CN113599563A - 一种医用聚氨酯泡沫敷料及其制备方法 - Google Patents

一种医用聚氨酯泡沫敷料及其制备方法 Download PDF

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CN113599563A
CN113599563A CN202110743684.4A CN202110743684A CN113599563A CN 113599563 A CN113599563 A CN 113599563A CN 202110743684 A CN202110743684 A CN 202110743684A CN 113599563 A CN113599563 A CN 113599563A
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polyurethane foam
film
layer
medical
foam dressing
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曹立亭
鲁建国
梁朝
尉伟杰
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Zhende Medical Co Ltd
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Zhende Medical Co Ltd
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Priority to CN202110743684.4A priority Critical patent/CN113599563A/zh
Priority to EP21947939.1A priority patent/EP4194016A1/en
Priority to PCT/CN2021/123520 priority patent/WO2023273012A1/zh
Publication of CN113599563A publication Critical patent/CN113599563A/zh
Priority to US18/179,956 priority patent/US20230270913A1/en
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Abstract

本发明公开了一种医用聚氨酯泡沫敷料及其制备方法，敷料包括：聚氨酯薄膜，复合于聚氨酯薄膜上的亲水性聚氨酯泡沫层，设置于亲水性聚氨酯泡沫层上的离型纸，位于离型纸下的软聚硅酮复合材料层；聚氨酯薄膜由离型膜和涂敷在离型膜上的PU树脂层或TPU树脂层组成；本发明的方法制备得到的产品不仅能够吸收压疮的伤口渗出液，还能够实现单面防水，且具有粘性，能够稳定的固定在伤口上，不会轻易移位，确保持续稳定的吸液。

