CN106459693A - 用于医学应用的改进的压敏粘合剂 - Google Patents
用于医学应用的改进的压敏粘合剂 Download PDFInfo
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Abstract
描述了粘合剂组合物,其包括与一种或多种非凝胶崩解剂组合的一种或多种胶凝剂。粘合剂组合物呈现相对高的流体处理能力和静态吸收性能,因而使其能够在广泛范围的医学应用中使用。还描述了利用粘合剂组合物的多种粘合剂制品——诸如敷料——和使用的相关方法。在优选的实施方式中,粘合剂组分是丙烯酸粘合剂,胶凝剂选自(i)羧甲基纤维素、(ii)高吸收性聚合物、和(iii)(i)和(ii)的组合,并且非凝胶崩解剂选自(i)完全预胶化马铃薯淀粉、(ii)微晶纤维素、和(iii)(i)‑(ii)中任一个的组合。
Description
相关申请的交叉引用
本申请要求2014年6月13日提交的美国临时申请号62/011,654的权益,其通过引用以其全部并入本文。
技术领域
本主题涉及压敏粘合剂、使用这种粘合剂的制品、和相关方法。
背景技术
用于医学应用——诸如外科敷料——中的压敏粘合剂通常包括水胶体,其在水的存在下形成凝胶。亲水性凝胶的形成促进伤口的自溶清创和随后愈合。
胶凝剂已被并入医学粘合剂中以增加水和流体——诸如伤口渗出液——通过粘合剂的静态吸收。然而,大部分胶凝剂是相对昂贵的并且消极地影响所得组合物的粘合性能。而且,水胶体颗粒已被分散在粘合剂基体内。然而,由于粘合剂基体通常是疏水性的,当水胶体颗粒彼此形成结合时发生水分穿过粘合剂的转移。这是对吸收的限制因素并且可能需要相对高负载的这种颗粒。因此,存在对于新策略的需求,在该策略中可以增加粘合剂的静态吸收和总体流体处理能力,而不会不期望地降低粘合性能或需要高负载的水胶体颗粒。
发明内容
本主题涉及压敏粘合剂,其包括至少一种胶凝剂和至少一种非凝胶崩解剂。并入非凝胶崩解剂提高了水分穿过粘合剂的转移并且提高了胶凝剂之间架桥,从而导致增强的静态吸收和流体处理能力。
在一个方面,本主题提供粘合剂组合物,其包括至少一种粘合剂组分、从5%至40%的至少一种胶凝剂、和从5%至40%的至少一种非凝胶崩解剂。
在另一个方面,本主题提供粘合剂制品,其包括限定第一面和第二面的薄膜衬底。制品还包括布置在第一面和第二面的至少一个上的粘合剂组合物,粘合剂组合物包括(i)至少一种粘合剂组分、(ii)从5%至40%的至少一种胶凝剂、和(iii)从5%至40%的至少一种非凝胶崩解剂。
在又另一个方面,本主题提供促进伤口愈合的方法,其包括提供包括薄膜衬底和布置在衬底上的粘合剂组合物层的粘合剂制品。粘合剂组合物包括(i)至少一种粘合剂组分、(ii)从5%至40%的至少一种胶凝剂、和(iii)从5%至40%的至少一种非凝胶崩解剂。方法还包括在伤口上施加粘合剂制品使得粘合剂组合物层朝向伤口定向并覆盖伤口。
将认识到,本文描述的主题可以是其他的和不同的实施方式并且其若干细节能够在许多方面改进,所有都不脱离要求保护的主题。因此,该描述被认为是说明性的而不是限制性的。
具体实施方式
本主题涉及压敏粘合剂组合物。粘合剂组合物包括(i)粘合剂组分或基体、(ii)一种或多种胶凝剂、和(iii)一种或多种非凝胶崩解剂。组合物呈现相对高的静态吸收(SA)、透潮率(MVTR)和流体处理能力(FHC)特性。在许多实施方式中并且如本文所述,通过添加微晶纤维素或其他试剂可以增加或提高静态吸收和MVTR。组合物还呈现与皮肤极好的相容性,从而使它们能够在医学领域使用以便将制品粘附至患者。
本主题还涉及粘合剂制品,并且具体涉及使用所提到的粘合剂组合物的医学制品。粘合剂制品包括一个或多个衬底或层、和本文所述的粘合剂组合物的至少一个层或区域。
本主题另外地涉及使用本文所述的粘合剂组合物的方法。方法通常涉及促进伤口愈合。
组合物
本主题的组合物将发现作为在医学应用——诸如控制伤口渗出液——中使用的流体管理粘合剂组合物的广泛应用。然而,本主题包括其他应用并且不限于医学领域。组合物包括一种或多种粘合剂组分、和一种或多种胶凝剂和一种或多种非凝胶崩解剂的组合。以本文所述的比例和方式的胶凝剂(一种或多种)与非凝胶崩解剂的组合的使用已被发现提供所得的粘合剂组合物的一系列有益性能。在许多实施方式中,粘合剂组合物是高透气性的。如本文使用的术语“高透气性的”是指呈现至少2000g/m2/24小时的流体处理能力(FHC)或至少800g/m2/24h的MVTR的粘合剂。
