CN107249653A - 含胶原的伤口敷料及其制备方法 - Google Patents

含胶原的伤口敷料及其制备方法 Download PDF

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CN107249653A
CN107249653A CN201680011546.4A CN201680011546A CN107249653A CN 107249653 A CN107249653 A CN 107249653A CN 201680011546 A CN201680011546 A CN 201680011546A CN 107249653 A CN107249653 A CN 107249653A
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implant
magnesium
tablet
magnesium alloy
collagen
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O·比伦施泰因
D·塔迪奇
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Botiss Biomaterials GmbH
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Abstract

本发明涉及制备植入物的方法，所述植入物特别构成伤口敷料。所述植入物由镁制得的片状物构成，其植入胶原非机织物中。

Description

含胶原的伤口敷料及其制备方法
发明领域
本发明涉及含胶原的植入物，其特别用作伤口敷料。本发明进一步涉及制备植入物的方法。
背景技术
含胶原的伤口敷料实际上已知为不同的实施变型。因此特别存在由胶原构成的非织造伤口敷料，其制备自天然胶原悬浮液。与由化学溶解的胶原制备的植入物相比，其通常具有易弯曲和抗拉的优点。
还存在由供体皮肤、特别是动物来源的供体皮肤制备的伤口敷料。在此特别是指猪源剖层皮肤，其通过湿法化学处理、特别是通过酸化和氧化处理制备，从而留下基本上无菌的胶原支架。这样的伤口敷料特别是用于烧伤的情况。
这种已知的植入物的不利之处是，其在弯曲状态下并非是形态稳定的；也即分别根据使用位置，植入物能够倾向于不希望地从伤口脱落或者陷入植入物覆盖的缺损部位。
这尤其涉及在颌部使用这种胶原植入物，在该处需要狭窄弯曲半径并且经常使用胶原植入物来预防软组织在骨缺损部位中向内生长，所述骨必要时事先用骨替代材料填充。
发明任务
相对地，本发明的任务是至少减少现有技术的所述缺点。
本发明的任务特别是，提供伤口敷料，其形态稳定性、特别是弯曲状况下的形态稳定性得到改善。
发明概要
本发明的任务已经通过制备植入物的方法以及通过根据独立权利要求之一的植入物解决。
本发明的优选实施方式和进一步变型从各从属权利要求的主题获悉。
本发明涉及制备植入物的方法，所述植入物特别是用作伤口敷料。
根据本发明，将由镁或镁合金构成的片状物用含胶原的制备物覆盖并且干燥含胶原的制备物。由此获得由胶原和镁构成的复合材料，在此情况下所述胶原至少部分包围所述镁。
片状物特别是指箔、网格、织物，特别是非织造物或针织物。它们特别具有大于0.5cm2的面积并且能够被使用者弯曲。优选使用由镁或镁合金构成的箔，其还能够具有凹槽，特别是其构成网格。
通过镁实现复合材料的改进的形态稳定性。特别是，其更少地倾向于陷入覆盖的缺损部位。同时，镁或镁合金是生物可吸收的材料，其在使用之后于一定时间之内分解，也即在使用之后不需要清除植入物。
由镁或镁合金构成的片状物的覆盖能够以任何方式进行，特别是通过用制备物覆盖片状物，通过浸泡、灌注或通过喷涂进行。
通过由镁或镁合金构成的片状物的覆盖，优选构成基本上连续的胶原层。在干燥后特别形成胶原非织造物。
但也可以想象的是，在由镁或镁合金构成的片状物上仅以某种方式构成细绒。特别可以想象的是，使用由镁或镁合金构成的具有凹槽的片状物，特别是构成网格的片状物。在后者实施变型的情况下，由胶原悬浮液构成的片状物也具有凹槽并且同样构成网状，原因是其仅用细绒覆盖下方的由镁或镁合金构成的支架。这样应用的悬浮液能够特别用作另一层、特别是胶原膜的粘合促进剂。
含胶原的制备物是液体并且通过干燥、特别是通过冻干凝固。
作为含胶原的制备物特别使用含胶原的悬浮液。优选使用天然胶原，亦即保持大部分胶原纤维并且并未化学溶解的胶原。特别是，使用天然I型胶原。这样的胶原悬浮液能够特别制备自供体皮肤、优选猪源供体皮肤。所述皮肤能够在此机械地例如通过切碎机来粉碎并且额外湿法化学制备，优选通过酸处理和氧化处理，从而特别是清除大部分脂肪并且保留实质无菌的原料。
特别是使用胶原悬浮液，其具有0.5至5％(数值均代表重量百分比)的固体份额。
