂和伤口接触部分,并且可在将要向伤口应用敷料之前从敷料移除。这减小了污染伤口敷料的风险,并有助于处理敷料。
这些可释放垫片通常使用在本领域已知的伤口敷料,并且可在本发明中采用的适当的材料是技术人员所熟知的。例如,可释放垫片可以是适当的塑料片或硅化纸或类似物。
可释放垫片可以是覆盖伤口敷料的下侧的单片,或者可由两个或多个片形成。可释放垫片还可包括突出部,以保证在使用前将衬垫容易地从敷料移除。特别地,在可释放垫片由两个或多个部分形成的情况下,这些部分可交叠或邻接,并从伤口敷料向外延伸,从而提供用于移除可释放垫片的简单方法。
本发明该方面的复合伤口敷料在负压伤口治疗中会特别有用。
因此,根据本发明的另一方面,提供了一种用于负压伤口治疗的伤口敷料,该伤口敷料包括安装有排放端口的封闭背衬层和包含凝胶纤维的三维织物材料。
三维织物材料和伤口敷料可具有与本发明其他方面相关的上述特征中的任一个或任意组合。背衬层是封闭的,以允许将负压施加于伤口。然而,背衬层也可对空气和水蒸气具有一定程度的可渗透性,因此背衬层可以是例如如上所述的聚氨酯微孔膜,但背衬层应当是足够不可渗透的,以允许施加负压。
排放端口典型地附接于伤口敷料的背衬层,背衬层在端口之下具有开口,以允许材料从敷料的内部通过排放端口。
通常,伤口敷料的结构将使得,在使用中,三维织物材料位于与伤口接触或与伤口连通。敷料的背衬层将在三维织物材料之上延伸,并将被密封地附接于伤口周围的健康皮肤,从而使负压可施加于敷料和伤口之间。诸如吸收体的一个或多个中间部件可插入敷料的三维织物材料和背衬层之间。
排放端口被设置为使得负压源可连接至排放端口。负压源可以是例如泵。当将负压施加于排放端口时,在伤口敷料之下形成部分真空。
本发明还提供了如上所述的复合敷料,但其包括根据本发明第一方面的编织结构,而不是三维织物材料。
还可将已知帮助或促进伤口康复的附加试剂结合至根据本发明的任一种伤口敷料中。例如,敷料还可包括抗微生物剂、防腐剂、抗真菌剂和/或消炎剂。可将这些试剂在编织之前结合至线中,或者可将这些试剂添加至最终的敷料。
本发明的伤口敷料可包括蜂蜜。很长时间以来,已知蜂蜜对于处理伤口是有效的,从至少2000年前就有了这种使用的记载。更近一些,研究已表明,蜂蜜具有潜在的抗微生物性、抗真菌性和消炎性,并且能够刺激人体内的淋巴活性和噬菌活性。进一步,已证明蜂蜜有助于坏死组织的清除,并刺激新组织的生长。在其抗菌活性方面,已报道蜂蜜对多余60种细菌具有抗菌效果,包括需氧菌、厌氧菌、革兰氏阳性菌和革兰氏阴性菌。特别地,蜂蜜已表现出对包括MRSA的细菌的抗生素抗性品系有效果。
在不希望被理论所束缚的情况下,相信蜂蜜的抗菌活性部分是由于释放低水平的过氧化氢(众所周知的抗微生物剂)。由于过氧化氢的产生是由蜂蜜的稀释(例如,由伤口渗出物)所激发的,所以蜂蜜具有在稀释时变得更有活性的独特性质,而不是活性更弱。
许多研究已经显示,保持潮湿伤口环境有助于伤口康复。然而,潮湿环境也促进细菌的生长,因此防治感染是严重的问题。因此,将蜂蜜添加至伤口敷料使伤口能够保持潮湿,同时抑制细菌生长并减少感染的可能性。
在本发明的特定实施方式中,伤口敷料可包括如上所述的编制结构或三维织物材料,其被蜂蜜浸渍或蜂蜜处于其表面上。可替换地,可将蜂蜜施加于敷料,或在应用敷料之前直接施加于伤口。
