CN113925994B - 一种负压封闭引流敷料及其制备方法 - Google Patents
一种负压封闭引流敷料及其制备方法 Download PDFInfo
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Abstract
本发明公开了一种负压封闭引流敷料及其制备方法,包括聚氨酯泡沫材料层,所述聚氨酯泡沫材料层表面包覆有可降解高分子层,所述聚氨酯泡沫材料层靠近创口的一侧复合有抗凝剂层。本发明为了解决聚氨酯泡沫黏连新生肉芽组织及堵塞两个问题,通过在聚氨酯泡沫与创口接触一面,涂覆抗凝剂层,使用时可以有效防止在创面性能血块,从而有效解决泡沫堵塞,引流不畅问题;另外,在负压长时间的作用下,会刺激创面肉芽组织生产并可能会长入泡沫内,这时含泡沫表面的可降解高分子会逐渐降解,新生的肉芽组织将与泡沫孔之间形成间隙,当移除泡沫时,不会破坏肉芽组织。
Description
技术领域
本发明属于敷料领域,涉及一种敷料,尤其涉及一种防堵塞,防黏连的负压封闭引流敷料及其制备方法。
背景技术
1992年,德国ULM大学Fleischman博士首创VSD负压引流技术,并在骨科中广泛应用。经过近30年的发展,负压伤口疗法(NPWT)已经成为创面治疗的主要手段之一。负压治疗系统主要包括泡沫材料,引流管,密封薄膜,负压源四部分,其中泡沫材料对负压治疗效果起主要作用,泡沫材料基本上分为聚乙烯醇和聚氨酯两大类。聚氨酯泡沫材料具有安装操作简便,促进创面血管化合组织增生能力强,不易发生干结皱缩,创面渗液引流能力强,适用于炎症水肿明显、污染严重的创面。
现有的聚氨酯敷料具有以下缺陷:1、聚氨酯泡沫材料为疏水性且孔径大,在应用于深部创腔或窦道时,肉芽组织易长入泡沫孔内,取出时易损伤造成出血。2、泡沫材料在使用过程中可能会被创面的血凝块,坏死组织等堵塞。
发明内容
本发明的目的是为了解决现有聚氨酯敷料为疏水性且孔径大,使用时肉芽组织易长入泡沫孔内,取出是易损伤;易被创面的血凝块、环死组织堵塞的缺陷而提供一种防堵塞,防黏连的负压封闭引流敷料。
本发明另一个目的是为了提供该防堵塞,防黏连的负压封闭引流敷料的制备方法。
为了实现上述目的,本发明采用以下技术方案:
一种负压封闭引流敷料,所述负压封闭引流敷料包括聚氨酯泡沫材料层,所述聚氨酯泡沫材料层表面包覆有可降解高分子层,所述聚氨酯泡沫材料层靠近创口的一侧复合有抗凝剂层。
在本发明中,负压技术主要治疗目的是促进创面修复,负压吸引作用于细胞膜,使之扩张、扭曲,细胞就认为是损伤,传导损伤的信息给细胞核,通过信号转换,引起细胞分泌前愈合生长因子,包括血管增殖因子,从而刺激组织生产更多的新生血管。聚氨酯泡沫材料由于孔径较大,新生肉芽组织很容易长入泡沫内,从而从创面去除泡沫时比较费力,创面易出血且量较多。负压技术另一个主要治疗目的是引流创面渗液。创面引流,一方面通过负压源持久的负压吸引来实现,另一方面,通过泡沫材料保持其网孔形状来实现,创面处的血凝块或渗出物很容易堵塞泡沫,造成引流不畅或负压治疗效果不佳。
抗凝剂是应用物理或化学方法,除掉或抑制血液中的某些凝血因子,阻止血液凝固,如天然抗凝剂(肝素,水蛭素等),Ca2+螯合剂(柠檬酸钠,EDTA等)。可降解医用高分子材料是指在体内环境中能够因分子链发生特异性或非特异性断裂而逐步降解,且降解产物可以被人体吸收或经代谢过程排出体外;这类材料在完成自身体内使命后能自动消除,不会对人类健康造成二次伤害,近年来已经成为一类备受关注的生物医用材料。本发明为了解决聚氨酯泡沫黏连新生肉芽组织及堵塞两个问题,通过在聚氨酯泡沫与创口接触一面,涂覆抗凝剂层,使用时可以有效防止在创面性能血块,从而有效解决泡沫堵塞,引流不畅问题;另外,在负压长时间的作用下,会刺激创面肉芽组织生产并可能会长入泡沫内,这时含泡沫表面的可降解高分子会逐渐降解,新生的肉芽组织将与泡沫孔之间形成间隙,当移除泡沫时,不会破坏肉芽组织。
