CN108384510B - 粘合剂组合物以及用于附着人皮肤的元件 - Google Patents
粘合剂组合物以及用于附着人皮肤的元件 Download PDFInfo
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Abstract
本发明的目的是提供一种意图提供与人皮肤进行附着的粘合剂组合物,其包含连续相以及水胶体不连续相,并且以粘合剂组合物的总重量为基准计,所述连续相包含:(i)1至12wt%的苯乙烯‑异戊二烯‑苯乙烯或苯乙烯‑丁二烯‑苯乙烯型的序列聚合物;(ii)(a)1至15%的丁基弹性体型聚合物,可以与高达25wt%的聚异丁烯型聚合物混合,或者(b)大于10%至30%的聚异丁烯型聚合物,不含丁基弹性体型聚合物,(iii)1%至小于10%的乙烯‑乙酸乙烯酯型聚合物,并且,这三种类型聚合物的总和为10%至40%。
Description
技术领域
本发明涉及旨在于主要构成粘合剂元件的粘合剂组合物,所述粘合剂元件为例如用于体液收集袋(如造瘘袋)或类似元件(如石膏)。
技术背景
粘合剂组合物是已知的,特别是用于体液收集袋,其包含基于聚合物、弹性体等的“连续相”和主要含有水胶体的“不连续相”。
连续相包含具有结构形成功能的不同共聚物、聚合物、弹性体、任选的具有增加组合物韧性功能的增塑剂、以及增粘剂树脂。
该术语区分了结构成分(texture ingredient)(弹性体、聚合物、共聚物)与增塑剂和增粘剂或增粘剂树脂,将在所考虑的领域中进行考虑,并不一定是绝对的。实际上,大多数聚合物、共聚物和弹性体或多或少具有结构性质(texture properties)(除非它们是液体或油性),例如在其它成分存在下的增塑剂和增粘剂,或者某些增粘剂树脂也可具有增塑剂功能。因此,这些成分的作用必须在用于直接或间接附着体液收集袋的粘合剂组合物的框架内进行考虑。但是,该术语使得能够区分用于附着体液收集袋的各种粘合剂组合物。
用于体液收集袋的粘合剂组合物用于通过围绕排出排泄物的孔直接胶合至人类皮肤来附着袋子。可以提供胶合以持续相对较短的时间(可以是少于一天),或相对长的时间(可以是约一周)。用于这些各种应用的粘合剂组合物因此具有不同性质,根据这些性质,它们必须保持固定一段或长或短的时间长度。然而,它们都具有一定量的共同性质。
用于附着体液收集袋的粘合剂组合物首先必须具有一定的机械性质。这些机械性能首先基本上是对有一定重量的袋子的机械阻力,不会使粘合剂组合物从皮肤脱落,然后是在粘合剂组合物的水平上不存在泄漏,以及最后具有良好的调适性(意图提供良好舒适性),这不仅是用于放置和移除的良好商品,而且特别有足够灵活性(flexibility),以使得患者尽可能地忘记粘合剂组合物和袋子的存在。
用于附着体液收集袋的粘合剂组合物还必须具有一定的化学性质。基本上粘合剂组合物必须不会引起皮肤刺激。
该袋子已知有多年历史了。典型地,这些袋子包含作为聚合物的SIS或SBS型聚合物,其任选地与PIB或丁基弹性体型聚合物混合。然而,该聚合物的结合并不完美。特别是,如果添加PIB是有利的,那么会导致一些剥离(de-cohesion)。因此,希望有一种聚合物配方,它可以使得能够获得一种具有重要“粘性”的组合物,从而能够快速地放在皮肤上,通过符合腹部轮廓而牢固地粘附,以支撑重量和袋子的约束,并有足够的内聚性(cohesion),以毫不费力且无残留地去除。
文献US4855335描述了一种组合物,其包含:12%至20%的矿物油、30%至40%的增粘剂树脂、15%至30%的水胶体、5%至10%的一种或多种聚异丁烯、7%至15%的苯乙烯共聚物、以及1%至8%的乙烯-乙酸乙烯酯共聚物。这表明EVA增加了尺寸稳定性。
然而,该配方并不令人满意,特别是树脂和/或水胶体的量并不适用于现有的组合物。
文献WO2011/157278描述一种粘合剂组合物,其包含:10-50%的极性相,该极性相包含EVA和极性油;10-50%的非极性相,该非极性相包含苯乙烯嵌段聚合物和聚异丁烯或丁基弹性体;以及高达60%的水胶体。