粘合剂组分
可以使用广泛系列的粘合剂。在许多实施方式中,利用溶剂基粘合剂。这种粘合剂的非限制性实例包括丙烯酸粘合剂、橡胶粘合剂、硅树脂粘合剂、聚氨酯粘合剂、混合粘合剂、以及其变体和组合。在某些实施方式中,粘合剂是压敏溶剂基粘合剂。具体地,粘合剂是压敏溶剂基丙烯酸粘合剂。
在Encyclopedia of Polymer Science and Engineering,Vol.13.Wiley-Interscience Publishers(纽约,1988)中可见有用的压敏粘合剂的描述。在Encyclopediaof Polymer Science and Technology,Vol.1,Interscience Publishers(纽约,1964)中可见有用的压敏粘合剂的另外的描述。
溶剂基丙烯酸粘合剂可以是能够粘附至哺乳动物皮肤并且不含已知对哺乳动物引起过度刺激或毒性的成分的任何压敏粘合剂。有用的丙烯酸酯共聚物可以是或可以不是自交联的并且由选自以下的至少两种单体形成:(1)丙烯酸或甲基丙烯酸的羟烷基酯,其中烷基包括2至4个碳原子,诸如丙烯酸-2-羟乙酯、甲基丙烯酸-2-羟乙酯、丙烯酸-2-羟丙酯和甲基丙烯酸-2-羟丙酯;(2)丙烯酸或甲基丙烯酸的烷基酯,其中酯的烷基包括4至18个碳原子,诸如丙烯酸正丁酯或甲基丙烯酸正丁酯、丙烯酸异丙酯或甲基丙烯酸异丙酯、甲基丙烯酸正己酯和丙烯酸-2-乙基己酯;(3)α,β-不饱和单羧酸或二羧酸、它们的酸酐和它们的烷基或烯基酯,其中烷基含有从1至3个碳原子并且烯基含有从2至5个碳原子,诸如丙烯酸、衣康酸、马来酸、马来酸酐、甲基丙烯酸烷基酯和富马酸或马来酸的二乙酯;(4)乙烯基单体,诸如乙酸乙烯酯、丙烯腈、丙酸乙烯酯、乙烯基吡咯烷酮和苯乙烯;(5)含有选自酰氨基、氨基和环氧基的官能团的单体,例如,丙烯酰胺、N-丁基丙烯酰胺、丙烯酸或甲基丙烯酸的烷基氨基烷基和氨基烷基衍生物,诸如氨基丙烯酸乙酯、氨基甲基丙烯酸乙酯和2-(二甲基氨基)甲基丙烯酸乙酯、甲基丙烯酸缩水甘油酯和丙烯酸缩水甘油酯;(6)丙烯酸或甲基丙烯酸的烷氧基烷基酯,例如甲氧基丙烯酸乙酯或甲氧基甲基丙烯酸乙酯、丁氧基丙烯酸乙酯或丁氧基甲基丙烯酸乙酯、甲氧基丙二醇丙烯酸酯或甲氧基丙二醇甲基丙烯酸酯和甲氧基聚乙二醇丙烯酸酯或甲氧基聚乙二醇甲基丙烯酸酯;和(7)1,6-己二醇二甲基丙烯酸酯。因为这些共聚物可以是自交联的,所以它们还可以含有选自本领域技术人员通常使用的那些交联剂,例如,有机过氧化物、多异氰酸酯、螯合物或金属——诸如钛或铝、或金属乙酰丙酮化物——诸如锌、镁和铝的乙酰丙酮化物。
这些粘合剂丙烯酸酯共聚物可以采取溶剂系统中的溶液的形式,该溶剂系统由单一有机溶剂或几种溶剂的混合物组成,其含有按重量计大约25%至大约55%的共聚物。合适的溶剂的实例包括芳香族溶剂,诸如甲苯、二甲苯等。合适的脂肪族溶剂包括酯类,诸如乙酸乙酯、乙酸丙酯、乙酸异丙酯、乙酸丁酯等;酮类,诸如甲基乙基酮、丙酮等;脂肪烃诸如庚烷、己烷、戊烷等。可以包括不影响粘合剂的基本性能的粘合剂组合物添加剂材料。填料、增粘剂、抗氧化剂、稳定剂等可以被添加至配方粘合剂。进一步地,不影响粘合剂的基本性能的药学活性组分,诸如例如,抗菌剂、抗炎剂、止痛剂、麻醉剂或其他药学上可接受的化合物可以以药学有效量包括在粘合剂层中。
有用的商业上可获得的粘合剂的实例是从Henkel Corporation可获得的DUROTACK 129A,其是在庚烷/异丙醇/乙酸乙酯/甲苯的溶剂掺合物中含有按重量计51%的固体的自固化丙烯酸压敏粘合剂。有用的商业可获得的粘合剂的另一个实例是从Henkel可获得的DUROTAK 380-2819,其是在乙酸乙酯/异丙醇/庚烷/甲苯/戊二酮的溶剂掺合物中含有按重量计40%的固体的自交联的溶液丙烯酸压敏粘合剂。
适合用于本主题中的粘合剂的另外的实例和其方面,包括美国专利号7,078,582中描述的那些。
虽然压敏粘合剂是优选的,但是应当理解本主题不限于此。
可以利用一种或多种橡胶基粘合剂。优选的橡胶基粘合剂的非限制性实例包括一种或多种苯乙烯-异戊二烯-苯乙烯聚合物、包括苯乙烯-乙烯/丙烯-苯乙烯聚合物的苯乙烯-烯烃-苯乙烯聚合物、聚异丁烯、苯乙烯-丁二烯-苯乙烯聚合物、聚异戊二烯、聚丁二烯、天然橡胶、硅树脂橡胶、丙烯腈橡胶、丁腈橡胶、聚氨酯橡胶、聚异丁烯橡胶、丁基橡胶、包括溴丁基橡胶的卤代丁基橡胶、丁二烯-丙烯腈橡胶、氯丁橡胶和苯乙烯-丁二烯橡胶。可以采用弹性体的掺合物或混合物。