Description

一种医用聚氨酯泡沫敷料及其制备方法
技术领域
本发明涉及医用敷料，特别是一种医用聚氨酯泡沫敷料及其制备方法。
背景技术
长期卧床、久坐轮椅或需要进行较长时间手术的病人由于不能自由活动，局部皮肤长期受压，导致血液流通不畅，久而久之，皮肤失去养分后发生坏死破溃形成压疮/褥疮。压疮/ 褥疮一旦形成要经过长期的护理，且一旦护理不当不仅增加病人痛苦而且病情严重有可能引发感染等。因此对于容易形成压疮/褥疮的病人要及时采取防护措施。
医用聚氨酯泡沫相对于传统的纱布类敷料具有更好的回弹性能、缓释压力和吸收压力的作用，且具有优越的渗液的吸收性能，此外还具有良好的生物学性能。可用于压疮/褥疮伤口发生后吸收伤口处渗出的脓液加速伤口的愈合，减小对伤口周围皮肤的伤害；但是现有的聚氨酯泡沫无法实现单面防水，且容易在伤口上移位，本发明解决这样的问题。
发明内容
为解决现有技术的不足，本发明的目的在于提供一种医用聚氨酯泡沫敷料及其制备方法，本产品不仅能够吸收压疮的伤口渗出液，还能够实现单面防水，且具有粘性，能够稳定的固定在伤口上，不会轻易移位，确保持续稳定的吸液。
为了实现上述目标，本发明采用如下的技术方案：
一种医用聚氨酯泡沫敷料，包括：聚氨酯薄膜，复合于聚氨酯薄膜上的亲水性聚氨酯泡沫层，设置于亲水性聚氨酯泡沫层上的离型纸，位于离型纸下的软聚硅酮复合材料层；聚氨酯薄膜由离型膜和涂敷在离型膜上的PU树脂层或TPU树脂层组成。
前述的一种医用聚氨酯泡沫敷料，聚氨酯薄膜经过电晕后表面的粗糙度是9-10。
前述的一种医用聚氨酯泡沫敷料，软聚硅酮复合材料层复合于亲水性聚氨酯泡沫层上；软聚硅酮复合材料层上设置有通孔。
前述的一种医用聚氨酯泡沫敷料，软聚硅酮复合材料层复合于聚氨酯薄膜上并位于亲水性聚氨酯泡沫层两侧。
前述的一种医用聚氨酯泡沫敷料，还包括：涂覆于离型纸表面的表面涂层，表面涂层为硅层或聚合物材料层。
前述的一种医用聚氨酯泡沫敷料，聚氨酯薄膜的厚度为15-18μm。
前述的一种医用聚氨酯泡沫敷料，医用聚氨酯泡沫敷料的厚度为1.5-7mm。
前述的一种医用聚氨酯泡沫敷料，医用聚氨酯泡沫敷料的厚度为4-5mm。
一种医用聚氨酯泡沫敷料的制备方法，包括如下步骤：
步骤一，制备聚氨酯薄膜：
在离型膜材料上涂敷PU/TPU树脂，涂胶量15-30g/m2，烘干得厚度为15-18μm聚氨酯薄膜，再进行一次电晕，电晕值1-4A，设备运行速度5-10m/min，使得聚氨酯薄膜经过电晕后表面的粗糙度为9-10级；
步骤二，制备亲水性聚氨酯泡沫：
亲水性聚氨酯泡沫的配方按照质量份数包括：60—87.5份异氰酸酯预聚物，12—36份水， 0.16—2.8份表面活性剂，0.34-1.2份碳酸氢钠；
按照配方混合，将预聚体和水，表面活性剂，碳酸氢钠水相分开搅拌，预聚体搅拌温度25 —35℃，水相温度15—25℃，使用低压发泡混合机将预聚体和水相在5000R/min的转速下进行混合，通过链接锥形塑料浇注头进行浇注，浇注头的出料尺寸直径可根据流量的大小进行切割，将混合后的料浇注在运行中的聚氨酯薄膜上，上面覆盖离型纸，离型纸表面涂覆有表面涂层，表面涂层为硅层或聚合物材料层、浇注在离型纸上的混合液经过上压板、下压板完成流平后常温固化7-10min，后进入烘箱进行烘干，烘干后的聚氨酯泡沫即为单面复合防水透气聚氨酯薄膜的聚氨酯泡沫，再经过收卷制作完成；
步骤三，设置软聚硅酮复合材料层；
将软聚硅酮复合材料层与亲水性聚氨酯泡沫层复合，复合压力范围5-7Kpa，设备的运行速度5-8m/min；软聚硅酮复合材料层上设置有通孔；
步骤四，以上制备完成的聚氨酯泡沫敷料经过分切、成型、包装灭菌等工序得到医用聚氨酯泡沫敷料。
前述的一种医用聚氨酯泡沫敷料的制备方法，上压板、下压板的间隙范围是0.05mm-15cm，上压板、下压板设置有定型过渡区和定型区；定型过渡区为中间高两边低的双向抛物线形状，定型区为平板。
本发明的有益之处在于：
本发明的结构设计不仅能够吸收压疮的伤口渗出液，还能够实现单面防水；
本发明通过设置软聚硅酮复合材料层，使得敷料具有粘性，能够稳定的固定在伤口上，不会轻易移位，确保持续稳定的吸液；
发明本发明的亲水性聚氨酯泡沫单面防水；
本发明提供了一种可连续生产的一次成型的聚氨酯泡沫制备方法；解决了单面防水覆膜聚氨酯泡沫需要分工序进行涂胶，之后进行聚氨酯泡沫与膜复合后工序复杂性，直接一次性连续生产出单面防水覆膜聚氨酯泡沫的，解决了单面防水覆膜聚氨酯泡沫透气性差的问题，可使正杯MVTR保持在1500g/m2/24h以上。如果选择高透的聚氨酯薄膜，正杯MVTR可达 3000g/m2/24h以上。
附图说明
图1是本发明的一种实施例的结构示意图；
图2是本发明的另一种实施例的结构示意图；
图3是本发明的另一种实施例的结构示意图；
图4是本发明制备过程中上压板与上离型纸接触面的示意图；
图5是本发明上压板的一种实施例的俯视图；
图6是本发明上压板、下压板的一种实施例的截面图；
图中附图标记的含义：
1聚氨酯薄膜，2亲水性聚氨酯泡沫层，3离型纸，4软聚硅酮复合材料层，401通孔，5表面涂层，601定型过渡区，602定型区，603基准。
具体实施方式
以下结合附图和具体实施例对本发明作具体的介绍。