然而,该配方并不令人满意,极性相的存在、特别是极性油的存在对组合物的组分造成限制。
因此,本发明能够获得所寻求的折衷,而没有现有技术的限制。
发明内容
本发明的目的是提供一种意图确保与人皮肤进行附着的粘合剂组合物,其包含连续相以及水胶体不连续相,并且以粘合剂组合物的总重量为基准计,所述连续相包含:
(i) 1至12wt%的苯乙烯-异戊二烯-苯乙烯或苯乙烯-丁二烯-苯乙烯型的序列聚合物;
(ii) (a)1至15%的丁基弹性体型聚合物,任选地与高达25wt%的聚异丁烯型聚合物混合,或者
(b)大于10%至30%的聚异丁烯型聚合物,不含丁基弹性体型聚合物,
(iii) 1%至小于10%的乙烯-乙酸乙烯酯型聚合物,
并且,这三种类型聚合物的总和为10至40%。
根据一实施方式,所述组合物基本不含极性油,并且/或者,其中极性相占小于10wt%。
根据另一实施方式,所述连续相包含:
(i) 2wt%至8wt%的苯乙烯-异戊二烯-苯乙烯或苯乙烯-丁二烯-苯乙烯型的序列聚合物;
(ii) (a)2%至10%的丁基弹性体型聚合物,任选地与高达25wt%的聚异丁烯型聚合物混合,
(iii) 2%至小于10%的乙烯-乙酸乙烯酯聚合物。
根据另一实施方式,所述连续相包含:
(ii) (a)2%至10%的丁基弹性体型聚合物,不含聚异丁烯型聚合物。
根据另一实施方式,所述连续相包含:
(ii) (a)2%至10%的丁基弹性体型聚合物,与10wt%至25wt%的聚异丁烯型聚合物混合。
根据另一实施方式,所述连续相包含:
(i) 2wt%至8wt%的苯乙烯-异戊二烯-苯乙烯或苯乙烯-丁二烯-苯乙烯型的序列聚合物;
(ii) (b)15%至30%的聚异丁烯型聚合物,不含丁基弹性体型聚合物,
(iii) 2%至小于10%的乙烯-乙酸乙烯酯聚合物。
根据另一实施方式,乙烯-乙酸乙烯酯聚合物包含30wt%至70wt%的乙酸乙烯酯单体。
根据另一实施方式,所述组合物包含10至30%的增粘剂树脂。
根据另一实施方式,所述组合物包含40至60%的水胶体不连续相。
根据另一实施方式,所述不连续相主要包含选自下组的至少一种化合物:选自纤维素纤维、羧甲基纤维素、羧甲基纤维素钠、交联或其它的羧甲基纤维素、和羟乙基纤维素;以及类似于树胶的化合物,如瓜尔胶或刺梧桐树胶或阿拉伯树胶;以及以下物质,例如黄原胶、淀粉如马铃薯淀粉、藻酸盐、果胶、明胶、车前草、角豆树提取物、琼脂糖、角叉菜胶、聚丙烯酰胺;或它们的混合物。
根据另一实施方式,所述不连续相不含动物来源的产物。
本发明的目的还在于一种元件,用于使得包含如本发明所述的粘合剂组合物的体液收集袋进行附着,并且在与意图与皮肤接触一侧的相反面上有膜。
根据另一实施方式,所述膜是聚乙烯膜、或者乙烯-丙烯酸乙烯酯共聚物、或者它们的混合物,所述膜的厚度优选为25至100μm。
因此,本发明提供粘合剂组合物,即,受压粘合的组合物。
按比例在聚合物中使用三种化合物,即SIS或SBS、EVA和丁基弹性体和/或PIB,使得能够获得折衷和三种其它性质。在粘合剂组合物中,苯乙烯共聚物(SIS或SBS)使得能够获得具有实质即时粘性(tack)、内聚性(cohesion)和结构的粘合剂。EVA使得能够通过使其更高的塑性来降低网络的弹性。聚异丁烯(PIB)或丁基(Butyl)可以通过提供更强的粘合性来替代树脂、特别是通过提高粘合剂组合物的适应性用低分子量的来替代。
在本申请中,所有%均以粘合剂组合物的总重量为基准给出,表示为重量百分数。
本发明的具体实施方式
SIS或SBS型聚合物
这些聚合物是常规的,并且是本领域已知的。这些是基于苯乙烯和异戊二烯或丁二烯(或者异戊二烯和丁二烯混合物)的嵌段共聚物。
苯乙烯-异戊二烯-苯乙烯型或苯乙烯-丁二烯-苯乙烯型的连续相的结构共聚物优选由苯乙烯-异戊二烯-苯乙烯的序列聚合物组成。这些聚合物可以含有不同量的而二嵌段或三嵌段,具有双序列或三序列(double or triple sequences)。