可以使用多种硅树脂粘合剂和/或硅胶粘合剂。硅树脂和/或硅胶粘合剂的实例包括但不限于从Dow Corning Corp.,Medical Products商业上可获得的那些和从GeneralElectric可获得的那些。从Dow Corning可获得的硅树脂粘合剂的实例包括以商品名BIO-PSA X7-3027、BIO-PSA X7-4919、BIO-PSA X7-2685、BIO-PSA X7-3122和BIO-PSA X7-4502销售的那些。在美国专利号4,591,622、4,584,355、4,585,836和4,655,767中描述了在本主题中有用的硅树脂压敏粘合剂的另外的实例。
胶凝剂
一般地,选择用于并入粘合剂组合物中的胶凝剂包括在与水分接触之后形成凝胶的任何物质。粘合剂中使用的通常的胶凝剂包括诸如羧甲基纤维素、羟乙基纤维素、甲基纤维素、交联羧甲基纤维素钠(crosscarmellose sodium)、淀粉乙醇酸酯等的材料。在本主题的具体实施方式中,胶凝剂可以选自(i)羧甲基纤维素和(ii)交联羧甲基纤维素钠中的一种或多种。
羧甲基纤维素的实例是商业上可获得的A800羧甲基纤维素。
交联羧甲基纤维素钠是内部交联的羧甲基纤维素钠。具体地,交联羧甲基纤维素钠是交联的、部分O-(羧甲基化)纤维素的钠盐。交联羧甲基纤维素钠的实例是从DMV-Fonterra商业上可获得的PRIMELLOSE。
本主题不限于用于胶凝剂的纤维素衍生的材料的使用。而是,在某些实施方式中,组合物可以包括代替纤维素衍生的材料或者与纤维素衍生的材料组合的其他胶凝剂。例如,合适的胶凝剂包括水胶体,诸如明胶、果胶、瓜耳胶、槐树豆胶、黄蓍胶、刺梧桐树胶、阿拉伯树胶、藻酸和其钠盐和/或钙盐。其他合成的水胶体——诸如聚乙烯醇、聚乙酸乙烯酯、聚乙烯吡咯烷酮、聚丙烯酸、聚羟烷基丙烯酸酯、聚丙烯酰胺、高分子量聚乙二醇和聚丙二醇——可以是有用的。其他水胶体包括交联的葡聚糖和淀粉-丙烯腈接枝共聚物。淀粉乙醇酸钠是淀粉的羧甲基醚的钠盐。淀粉乙醇酸钠的分子量通常在从500,000至11,000,000的范围内。
在本主题的某些实施方式中,胶凝剂可以包括一种或多种高吸收性聚合物(SAP)。
粘合剂组合物中有用的高吸收性聚合物(SAP)包括水可膨胀的、形成水凝胶的吸水性聚合物,其能够吸收大量的液体——诸如水、体液(例如,尿液、血液)等。此外,SAP能够在中等压力下保留这种吸收的流体。通常,SAP吸收其自身重量的许多倍的水,具体地至少50倍,更具体地至少100倍,和最具体地至少150倍其重量的水。此外,SAP呈现在负载下良好的盐水流体吸收和高盐水流体吸收能力。通常,SAP吸收至少10倍,具体地至少30倍,并且更具体地至少50倍其重量的盐水流体。尽管SAP能够吸收许多倍其自身重量的水和/或盐水,但是它不会溶解在这些流体中。
SAP吸收水和/或盐水流体的能力与SAP中存在的交联度有关。增加交联度增加了SAP在负载下的总流体保持能力。交联度通常被优化以获得其中吸收的速率和量被优化的组合物。具体的SAP是至少10%,更具体地从大约10%至大约50%,并且最具体地从大约20%至40%交联的。合适的SAP的实例包括交联的和聚合的α,β-β烯键式不饱和单羧酸和二羧酸和酸酐单体,其包括例如丙烯酸、甲基丙烯酸、巴豆酸、马来酸/马来酸酐、衣康酸、富马酸、和其组合。
本主题中有用的高吸收性聚合物包括,例如,交联的丙烯酸酯聚合物、乙烯醇-丙烯酸酯共聚物的交联产物、马来酸酐接枝聚乙烯醇的交联产物、丙烯酸酯-甲基丙烯酸酯共聚物的交联产物、丙烯酸甲酯-乙酸乙烯酯共聚物的交联皂化产物、淀粉丙烯酸酯接枝共聚物的交联产物、淀粉丙烯腈接枝共聚物的交联皂化产物、羧甲基纤维素聚合物的交联产物和异丁烯-马来酸酐共聚物的交联产物、和其组合。
