CN106390213A - 一种多功能的硅凝胶负压引流装置及其制备方法 - Google Patents
一种多功能的硅凝胶负压引流装置及其制备方法 Download PDFInfo
- Publication number
- CN106390213A CN106390213A CN201610743422.7A CN201610743422A CN106390213A CN 106390213 A CN106390213 A CN 106390213A CN 201610743422 A CN201610743422 A CN 201610743422A CN 106390213 A CN106390213 A CN 106390213A
- Authority
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- Prior art keywords
- glue
- line
- silica hydrogel
- sensitive adhesive
- drainage device
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
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- Medicinal Preparation (AREA)
Abstract
本发明提出一种多功能的硅凝胶负压引流装置及其制备方法,包括:敷料本体、引流机构及负压源;敷料本体包括由上往下依序设置的聚氨酯膜、吸收层、过滤层和胶层,胶层为带有通气孔的双面胶层,双面胶层包括医用压敏胶和硅凝胶,胶层的两边分别设有第一手持边和第二手持边,胶层上设置有多个刀口,多个刀口错位均匀分布,第一手持边和第二手持边向两边拉开时,刀口形成具有菱形空隙的渗透区。本发明采用粘接性好且亲肤性佳的双面胶层,并在硅凝胶中添加了合适量的纳米银、植物提取物、生长因子及止痒剂,显著地加快了伤口的愈合。
Description
技术领域
本发明涉及医疗器械技术领域,特别是指一种多功能的硅凝胶负压引流装置及其制备方法。
背景技术
负压伤口治疗是在伤口处施加可控的负压,负压由负压泵产生,通过覆盖在伤口上的“过滤器”(泡沫或纱布)对伤口施加持续或间断的不同压力的负压。引流管与密封伤口的透明膜辅料相连,引流液被不断地吸入储液罐。负压治疗可以去除伤口渗液,坏死组织与细菌,有效减轻水肿,促进血管再生与改善局部血液循环,增加局部氧气供应,从而促进伤口愈合。由于负压治疗具有确切的疗效,因而已被广泛接受并应用于临床。
专利:硅凝胶负压封闭引流敷料(申请号201510924870.2,公布号CN 105434107A)公开了一种硅凝胶负压封闭引流敷料,包括敷料体,敷料体上连接有在负压作用下能够将渗出液进行排除的引流结构,敷料体包括能够粘附于人体的硅凝胶层,硅凝胶层上均布有通孔,硅凝胶层上依次设置具有存储和过滤功能的储液过滤层以及具有吸收渗出液功能的吸收结构。该专利可以防止伤口出血,加速伤口愈合,但是该专利中起粘附作用的硅凝胶层,该硅凝胶层为硅凝胶负载于PU膜上,PU膜涂覆硅凝胶的一面与人体皮肤粘接,另一面与储液过滤层粘接,硅凝胶层与皮肤的粘接性较好,但是另一面与储液过滤层基本无粘接性,使用中硅凝胶层与储液过滤层之间会发生错位,导致引流装置的密封性差,影响引流效果,不利于伤口的愈合。另外,硅凝胶只有保湿、粘接的基本性能,当伤口愈合时会产生瘙痒等症状,硅凝胶紧贴伤口设置不能起到缓解这些症状的作用,因而该专利的使用将受到局限。
发明内容
为解决以上现有技术的不足,本发明提出了一种多功能的硅凝胶负压引流装置及其制备方法。
本发明的技术方案是这样实现的:
一种多功能的硅凝胶负压引流装置,包括:敷料本体、与敷料本体连接的引流机构及负压源;