对于酸处理能够使用特别是盐酸或磷酸。优选不含氯阴离子的酸，亦即特别使用磷酸，原因是前者会加速镁的腐蚀。
由镁或镁合金构成的片状物能够，如本发明实施方式预计，具有涂层、特别是钝化层。特别预计的是使用片状物，其具有由氟化镁构成的钝化层。其能够产生如下：将片状物浸入氢氟酸。
优选地，将含胶原的制备物至少在覆盖由镁或镁合金构成的片状物之前中和，特别是中和至大于5.5、优选大于6.5的pH值。由此预防镁或钝化层溶解的风险。
所述中和用碱性缓冲液，特别是磷酸盐缓冲液如磷酸三钠进行。
由镁或镁合金构成的片状物能够特别构成网格。优选地，片状物构成具有凹槽的箔。与例如由金属丝针织的网格相比，其导致更好的形态稳定性。
特别地，将20至300μm厚度的引入凹槽的镁箔用作基材。
凹槽用于构成改善的联接。
在本发明的进一步变型中，将由镁或镁合金构成的片状物施用至载体上。
用作载体的特别是胶原膜，例如湿法化学制备的和冻干的动物或人源皮肤。能够特别使用湿法化学制备的猪源剖层皮肤。
在将由镁或镁合金构成的片状物施用至载体上之后，优选将片状物用含胶原的制备物覆盖并且形成由三种组分构成的复合材料，所述组分是载体，载体上布置的胶原非织造物、其通过干燥制备物获得，以及由镁或镁合金构成的片状物、其植入胶原非织造物并同时与载体结合。
特别地，通过使用含胶原的悬浮液能够产生复合物，在所述复合物的情况下不需要将由镁或镁合金构成的片状物与载体通过额外试剂联接。
然而可以想象的是，为了改善复合物的粘合而将载体例如通过缝合与由镁或镁合金构成的片状物联接。
进一步地，由镁或镁合金构成的片状物能够具有改善复合物的结构，其形式是例如粗糙化或小倒钩。
但还可以想象的是，将由镁或镁合金构成的片状物引入某种方式的口袋。因此能够特别制备剖层皮肤，其然后由上部和下部胶原膜组成。在这样形成的口袋中，嵌入由镁或镁合金构成的片状物。
进一步可以想象的是，将由镁或镁合金构成的片状物安排在二个胶原膜之间。特别是能够由二个胶原膜大致通过缝合形成口袋。本发明的该实施方式并不排除的是，将由镁或镁合金构成的片状物在嵌入胶原膜之间以前用胶原悬浮液覆盖，其然后用作相邻膜的粘合促进剂。特别地，将用仍湿润的胶原悬浮液涂层的由镁或镁合金构成的片状物引入两个胶原膜之间，然后必要时还压缩胶原膜并且冻干产生的复合物。
通过本发明提供的复合材料应该具有小于4，优选小于3mm的厚度。
本发明额外涉及植入物，其特别是可如上文描述制备的。
植入物包括由镁或镁合金构成的片状物。所述片状物与含胶原的片状物结合，特别是将由镁或镁合金构成的片状物包埋入含胶原的片状物。
但还可以想象的是，将含胶原的片状物与相邻的由镁或镁合金构成的片状物结合，比如说通过缝合或粘合。特别地，能够使用上述载体也即胶原膜。所述膜还能够例如交织起来。
含胶原的片状物特别指胶原非织造物。其能够如上文所述通过冻干天然胶原的悬浮液而制备。
含胶原的片状物能够构成连续的层，但其也能够具有凹槽。特别是在使用网状的由镁或镁合金构成的片状物的情况下，其能够仅用胶原非织造物构成的细绒覆盖。
在本发明的进一步变型的情况下，植入物包括载体、特别是由胶原膜构成的载体，其上设置含胶原的片状物。
由镁或镁合金构成的片状物优选至少逐段地具有凹槽并且特别构成网格。
由镁或镁合金构成的片状物具有优选20μm至1mm，特别优选50μm至300μm的厚度。
植入物特别是弯曲的并且是形态稳定的从而不陷入缺损部位。
附图简述
本发明主题应该在下文中参考附图1至4进一步解释。
本发明植入物的示例制备应该参考图1至图3来解释。
图4显示植入物的照片。
附图详述
图1显示载体1的示意图。在该实施例中，其由湿法化学制备的猪源剖层皮肤组成。因此是指胶原膜。
在载体1上放置由镁或镁合金构成的片状物2。
片状物在该实施例中构成由箔组成的网格，所述箔由镁或镁合金构成。网格的凹槽在该实施例中是菱形。
由镁或镁合金构成的片状物2并不完全达到载体1的边缘。
如图2所示，将载体1和由镁或镁合金构成的片状物用含胶原的制备物3覆盖。
在该实施例中涉及0.5至5％的猪源胶原悬浮液。胶原悬浮液在施用之前通过磷酸盐缓冲液中和，特别是调整至7+/-0.5的pH值。
含胶原的制备物3然后用适当的操作工具涂抹。
然后，将这样制备的复合材料放置15至120分钟，直至载体1被良好润湿。
随后进行冻干6小时至5天。
图3显示所制备的复合材料的示意剖视图。
其由下述组成：载体1，其上是包埋入胶原非织造物4的由镁或镁合金构成的片状物2，所述胶原非织造物4由含胶原的制备物形成。
胶原非织造物4同时负责与载体1的牢固连接。
图4显示本发明复合材料的照片，其中将不同的层撕裂开。
观察到的是，形成胶原膜的载体以及从其撕裂的胶原非织造物4，在胶原非织造物4中包埋的是由镁构成的网格5。
通过本发明能够以简单方式提供形态稳定的生物可吸收的膜，其也特别适于覆盖骨骼/颌部的缺损部位，而没有复合材料下陷的倾向。

