CN110811604A - 一种柔性心电图电极贴片及制备方法 - Google Patents

一种柔性心电图电极贴片及制备方法 Download PDF

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CN110811604A
CN110811604A CN201910956105.7A CN201910956105A CN110811604A CN 110811604 A CN110811604 A CN 110811604A CN 201910956105 A CN201910956105 A CN 201910956105A CN 110811604 A CN110811604 A CN 110811604A
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陈伟
方寅
刘昊
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Hangzhou Qianhe Cell Biotechnology Co ltd
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Abstract

本发明公开了一种柔性心电图电极贴片及制备方法，主要包括医用压敏胶层、导电薄膜、PET绝缘背衬膜，导电薄膜的上表面设有医用压敏胶层，导电薄膜的下表面固定在刷有导电层和绝缘层的PET绝缘背衬膜上，导电薄膜和PET绝缘背衬膜向外延伸形成电极连接处。其中导电薄膜的制备方法为：将聚丙烯酸甲酯和聚丙烯酸乙酯按重量比1:10配制，和海藻酸钠进行室温下的乳液聚合形成凝胶材料；将柔性电极材料聚3,4‑乙烯二氧噻吩与凝胶材料聚合成导电薄膜，其中聚3,4‑乙烯二氧噻吩1‑2重量份、聚丙烯酸甲酯和聚丙烯酸乙酯90‑95重量份、海藻酸钠2‑3重量份。本发明的有益效果为：利用可降解凝胶薄膜，设计制成心电图柔性电极，实现可穿戴式的心电图电极以及长期监测的功能。