敷料本体包括由上往下依序设置的聚氨酯膜、吸收层、过滤层和胶层,胶层为带有通气孔的双面胶层,双面胶层与过滤层连接的一面为医用压敏胶,另一面为能够与人体连接的硅凝胶;聚氨酯膜的下表面也设有医用压敏胶,聚氨酯膜的外缘与胶层的外缘粘连使得吸收层和过滤层包覆于聚氨酯膜和胶层之间(为了改善过滤效果,阻止小体积的坏死组织进入吸收层2,吸收层2与过滤层3之间还设有生物过滤膜);
胶层的两边分别设有第一手持边和第二手持边,胶层上设置有多个刀口,多个刀口错位均匀分布,第一手持边和第二手持边向两边拉开时,刀口形成具有菱形空隙的渗透区。
优选的,100重量份的硅凝胶中还包括如下重量份的组分:纳米银0.01-0.05重量份、植物提取物0.2-0.4重量份、生长因子0.5-4重量份及止痒剂0.3-0.5重量份。
本发明采用粘接性好且亲肤性佳的双面胶层,胶层4的两边分别设置有第一手持边42和第二手持边43,在外力作用下,胶层4上的刀口自动裂开形成具有菱形空隙的渗透区44,既有助于改善胶层4与人体的适应性,不至于产生紧绷感,又有利于渗液的引出和导出,使用方便。胶层4上设有硅凝胶的一面与人体粘接,设有医用压敏胶的一面与过滤层3粘接,提高了硅凝胶负压引流装置的密闭性及引流效率,有助于伤口更快的愈合。另外,还添加了可以促进皮肤生长的生长因子,具有杀菌、消炎、止痒作用的植物提取物以及专门的止痒剂,有效地缓解了伤口愈合带来的不适,显著地加速了伤口的愈合。
优选的,纳米银的粒径范围为25-50nm,植物提取物为重量比1:2:3的苦参、薄荷、樟树树干或树根的混合提取物,樟树为50年以上树龄的樟树,止痒剂为甲基纳曲酮。
表皮生长因子(Epidermal growth factor,EGF)是最早发现的生长因子,对调节细胞生长、增殖和分化起着重要作用。表皮生长因子是一种小肽,由53个氨基酸残基组成,是类EGF大家族的一个成员。
纳米银具有超强的渗透性和杀菌性,还可以促进伤口愈合,促进受损细胞的修复与再生,去腐生肌,抗菌消炎改善创伤周围组织的微循环,有效地激活并促进组织细胞的生长,加速伤口的愈合,减少疤痕的生成。
苦参具有抗菌消炎的作用;薄荷提取物中含有薄荷脑,薄荷脑可以引发与低温相同的清凉感,使皮肤冷却,缓解诱导性的皮肤瘙痒;樟树叶提取物中有樟脑,樟脑具有杀虫止痒、消肿止痛、轻度麻醉的作用,可以用于治疗皮肤瘙痒,其主要成为为纯粹的右旋樟脑,50年以上树龄的樟树,其树干或树根含有的右旋樟脑更多;甲基纳曲酮具有治疗皮肤瘙痒的功能。苦参、薄荷脑、樟脑及甲基纳曲酮共同作用,对伤口愈合中产生的皮肤瘙痒问题可以标本兼治,上述的添加比例具有非常好的治疗效果,且不会对伤口产生伤害。
优选的,聚氨酯膜的上表面设有PE保护膜;胶层的下表面设有PE或者PET氟塑离型膜,PE或者PET氟塑离型膜包括覆盖于胶层下表面的两片PE或者PET氟塑离型膜,两片PE或者两片PET氟塑离型膜相邻的一侧互相重叠;胶层还包括用于负载医用压敏胶和硅凝胶的PU膜;吸收层的面积不小于过滤层的面积,吸收层完全覆盖住过滤层。
本发明还提出一种多功能的硅凝胶负压引流装置的制备方法,敷料本体的生产工艺包括如下步骤:
第一步,制备胶层:
将医用压敏胶以丝网印刷或刮刀涂布的方式设于PU膜载体上,并在医用压敏胶上覆盖一保护层;
将混合硅凝胶涂覆在PU膜载体的另一面并进行固化得到硅凝胶层,之后将经过消毒、杀菌处理的PE或者PET氟塑离型膜覆盖于硅凝胶层上;
在上一步得到的产品上以错位方式通透切割形成多行多列刀口,相邻的两列中,前一列刀口所在位置与后一列刀口所在位置仅只有部分位于同一水平上;
第二步,制备设有医用压敏胶的聚氨酯膜:
将医用压敏胶以丝网印刷或者刮刀涂布的方式设于聚氨酯膜上;
第三步,复合:
撕去保护层,将过滤层、吸收层依序复合在胶层中设有医用压敏胶的一面与聚氨酯膜中设有医用压敏胶的一面之间;
第四步,后续加工:包括灭菌、冲裁、筛选、质检、包装。
生产需要在10万级以上的洁净环境中进行,上述PU膜载体、保护层、PE或者PET氟塑离型膜均需作无菌处理后方可使用。
优选的,丝网印刷中采用100-150网目/inch的不锈钢网版或者PET网版。
优选的,硅凝胶层的厚度为0.08-0.25mm。
更为优选的,硅凝胶层的厚度为0.15-0.2mm。