作为本发明的一种优选方案,所述可降解高分子层的厚度为30-100μm。
作为本发明的一种优选方案,所述抗凝剂层的厚度为3-5mm。
作为本发明的一种优选方案,所述可降解高分子层为生物医用高分子溶液制成的可降解的高分子薄膜。
作为本发明的一种优选方案,所述抗凝剂层中的抗凝剂包括肝素钠,EDTA,枸橼酸钠中的一种或多种的组合。
本发明提供了上述负压封闭引流敷料的制备方法,包括以下步骤:
1)裁剪合适尺寸的聚氨酯泡沫材料,清洗后烘干,待用;
2)配制可降解生物医用高分子溶液,待用;
3)配制抗凝剂溶液,待用;
4)将步骤1)得到的聚氨酯泡沫材料放入步骤2)得到的生物医用高分子溶液中浸泡,浸泡完毕后干燥,得到表面包覆可降解高分子层的聚氨酯泡沫材料;
5)将步骤3)得到的抗凝剂溶液倒入器皿内,溶液深度为3~5mm,将步骤4)得到的表面包覆可降解高分子层的聚氨酯泡沫材料一侧放置于抗凝剂溶液中浸泡,浸泡完后进行烘干,得到负压封闭引流敷料。
作为本发明的一种优选方案,步骤1)中,清洗是将切割好的聚氨酯泡沫材料以纯化水为清洗介质,使用超声波加滚筒方式清洗3次,烘干温度为60-80℃。
作为本发明的一种优选方案,步骤2)中,可降解生物医用高分子溶液是通过质量分数0.5%胶原蛋白和质量分数0.02%戊二醛按照1000:1的体积比交联30s制得的。
作为本发明的一种优选方案,步骤3)中,抗凝剂溶液是将抗凝剂与溶剂混合制得,所述的溶剂包括生理盐水或者纯化水。
作为本发明的一种优选方案,步骤4)中,聚氨酯泡沫材料与可降解生物医用高分子溶液的重量比为1:10,浸泡时间为0.5-1h。
与现有技术相比,本发明具有以下有益效果:
1)本发明通过在聚氨酯泡沫与创口接触一面,涂覆抗凝剂层,使用时可以有效防止在创面性能血块,从而有效解决泡沫堵塞,引流不畅问题;另外,在负压长时间的作用下,会刺激创面肉芽组织生产并可能会长入泡沫内,这时含泡沫表面的可降解高分子会逐渐降解,新生的肉芽组织将与泡沫孔之间形成间隙,当移除泡沫时,不会破坏肉芽组织;
2)本发明的制备方法简单,无需采用多余设备。
具体实施方式
下面将结合本发明实施例,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例。基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。
实施例1:
本实施例提供了制备一层含肝素钠抗凝剂,一层含医用可降解胶原蛋白负压引流海绵的方法如下:
1)将聚氨酯泡沫材料切割成15mm×20mm×25mm方形尺寸,然后以纯化水为清洗介质,使用超声波加滚筒方式清洗3次,再在干燥箱内60℃烘干至恒重;
2)使用质量分数0.5%胶原蛋白和质量分数0.02%戊二醛按照1000:1的体积比交联30s制备胶原蛋白溶液;
3)使用生理盐水配制1g/L肝素钠溶液;
4)将聚氨酯泡沫放置在配好的胶原蛋白溶液内进行浸泡,按照聚氨酯泡沫与胶原蛋白溶液为1:10的重量比浸泡0.5~1h,浸泡完毕后放入烘箱内干燥至恒重,干燥后在泡沫孔径表面形成一层30~100μm薄膜;
5)将配好的肝素钠溶液倒入不锈钢器皿内,溶液深度为3~5mm,此深度可以保证聚氨酯泡沫一侧能够完全浸泡到肝素钠溶液,形成抗凝剂层;将泡沫一面放置在装有肝素钠的不锈钢器皿中,浸泡0.5~1h;取出上步浸泡好的海绵,放入内60℃干燥箱内烘干至恒重,制备得到一双层泡沫结构,一层为肝素钠层,一层为胶原蛋白层。
实施例2:
本实施例制备一层含枸橼酸钠抗凝剂,一层含医用可降解胶原蛋白负压引流海绵的方法如下:
1)将聚氨酯泡沫材料切割成15mm×20mm×25mm方形尺寸,然后以纯化水为清洗介质,使用超声波加滚筒方式清洗3次,再在干燥箱内60℃烘干至恒重;
2)使用质量分数0.5%胶原蛋白和质量分数0.02%戊二醛按照1000:1的体积比交联30s制备胶原蛋白溶液;.