高吸收性颗粒优选地是球形的并且具有从大约1微米(μm)至大约400(μm)的平均颗粒尺寸。在许多实施方式中,颗粒具有从大约20μm至大约200μm,并且具体地从20μm至150μm的平均颗粒尺寸。在一个实施方式中,颗粒的颗粒尺寸小于150μm,或小于100μm。有用的商业上可获得的高吸收性颗粒包括,例如,以AQUA KEEP系列商品名可获得的聚丙烯酸钠高吸收性颗粒,其包括,例如,以商品名AQUA KEEP 1 OSH-NF可获得的具有从大约20μm至大约30μm的平均颗粒尺寸的颗粒,以商品名AQUA KEEP 10SH-P可获得的具有从200μm至300μm的平均颗粒尺寸的颗粒,以商品名AQUA KEEP SA60S可获得的具有从320μm至370μm的平均颗粒尺寸的颗粒,以商品名AQUA KEEP SA60SX、SA55SXπ和SA 60SL II可获得的具有从350μm至390μm的平均颗粒尺寸的颗粒,和从Sumitomo Seika Chemicals Col,Ltd.(日本)以商品名AQUA KEEP SA60N TYPE II可获得的具有从250λm至350μm的平均颗粒尺寸的颗粒。还可获得的高吸收性材料是来自BASF,Ludwigshafen,Germany的Luquasorb 1010和Luquasorb1030。
在某些实施方式中,本主题的组合物包括从5%至40%,和在具体的实施方式中从10%至35%的总重量比例的一种或多种胶凝剂。
非凝胶崩解剂
本主题的组合物还包括一种或多种非凝胶崩解剂。崩解剂是用于促进药物释放的赋形剂,当其被添加至片剂并且当与水性流体接触时引起片剂解体。本文所使用的术语“非凝胶崩解剂”是指在与流体接触期间和与流体接触之后不形成凝胶的崩解剂。具体地,非凝胶崩解剂用于促进水通过粘合剂组合物的吸收和贯穿,增加组合物的总孔隙率,和/或增加组合物的毛细管作用或芯吸作用;同时不形成凝胶。非凝胶崩解剂可以选自(i)微晶纤维素、(ii)马铃薯淀粉和(iii)改性淀粉中的一种或多种。还可以使用(i)-(iii)的组合。
可以使用广泛系列的微晶纤维素材料。这种材料的实例是从FMC Biopolymer商业上可获得的AVICEL PH105。
可以使用广泛系列的马铃薯淀粉。马铃薯淀粉经受一种或多种操作以完全地预胶化马铃薯淀粉。通常可以利用诸如在水的存在下加热淀粉分子的操作从而允许分子中的氢键合位点接合更多水。这不可逆地溶解淀粉颗粒。本文所使用的术语“预胶化的淀粉”是指在水的存在下已被化学和/或机械加工以使所有或部分淀粉颗粒破裂并且随后干燥的淀粉。例如,通过马铃薯淀粉的受控的热预胶化接着喷雾干燥可以制备完全预胶化的淀粉。通常完全预胶化的淀粉极易溶解在冷水中。完全预胶化的马铃薯淀粉的实例是从DMV-Fonterra商业上可获得的PREJEL。化学交联的和羧甲基化的马铃薯淀粉的实例是从DMV-Fonterra商业上可获得的PRIMOJEL。
在某些实施方式中,本主题的组合物包括从5%至40%,和在具体的实施方式中从15%至35%的总重量比例的一种或多种非凝胶崩解剂。
可以利用多种颗粒尺寸的非凝胶崩解剂(一种或多种)。在本主题的许多实施方式中,选择非凝胶崩解剂(一种或多种)使得在并入组合物中之后,崩解剂(一种或多种)被有效地并入粘合剂组分中。在许多实施方式中,已经发现小于大约200微米的颗粒尺寸是有用的。例如,在某些实施方式中,非凝胶崩解剂是微粒形式并且具有从大约1微米至大约150微米、更具体地在从10至100微米的范围内,并且在某些实施方式中在从20至80微米范围内的平均颗粒尺寸。然而,本主题包括使用具有20微米或更大的颗粒尺寸的非凝胶崩解剂(一种或多种)的颗粒尺寸。
虽然非凝胶崩解剂(一种或多种)已经被描述为(i)马铃薯淀粉和具体地完全预胶化的马铃薯淀粉和(ii)微晶纤维素中的一种或多种,但是应当理解本主题包括使用其他合适的非凝胶崩解剂。
另外的添加剂
一种或多种另外的添加剂可以并入到粘合剂组合物。具体地,另外的添加剂包括药用化合物。这种药用化合物包括但不限于抗菌剂、抗生素、抗真菌剂、抗病毒剂、抗凝血剂、麻醉剂、抗炎剂、止痛剂、抗癌剂、血管舒张物质、伤口愈合剂、血管生成剂、血管生成抑制剂(angiostatic agent)、免疫增强剂(immune boosting agent)、生长因子和其他生物制剂。合适的抗菌剂包括但不限于双胍化合物、三氯生、青霉素、四环素、氨基糖苷——诸如庆大霉素和妥布霉素TM、多粘菌素、利福平、杆菌肽、红霉素、万古霉素、新霉素、氯霉素、咪康唑、喹诺酮——诸如奥索利酸、诺氟沙星、萘啶酸、培氟沙星、依诺沙星和环丙沙星、氨磺酰、壬苯聚醇9、梭链孢酸、头孢菌素和这种化合物和类似化合物的组合。另外的抗菌剂化合物提供提高的抗菌活性。
