CN113616420B - 抑菌铜基合金功能性复合敷料 - Google Patents
抑菌铜基合金功能性复合敷料 Download PDFInfo
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- CN113616420B CN113616420B CN202110900550.9A CN202110900550A CN113616420B CN 113616420 B CN113616420 B CN 113616420B CN 202110900550 A CN202110900550 A CN 202110900550A CN 113616420 B CN113616420 B CN 113616420B
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- copper
- based alloy
- functional composite
- wound surface
- dressing
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Abstract
本发明涉及医用材料技术领域,公开了抑菌铜基合金功能性复合敷料,由功能性复合海绵和铜基合金生物支架组成。本发明具有抑菌抗炎、形变记忆、便携可控、促愈保湿、防粘安全等多种功效,搭载中空负压引流装置使用,可使得本发明在负压增大的作用下紧实地贴覆于创面表面,通过功能性复合海绵的虹吸作用充分引流出深部的分泌物,同时铜基合金可充分发挥抑菌抗炎、促血管生长的作用;本发明极大促进了深、浅部肉芽组织的生长,充分有效地引流了创面深部的分泌物,改善了创面局部的微循环,高效持续地抗炎抑菌,可有效避免敷料与创面粘连;本发明设备投资少,产品流程短,可快速实现工业化规模生产,能耗更低,具有更强的市场竞争力。
Description
技术领域
本发明涉及医用材料技术领域,具体涉及抑菌铜基合金功能性复合敷料。
背景技术
随着生活方式的改变,慢性难愈性创面逐年增加,如:糖尿病足、压疮、慢性血管性溃疡及严重创伤等发病率不断上升,导致慢性难愈性创面成为临床治疗的难点和负担,此类患者对创面敷料的使用频率及需求十分紧张。针对各类创面修复再生,临床的治疗手段仍旧离不开创面敷料,随着科学技术的发展,新型功能性创面敷料逐渐普及,这些新型功能性创面敷料包括:金属离子抗菌敷料、生物活性敷料、人工皮肤等,这些敷料大多已经在国外开始应用或者即将投入使用,国内的功能性敷料也开始缓慢应用,但是由于研发技术有限、功能单一、造价成本高,导致国内功能性创面敷料的应用范围较为局限。目前虽然研究了较多的创面敷料,但是大多新型创面敷料在抑菌抗炎、抑制瘢痕等方面或多或少存在一些缺陷和不足,在一定程度上限制了其应用范围。专利CN103480027A“一种细菌纤维素复合壳聚糖纤维湿性敷料的制备方法”利用从多种微生物中提取的细菌纤维素复合壳聚糖电纺丝溶液作为创面敷料,起到了维持创面湿润和有效抑菌的效用,但其中的细菌纤维素的提取工艺较复杂且来源有限,尚不能达到大型规模化生产,也导致成本偏高,难以广泛应用到临床实际中。