与现有技术相比,本发明采用粘接性好且亲肤性佳的双面胶层,并在硅凝胶中添加了合适量的纳米银、植物提取物、生长因子及止痒剂,两者共同作用加快了伤口的愈合。
附图说明
为了更清楚地说明本发明实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本发明的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动性的前提下,还可以根据这些附图获得其他的附图。
图1为敷料本体的剖面结构示意图;
图2为图1中胶层的俯视图。
图中:1、聚氨酯膜;11、PE保护膜;2、吸收层;3、过滤层;4、胶层;41、PE或者PET氟塑离型膜;42、第一手持边;43、第二手持边;44、渗透区。
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作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
一种多功能的硅凝胶负压引流装置,包括:敷料本体、与敷料本体连接的引流机构及负压源9;
敷料本体包括由上往下依序设置的聚氨酯膜1、吸收层2、过滤层3和胶层4,胶层4为带有通气孔的双面胶层,双面胶层与过滤层3连接的一面为医用压敏胶,另一面为能够与人体连接的硅凝胶;聚氨酯膜1的下表面也设有医用压敏胶,聚氨酯膜1的外缘与胶层4的外缘粘连使得吸收层2和过滤层3包覆于聚氨酯膜1和胶层4之间;
胶层4的两边分别设有第一手持边42和第二手持边43,胶层4上设置有多个刀口,多个刀口错位均匀分布,第一手持边42和第二手持边43向两边拉开时,刀口形成具有菱形空隙的渗透区44;
100重量份的硅凝胶中还包括如下重量份的组分:纳米银0.05重量份、植物提取物0.3重量份、生长因子0.5重量份及止痒剂0.5重量份。
纳米银的粒径范围为30nm,植物提取物为重量比1:2:3的苦参、薄荷、50年树龄以上的樟树树干或树根的混合提取物,止痒剂为甲基纳曲酮。
上述敷料本体的生产工艺包括如下步骤:
第一步,制备胶层4:
将医用压敏胶以丝网印刷的方式设于PU膜载体上,并在医用压敏胶上覆盖一保护层;
将混合硅凝胶涂覆在PU膜载体的另一面并进行固化得到厚度为0.08mm硅凝胶层,之后将经过消毒、杀菌处理的PET氟塑离型膜41覆盖于硅凝胶层上;
在上一步得到的产品上以错位方式通透切割形成多行多列刀口,相邻的两列中,前一列刀口所在位置与后一列刀口所在位置仅只有部分位于同一水平上;
第二步,制备设有医用压敏胶的聚氨酯膜1:
将医用压敏胶以丝网印刷的方式设于聚氨酯膜1上,第一步与第二步的丝网印刷中均采用120网目/inch的不锈钢网版或者PET网版;
第三步,复合:
撕去保护层,将过滤层3、吸收层2依序复合在胶层4中设有医用压敏胶的一面与聚氨酯膜1中设有医用压敏胶的一面之间;
第四步,后续加工:包括灭菌、冲裁、筛选、质检、包装。
实施例2
一种多功能的硅凝胶负压引流装置,包括:敷料本体、与敷料本体连接的引流机构及负压源9;
敷料本体包括由上往下依序设置的聚氨酯膜1、吸收层2、过滤层3和胶层4,胶层4为带有通气孔的双面胶层,双面胶层与过滤层3连接的一面为医用压敏胶,另一面为能够与人体连接的硅凝胶;聚氨酯膜1的下表面也设有医用压敏胶,聚氨酯膜1的外缘与胶层4的外缘粘连使得吸收层2和过滤层3包覆于聚氨酯膜1和胶层4之间;
胶层4的两边分别设有第一手持边42和第二手持边43,胶层4上设置有多个刀口,多个刀口错位均匀分布,第一手持边42和第二手持边43向两边拉开时,刀口形成具有菱形空隙的渗透区44;
100重量份的硅凝胶中还包括如下重量份的组分:纳米银0.03重量份、植物提取物0.2重量份、生长因子4重量份及止痒剂0.4重量份。
纳米银的粒径范围为25nm,植物提取物为重量比1:2:3的苦参、薄荷、50年树龄以上的樟树树干或树根的混合提取物,止痒剂为甲基纳曲酮。
上述敷料本体的生产工艺包括如下步骤:
第一步,制备胶层4:
将医用压敏胶以刮刀涂布的方式凃在PU膜载体上,并在医用压敏胶上覆盖一保护层;
