CN101018533B - 以抗菌剂涂覆基质的方法及由其形成的产品 - Google Patents

以抗菌剂涂覆基质的方法及由其形成的产品 Download PDF

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CN101018533B
CN101018533B CN2005800251352A CN200580025135A CN101018533B CN 101018533 B CN101018533 B CN 101018533B CN 2005800251352 A CN2005800251352 A CN 2005800251352A CN 200580025135 A CN200580025135 A CN 200580025135A CN 101018533 B CN101018533 B CN 101018533B
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戴文·C·金泽尔
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Abstract

一种以掺入药剂如银的抗菌聚合物均匀地涂覆泡沫或敷料的方法，和由该方法形成的泡沫或敷料。这样的泡沫或敷料在结合负压创伤治疗时尤其有效。

Description

以抗菌剂涂覆基质的方法及由其形成的产品
相关申请的交互引用
本申请要求2004年7月26日提交的美国临时专利申请No.60/591,014的优先权，其内容在此并入作为参考。
发明背景
发明领域
本发明一般涉及一种涂覆网状泡沫的方法，更具体但非限制地涉及一种用抗菌剂涂覆网状泡沫的方法，所述方法提供了遍布网状泡沫的均匀涂覆，并涉及由此方法形成的产品。
相关技术详述
许多种新型和/或已建立的抗菌化合物结合创伤敷料能控制微生物污染并可能降低感染率。涂覆均匀性是创伤敷料抗菌性的必需关键。整个体积的敷料能够用聚合物涂覆系统均匀涂覆的任何涂覆医用创伤敷料或泡沫的方法尚属未知。这有多种原因。
尤其是有些泡沫很厚，通常在约1.25英寸的范围。这些敷料的厚度限制了涂覆方法，因为无法确保对遍布整个结构的均匀涂覆，从而所述结构能够全向地分隔而仍然具有暴露用于创伤的期望的抗菌剂。
现有一些涂覆方法，诸如气相沉积(物理的和化学的)、静电涂覆、喷涂和溅射涂覆。然而，这些涂覆方法昂贵，并且不适于均匀涂覆某些敷料的三维表面，诸如网状泡沫。此外，这些方法具有广泛的环境问题，这困扰着在医用工业中敷料的使用者。
存在把抗菌剂加到敷料的其它方法，诸如在发泡工艺本身中的添加剂或使用辅助治疗或复合产品(如在连接到泡沫的薄抗菌敷料上)，但难以使用。尤其是已知这些方法机械地影响泡沫并实质上影响泡沫的渗透性。
由于创伤的大小和形状具有几乎无限的差异，创伤敷料必须适于适合创伤并提供合适的抗菌性以防止进一步感染。因此，需要开发一种以抗菌剂均匀地涂覆敷料或泡沫的方法，所述抗菌剂足以消毒创伤而使用简单且价格便宜，从而泡沫将适于在原处调整以适合创伤的形状和大小。
发明概要
本发明通过开发均匀涂覆泡沫或敷料的方法以及由此方法以抗菌聚合物形成的泡沫或敷料满足了这个和其它需要。这样的泡沫或敷料对负压创伤治疗尤其有用。
附图说明
通过参考本发明下述具体实施方式并结合附图，可获得对本发明方法和装置的更完整理解，其中相同的参考数字指代相同的元件。
图1是以抗菌剂均匀地涂覆创伤敷料的方法流程图；
图2是图1方法某些步骤的示意图；
图3是使用图1方法涂覆的敷料应用到创伤部位的顶平面示意图；
图4是图3敷料在创伤部位结合负压治疗装置的侧视图；以及
图5是图3敷料沿5-5线的截面图，说明了敷料的均匀涂覆。
具体实施方式
本发明提供了一种使用新方法以掺入药剂如Au的抗菌聚合物均匀涂覆创伤敷料的方法，以及该方法形成的一种创伤敷料。均匀涂覆的方法使得敷料使用者在任何方向分隔敷料，并仍然使所有暴露表面以足够消毒创伤的抗菌剂均匀涂覆。
用银凝胶聚合物均匀地涂覆聚氨酯泡沫。聚合物涂料本身含有PVP或聚乙烯吡咯烷，其是具有吡咯烷酮(pyrroloidone)侧基的水溶性聚合物，通常用作食品添加剂、稳定剂、澄清剂、压片佐剂和分散剂。它最通常已知的是作为聚维酮碘(一种聚维酮-碘制剂)的聚合物成分。此外，涂料可包括壳聚糖，它是甲壳质的脱乙酰化衍生物，是从虾、蟹和其它甲壳类的壳精炼的多糖。壳聚糖也已经用于止血敷料。所述聚合物的第三种任选成分优选地是硅铝酸钠银，其是含有以重量计20％活性离子银的银盐粉。