蜂蜜在全世界范围内由许多不同花源生产,其抗菌活性随着蜂蜜源和其经历的处理过程的改变而改变。例如,印度的莲花蜂蜜被认为对眼部疾病较好,而麦卢卡蜂蜜(由麦卢卡灌木的花粉产生的单一花种蜂蜜)由于其防腐特性为人所知。麦卢卡植物是薄子木(Leptospermum)属的一部分,由该属的植物产生的蜂蜜(诸如麦卢卡蜂蜜或松红梅蜂蜜)由于其特别强的抗菌特性而为人所知。优选地,本发明中所使用的蜂蜜由薄子木属的植物生产。更优选地,蜂蜜是麦卢卡蜂蜜或松红梅蜂蜜(jellybush honey)。
本发明的伤口敷料还可包括银。尽管金属银惰性相对较强,但离子银已表现出具有抗微生物活性,并且之前已被用于伤口敷料中。在使用中,银阳离子结合至细菌中蛋白质和核酸上带负电的位点。这导致了许多效果,包括改变蛋白质结构、使细胞壁破裂和/或细胞死亡。可以相信,银离子具有与细菌中多个不同功能基团(包括硫醇基团、羧化物、磷酸盐、吲哚和胺)相互作用的多个攻击位点。这使得对银的细菌耐药性的发展非比寻常。
优选地,将银结合至伤口敷料中将导致在时间上不断释放低浓度的银离子。这种缓慢的释放已表明激励康复,并抑制微生物的生长。用于将银结合至伤口敷料中的方法是本领域已知的,形式是银可被使用的形式。在本发明中可使用本领域已知的任何适当的方法或形式。例如,银可以是银磺胺嘧啶的形式。
可结合至根据本发明的伤口敷料和线中的另一种抗微生物剂是聚六亚甲基双胍(PHMB;还已知为聚氨丙基双胍)。作为Arch Personal Care Products公司(地址:70TylerPlace,South Plainfield,NJ07080,USA)的商标为CQ的20%水溶液,PHMB是可用的。
可将PHMB应用于根据本发明的编织结构或三维织物材料(在该材料被生产出来后)。这可通过将PHMB的水溶液喷洒在该材料上,或者通过将该材料浸入这种溶液中来实现。
在其他实施方式中,将PHMB应用于或结合至该材料由其生产的线中。可通过将线浸入PHMB的溶液中而将PHMB应用于线。可通过将PHMB包含于用于利用溶剂纺丝来生产凝胶纤维的溶液中,而将PHMB结合至线中,该溶液例如藻酸钠溶液或果胶溶液,藻酸钠溶液是利用溶剂纺丝通过钙离子溶液而转变为藻酸钙纤维,果胶溶液是在水溶性有机溶剂浴中进行溶剂纺丝。
在根据本发明的编织结构或三维织物材料中的诸如银或PHMB的抗微生物剂的浓度可在很宽的范围内变化。然而,抗微生物剂典型地以材料的重量比0.1和10%之间的水平存在,更典型地在重量比0.1和5%之间,更常见地在重量比0.1和2%之间或重量比0.1和1%之间。
附图说明
下面将参照附图,仅作为示例,更详细地描述本发明,其中:
图1(a)和1(b)是示出了根据本发明利用线编织的织物结构的垫纱示意图;
图2示出了根据本发明的伤口敷料基本为方形的第一实施方式;
图3示出了方形的第二伤口敷料,其与图2的伤口敷料类似,并已浸渍有蜂蜜;
图4示出了根据本发明的伤口敷料的管状第三实施方式;
图5示出了根据本发明的伤口敷料的第四实施方式,其是用编织的稀松布加固的藻酸盐泡沫的形式,该编织的稀松布包括根据本发明的线;
图6是根据本发明的衬垫织物的非等比例示意性透视图,其包括构成根据本发明的伤口敷料的第五实施方式的凝胶纤维;
图7是根据本发明的伤口敷料的第六实施方式的上侧透视图,结合了图6所示形式的凝胶衬垫织物;
图8是图7的伤口敷料的下侧平面图;
图9是沿图8中VIII-VIII线的非等比例剖视图;
图10是根据本发明的伤口敷料的第七实施方式类似于图9的示图,结合了凝胶衬垫织物,并适用于负压伤口治疗(NPWT);