在一个实施方式中,压敏粘合剂含有能够经皮吸收或递送至皮肤表面上的一种或多种药物(一种或多种)。如本文所使用,术语“药物”是指包括至少一种活性成分的组合物,其可以与适合用于皮肤施加的药学上可接受的载体一起被添加至压敏粘合剂层。在某些实施方式中,药物可以进一步包括一种或多种赋形剂,其包括但不限于防腐剂、抗氧化剂、保湿剂、软化剂、缓冲剂、增溶剂、渗透增强剂、皮肤保护剂、和其混合物。
粘合剂制品
本主题还包括广泛系列的粘合剂制品和具体地使用所提到的组合物的粘合剂医学制品。制品包括一个或多个衬底或其他层或组分,所提到的粘合剂组合物的一个或多个层或区域,和通常覆盖粘合剂组合物的层或区域的衬垫或衬垫组件。制品可以任选地包括一个或多个覆盖层或背衬层或组分。
衬底或其他层(一个或多个)
衬底材料包括但不限于弹性聚氨酯、聚酯、或聚醚酰胺膜。期望的性能包括高透潮性和透氧性、弹性、一致性以及在某些实施方式中的透明性。一次性次级背衬膜诸如聚丙烯(PP)或聚乙烯(PE)可用于提供额外的处理的容易性。可选地,透气的纸或织物背衬还可以适合使用。在“A Review on Designing the Waterproof Breathable Fabrics”,A.Mukhopadhyay;V.K.Midha,Journal of Industrial Textiles,Part 1-37,225(2008)&Part II-38,17(2008)和美国专利号6,495,229和相关专利中提供了这种纸或织物背衬的另外的实例。
广泛系列的材料可用于一种或多种覆盖层或背衬层(一个或多个),诸如但不限于聚氨酯、纸、聚乙烯、聚丙烯和其它聚合物膜层。每种这些材料的具体方面如下。
聚氨酯-由三层聚合物纤维组成的熔喷非织造纤维网,其具有掺合的聚乙烯和KRATON的中心层、压敏粘合剂,和聚氨酯的外层;如在Joseph等的美国专利号6,107,219中针对背衬样品16所述制备;表示合适的弹性、不可撕裂背衬或覆盖层。
纸-HammermillLaserprint纸(0.11mm厚度,产品号00460-4,InternationalPaper,Memphis,Tenn.);表示通常不可拉伸的、可撕裂的背衬。
聚乙烯-熔喷非织造聚乙烯(0.04mm厚,型号TM07-27-98-02,Trans Web LLC,Vineland,N.J.);表示通常可拉伸的、可撕裂的背衬。
聚丙烯-熔喷非织造聚丙烯(基重20g/m2,Kimberly Clark,Irving,Tex.);表示通常不可拉伸的、可撕裂的背衬。
膜-包括60%的乙烯/乙酸乙烯酯共聚物、35%的线性低密度聚乙烯、5%的稳定剂和其他添加剂的聚合物膜(PGI产品号6012,Polymer Group,Inc.,Gainesville,Ga.);膜具有1.15oz/yd2(27g/m2)的基重,5密耳(0.13mm)厚,并且具有椭圆形的孔(在最大尺寸上大约0.2mm宽乘0.3mm长),其中椭圆孔的长度尺寸平行于膜的纵向取向。膜具有以交错线模式排列的大约530个孔/cm2。膜的一侧是“平滑的”(微蚀刻/压纹以便平滑)并且另一面是“粗糙的”(使材料被推出以形成孔的侧)。
在美国专利号7,078,582中描述了适合用于覆盖层的多种材料的另外的细节。优选的衬底可以是防水的,具有至少800g/m2/24小时的透气性并且可以具有从0.20至3密耳的厚度。
粘合剂层或区域
粘合剂制品包括所提到的粘合剂组合物的一个或多个层或区域。粘合剂层或区域被通过已知的施加技术施加或以其他方式沉积在衬底上。通常,粘合剂以层的形式被施加,其具有从0.01mm至大约5mm或更厚,并且在具体实施方式中在从0.05mm至2mm的厚度范围内的厚度。粘合剂的表面覆盖率可以从5%(在这种情况中,这将是花样涂布)至100%(完全涂布的衬底)变化。
衬垫
用于衬垫的合适的材料包括用牛皮纸、聚酯、聚丙烯(PP)、聚乙烯(PE)或其他复合构造制成的那些。剥离涂层优选地用提供有益性能的低能量材料如硅氧烷、含氟化合物等涂布。在Handbook of Pressure Sensitive Adhesives,Van Nostrand Reinbhold,1982第384页第18章中提供了代表性的硅氧烷材料的实例。美国专利号4,472,480中描述了合适的含氟化合物的实例。
本主题包括这些材料的多种组合。在使用最佳面材、粘合剂和衬垫组合设计功能层压材料中本领域技术人员将领会具体的选择和应用。