3)使用纯化水配制质量分数5%枸橼酸钠溶液;
4)将聚氨酯泡沫放置在配好的胶原蛋白溶液内进行浸泡,按照聚氨酯泡沫与胶原蛋白溶液为1:10的重量比浸泡0.5~1h,浸泡完毕后放入烘箱内干燥至恒重,干燥后在泡沫孔径表面形成一层30~100μm薄膜;
5)将配好的枸橼酸钠溶液倒入不锈钢器皿内,溶液深度为3~5mm,此深度可以保证聚氨酯泡沫一侧能够完全浸泡到枸橼酸钠溶液,形成抗凝剂层;将泡沫一面放置在装有枸橼酸钠溶液的不锈钢器皿中,浸泡0.5~1h;取出上步浸泡好的海绵,放入内60℃干燥箱内烘干至恒重,制备得到一双层泡沫结构,一层为枸橼酸钠层,一层为胶原蛋白层。
实施例3:
本实施例制备一层含枸橼酸钠抗凝剂,一层含医用可降解胶原蛋白负压引流海绵的方法如下:
1)将聚氨酯泡沫材料切割成15mm×20mm×25mm方形尺寸,然后以纯化水为清洗介质,使用超声波加滚筒方式清洗3次,再在干燥箱内60℃烘干至恒重;
2)使用质量分数0.5%胶原蛋白和质量分数0.02%戊二醛按照1000:1的体积比交联30s制备胶原蛋白溶液;.
3)使用纯化水配制10%EDTA溶液;
4)将聚氨酯泡沫放置在配好的胶原蛋白溶液内进行浸泡,按照聚氨酯泡沫与胶原蛋白溶液为1:10的重量比浸泡0.5~1h,浸泡完毕后放入烘箱内干燥至恒重,干燥后在泡沫孔径表面形成一层30~100μm薄膜;
5)将配好的EDTA溶液倒入不锈钢器皿内,溶液深度为3~5mm,此深度可以保证聚氨酯泡沫一侧能够完全浸泡到EDTA溶液,形成抗凝剂层;将泡沫一面放置在装有EDTA溶液的不锈钢器皿中,浸泡0.5~1h;取出上步浸泡好的海绵,放入内60℃干燥箱内烘干至恒重,制备得到一双层泡沫结构,一层为EDTA层,一层为胶原蛋白层。
以上所述,仅为本发明的较佳实施例,并非对本发明任何形式上和实质上的限制,应当指出,对于本技术领域的普通技术人员,在不脱离本发明方法的前提下,还将可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。凡熟悉本专业的技术人员,在不脱离本发明的精神和范围的情况下,当可利用以上所揭示的技术内容而做出的些许更动、修饰与演变的等同变化,均为本发明的等效实施例;同时,凡依据本发明的实质技术对上述实施例所作的任何等同变化的更动、修饰与演变,均仍属于本发明的技术方案的范围内。
Claims (6)
1.一种负压封闭引流敷料的制备方法,其特征在于,所述制备方法包括以下步骤:
1)裁剪合适尺寸的聚氨酯泡沫材料,清洗后烘干,待用;
2)配制可降解生物医用高分子溶液,待用;
3)配制抗凝剂溶液,待用;
4)将步骤1)得到的聚氨酯泡沫材料放入步骤2)得到的生物医用高分子溶液中浸泡,浸泡完毕后干燥,得到表面包覆可降解高分子层的聚氨酯泡沫材料;
5)将步骤3)得到的抗凝剂溶液倒入器皿内,溶液深度为3~5mm,将步骤4)得到的表面包覆可降解高分子层的聚氨酯泡沫材料一侧放置于抗凝剂溶液中浸泡,浸泡完后进行烘干,得到负压封闭引流敷料。
2.根据权利要求1所述一种负压封闭引流敷料的制备方法,其特征在于,步骤1)中,清洗是将切割好的聚氨酯泡沫材料以纯化水为清洗介质,使用超声波加滚筒方式清洗3次,烘干温度为60-80℃。
3.根据权利要求1所述一种负压封闭引流敷料的制备方法,其特征在于,步骤2)中,可降解生物医用高分子溶液是通过质量分数0.5%胶原蛋白和质量分数0.02%戊二醛按照1000:1的体积比交联30s制得的。
4.根据权利要求1所述一种负压封闭引流敷料的制备方法,其特征在于,步骤3)中,抗凝剂溶液是将抗凝剂与溶剂混合制得,所述的溶剂包括生理盐水或者纯化水。
5.根据权利要求1所述一种负压封闭引流敷料的制备方法,其特征在于,步骤4)中,聚氨酯泡沫材料与可降解生物医用高分子溶液的重量比为1:10,浸泡时间为0.5-1h。
6.一种如权利要求1-5任一项所述的制备方法制得的负压封闭引流敷料,其特征在于,所述负压封闭引流敷料包括聚氨酯泡沫材料层,所述聚氨酯泡沫材料层表面包覆有可降解高分子层,所述聚氨酯泡沫材料层靠近创口的一侧复合有抗凝剂层,所述可降解高分子层的厚度为30-100μm,所述抗凝剂层的厚度为3-5mm,所述可降解高分子层为生物医用高分子溶液制成的可降解的高分子薄膜,所述抗凝剂层中的抗凝剂包括肝素钠,EDTA,枸橼酸钠中的一种或多种的组合。
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