Claims (15)

1.制备植入物特别是伤口敷料的方法，其中将由镁或镁合金构成的片状物用含胶原的制备物覆盖并且干燥含胶原的制备物。
2.根据前述权利要求的制备植入物的方法，其特征在于，将含胶原的悬浮液用作含胶原的制备物。
3.根据前述权利要求的制备植入物的方法，其特征在于，使用含有天然胶原的悬浮液。
4.根据前述权利要求之一的制备植入物的方法，其特征在于，所述由镁或镁合金构成的片状物被构造成网格。
5.根据前述权利要求之一的制备植入物的方法，其特征在于，所述由镁或镁合金构成的片状物被构造成形态稳定的。
6.根据前述权利要求之一的制备植入物的方法，其特征在于，所述由镁或镁合金构成的片状物被施用至载体上。
7.根据前述权利要求的制备植入物的方法，其特征在于，将胶原膜、特别是冻干的动物或人源皮肤用作载体。
8.根据前述权利要求之一的制备植入物的方法，其特征在于，将所述含胶原的制备物至少在覆盖由镁或镁合金构成的片状物之前调整至大于5.5，优选大于6.5的pH值。
9.根据前述权利要求之一的制备植入物的方法，其特征在于，所述干燥含胶原的制备物通过冻干进行。
10.包含由镁或镁合金构成的片状物的植入物，特别是用根据上述权利要求之一的方法可制备的植入物，其与含胶原的片状物结合，特别是植入含胶原的片状物中。
11.根据前述权利要求的植入物，其特征在于，所述植入物包含载体、特别是由胶原膜构成的载体，所述含胶原的片状物设置在载体上。
12.根据前述权利要求之一的植入物，其特征在于，所述由镁或镁合金构成的片状物至少逐段地具有凹槽，特别是构成网格的凹槽。
13.根据前述权利要求之一的植入物，其特征在于，所述由镁或镁合金构成的片状物具有20μm至1mm，优选50μm至300μm的厚度。
14.根据前述权利要求之一的植入物，其特征在于，所述植入物被构成弯曲的。
15.根据前述权利要求之一的植入物，其特征在于，所述含胶原的片状物构成非织造物和/或胶原膜。
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