本文所述的本主题制品可以并入广泛系列的医学产品或者与广泛系列的医学产品结合使用。这种产品的代表性的实例包括但不限于绷带、敷料、纱布、带和相关产品,伤口闭合产品诸如补片(patch)、覆盖物(cover)等,闭合条泡沫填料、手术带和垫。在其中本主题制品被并入真空辅助闭合(VAC)产品和治疗中和/或与真空辅助闭合(VAC)产品和治疗结合使用的许多应用是预期的。
方法
本主题还提供使用所提到的组合物的多种方法。方法针对促进伤口愈合,其还可以包括吸收流体——诸如伤口渗出液,和流体管理应用。一般地,方法包括提供诸如本文所述的粘合剂制品的一种或多种操作,该粘合剂制品包括所提到的粘合剂组合物的至少一个层或区域。通常,粘合剂制品是敷料的形式。方法还包括沿着患者的皮肤或其他身体区域施加粘合剂制品至生物表面——诸如暴露的伤口区域——上的一种或多种操作。施加制品使得粘合剂层或区域朝向伤口区域定向,并且在许多应用中接触伤口区域。作为所提到的组合物的独特的流体处理特性的结果,方法实现了下列中的一个或多个:促进伤口愈合、吸收流体——诸如伤口渗出液、和管理或控制伤口中或伤口周围的流体。
实施例
进行了一系列的试验以评价本主题的组合物。组合物包括粘合剂组分、胶凝剂和非凝胶崩解剂。粘合剂是从Henkel商业上可获得的DUROTAK 129A。胶凝剂选为从多个供应商商业上可获得的A800羧甲基纤维素。非凝胶崩解剂选自从FMC Biopolymer以名称AVICELPH105可获得的微晶纤维素。
参考以下阐述的表1,使用所提到的组分以指定的重量百分比制备样品1-9:
对于样品1-3,评价的组合物包括A800组分作为胶凝剂,没有任何其他组分。在样品7-9中,评价的组合物包括AVICEL PH105作为崩解剂组分,没有任何其他组分。样品4-6评价了胶凝剂和非凝胶崩解剂的组合。样品4-6对应于本主题的实施方式。
以下测试方法用于评价表1中提到的样品:
表2-测试方法
测试 | 标准 |
180°剥离 | --- |
透潮率(MVTR) | T06/022,EN13726,ASTM E 96-80 |
静态吸收(SA) | T06/022,EN13726,ASTM E 96-80 |
流体处理能力(FHC) | T06/022,EN13726,ASTM E 96-80 |
180度剥离
直接涂布在PET膜上或者从剥离衬垫层压至PET膜的粘合剂的样品被切割成大约2.54cm×大约20cm的测试条。用以大约30cm/min的速率来回移动的2kg橡胶包覆的钢辊筒将粘合剂样品滚压在不锈钢、HDPE或卡纸板的测试板上。在24小时的停留时间之后,以针对测试板180度——即,在其自身上向后折叠并且平行于板的表面——并且以大约30cm/min的速率,在Instron Tensile Tester中从测试板剥离测试条。以牛顿每米(N/m)计测量从测试板去除粘合剂条的力。进行三次测试并且报告平均值。
透潮率、静态吸收和流体处理能力
在T06/022(其对应于EN13726和ASTM E 96-80)中阐述了用于测量透潮率(MVTR)、静态吸收(SA)和流体处理能力(FHC)的方法,并且方法一般地如下。
流体处理能力是复合材料吸收水分并将其蒸发至环境的组合能力的测量。透潮率(MVTR)测量以克/米/天为单位测量的水分渗透穿过伤口敷料的速率。静态吸收测量吸收到已知表面的流体的量。通过将切割成Paddington杯的尺寸的样品在具有橡胶圈的面上层压至杯子进行该测试。将环形密封圈放置在杯子的样品上并且固定螺杆。称重杯子(W1)。然后倒置杯子并且用20ml的NaCl溶液(在去离子水中0.9%wt)填充。将金属密封板固定至杯子的顶面。称重填充的杯子(W2)。以样品面向下将杯子放置到在37℃的烘箱中持续24小时。在24小时之后,将杯子从烘箱移除并且允许冷却至室温持续30分钟。然后称重杯子(W3)。去除金属密封板并且清空杯子。使杯子在纸巾(tissue)上静置15分钟以去除NaCl溶液,并且然后称重(W4)。测试条件是23℃(±2°)和50%(±2%)的相对湿度。透潮率(MVTR)等于(W2-W3)×1000。静态吸收等于(W4-W1)×1000。如下确定以g/m2/24小时计的流体处理能力(FHC):FHC=(W2-W3)+(W4-W1)。