将混合硅凝胶涂覆在PU膜载体的另一面并进行固化得到厚度为0.15mm硅凝胶层,之后将经过消毒、杀菌处理的PE覆盖于硅凝胶层上;
在上一步得到的产品上以错位方式通透切割形成多行多列刀口,相邻的两列中,前一列刀口所在位置与后一列刀口所在位置仅只有部分位于同一水平上;
第二步,制备设有医用压敏胶的聚氨酯膜1:
将医用压敏胶以刮刀涂布的方式涂在聚氨酯膜1上;
第三步,复合:
撕去保护层,将过滤层3、吸收层2依序复合在胶层4中设有医用压敏胶的一面与聚氨酯膜1中设有医用压敏胶的一面之间;
第四步,后续加工:包括灭菌、冲裁、筛选、质检、包装。
实施例3
一种多功能的硅凝胶负压引流装置,包括:敷料本体、与敷料本体连接的引流机构及负压源9;
敷料本体包括由上往下依序设置的聚氨酯膜1、吸收层2、过滤层3和胶层4,胶层4为带有通气孔的双面胶层,双面胶层与过滤层3连接的一面为医用压敏胶,另一面为能够与人体连接的硅凝胶;聚氨酯膜1的下表面也设有医用压敏胶,聚氨酯膜1的外缘与胶层4的外缘粘连使得吸收层2和过滤层3包覆于聚氨酯膜1和胶层4之间;
胶层4的两边分别设有第一手持边42和第二手持边43,胶层4上设置有多个刀口,多个刀口错位均匀分布,第一手持边42和第二手持边43向两边拉开时,刀口形成具有菱形空隙的渗透区44;
100重量份的硅凝胶中还包括如下重量份的组分:纳米银0.01重量份、植物提取物0.4重量份、生长因子2重量份及止痒剂0.3重量份。
纳米银的粒径范围为50nm,植物提取物为重量比1:2:3的苦参、薄荷、50年树龄以上的樟树树干或树根的混合提取物,止痒剂为甲基纳曲酮。
上述敷料本体的生产工艺包括如下步骤:
第一步,制备胶层4:
将医用压敏胶以丝网印刷的方式设于PU膜载体上,并在医用压敏胶上覆盖一保护层;
将混合硅凝胶涂覆在PU膜载体的另一面并进行固化得到厚度为0.2mm硅凝胶层,之后将经过消毒、杀菌处理的PET氟塑离型膜41覆盖于硅凝胶层上;
在上一步得到的产品上以错位方式通透切割形成多行多列刀口,相邻的两列中,前一列刀口所在位置与后一列刀口所在位置仅只有部分位于同一水平上;
第二步,制备设有医用压敏胶的聚氨酯膜1:
将医用压敏胶以丝网印刷的方式设于聚氨酯膜1上,第一步与第二步的丝网印刷中均采用150网目/inch的不锈钢网版或者PET网版;
第三步,复合:
撕去保护层,将过滤层3、吸收层2依序复合在胶层4中设有医用压敏胶的一面与聚氨酯膜1中设有医用压敏胶的一面之间;
第四步,后续加工:包括灭菌、冲裁、筛选、质检、包装。
实施例4
一种多功能的硅凝胶负压引流装置,包括:敷料本体、与敷料本体连接的引流机构及负压源9;
敷料本体包括由上往下依序设置的聚氨酯膜1、吸收层2、过滤层3和胶层4,胶层4为带有通气孔的双面胶层,双面胶层与过滤层3连接的一面为医用压敏胶,另一面为能够与人体连接的硅凝胶;聚氨酯膜1的下表面也设有医用压敏胶,聚氨酯膜1的外缘与胶层4的外缘粘连使得吸收层2和过滤层3包覆于聚氨酯膜1和胶层4之间;
胶层4的两边分别设有第一手持边42和第二手持边43,胶层4上设置有多个刀口,多个刀口错位均匀分布,第一手持边42和第二手持边43向两边拉开时,刀口形成具有菱形空隙的渗透区44;
100重量份的硅凝胶中还包括如下重量份的组分:纳米银0.01重量份、植物提取物0.4重量份、生长因子2重量份及止痒剂0.3重量份。
纳米银的粒径范围为50nm,植物提取物为重量比1:2:3的苦参、薄荷、50年树龄以上的樟树树干或树根的混合提取物,止痒剂为甲基纳曲酮。
上述敷料本体的生产工艺包括如下步骤:
第一步,制备胶层4:
将医用压敏胶以丝网印刷的方式设于PU膜载体上,并在医用压敏胶上覆盖一保护层;
将混合硅凝胶涂覆在PU膜载体的另一面并进行固化得到厚度为0.25mm硅凝胶层,之后将经过消毒、杀菌处理的PE覆盖于硅凝胶层上;
在上一步得到的产品上以错位方式通透切割形成多行多列刀口,相邻的两列中,前一列刀口所在位置与后一列刀口所在位置仅只有部分位于同一水平上;
第二步,制备设有医用压敏胶的聚氨酯膜1:
将医用压敏胶以丝网印刷的方式设于聚氨酯膜1上,第一步与第二步的丝网印刷中均采用130网目/inch的不锈钢网版或者PET网版;
第三步,复合:
撕去保护层,将过滤层3、吸收层2依序复合在胶层4中设有医用压敏胶的一面与聚氨酯膜1中设有医用压敏胶的一面之间;
第四步,后续加工:包括灭菌、冲裁、筛选、质检、包装。
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内,所作的任何修改、等同替换、改进等,均应包含在本发明的保护范围之内。
Claims (8)
1.一种多功能的硅凝胶负压引流装置,其特征在于,包括:敷料本体、与所述敷料本体连接的引流机构及负压源(9);
所述敷料本体包括由上往下依序设置的聚氨酯膜(1)、吸收层(2)、过滤层(3)和胶层(4),胶层(4)为带有通气孔的双面胶层,所述双面胶层与过滤层(3)连接的一面为医用压敏胶,另一面为能够与人体连接的硅凝胶;聚氨酯膜(1)的下表面也设有医用压敏胶,聚氨酯膜(1)的外缘与胶层(4)的外缘粘连使得吸收层(2)和过滤层(3)包覆于聚氨酯膜(1)和胶层(4)之间;
胶层(4)的两边分别设有第一手持边(42)和第二手持边(43),胶层(4)上设置有多个刀口,多个所述刀口错位均匀分布,第一手持边(42)和第二手持边(43)向两边拉开时,所述刀口形成具有菱形空隙的渗透区(44)。
2.根据权利要求1所述的多功能的硅凝胶负压引流装置,其特征在于,100重量份的所述硅凝胶中还包括如下重量份的组分:纳米银0.01-0.05重量份、植物提取物0.2-0.4重量份、生长因子0.5-4重量份及止痒剂0.3-0.5重量份。
3.根据权利要求1所述的多功能的硅凝胶负压引流装置,其特征在于,
聚氨酯膜(1)的上表面设有PE保护膜(11);
胶层(4)的下表面设有PE或者PET氟塑离型膜(41),PE或者PET氟塑离型膜(41)包括覆盖于胶层(4)下表面的两片PE或者两片PET氟塑离型膜,两片所述PE或者两片所述PET氟塑离型膜相邻的一侧互相重叠;
胶层(4)还包括用于负载所述医用压敏胶和所述硅凝胶的PU膜;
吸收层(2)的面积不小于过滤层(3)的面积,吸收层(2)完全覆盖住过滤层(3)。
4.根据权利要求2所述的多功能的硅凝胶负压引流装置,其特征在于,所述纳米银的粒径范围为25-50nm,所述植物提取物为重量比1:2:3的苦参、薄荷、樟树树干或树根的混合提取物,樟树为50年以上树龄的樟树,所述止痒剂为甲基纳曲酮。
5.一种如权利要求3所述的多功能的硅凝胶负压引流装置的制备方法,其特征在于,所述敷料本体的生产工艺包括如下步骤:
第一步,制备胶层(4):
将医用压敏胶以丝网印刷或者刮刀涂布的方式设于PU膜载体上,并在所述医用压敏胶上覆盖一保护层;
将混合硅凝胶涂覆在所述PU膜载体的另一面并进行固化得到硅凝胶层,之后将经过消毒、杀菌处理的PE或者PET氟塑离型膜(41)覆盖于所述硅凝胶层上;
在上一步得到的产品上以错位方式通透切割形成多行多列刀口,相邻的两列中,前一列刀口所在位置与后一列刀口所在位置仅只有部分位于同一水平上;
第二步,制备设有医用压敏胶的聚氨酯膜(1):
将医用压敏胶以丝网印刷或者刮刀涂布的方式设于聚氨酯膜(1)上;
第三步,复合:
撕去所述保护层,将过滤层(3)、吸收层(2)依序复合在胶层(4)中设有医用压敏胶的一面与聚氨酯膜(1)中设有医用压敏胶的一面之间;
第四步,后续加工:包括灭菌、冲裁、筛选、质检、包装。
6.根据权利要求5所述的多功能的硅凝胶负压引流装置的制备方法,其特征在于,所述丝网印刷中采用100-150网目/inch的不锈钢网版或者PET网版。
7.根据权利要求5所述的多功能的硅凝胶负压引流装置的制备方法,其特征在于,所述硅凝胶层的厚度为0.08-0.25mm。
8.根据权利要求7所述的多功能的硅凝胶负压引流装置的制备方法,其特征在于,所述硅凝胶层的厚度为0.15-0.2mm。
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