首先参考图1，用银聚合物涂料或抗菌涂料浸渍泡沫的方法100显示于流程图。首先，亲水胶与银结合以产生涂覆溶液，102。然后将溶液置于收集槽并在封闭、黑暗的环境中持续搅拌，104。黑暗环境是任选的，但由于银的感光性是被包括的。在暴露于光的环境，泡沫可变色，这导致不美观的外表。将可包括网状聚氨酯冲切(die cut)的泡沫置于收集槽，106。然后用溶液饱和泡沫，这通过浸泡或挤压泡沫而实现，108。然后，从泡沫除去多余的溶液，110。可使用轧辊或类似装置来控制从泡沫除去的溶液的量。任选地，可计算饱和泡沫(尽管仍是湿的)的重量，112。
然后把泡沫置于设定预定温度和时间的对流强制气烘箱以完全干燥溶液涂覆的泡沫，114。可选地，为了证实泡沫的干燥状态，可再次检查泡沫的重量，116。如果光敏感性仍是问题，可将泡沫包裹于水蒸气透过率(MVTR)袋以限制泡沫暴露于光和湿气，118。所述泡沫可备用于一些部位，如部分皮层烧伤、外伤性创伤、手术创伤、裂伤、糖尿病创伤、压迫性溃疡、小腿溃疡、皮瓣和移植。
在一个实施例中，由上述方法制备的泡沫被描述为对两种常见菌-金黄色葡萄球菌和绿脓假单胞菌达到体外效力，所述泡沫带有20％银盐载荷(以重量计4％银，尽管约0.1％至约6％已经表现为至少部分有效)。敷料通过受控的和稳态释放离子银而维持效力72小时。具体地，银涂料和富含阴离子的外部环境之间存在扩散梯度，其导致银离子的分解和最终转运。使用上述方法，在约24小时和约72小时之间已经消除了超过6log的减少量或约99.9999％的病原菌。
所述涂覆方法可以易于掺入其它添加剂，如酶清创剂、麻醉剂、生长因子和许多其它生物治疗剂。此外，可针对涂覆厚度特异性地配制涂料，尽管很薄的涂层(约2至10微米)是优选的。制剂可进一步适于允许大颗粒尺寸和不同释放动力学，如释放浓度和速率以及持续时间。
均匀和浸渍的涂覆允许在泡沫外和泡沫内递送银离子。以这种方式，创床上和敷料内的菌都被消除。当敷料结合负压治疗时，这尤其有用。而且，减少气味也是此方法的附加优势。
现在参考图2，其为图1方法100某些步骤的示意图。首先，亲水胶与抗菌剂或其它药剂(如银)的溶液展示于接受搅拌的槽，200。然后，将泡沫插入到搅拌槽，202。饱和后，移出泡沫并供应到滚筒或类似装置以除去多余溶液，204。收集多余的溶液，206，并由足以从溶液除去颗粒和打破在方法中形成的任何溶液大块的精细滤器过滤，208。在某些银溶液涂覆试验中发现150-微米的滤器是有效的。然后将过滤的溶液转回到槽以重新利用，210。
将从除去步骤204获得的泡沫置于对流烘箱以干燥，212。在某些银溶液涂覆试验中，当烘箱的温度设定为约90℃时，发现20分钟是有效的干燥时间。然而，优选的是干燥泡沫约至少6分钟以最小化涂料的任何破裂。然后将泡沫包裹于合适的容器中，如MVTR袋或类似容器以运载到使用者，214。
现在参考图3，其为使用图1方法涂覆的敷料300应用于创伤部位302的顶平面示意图。如箭头所示，敷料300的银离子接触创伤部位302并有效消除其上形成的菌。
敷料300当结合负压治疗装置(如由Kinetic Concepts，Inc.制造)使用时尤其有效。图4是图3敷料300在创伤部位302结合负压治疗装置400的侧视图，所述负压治疗装置400包括控制系统402、覆盖敷料300和创伤部位302的手术薄膜(drape)404、连接到控制系统402并通过敷料300连接到创伤部位302的真空软管406、以及连接真空软管406到手术薄膜404的连接件408。由控制系统402经由敷料300应用负压，有效地通过均匀涂覆的敷料300牵引有害病原体，从而杀死病原体。此外，敷料300与创伤部位302接触的其它表面达到同样效果。
现在参考图5，其为图3敷料300沿5-5线的截面图，说明了敷料300的均匀涂覆。敷料300具有上表面500、下表面502、侧表面504、506和内表面508。使用银涂料涂覆所有表面500、502、504、506和508，从而通过银离子从敷料300移动，提供对直接接触所述表面或间接暴露于所述表面的任何病原体的有效屏障。
上述描述是用于实现本发明的优选实施方案，本发明的范围不必限制于该描述。本发明的范围由所附权利要求限定。