创面封闭式负压引流技术已广泛应用于我国临床的创伤修复中,其原理主要是通过充分引流创面局部的渗出液及异常分泌物,给予创面一个负压微环境以促进局部的微循环,从而达到快速促进创面愈合的目的。创面封闭式负压引流治疗体系主要包括负压吸引机、引流管、海绵敷料、医用封闭半透膜、负压吸引连接盘、引流物收集器皿等,目前针对其中各环节的创新研发层出不穷,特别是针对海绵敷料的研究,由于它在整个创面封闭式负压引流中既是直接与创面接触的介质,也是负压吸引装置发挥虹吸作用的媒介,起到了决定性作用。目前常用的医用海绵敷料材料中有效的抑菌抗炎成分主要为:壳聚糖、海藻酸盐、纳米金属离子等,其中有效成分的作用持续时长有限且制作工艺繁杂。因此,从技术及功能上作出全面地改进才能使功能性海绵创面敷料实现质的突破,才能从实际上真正改善慢性创面的疗效,为广大患者带来福音。
发明内容
基于以上问题,本发明提供抑菌铜基合金功能性复合敷料,本发明功能多样、抑菌效率高、可有效避免敷料创面粘连,还具有持久抑菌、抗炎促愈、绿色环保、安全无害的特点,本发明设备投资少,产品流程短,可快速实现工业化规模生产,能耗更低,具有更强的市场竞争力。
为解决以上技术问题,本发明提供了以下技术方案:
抑菌铜基合金功能性复合敷料,由功能性复合海绵和铜基合金生物支架组成,所述功能性复合海绵为PU海绵,包括如下质量份数的化学成分:聚酯多元醇100份,甲苯二异氰酸酯100份,发泡剂50份,灭菌纯水700份,氧化铜1份,磷酸锆1份,氧化锌1份,1,2-苯并异噻唑-3-酮1份,二甲胺基/N,N-二甲基-N-苯基-(N-氟二氯甲硫基)-磺酰胺1份,N-苯并咪唑-2-基氨基甲酸甲酯1份,戊唑醇1份,2-[(二氯氟甲基)-硫]-1H-异吲哚-1,3-(2H)-二酮1份,聚丙烯酸钠2份;所述铜基合金生物支架由多种铜基合金粉末混合预热堆放后经选择性激光熔化3D打印技术制成,所述铜基合金生物支架为50μm铜基合金微丝网络生物支架。
进一步的,所述铜基合金粉末包括Cu-20wt%Fe和Cu-10wt%Fe中的任意一种,Cu-20wt%Fe中纯铁与电解铜的质量配比为2:3,Cu-10wt%Fe中纯铁与电解铜的质量配比为1:4。
进一步的,所述功能性复合海绵与创面接触的一面涂覆有高分子聚合物混纺或纺丝溶液。
进一步的,所述高分子聚合物混纺或纺丝溶液包括如下质量的成分中的任意一种:1.5g聚乳酸,2.5g左旋聚乳酸,5.5g透明质酸,4.5g明胶。
进一步的,所述铜基合金生物支架包含不同直径的孔,孔径大小为70~150μm。
与现有技术相比,本发明的有益效果是:本发明具有抑菌抗炎、形变记忆、便携可控、促愈保湿、防粘安全等多种功效,搭载中空负压引流装置使用,可使得本发明在负压增大的作用下紧实地贴覆于创面表面,通过功能性复合海绵的虹吸作用充分引流出深部的分泌物,同时铜基合金可充分发挥抑菌抗炎、促血管生长的作用;本发明将具有形变记忆能力的功能性复合海绵和具备高效持久抑菌功效的铜基合金生物支架结合,极大促进了深、浅部肉芽组织的生长,充分有效地引流了创面深部的分泌物,改善了创面局部的微循环,高效持续地抗炎抑菌,可有效避免敷料与创面粘连;本发明设备投资少,产品流程短,可快速实现工业化规模生产,能耗更低,具有更强的市场竞争力。
附图说明
图1为本发明的实施例2应用于大鼠创面组织学结果图;
图2为本发明的实施例3应用于大鼠创面组织学结果图;
图3为本发明的实施例2和实施例3的抑菌铜基合金功能性复合敷料的杀菌试验结果对比图;
图4为本发明的实施例2和实施例3的抑菌铜基合金功能性复合敷料的细胞毒性试验结果图。
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明白,下面结合实施例和附图,对本发明作进一步的详细说明,本发明的示意性实施方式及其说明仅用于解释本发明,并不作为对本发明的限定。
实施例1:
本实施例提供抑菌铜基合金功能性复合敷料,由具有形变记忆能力的功能性复合海绵和具备高效持久抑菌功效的铜基合金生物支架组成,所述功能性复合海绵为聚氨酯(PU)海绵,包括如下质量份数的化学成分:聚酯多元醇100份,甲苯二异氰酸酯100份,发泡剂50份,灭菌纯水700份,氧化铜1份,磷酸锆1份,氧化锌1份,1,2-苯并异噻唑-3-酮1份,二甲胺基/N,N-二甲基-N-苯基-(N-氟二氯甲硫基)-磺酰胺1份,N-苯并咪唑-2-基氨基甲酸甲酯1份,戊唑醇1份,2-[(二氯氟甲基)-硫]-1H-异吲哚-1,3-(2H)-二酮1份,聚丙烯酸钠2份,上述成分共同混合发泡后形成PU海绵。本实施例的功能性复合海绵与创面接触的一面涂覆有高分子聚合物混纺或纺丝溶液,本实施例采用静电纺丝技术将高分子聚合物混纺或纺丝溶液喷涂覆盖于功能性复合海绵底部而成。本实施例的高分子聚合物混纺或纺丝溶液包括如下质量的成分中的任意一种:1.5g聚乳酸,2.5g左旋聚乳酸,5.5g透明质酸,4.5g明胶。
上述铜基合金生物支架由多种铜基合金粉末混合预热堆放后经选择性激光熔化3D打印技术制成,铜基合金生物支架为50μm铜基合金微丝网络生物支架,本实施例的铜基合金粉末包括Cu-20wt%Fe和Cu-10wt%Fe中的任意一种,Cu-20wt%Fe中纯铁与电解铜的质量配比为2:3,Cu-10wt%Fe中纯铁与电解铜的质量配比为1:4。
本实施例的铜基合金粉末的制备方法如下:利用真空气体保护熔炼技术和氩气保护下的在线退火工艺制得铜基合金粉末,在线退火工艺为公开号为CN110814305A、题目为一种Cu-Fe复合材料双熔体混合铸造装备与工艺的专利中的技术,其中双熔体混合铸造法的工艺参数为:纯铜熔体温度为1300℃,铜铁母合金熔体温度为1600℃,混合腔温度为1300℃,结晶器冷却水流量为2000L/h。
本实施例的铜基合金生物支架的制备方法如下:首先将预生产的铜基合金微丝网络生物支架的三维结构图输入3D打印设备的电脑系统,将铜基合金粉末预热堆放,然后使用3D打印设备的刮平棍子将表面的粉末均匀铺平,高能电子束在3D打印设备电脑系统的控制下根据支架三维结构图的分层信息进行选择性融化后凝固,这样完成一层的打印生产后再进行下一层的融化,最后去除多余的粉末后形成最终需要的空间结构的铜基合金微丝网络生物支架,生产的支架具有不同直径的孔,孔径大小为70~150μm。
本实施例的抑菌铜基合金功能性复合敷料需搭载中空负压引流装置使用,本实施例的中空负压引流装置为公开号为CN106730097A、题目为一种用于创面清创循环水疗的交替中空负压引流治疗系统的中空负压引流治疗体系。当仪器感知负压值超过有效愈合阈值时,可智能性反馈信息至引流装置,通过高导、耐蚀的铜基合金生物支架微丝传导至功能性复合海绵,功能性复合海绵回弹在创面局部形成一中空负压环境以便于表面的肉芽组织生长及血运灌流,使慢性难愈性创面能够更快、更好、更有效地愈合。
本实施例的抑菌铜基合金功能性复合敷料搭配中空负压引流装置使用可保证创面微环境的平衡稳态,利于各类创面愈合及组织再生,它的搭载针对性地解决了慢性难愈性创面局部乏氧的难题,可以为慢性难愈性创面交互式局部间歇供氧。本实施例的技术方案填补了目前临床负压引流治疗方式的疗效盲区,通过结合新型功能性生物材料的特性可以为当前功能性创面敷料的研发提供崭新的方向,使广大创面患者群体从实际中获益。
本实施例的功能性复合海绵与铜基合金生物支架通过3D打印技术生成后,在铜基合金生物支架的框架中进行功能性复合海绵的发泡,从而使二者嵌合在一起,铜基合金微丝可以穿插在海绵的孔隙中,进而形成了抑菌铜基合金功能性复合敷料。