Description

一种柔性心电图电极贴片及制备方法
技术领域
本发明涉及生物材料领域，主要是一种柔性心电图电极贴片及制备方法。
背景技术
目前市场上常用的心电图检查设备包括有静态心电图机(ECG)、动态心电图机(Holter)和心电监护仪。静态心电图机一般采用金属电极，反复多次重复使用；而动态心电图机和心电监护仪采用一次性心电图电极片，目前最常用的心电图电极贴片为中间带导电金属片的胶片。
发明内容
本发明的目的在于克服现有技术存在的不足，而提供一种柔性心电图电极贴片及制备方法，利用可降解凝胶薄膜，设计制成心电图柔性电极，实现可穿戴式的心电图电极以及长期监测的功能。
本发明的目的是通过如下技术方案来完成的。一种柔性心电图电极贴片，主要包括医用压敏胶层、导电薄膜、PET绝缘背衬膜，导电薄膜的上表面设有医用压敏胶层，导电薄膜的下表面固定在刷有导电层和绝缘层的PET绝缘背衬膜上，导电薄膜和PET绝缘背衬膜向外延伸形成电极连接处。
本发明公开了一种柔性心电图电极贴片的制备方法，首先制备导电薄膜，然后将导电薄膜的下表面固定在刷有导电层和绝缘层的PET绝缘背衬膜上，最后在导电薄膜的上表面粘接医用压敏胶层；其中导电薄膜的制备方法为：将聚丙烯酸甲酯和聚丙烯酸乙酯按重量比1:10配制，和海藻酸钠进行室温下的乳液聚合形成凝胶材料；将柔性电极材料聚3,4-乙烯二氧噻吩与凝胶材料聚合成导电薄膜，其中聚3,4-乙烯二氧噻吩1-2重量份、聚丙烯酸甲酯和聚丙烯酸乙酯90-95重量份、海藻酸钠2-3重量份。
本发明的有益效果为：生物相容性很好，与皮肤接触的地方极其舒适，特别是在做慢性长期监测的过程中不会出现皮肤红肿，瘙痒，局部肿胀等不良反应；另外由于合成可降解凝胶薄膜的材料来源为食用或医用可口服，所以对身体没有任何伤害。与传统的金属电极和目前常用的一次性心电图电极片相比，我们的导电高分子凝胶心电图贴片实现了轻薄小巧操作简便，舒适性强，粘性牢固，与皮肤接触性良好(即使有汗液也不会影响粘附)等一系列优点；同时本发明的心电图电极片虽然粘性很强，但在取下贴片的过程中没有任何的疼痛感；测试心电图数据信号噪音非常小，数据准确；另外这种柔性电极是生物可降解材料，可回收，不会给环境带来任何污染。
附图说明
图1为本发明的立体结构示意图。
图2为本发明的主视结构示意图。
图3为本发明的A-A剖视结构示意图。
图4为本发明的分解结构示意图。
图5为金属电极片24小时静态心电图。
图6为柔性心电图电极贴片24小时静态心电图。
图7为金属电极片48小时静态心电图。
图8为柔性心电图电极贴片48小时静态心电图。
图9为金属电极片72小时静态心电图。
图10为柔性心电图电极贴片72小时静态心电图。
附图标记说明：医用压敏胶层1、导电薄膜2、PET绝缘背衬膜3、电极连接处4。
具体实施方式
下面将结合附图对本发明做详细的介绍：
如图1-4所示，本发明公开了一种柔性心电图电极贴片，主要包括医用压敏胶层1、导电薄膜2、PET绝缘背衬膜3，导电薄膜2的上表面设有医用压敏胶层1，导电薄膜2的下表面固定在刷有导电层和绝缘层的PET绝缘背衬膜3上，导电薄膜2和PET绝缘背衬膜3向外延伸形成电极连接处4。
本发明同时公开了一种柔性心电图电极贴片的制备方法，首先制备导电薄膜2，然后将导电薄膜2的下表面固定在刷有导电层(Ag/AgCl涂层)和绝缘层的PET绝缘背衬膜3上，最后在导电薄膜2的上表面粘接医用压敏胶层1；其中导电薄膜2的制备方法为：将聚丙烯酸甲酯和聚丙烯酸乙酯按重量比1:10配制，和生物相容性极好的海藻酸钠进行室温下的乳液聚合形成凝胶材料；将柔性电极材料聚3,4-乙烯二氧噻吩(生物相容性很高的导电高分子材料)与凝胶材料聚合成导电薄膜2，其中聚3,4-乙烯二氧噻吩1-2重量份、聚丙烯酸甲酯和聚丙烯酸乙酯90-95重量份、海藻酸钠2-3重量份。
实施例配方1：聚3,4-乙烯二氧噻吩1重量份、聚丙烯酸甲酯和聚丙烯酸乙酯90重量份、海藻酸钠2重量份。
实施例配方2：聚3,4-乙烯二氧噻吩2重量份、聚丙烯酸甲酯和聚丙烯酸乙酯95重量份、海藻酸钠3重量份。
本发明是利用可降解的柔性电极材料来用做心电图的长期监测，以及用于可穿戴心电图检测设备。从而减轻做心电图过程中所带来的不适反应。本发明采用的导电薄膜的机械性能非常优良。杨氏模量和皮肤极其类似～50kP。可拉伸性能非常好，可以达到原长的几倍。电导率的性能也极其优异100Ω.cm。另外这种电极是透明的电极，我们可以在薄膜中设计更复杂电路检测系统，为我们设计第二代和第三代的电极打下牢固的平台。我们通过模压的方法把透明薄膜电极做成500μm的薄片。然后把导电薄膜固定在刷有导电层和绝缘层的PET绝缘背衬膜3上，做成柔性电极装置，背后通过鳄鱼夹以及导线连到心电图的发射接收装置上。
本发明的实验结果：前期我们利用所发明的心电图电极做了小鼠动物实验，我们胶的贴片贴在小鼠身上分别测试了24小时、48小时和72小时(图5-10)，小鼠的皮肤周围没有任何的不良反应；同时我们找了3例志愿者开展了相关测试，静态心电图结果提示测试的心电图数据噪音小，准确度高，采集的数据准确性高，与金属电极片的结果没有差异，同时志愿者的主管感受明显较金属电极片舒适，同时志愿者于24小时后取下贴片后无明显疼痛感，皮肤也未见红肿、瘙痒等任何不良反应。
可以理解的是，对本领域技术人员来说，对本发明的技术方案及发明构思加以等同替换或改变都应属于本发明所附的权利要求的保护范围。

Claims (2)

1.一种柔性心电图电极贴片，其特征在于：主要包括医用压敏胶层(1)、导电薄膜(2)、PET绝缘背衬膜(3)，导电薄膜(2)的上表面设有医用压敏胶层(1)，导电薄膜(2)的下表面固定在刷有导电层和绝缘层的PET绝缘背衬膜(3)上，导电薄膜(2)和PET绝缘背衬膜(3)向外延伸形成电极连接处(4)。
2.一种制备如权利要求1所述的柔性心电图电极贴片的方法，其特征在于：首先制备导电薄膜(2)，然后将导电薄膜(2)的下表面固定在刷有导电层和绝缘层的PET绝缘背衬膜(3)上，最后在导电薄膜(2)的上表面粘接医用压敏胶层(1)；其中导电薄膜(2)的制备方法为：将聚丙烯酸甲酯和聚丙烯酸乙酯按重量比1:10配制，和海藻酸钠进行室温下的乳液聚合形成凝胶材料；将柔性电极材料聚3,4-乙烯二氧噻吩与凝胶材料聚合成导电薄膜(2)，其中聚3,4-乙烯二氧噻吩1-2重量份、聚丙烯酸甲酯和聚丙烯酸乙酯90-95重量份、海藻酸钠2-3重量份。
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