如图1所示，一种医用聚氨酯泡沫敷料，包括：聚氨酯薄膜1，复合于聚氨酯薄膜1上的亲水性聚氨酯泡沫层2，设置于亲水性聚氨酯泡沫层2上的离型纸3，位于离型纸3下的软聚硅酮复合材料层4；聚氨酯薄膜1由离型膜和涂敷在离型膜上的PU树脂层或TPU树脂层组成。作为一种实施例，离型膜材料可选PE、PET、PP等材料。
一种医用聚氨酯泡沫敷料的制备方法，其特征在于，包括如下步骤：
步骤一，制备聚氨酯薄膜：
在离型膜材料上涂敷PU/TPU树脂，涂胶量15-30g/m2，烘干得厚度为15-18μm聚氨酯薄膜，再进行一次电晕，电晕值1-4A，设备运行速度5-10m/min，使得聚氨酯薄膜经过电晕后表面的粗糙度为9-10级；
可根据离型膜表面的雾面程度制作不同光感质地的薄膜，涂敷的树脂经过烘干溶剂后可得聚氨酯薄膜1。可根据对于薄膜材料的透气性强度等的要求选择涂胶量，当前优选15-30g/m2，为增加最终产品的透气性优选23g/m2，更优选择为17g/m2，此时得到的聚氨酯薄膜1的厚度为15-18μm。为增加表面的粗糙度，涂布完成之后可进行一次电晕，聚氨酯薄膜1经过电晕后表面的粗糙度为9-10级，以便增加在防水覆膜聚氨酯泡沫制作时聚氨酯泡沫与聚氨酯薄膜 1表面的结合力。
步骤二，制备亲水性聚氨酯泡沫：
亲水性聚氨酯泡沫的配方按照质量份数包括：60—87.5份异氰酸酯预聚物，12—36份水， 0.16—2.8份表面活性剂，0.34-1.2份碳酸氢钠；作为一种实施例，异氰酸酯预聚物为甲苯二异氰酸酯TDI、二苯基甲烷二异氰酸酯MDI、六亚甲烷二异氰酸酯HDI或以上两种或两种以上的混合物，这里并非穷举，只要是能够得到亲水性聚氨酯泡沫的异氰酸酯预聚物都在本发明的保护范围之内。作为一种实施例，亲水性聚氨酯泡沫的配方按照质量份数为：TDI预聚体质量份数：75份，水质量份数：23.75份，表面活性剂质量份数：0.75份，NaHCO3质量份数：0.5份。作为另一种实施例，TDI预聚体质量份数：70份，水质量份数：28.2份，表面活性剂质量份数：1.8份。
按照配方混合，将预聚体和水，表面活性剂，碳酸氢钠水相分开搅拌，预聚体搅拌温度25 —35℃，水相温度15—25℃，将材料浇注在制作好的聚氨酯薄膜上，浇注的具体方法和参数是使用低压发泡混合机将预聚体和水相在5000R/min的转速下进行混合，通过链接锥形塑料浇注头进行浇注，浇注头的出料尺寸直径可根据流量的大小进行切割，将混合后的料浇注在运行中的聚氨酯薄膜上，上面覆盖离型纸，离型纸表面涂覆有表面涂层5，经过流平和常温固化7-10min，流平的具体方法是：浇注在离型纸上的混合液经过上压板、下压板，上压板、下压板的间隙范围是0.05mm-15cm，当前根据需求使用范围优选为0.05mm—8mm。上压板、下压板设置有定型过渡区601和定型区602，定型过渡区601和定型区602相对于基准603变形；定型过渡区为中间高两边低的双向抛物线形状，定型区为平板，如图6所示，定型过渡区采用抛物线曲率过度整型，保证成型过程中变化均匀，受力过程也均匀，定型过渡区的作用主要为分散液体的基础上进行一定程度的定型。压板经过配方的发泡时间进行设计，可以生产出不同厚度的聚氨酯泡沫产品，然后进入烘箱进行烘干，烘干后的聚氨酯泡沫即为单面复合防水透气聚氨酯薄膜1的聚氨酯泡沫，经过收卷制作完成；作为一种优选，材料可以经过传送辊进行张力调节，可以通过纠偏装置进行纠偏使泡沫收卷均匀，不跑偏，收卷时可复合离型纸，减少两层泡沫之间的黏结，方便下工序材料的使用，无需进行二次倒卷。
表面涂层5为硅层或聚合物材料层，如图2、3所示，优选涂聚合物材质；离型纸3平方米重可选140-170g/m2。之后进行常温固化7-10min，后进入烘箱进行烘干，烘干后的聚氨酯泡沫即为单面复合防水透气聚氨酯薄膜1的聚氨酯泡沫。可根据流量以及刮板厚度的不同制作不同厚度(1.5-7mm)的医用聚氨酯泡沫敷料，考虑到用于压疮预防，作为一种优选，医用聚氨酯泡沫敷料厚度为4-5mm。
作为一种实施例，表面活性剂可为PE800，PE6300，PE6200，PE6100等低泡型非离子活性物种的一种或多种，这里并非穷举。
步骤三，设置软聚硅酮复合材料层；
将软聚硅酮复合材料层4与亲水性聚氨酯泡沫层2复合，复合压力范围5-7Kpa，运行速度5-8m最佳；软聚硅酮复合材料层4上设置有通孔401。设置软聚硅酮复合材料层的目的是为了让产品具有粘性；
步骤四，以上制备完成的聚氨酯泡沫敷料经过分切、成型、包装灭菌等工序得到医用聚氨酯泡沫敷料。
本发明解决了块泡无法连续生产卷材的泡沫卷材的问题以及厚度难以控制的问题，采用一次成型的方法进行产品生产，生产后的泡沫卷材无需进行二次倒卷即可实现下一道工序的制作同时还解决了涂胶覆膜形式所造成的透气性损失的问题。表面涂敷的软聚硅酮材料不粘连皮肤，皮肤友好。
本发明的流平部分厚度通过上压板、下压板进行控制，上压板形状设计根据发泡速度进行设计，能够更准确的进行厚度控制，解决了当前生产工艺中难以制作超薄材料的困境，最薄可做到1mm，切厚度偏差在±0.2mm。
本发明的结构设计不仅能够吸收压疮的伤口渗出液，还能够实现单面防水；通过设置软聚硅酮复合材料层4，使得敷料具有粘性，能够稳定的固定在伤口上，不会轻易移位，确保持续稳定的吸液。
以上显示和描述了本发明的基本原理、主要特征和优点。本行业的技术人员应该了解，上述实施例不以任何形式限制本发明，凡采用等同替换或等效变换的方式所获得的技术方案，均落在本发明的保护范围内。