参考表1,可见在实施例4-6中具有胶凝剂和非凝胶崩解剂的根据本主题的粘合剂组合物,呈现相对高的透潮率(MVTR),诸如例如大于1320g/m2/24小时;相对高的静态吸收性能,诸如例如大于1450g/m2/24小时;和相对高的流体处理能力,诸如例如大于2000g/m2/24小时,在某些实施方式中大于2200g/m2/24小时,在某些实施方式中大于2400g/m2/24小时,在某些实施方式中大于2600g/m2/24小时,和在具体的实施方式中大于2800g/m2/24小时。
与本文所述的胶凝剂(一种或多种)组合使用非凝胶崩解剂(一种或多种)在某些实施方式中可以用于增加粘合剂组合物的静态吸收和流体处理能力。因而,通过使用较少的胶凝剂配方设计师可以节省成本,并且通过并入非凝胶崩解剂(一种或多种)仍然获得相同或更高水平的静态吸收、MVTR和流体处理能力。此外,在使用非凝胶崩解剂(一种或多种)时,在某些应用中可以降低胶凝剂的量,其从而增加压敏粘合剂的初始粘性。
关于180度剥离特性还评价了根据本主题的组合物。组合物呈现相对低的180°剥离值,诸如例如小于0.196N/m。这表明了它们作为可以从皮肤去除而不损害皮肤的医学制品中的皮肤粘合剂的潜在有用性。
从该技术的未来应用和发展中许多其他益处无疑将变得显而易见。
本文所提到的所有专利、申请、标准和文章在此通过引用以其全部并入。
本主题包括本文所述的特征和方面的所有可操作的组合。因而,例如,如果与一个实施方式相关联地描述了一个特征并且与另一个实施方式相关地描述了另一个特征,应当理解本主题包括具有这些特征的组合的实施方式。
如上所述,本主题解决了与先前的策略、系统和/或装置相关联的许多问题。然而,将领会的是,本领域技术人员可以对组分的细节、材料和排列中的做出多种改变——其已在本文中描述并阐明以便解释本主题的性质——而不脱离如所附权利要求中所表达的要求保护的主题的原理和范围。
Claims (45)
1.一种粘合剂组合物,其包括:
至少一种粘合剂组分;
从5%至40%的至少一种胶凝剂;和
从5%至40%的至少一种非凝胶崩解剂。
2.根据权利要求1所述的组合物,其中所述粘合剂组分是压敏粘合剂。
3.根据权利要求1-2中任一项所述的组合物,其中所述粘合剂组分是溶剂基粘合剂。
4.根据权利要求1-3中任一项所述的组合物,其中所述粘合剂组分是丙烯酸粘合剂。
5.根据权利要求1-4中任一项所述的组合物,其中所述胶凝剂选自(i)羧甲基纤维素、(ii)高吸收性聚合物、和(iii)(i)和(ii)的组合。
6.根据权利要求1-5中任一项所述的组合物,其中所述非凝胶崩解剂选自(i)完全预胶化马铃薯淀粉、(ii)微晶纤维素、和(iii)(i)-(ii)中任一个的组合。
7.根据权利要求1-6中任一项所述的组合物,其进一步包括:
至少一种另外的添加剂。
8.根据权利要求1-7中任一项所述的组合物,其中所述组合物呈现至少2000g/m2/24小时的流体处理能力(FHC)。
9.根据权利要求8所述的组合物,其中所述组合物呈现至少2200g/m2/24小时的流体处理能力。
10.根据权利要求8所述的组合物,其中所述组合物呈现至少2400g/m2/24小时的流体处理能力。
11.根据权利要求8所述的组合物,其中所述组合物呈现至少2600g/m2/24小时的流体处理能力。
12.根据权利要求8所述的组合物,其中所述组合物呈现至少2800g/m2/24小时的流体处理能力。
13.根据权利要求1-12中任一项所述的组合物,其中所述组合物呈现至少800g/m2/24小时的透潮率(MVTR);和至少500g/m2/24小时的静态吸收(SA)。
14.根据权利要求1-12中任一项所述的组合物,其中所述组合物呈现至少1320g/m2/24小时的透潮率(MVTR);和至少1450g/m2/24小时的静态吸收(SA)。
15.根据权利要求1-14中任一项所述的组合物,其中所述组合物呈现小于0.196N/m的180°剥离值。
16.一种粘合剂制品,其包括:
限定第一面和第二面的薄膜衬底;和
布置在所述第一面和第二面的至少一个上的粘合剂组合物,所述粘合剂组合物包括(i)至少一种粘合剂组分,(ii)从5%至40%的至少一种胶凝剂,和(iii)从5%至40%的至少一种非凝胶崩解剂。
17.根据权利要求16所述的制品,其中所述粘合剂组分是压敏粘合剂。
18.根据权利要求16-17中任一项所述的制品,其中所述粘合剂组分是溶剂基粘合剂。
19.根据权利要求16-18中任一项所述的制品,其中所述粘合剂组分是丙烯酸粘合剂。