本实施例的功能性复合海绵结合铜基合金生物支架,显著地增大了铜基合金生物支架与创面中的细菌接触的比表面积,可发挥持久高效的抑菌作用,并且其所用的原料成本大大减少;另外由于所加工的铜基合金生物支架具有高强超弹、耐蚀高导、形变记忆、柔软顺滑的性能,可以很好地与PU海绵融合且与人体皮肤接触时无任何异物感和不适感,二者结合后搭载中空负压引流装置,充分地解决了目前临床上VSD治疗中敷料与创面粘连、创面表面肉芽生长有限、创面局部感染、易漏气阻塞等缺陷,另外这种局部的中空环境可更智能个性化地调节负压值大小,对于创面的愈合、创面组织的再生修复十分有利,可以显著减少创面愈合后瘢痕增生的问题。
实施例2:
本实施例的功能性复合海绵的配方及制作方式与实施例1相同,本实施例的高分子聚合物混纺或纺丝溶液为明胶,明胶的质量为4.5g。本实施例用于制备铜基合金生物支架的铜基合金粉末为Cu-20wt%Fe,是通过Cu-20wt%Fe合金粉末混合预热堆放后经选择性激光熔化3D打印技术制成Cu-20wt%Fe合金微丝(直径50μm)网络生物支架,生产的支架的孔隙直径为70μm。
将本实施例制备的抑菌铜基合金功能性复合敷料按照“JISZ2801-2000《抗菌加工制品-抗菌性试验方法和抗菌效果》、GB/T2591-2003《抗菌塑料抗菌性能实验方法和抗菌效果》”等相关标准规定进行抗菌性能检测,其中抑菌率的计算公式为:抑菌率(%)=[(空白组菌落数-实验组菌落数)/空白组菌落数]×100%。
实验方法:稀释平板法,具体实验步骤如下:培养基选用水解酪蛋白(MH)琼脂,pH为7.2-7.4,琼脂厚度为4mm,分别取ATCC25923、ATCC27853、ATCC22019、MRSA四种菌种液(浓度1.5×106CFU/mL)依次滴加到空白对照和本实施例中的抑菌铜基合金功能性复合敷料上,用灭菌镊子将覆盖膜分别覆在各个样品上,使菌液均匀接触样品,置于灭菌平皿中,放在恒温培养箱中37℃、相对湿度90%以上条件下培养24h;取出已培养24h的样品,分别加入10mL洗脱液,反复清洗样品及覆盖膜,充分摇匀后,分别取0.05mL滴加到营养琼脂培养基,每个样品做三个平行样,并用灭菌三角耙涂匀,置于37℃恒温箱中培养48h后按照GB/T4789.2的方法进行活菌计数,抗菌性能检测结果见表1。
表1.抑菌铜基合金功能性复合敷料的抑菌性能
注:ATCC25923即金黄色葡萄球菌,ATCC27853即铜绿假单胞菌,ATCC22019即近平滑念珠菌,MRSA即耐甲氧西林金黄色葡萄球菌
将本实施例制备的抑菌铜基合金功能性复合敷料按照《GB/T16886.5-2017医疗器械生物学评价第5部分:体外细胞毒性试验》测试方法进行检测,采用L929小鼠成纤维细胞作为体外细胞毒性试验的工作细胞株。
本实施例提供的敷料在试验过程中,样品底下及周围细胞形态均正常,无毒性倾向性,毒性等级为0级,满足检测要求,通过检测。
20只SD大鼠随机分组,用取皮打孔器制作2.5×2.5cm全厚皮层缺损模型。实验组:创面覆盖本实施例制备的抑菌铜基合金功能性复合敷料并搭载实施例1中所述的中空负压引流装置;对照组:覆盖普通的医用PU海绵敷料搭载实施例1所述的中空负压引流装置。两组的负压值均设置为100mmHg,术后连续10天对创面进行大鼠的创面进行观测,计算创面的面积收缩率与愈合速率,比较实验组和对照组之间的瘢痕形成和粘连情况。
见附图1,分别为创面组织在第3天、第5天、第7天、第9天的炎性细胞变化情况,结果显示:实验组的创面收缩率及愈合速率较对照组明显高,且实验组的组织学观测显示炎性细胞浸润少;实验组与创面的粘连情况优于对照组,且实验组的创面未发生感染现象。