Claims (10)

1.一种医用聚氨酯泡沫敷料，其特征在于，包括：聚氨酯薄膜，复合于所述聚氨酯薄膜上的亲水性聚氨酯泡沫层，设置于亲水性聚氨酯泡沫层上的离型纸，位于离型纸下的软聚硅酮复合材料层；所述聚氨酯薄膜由离型膜和涂敷在离型膜上的PU树脂层或TPU树脂层组成。
2.根据权利要求1所述的一种医用聚氨酯泡沫敷料，其特征在于，聚氨酯薄膜经过电晕后表面的粗糙度是9-10。
3.根据权利要求1所述的一种医用聚氨酯泡沫敷料，其特征在于，所述软聚硅酮复合材料层复合于亲水性聚氨酯泡沫层上；所述软聚硅酮复合材料层上设置有通孔。
4.根据权利要求1所述的一种医用聚氨酯泡沫敷料，其特征在于，所述软聚硅酮复合材料层复合于聚氨酯薄膜上并位于亲水性聚氨酯泡沫层两侧。
5.根据权利要求1所述的一种医用聚氨酯泡沫敷料，其特征在于，还包括：涂覆于所述离型纸表面的表面涂层，表面涂层为硅层或聚合物材料层。
6.根据权利要求1所述的一种医用聚氨酯泡沫敷料，其特征在于，所述聚氨酯薄膜的厚度为15-18μm。
7.根据权利要求1所述的一种医用聚氨酯泡沫敷料，其特征在于，所述医用聚氨酯泡沫敷料的厚度为1.5-7mm。
8.根据权利要求7所述的一种医用聚氨酯泡沫敷料，其特征在于，所述医用聚氨酯泡沫敷料的厚度为4-5mm。
9.一种医用聚氨酯泡沫敷料的制备方法，其特征在于，包括如下步骤：
步骤一，制备聚氨酯薄膜：
在离型膜材料上涂敷PU/TPU树脂，涂胶量15-30g/m2，烘干得厚度为15-18μm聚氨酯薄膜，再进行一次电晕，电晕值1-4A，设备运行速度5-10m/min，使得聚氨酯薄膜经过电晕后表面的粗糙度为9-10级；
步骤二，制备亲水性聚氨酯泡沫：
亲水性聚氨酯泡沫的配方按照质量份数包括：60—87.5份异氰酸酯预聚物，12—36份水，0.16—2.8份表面活性剂，0.34-1.2份碳酸氢钠；
按照配方混合，将预聚体和水，表面活性剂，碳酸氢钠水相分开搅拌，预聚体搅拌温度25—35℃，水相温度15—25℃，使用低压发泡混合机将预聚体和水相在5000R/min的转速下进行混合，通过链接锥形塑料浇注头进行浇注，浇注头的出料尺寸直径可根据流量的大小进行切割，将混合后的料浇注在运行中的聚氨酯薄膜上，上面覆盖离型纸，离型纸表面涂覆有表面涂层，表面涂层为硅层或聚合物材料层、浇注在离型纸上的混合液经过上压板、下压板完成流平后常温固化7-10min，后进入烘箱进行烘干，烘干后的聚氨酯泡沫即为单面复合防水透气聚氨酯薄膜的聚氨酯泡沫，再经过收卷制作完成；
步骤三，设置软聚硅酮复合材料层；
将软聚硅酮复合材料层与亲水性聚氨酯泡沫层复合，复合压力范围5-7Kpa，设备的运行速度5-8m/min；软聚硅酮复合材料层上设置有通孔；
步骤四，以上制备完成的聚氨酯泡沫敷料经过分切、成型、包装灭菌等工序得到医用聚氨酯泡沫敷料。
10.根据权利要求9所述的一种医用聚氨酯泡沫敷料的制备方法，其特征在于，所述上压板、下压板的间隙范围是0.05mm-15cm，上压板、下压板设置有定型过渡区和定型区；所述定型过渡区为中间高两边低的双向抛物线形状，所述定型区为平板。
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