Claims (20)

1.一种制备用于放置在创伤部位的泡沫的方法，所述方法包括以下步骤：
使亲水胶与银结合以产生涂覆溶液；
在封闭环境搅拌所述涂覆溶液；
将所述泡沫置于所述封闭环境；
以所述涂覆溶液饱和所述泡沫；
从所述饱和泡沫除去多余的涂覆溶液；并
干燥所述饱和泡沫。
2.根据权利要求1所述的方法，其中所述泡沫包括聚氨酯。
3.根据权利要求1所述的方法，其中所述涂覆溶液包括银水凝胶聚合物。
4.根据权利要求3所述的方法，其中所述涂覆溶液含有PVP。
5.根据权利要求3所述的方法，其中所述涂覆溶液含有壳聚糖。
6.根据权利要求3所述的方法，其中所述涂覆溶液含有硅铝酸钠银。
7.根据权利要求1所述的方法，其还包括在所述结合亲水胶步骤后将所述涂覆溶液置于收集槽中的步骤。
8.根据权利要求1所述的方法，其中所述环境是黑暗环境以防止所述泡沫变色。
9.根据权利要求1所述的方法，其中所述泡沫包括网状聚氨酯冲切。
10.根据权利要求1所述的方法，其中所述以所述涂覆溶液饱和所述泡沫的步骤通过将所述泡沫浸泡在所述涂覆溶液中而实现。
11.根据权利要求1所述的方法，其中所述以所述涂覆溶液饱和所述泡沫的步骤通过在所述涂覆溶液中挤压所述泡沫以使得所述泡沫吸收所述涂覆溶液而实现。
12.根据权利要求1所述的方法，其还包括在饱和所述泡沫的步骤后称量所述饱和泡沫的步骤。
13.根据权利要求12所述的方法，其还包括在干燥所述泡沫的步骤后再次称量所述泡沫的步骤。
14.根据权利要求1所述的方法，其中所述干燥所述饱和泡沫的步骤包括将所述泡沫置于设定为预定温度的对流强制气烘箱一段预定时间。
15.根据权利要求1所述的方法，其还包括将所述泡沫包裹于水蒸气透过率袋以限制所述泡沫暴露于光和湿气。
16.一种泡沫，其通过以下步骤制备：
使亲水胶与银结合以产生涂覆溶液；
在封闭环境搅拌所述涂覆溶液；
将所述泡沫置于所述封闭环境；
以所述涂覆溶液饱和所述泡沫；
从所述饱和泡沫除去多余的涂覆溶液；并
干燥所述饱和泡沫。
17.一种泡沫，其通过以下步骤制备：
使亲水胶与银结合以产生涂覆溶液；
在收集槽中搅拌所述涂覆溶液；
将泡沫置于所述收集槽；
通过将所述泡沫浸泡于所述涂覆溶液一段预定时间，以所述涂覆溶液饱和所述泡沫；
通过滚筒滚动所述饱和泡沫，从所述饱和泡沫除去多余的涂覆溶液；
在对流烘箱中以90℃的温度干燥所述饱和泡沫至少6分钟以完全干燥所述泡沫。
18.根据权利要求17所述的泡沫，其中所述涂覆溶液包括清创剂。
19.根据权利要求17所述的泡沫，其中所述涂覆溶液包括麻醉剂。
20.根据权利要求17所述的泡沫，其中所述涂覆溶液包括生长因子。
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WO2006014917A2 (en) 2006-02-09
IL180915A0 (en) 2007-07-04
BRPI0513604A (pt) 2008-05-13
NZ553254A (en) 2009-10-30
NO20070695L (no) 2007-02-07
EP1771138A4 (en) 2009-08-19
ZA200701467B (en) 2008-07-30
RU2007105973A (ru) 2008-09-10
WO2006014917A3 (en) 2006-04-06
HK1102259A1 (en) 2007-11-09
EP1771138A2 (en) 2007-04-11
JP2008507380A (ja) 2008-03-13
CA2574927A1 (en) 2006-02-09
MX2007001018A (es) 2007-08-07
KR20070054642A (ko) 2007-05-29
AU2005269545A1 (en) 2006-02-09
CN101018533A (zh) 2007-08-15
US20060029675A1 (en) 2006-02-09

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