图11是适于NPWT的伤口敷料的第八实施方式类似于图10的视图,其具有硅凝胶皮肤接触层,该接触层跨越敷料下侧的整个范围延伸;
图12是图11的伤口敷料的下侧平面图,其中去除了释放垫片(liner);
图13是根据本发明的伤口敷料的第九实施方式类似于图11和图12的示图,其也适于NPWT;以及
图14是图13的伤口敷料的下侧平面图,其中去除了释放垫片。
具体实施方式
首先参照图1(a),示出了用于经编织物的图案的垫纱(lapping)示意图1。垫纱示意图由点的网格形成。每个点表示针头2,线3和4表示编织织物中线的路径。针头的每个水平行表示一个路线(course),即,单针迹形成过程。针头的每个竖直列涉及独立的线3(经线),这些独立的线中的每一根均沿列竖直向上行进,以形成绕每个针头2的闭合环5。垫纱示意图还包括单根纬线4,其跨越每个路径水平移动,以与经线3的闭合环5互锁,从而形成织物结构。所得到的织物具有钩编针迹图案。
图1(b)是示出了用于经编织物的可选结构的垫纱示意图,该结构用两个针经纱以闭合的特立可得(tricot,经向斜纹)针迹图案形成。针头的每个竖直列涉及独立的线6(经线)。该线绕该列中的第一个针头形成闭合环7。然后,其向上行进,并绕上一行中的针头(但处于相邻列8)形成闭合环。然后,该线向上行进,并绕第三行中的针头(但处于第一列)形成闭合环。该线以这种方式继续向上,形成锯齿状图案。垫纱示意图还包括单根纬线9,其跨越每个路径水平移动,以与经线的闭合环互锁,从而形成织物结构。其是互锁环系统,该互锁环系统赋予了编织织物其抗拉强度以及弹性程度。
图1的垫纱示意图可用于生产编织的织物。如图2所示,这种编织织物可生产为方形,并形成10cmx10cm的方形伤口敷料10。
图3示出了本发明进一步的实施方式,其中方形伤口敷料20(类似于图2的敷料10)已配有25g的麦卢卡蜂蜜(manuka honey)21。蜂蜜21沉积在伤口敷料20的表面上,并基本上被完全吸收在编织的衬底中。蜂蜜在伤口敷料20的范围上不规则地延伸,覆盖了表面区域的相当大一部分。
图4示出了穿在手臂或腿上的类型的管状敷料30,其利用编织为图1(a)或图1(b)的图案的织物生产。通过编织成圆形,生产了管状敷料30,从而使得沿敷料长度方向向下没有接缝。
可选地,可由平面的编织材料片生产管状敷料30,该平面的编织材料片沿相对边缘缝在一起,以形成管。管状敷料可生产为独立单元,或者生产为可被切至所需尺寸的延伸的管。
图5示出了根据本发明的伤口敷料的进一步的实施方式,在该实例中是藻酸盐泡沫敷料40。敷料40包括藻酸盐泡沫的第一层和第二层41、42,第一层和第二层41、42由片状编织织物43(类似于图2中的片10)加固,片状编织织物43夹在泡沫的层41、42之间。
通过将第一量的藻酸盐溶液(典型地包含藻酸钠、钙离子源和螯合剂,以防止藻酸钙的过早沉淀)注入矩形模具中来制造敷料40。允许该溶液部分固化,并且将片状编织织物43置于部分固化的溶液的顶部上。然后,将第二量的藻酸盐溶液注入编织织物43的顶部上,允许继续固化两个量的溶液,直至在编织织物43的两侧上形成水凝胶。然后,对产物进行冷冻干燥,以从水凝胶中去除水,并产生泡沫层41、42。
现参照图6,衬垫(spacer)织物50包括上表面层52、下表面层53和连接层54,连接层54包括在上表面层52和下表面层53之间延伸的连接线55。利用包括凝胶纤维和非凝胶纤维素纤维的混合物的线,通过适于生产这种编织结构的传统方法编织衬垫织物。凝胶纤维以较大比例存在(约90%),较小比例的非凝胶纤维用于保持织物的完整性,甚至在凝胶纤维胶凝之后也保持其完整性。