实施例3:
本实施例的功能性复合海绵的配方及制作方式与实施例1相同,本实施例的高分子聚合物混纺或纺丝溶液为透明质酸,透明质酸的质量为5.5g。本实施例用于制备铜基合金生物支架的铜基合金粉末为Cu-10wt%Fe,是通过Cu-10wt%Fe合金粉末混合预热堆放后经选择性激光熔化3D打印技术制成Cu-10wt%Fe合金微丝(直径50μm)网络生物支架,生产的支架的孔隙直径为150μm。
本实施例采用实施例2中的相关检测方法及标准对本实施例制备的抑菌铜基合金功能性复合敷料的抗菌性能进行了检测,结果见表2:
表2.抑菌铜基合金功能性复合敷料的抑菌性能
注:ATCC25923即金黄色葡萄球菌,ATCC27853即铜绿假单胞菌,ATCC22019即近平滑念珠菌,MRSA即耐甲氧西林金黄色葡萄球菌
本实施例还采用实施例2中的方法对本实施例制备的抑菌铜基合金功能性复合敷料的体外细胞毒性和体内试验进行了测试,体外细胞毒性测试结果显示样品底下及周围细胞形态均正常,无毒性倾向性,毒性等级为0级,满足检测要求,通过检测。见附图2,体内试验结果显示:实验组的创面收缩率及愈合速率较对照组高,且实验组的组织学观测显示炎性细胞、成纤维细胞浸润少;实验组与创面的粘连情况优于对照组,且实验组的创面未发生感染现象。
见附图3,为本实施例与实施例2在30min内相较空白对照组的杀菌效果,可见本实施例与实施例2中的复合辅料均可发挥优异的杀菌作用。见附图4,可见实例2和实例3中的L929小鼠成纤维细胞在5天内的存活率均高于70%,表明二者的生物相容性均良好。
如上即为本发明的实施例。上述实施例以及实施例中的具体参数仅是为了清楚表述发明验证过程,并非用以限制本发明的专利保护范围,本发明的专利保护范围仍然以其权利要求书为准,凡是运用本发明的说明书及附图内容所作的等同结构变化,同理均应包含在本发明的保护范围内。
Claims (4)
1.抑菌铜基合金功能性复合敷料,其特征在于,由功能性复合海绵和铜基合金生物支架组成,所述功能性复合海绵与创面接触的一面涂覆有高分子聚合物混纺或纺丝溶液,所述功能性复合海绵为PU海绵,包括如下质量份数的化学成分:聚酯多元醇100份,甲苯二异氰酸酯100份,发泡剂50份,灭菌纯水700份,氧化铜1份,磷酸锆1份,氧化锌1份,1,2-苯并异噻唑-3-酮1份,二甲胺基/N,N-二甲基-N-苯基-(N-氟二氯甲硫基)-磺酰胺1份,N-苯并咪唑-2-基氨基甲酸甲酯1份,戊唑醇1份,2-[(二氯氟甲基)-硫]-1H-异吲哚-1,3-(2H)-二酮1份,聚丙烯酸钠2份;所述铜基合金生物支架由多种铜基合金粉末混合预热堆放后经选择性激光熔化3D打印技术制成,所述铜基合金生物支架为50μm铜基合金微丝网络生物支架。
2.根据权利要求1所述的抑菌铜基合金功能性复合敷料,其特征在于,所述铜基合金粉末包括Cu-20wt%Fe和Cu-10wt%Fe中的任意一种,Cu-20wt%Fe中纯铁与电解铜的质量配比为2:3,Cu-10wt%Fe中纯铁与电解铜的质量配比为1:4。
3.根据权利要求2所述的抑菌铜基合金功能性复合敷料,其特征在于,所述高分子聚合物混纺或纺丝溶液包括如下质量的成分中的任意一种:1.5g聚乳酸,2.5g左旋聚乳酸,5.5g透明质酸,4.5g明胶。
4.根据权利要求1所述的抑菌铜基合金功能性复合敷料,其特征在于,所述铜基合金生物支架包含不同直径的孔,孔径大小为70~150μm。
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