20.根据权利要求16-19中任一项所述的制品,其中所述胶凝剂选自(i)羧甲基纤维素、(ii)高吸收性聚合物、和(iii)(i)和(ii)的组合。
21.根据权利要求16-20中任一项所述的制品,其中所述非凝胶崩解剂选自(i)完全预胶化的马铃薯淀粉、(ii)微晶纤维素、和(iii)(i)-(ii)中任一项的组合。
22.根据权利要求16-21中任一项所述的制品,其进一步包括:
至少一种另外的添加剂。
23.根据权利要求16-22中任一项所述的制品,其中所述组合物呈现至少2000g/m2/24小时的流体处理能力(FHC)。
24.根据权利要求23所述的制品,其中所述组合物呈现至少2200g/m2/24小时的流体处理能力。
25.根据权利要求23所述的制品,其中所述组合物呈现至少2400g/m2/24小时的流体处理能力。
26.根据权利要求23所述的制品,其中所述组合物呈现至少2600g/m2/24小时的流体处理能力。
27.根据权利要求23所述的制品,其中所述组合物呈现至少2800g/m2/24小时的流体处理能力。
28.根据权利要求16-27中任一项所述的制品,其中所述组合物呈现至少1320g/m2/24小时的透潮率(MVTR);和至少1450g/m2/24小时的静态吸收(SA)。
29.根据权利要求16-28中任一项所述的制品,其中所述组合物呈现小于0.196N/m的180°剥离值。
30.根据权利要求16-29中任一项所述的制品,其中所述粘合剂组合物以层布置在所述衬底上并且所述层具有在从0.05mm至2mm范围内的厚度。
31.一种促进伤口愈合的方法,其包括:
提供粘合剂制品,所述粘合剂制品包括薄膜衬底和布置在所述衬底上的粘合剂组合物的层,所述粘合剂组合物包括(i)至少一种粘合剂组分、(ii)从5%至40%的至少一种胶凝剂、和(iii)从5%至40%的至少一种非凝胶崩解剂;
在伤口上施加所述粘合剂制品使得所述粘合剂组合物的所述层朝向所述伤口定向并且覆盖所述伤口。
32.根据权利要求31所述的方法,其中所述粘合剂组分是压敏粘合剂。
33.根据权利要求31-32中任一项所述的方法,其中所述粘合剂组分是溶剂基粘合剂。
34.根据权利要求31-33中任一项所述的方法,其中所述粘合剂组分是丙烯酸粘合剂。
35.根据权利要求31-34中任一项所述的方法,其中所述胶凝剂选自(i)羧甲基纤维素、(ii)高吸收性聚合物、和(iii)(i)和(ii)的组合。
36.根据权利要求31-35中任一项所述的方法,其中所述非凝胶崩解剂选自(i)完全预胶化的马铃薯淀粉、(ii)微晶纤维素、和(iii)(i)-(ii)中任一项的组合。
37.根据权利要求31-36中任一项所述的方法,其进一步包括:
至少一种另外的添加剂。
38.根据权利要求31-37中任一项所述的方法,其中所述组合物呈现至少2000g/m2/24小时的流体处理能力(FHC)。
39.根据权利要求38所述的方法,其中所述组合物呈现至少2200g/m2/24小时的流体处理能力。
40.根据权利要求38所述的方法,其中所述组合物呈现至少2400g/m2/24小时的流体处理能力。
41.根据权利要求38所述的方法,其中所述组合物呈现至少2600g/m2/24小时的流体处理能力。
42.根据权利要求38所述的方法,其中所述组合物呈现至少2800g/m2/24小时的流体处理能力。
43.根据权利要求31-42中任一项所述的方法,其中所述组合物呈现至少1320g/m2/24小时的透潮率(MVTR);和至少1450g/m2/24小时的静态吸收(SA)。
44.根据权利要求31-43中任一项所述的方法,其中所述组合物呈现小于0.196N/m的180°剥离值。
45.根据权利要求31-44中任一项所述的方法,其中所述粘合剂组合物以层布置在所述衬底上并且所述层具有在从0.05mm至2mm范围内的厚度。
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CN1263549A (zh) * | 1997-07-17 | 2000-08-16 | 亨克尔两合股份公司 | 制造水性粘合剂体系的凝聚体 |
CN1345210A (zh) * | 1999-03-17 | 2002-04-17 | 科洛普拉斯特公司 | 压力敏感型粘结剂组合物 |
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