这些聚合物的描述可以参考文献WO2011/157278,第8页,第6-18行的明确提及的段落。还可以参考文献US4855335,第三栏,第16-23行的明确提及的段落。
根据本发明合适的苯乙烯-异戊二烯-苯乙烯或苯乙烯-丁二烯-苯乙烯结构型共聚物的示例是:例如,购自壳牌化学公司(Shell Chemical Company)的某些共聚物“Kraton”,例如D11型(D1161、D1117和D1112),或如购自台橡收购公司(Dexco)的“Vector4113”或购自壳牌公司(Shell)的“Cariflex S-1707”的共聚物。
丁基或PIB型聚合物
这些聚合物也是常规的。
通常以术语“丁基”标记的聚合物是包含少部分异戊二烯的聚丁基弹性体。可以使用以购自埃克森公司(Exxon)名为Butyl 268、或者购自Togliatti/Nizhnekamsk的ButylBK的销售的那些聚丁基弹性体。
丁基弹性体的分子量适应于应用,例如分子量Mn为200,000至600,000。
聚合物PIB也是本领域技术人员众所周知的。可以使用从巴斯夫公司(BASF)获得的Oppanol系列产品,例如等级B10、B12和B15。PIB的分子量适应于应用,例如分子量Mn小于100,000,优选40,000至60,000。
EVA
该类型的聚合物也是已知的。例如,可以使用含有30wt%至70wt%的单体丙烯酸乙烯酯的EVA。
可以使用LEVAMELT系列等级400或700或Evatane系列的那些EVA。
增粘剂树脂
本发明中使用的增粘剂树脂是常规的。
更确切地说,所使用的增粘剂树脂、增粘剂可以包括高活性增粘剂树脂(例如,基于萜烯树脂的高活性增粘剂树脂)、和/或具有中等活性的增粘剂树脂和/或具有低活性但还具有增强性质的增粘剂树脂的混合物。合适测试的说明可以参考文献EP1871845。
这些增粘剂树脂是常规的。因此可以使用萜烯型树脂,例如萜烯-苯乙烯,其软化温度可以为约105℃(环球法),质量分子量为约1000。还可以使用具有增强作用的树脂。例如,可以使用基本上由例如分子量在300至3000之间的α-甲基苯乙烯所衍生的热塑性聚合物。因此,可以调节组合物的弹性。还可使用完全氢化的树脂。
该树脂的示例是以名字Regalite、Arkon、Dercolyte、Piccolyte S、Zonatac、Kristalex、Piccotex和Escorez销售的树脂。
本领域技术人员将理解,各种类型树脂各自的量可以变化。
水胶体
由水胶体形式的亲水性聚合物构成的不连续相是本领域已知的类型,包含显著量化合物,例如,纤维素纤维、羧甲基纤维素、羧甲基纤维素钠、交联或其它形式的羧甲基纤维素、和羟乙基纤维素;以及类似于瓜尔胶的化合物;以及以下物质,例如黄原胶、藻酸盐、果胶、明胶、车前草、角豆树提取物、阿拉伯胶、琼脂糖、角叉菜胶和聚丙烯酰胺。
本发明所用的水胶体是常规的。
增塑剂
将使用增塑剂,更优选的是非极性油。该油或增塑剂的示例是聚α-烯烃,例如,以名字Durasyn可购得的一种聚α-烯烃。还可以使用矿物油、石蜡、蓖麻油、购自壳牌公司(Shell)的合成石蜡、购自太阳公司(Sun)的“Sun 5512”树脂、或购自赫科勒斯公司(Hercules)的“Primol”。
粘合剂组合物可以包含其它试剂或添加剂,如具有药物作用的试剂,例如选自壳聚糖和α-L-岩藻糖,或添加剂如抗氧化剂。
本发明还涉及一种用于使得包含上述粘合剂组合物的体液收集袋进行附着的元件,在与必须与皮肤接触一侧的相反的面上有本领域已知的常规涂层膜。
该膜是厚度合适的聚乙烯或EVA膜。
组合物的实施例
表中的组合物通过根据重量比例使得组分混合来制备。成分提供于表中。引入的顺序是表中出现的顺序。
在每次引入之后,进行约10分钟的混合,以获得良好的均匀性。最后的混合持续约50分钟。将由此获得的组合物以约60分钟的挤出时间、1mm厚的片材的形式挤出,并切割为元件,用于使得体液收集袋附着的测试。