如果必要或需要,例如为了降低从使用中的织物50失去纤维段的风险,在衬垫织物50的边缘处,可将上表面层52、下表面层53和连接层54熔合在一起,以产生密封。
图6的衬垫织物50可以传统凝胶敷料(诸如具有凝胶藻酸盐或羧甲基纤维素纤维无纺垫形式的凝胶敷料)的方式用作为简单形式的伤口敷料。将这种敷料简单地应用于伤口表面并吸收伤口渗出物。随着渗出物被吸收,纤维转变成在伤口表面保持潮湿环境且是非粘着性的凝胶,这使得敷料能够被移除,而不造成伤口的痛苦。
可选地,图1的衬垫织物50可形成复合伤口敷料的部件。图7至图14示出了这样的复合伤口敷料的实施方式。
将图7至图9的伤口敷料概括地标记为60并一般为方形形式,并且包括聚氨酯微孔膜的背衬层61,具有中央部分62和边沿63。中央部分62覆盖复合体,复合体包括类似于图6中所示材料的方形三维织物材料件65和吸收泡沫垫66。织物材料65和泡沫垫66通过任何适当的方式(例如,通过粘合剂)彼此附贴。三维织物65在图8中示出为隐藏的细节,并且复合物在图9中可见。
背衬层61的下侧承载了粘合剂(例如丙烯酸粘合剂)的涂层67,借助于粘合剂的涂层67,背衬层在其中央部分62附贴于吸收垫66。边沿63上的粘合剂涂层67用于将敷料60附接于伤口周围的皮肤,从而在使用中,使三维织物65覆盖伤口。伤口敷料60提供有两段式的释放垫片64,就在将要使用前,将释放垫片64从敷料移除,从而暴露三维织物材料65和边沿63的下侧上的粘合剂67。伤口敷料60的下侧在图8中示出,其中以虚线将三维织物材料1652示出为隐藏细节。
图9是上述伤口敷料60的剖视图。伤口敷料包括复合体,该复合体包括三维织物材料65和吸收泡沫垫66。三维织物材料65和吸收垫66被聚氨酯膜的背衬层61覆盖,吸收垫66被粘合剂的涂层67固定至背衬层61的下侧。背衬层61延伸超过三维织物材料65和吸收垫66在所有侧的边缘,以形成边沿63,边沿63也被涂覆有粘合剂67。可释放的垫片64包括两片适当的塑料膜或其他传统材料,两片适当的塑料膜或其他传统材料交叠以形成拉片,以有助于移除垫片64,可释放的垫片64覆盖粘合剂67和三维织物材料65的暴露表面。在将要使用之前,移除可释放的垫片64。
图10示出了根据本发明的伤口敷料进一步的实施方式,其一般地标记为70,并适于在负压伤口治疗中使用。该敷料70在结构上大体类似于图7至图9的敷料,敷料的相应部件用相同的参考标号表示。因此,敷料70一般为方形形式,并且包括聚氨酯微孔膜的背衬层61,具有中央部分62和边沿63。中央部分62覆盖复合体,复合体包括类似于图6中所示材料的方形三维织物材料65和吸收泡沫垫66。织物材料65和泡沫垫66通过任何适当的方式(例如,通过粘合剂)彼此附贴。三维织物65在图8中示出为隐藏的细节,并且复合物在图9中可见。
背衬层61的下侧承载了粘合剂(例如丙烯酸粘合剂)的涂层67,借助于粘合剂的涂层67,背衬层在其中央部分62附贴于吸收垫66。边沿63上的粘合剂涂层67用于将敷料60附接于伤口周围的皮肤,从而在使用中,使三维织物65覆盖伤口。伤口敷料60提供有两段式的释放垫片64,在将要使用前,将释放垫片64从敷料移除,从而暴露三维织物材料65和边沿63的下侧上的粘合剂67。
伤口敷料70包括复合体,该复合体包括三维织物材料65和吸收泡沫垫66。三维织物材料65和吸收垫66被聚氨酯膜的背衬层61覆盖,吸收垫66被粘合剂的涂层67固定至背衬层61的下侧。背衬层61延伸超过三维织物材料65和吸收垫66在所有侧的边缘,以形成边沿63,边沿63也被涂覆有粘合剂67。可释放的垫片64包括两片适当的塑料膜或其他传统材料,两片适当的塑料膜或其他传统材料交叠以形成拉片,以有助于移除垫片64,可释放的垫片64覆盖粘合剂67和三维织物材料65的暴露表面。在将要使用之前,移除可释放的垫片64。
敷料70与敷料60的不同之处在于,背衬层61设置有中央开口76,并且将排放端口75直接在开口76上附贴于背衬层61。在塑料材料中由注塑成型形成排放端口75,排放端口75包括具有中央孔75a的竖立构件,中央孔75a与开口76对准。
以与敷料60相同的方式将敷料70应用于伤口。通过将排放端口75附接(借助于柔性管)至减压源(例如,泵),敷料70可用于NPWT。敷料70内部的压力从而减小至小于环境大气压力。过量的伤口渗出物通过三维织物材料65、吸收垫66和排放端口75被抽出,并以传统方式被收集在适当的容器中。
在图11和12中示出了伤口敷料的进一步实施方式,其一般地标记为80,也适用于NPWT。敷料80与图10的敷料70大体上相似,敷料的相应部件由相同的参考标号表示。
然而,在敷料80中,硅凝胶皮肤接触层88跨越敷料80下侧的整个范围延伸。皮肤接触层88包括承载了硅凝胶涂层的熔喷聚氨酯片。熔喷聚氨酯的相对侧涂覆有丙烯酸酯粘合剂,熔喷聚氨酯通过丙烯酸酯粘合剂附贴至背衬层61的边沿63和三维织物材料65的下侧。皮肤接触层形成有穿孔89的规则阵列,穿孔89具有约5mm的直径,从而允许伤口渗出物从伤口进入三维织物材料65。
最后,在图13和14中示出了伤口敷料的实施方式,其一般地标记为90,也适用于NPWT。敷料90与图11的敷料80大体上相似,敷料的相应部件由相同的参考标号表示。
然而,在敷料90中,硅凝胶层91存在于敷料90的边沿63周围,并与三维织物材料65部分交叠。换言之,硅凝胶层91形成有尺寸稍小于三维织物材料65的中央开口,从而使得织物材料65的大部分暴露,并在使用中与伤口直接接触。硅凝胶层91的成分与关于图11描述的皮肤接触层88的成分相同,除了穿孔92具有更小的直径。在使用中,硅凝胶层91与伤口边缘周围的皮肤接触,并且三维织物材料65直接接触伤口。
Claims (33)
1.一种编织结构,用作为伤口敷料或伤口敷料的部件,所述编织结构由线编制而成,所述线由凝胶纤维和纤维素非凝胶纤维的混合物以及选自抗微生物剂、防腐剂、抗真菌剂和/或消炎剂的可选的一个或多个附加试剂组成,其中所述线包括重量比至少50%的凝胶纤维。
2.如权利要求1所述的编织结构,其中所述凝胶纤维是选自由以下各项构成的组的纤维:果胶纤维、藻酸盐纤维、由藻酸盐和另一种多糖制成的纤维、壳聚糖纤维、透明质酸纤维、其他多糖的纤维或由树胶衍生的纤维、以及以化学方法改性的纤维素纤维或其组合。
3.如权利要求2所述的编织结构,其中所述凝胶纤维是藻酸盐纤维和/或果胶纤维。
4.如权利要求3所述的编织结构,其中所述凝胶纤维是藻酸钙。
5.如权利要求1所述的编织结构,其中所述纤维素纤维是莱赛尔纤维或粘胶纤维。
6.如权利要求1所述的编织结构,包括藻酸钙和粘胶纤维。
7.如权利要求1所述的编织结构,包括藻酸钙和莱赛尔纤维。
8.如权利要求1所述的编织结构,包括果胶和粘胶纤维。