然后对元件进行测试。
F最大和粘性:测试由如下组成:在确定的剥离前与组合物的接触时间以及剥离速度的条件下,使用牵引机进行冲头(punch)的剥离,并测定冲头剥离所需的力(F最大)。粘性用相同但接触时间非常短的测试进行测定。
F压缩和松弛(relaxation):所述测试由如下组成:在确定的与组合物接触的条件下,使用牵引机进行压缩测试,从而测定刚性(F压缩)以及松弛的能力(松弛%)。
下表提供了测试的组合物和测定值。
现在考虑根据本发明组合物的其它性质。
患者的测试
测试在医院环境条件下进行,即,其中通过医院人员进行安装和拆除。医院工作人员或患者确定了几个参数,其中有即时粘合性、去除组合物后皮肤上残留物的存在、袋子的易施用性、袋子的易拆除性、当由患者佩戴时袋子的适应性和粘合性。
所获得的结果是出色的,并且实现了折衷。
如此,本发明涉及对于造瘘袋具有所寻求的折衷的粘合剂组合物和用于附着的元件。
Claims (12)
1.一种旨在于提供与人皮肤进行附着的粘合剂组合物,其包含连续相以及水胶体不连续相,并且以粘合剂组合物的总重量为基准计,所述连续相包含:
(i)1wt%至12wt%的苯乙烯-异戊二烯-苯乙烯或苯乙烯-丁二烯-苯乙烯型的序列聚合物;
(ii)(a)1wt%至15wt%的丁基弹性体型聚合物,任选地与高达25wt%的聚异丁烯型聚合物混合,或者
(b)大于10wt%至30wt%的聚异丁烯型聚合物,不含丁基弹性体型聚合物,
(iii)1%至小于10%的乙烯-乙酸乙烯酯型聚合物,
并且,这三种类型聚合物的总和为10wt%至40wt%,
其中,所述组合物不含极性油,并且/或者,其中,极性相占小于10wt%,
其中,所述组合物包含40wt%至60wt%的水胶体不连续相。
2.如权利要求1所述的组合物,其特征在于,所述连续相包含:
(i)2wt%至8wt%的苯乙烯-异戊二烯-苯乙烯或苯乙烯-丁二烯-苯乙烯型的序列聚合物;
(ii)(a)2wt%至10wt%的丁基弹性体型聚合物,任选地与高达25wt%的聚异丁烯型聚合物混合,
(iii)2wt%至小于10wt%的乙烯-乙酸乙烯酯聚合物。
3.如权利要求1所述的组合物,其包含:
(ii)(a)2%至10%的丁基弹性体型聚合物,不含聚异丁烯型聚合物。
4.如权利要求1所述的组合物,其包含:
(ii)(a)2wt%至10wt%的丁基弹性体型聚合物,与10wt%至25wt%的聚异丁烯型聚合物混合。
5.如权利要求1所述的组合物,其特征在于,所述连续相包含:
(i)2wt%至8wt%的苯乙烯-异戊二烯-苯乙烯或苯乙烯-丁二烯-苯乙烯型的序列聚合物;
(ii)(b)15wt%至30wt%的聚异丁烯型聚合物,不含丁基弹性体型聚合物,
(iii)2wt%至小于10wt%的乙烯-乙酸乙烯酯聚合物。
6.如权利要求1所述的组合物,其特征在于,乙烯-乙酸乙烯酯聚合物包含30wt%至70wt%的乙酸乙烯酯单体。
7.如权利要求1所述的组合物,其包含10wt%至30wt%的增粘剂树脂。
8.如权利要求1所述的组合物,其特征在于,所述不连续相主要包含选自下组的至少一种化合物:纤维素纤维、羧甲基纤维素、羧甲基纤维素钠、交联或其它的羧甲基纤维素、羟乙基纤维素、瓜尔胶、刺梧桐树胶、阿拉伯树胶、黄原胶、淀粉、藻酸盐、果胶、明胶、车前草、角豆树提取物、琼脂糖、角叉菜胶、聚丙烯酰胺;或它们的混合物。
9.如权利要求1所述的组合物,其特征在于,所述不连续相不含动物来源的产物。
10.一种用于使得包含如前述权利要求中任一项所述的粘合剂组合物的体液收集袋进行附着的元件,并且,在与意图与皮肤接触一侧相反的面上有膜。
11.如权利要求10所述的元件,其特征在于,所述膜是聚乙烯膜、或者乙烯-丙烯酸乙烯酯共聚物、或者它们的混合物。
12.如权利要求11所述的元件,其特征在于,所述膜的厚度为25至100μm。
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