9.如权利要求1所述的编织结构,包括果胶和莱赛尔纤维。
10.如权利要求1-9中任一项所述的编织结构,还包括选自抗微生物剂、防腐剂、抗真菌剂和/或消炎剂的一个或多个附加试剂。
11.如权利要求10所述的编织结构,其被浸透有或涂覆有蜂蜜。
12.如权利要求10所述的编织结构,其结合有聚六亚甲基双胍。
13.一种复合伤口敷料,包括根据权利要求1-9中任一项所述的编织结构。
14.如权利要求13所述的复合伤口敷料,还包括背衬层。
15.如权利要求14所述的复合伤口敷料,其中所述背衬层具有至少为300g/m2/24h的水蒸气传输率。
16.如权利要求14或15所述的复合伤口敷料,其中所述背衬层是聚氨酯膜。
17.如权利要求14-15中任一项所述的复合伤口敷料,其中所述背衬层在所有侧均延伸超过所述编织结构的边缘,形成所述编织结构周围的边沿。
18.如权利要求14-15中任一项所述的复合伤口敷料,其中所述背衬层在其下侧承载粘合剂。
19.如权利要求18所述的复合伤口敷料,其中所述粘合剂是丙烯酸粘合剂。
20.如权利要求13-15中任一项所述的复合伤口敷料,其中所述伤口敷料的整个下侧承载粘合剂层。
21.如权利要求20所述的复合伤口敷料,其中所述粘合剂层包括穿孔。
22.如权利要求21所述的复合伤口敷料,其中所述穿孔具有4-10mm的直径。
23.如权利要求13-15中任一项所述的复合伤口敷料,其中所述伤口敷料的下侧承载粘合剂层,所述粘合剂层形成有中央开口,所述编织结构通过所述中央开口暴露。
24.如权利要求23所述的复合伤口敷料,其中所述粘合剂层包括穿孔。
25.如权利要求23所述的复合伤口敷料,其中所述粘合剂层是硅凝胶。
26.如权利要求25所述的复合伤口敷料,其中所述硅凝胶承载在熔喷无纺材料的层上。
27.如权利要求26所述的复合伤口敷料,其中所述熔喷无纺材料是熔喷聚氨酯(MBPU)。
28.如权利要求27所述的复合伤口敷料,其中所述熔喷聚氨酯的相对侧涂覆有丙烯酸粘合剂。
29.如权利要求13-15中任一项所述的复合伤口敷料,还包括吸收体。
30.如权利要求29所述的复合伤口敷料,其中所述吸收体是泡沫垫。
31.如权利要求29所述的复合伤口敷料,其中所述吸收体是超强吸收聚合材料。
32.如权利要求13-15中任一项所述的复合伤口敷料,其中所述伤口敷料还包括可释放垫片。
33.如权利要求13-15中任一项所述的复合伤口敷料,还包括选自抗微生物剂、防腐剂、抗真菌剂和/或消炎剂的一个或多个附加试剂。
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EP2773799A1 (en) | 2014-09-10 |
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GB2496310A (en) | 2013-05-08 |
GB2504873A (en) | 2014-02-12 |
GB2504873B (en) | 2015-10-14 |
CA2853755A1 (en) | 2013-05-10 |
US20180015197A1 (en) | 2018-01-18 |
GB201318810D0 (en) | 2013-12-11 |
CN104024498A (zh) | 2014-09-03 |
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