WO2015180464A1 - 一次性皮肤表面干电极及其制作方法 - Google Patents

一次性皮肤表面干电极及其制作方法 Download PDF

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WO2015180464A1
WO2015180464A1 PCT/CN2014/095266 CN2014095266W WO2015180464A1 WO 2015180464 A1 WO2015180464 A1 WO 2015180464A1 CN 2014095266 W CN2014095266 W CN 2014095266W WO 2015180464 A1 WO2015180464 A1 WO 2015180464A1
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electrode
flexible pcb
layer
array
dry
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PCT/CN2014/095266
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English (en)
French (fr)
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林科
张杨
王新安
潘辉
张兴
汪波
郭朝阳
黄继攀
黄枫
陈啸飞
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北京大学深圳研究生院
深圳市新宇腾跃电子有限公司
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Publication of WO2015180464A1 publication Critical patent/WO2015180464A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof

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  • the present invention relates to the field of medical devices, and in particular to a disposable skin surface dry electrode and a method of fabricating the same.
  • Bioelectrical signals such as ECG signals, EEG signals, and EMG signals are very important for diagnosing human diseases and detecting human health.
  • the collection of these biopotentials is mainly obtained by contacting the electrodes with human skin, and the effect of good electrodes on improving the quality of the collected signals is self-evident.
  • the wet electrode Today, the main electrode on the market is the wet electrode, commercial Ag/AgCl. Electrode. Because the stratum corneum of the outermost layer of the skin cannot conduct electricity, the wet electrode needs to be pretreated with the skin during use, corroding the stratum corneum or allowing a high concentration of conductive ions to penetrate the stratum corneum.
  • the pretreatment method includes applying a conductive solution, applying a conductive paste, and using a conductive paste on the electrode. The presence of skin pretreatment prevents the electrodes from being used for a long period of time and may cause side effects such as skin ulceration or allergies.
  • the contact dry electrode has a flexible film dry electrode, a conductive foam dry electrode, a conductive fiber dry electrode, a carbon nanotube dry electrode, and the like.
  • the conductive foam dry electrode is bulky and the contact stability is not good.
  • the current technology of flexible film dry electrodes, conductive fiber dry electrodes and carbon nanotube dry electrodes is not yet mature.
  • metal and silicon are generally used as the substrate, the metal lacks toughness, is not easily recovered after bending, and may be broken, while silicon is more brittle and more easily broken.
  • the mainstream process of dry electrodes is a micromachining process.
  • an embodiment provides a method of fabricating a disposable skin surface dry electrode for making a flexible PCB based
  • the preparation of the disposable skin surface dry electrode, the manufacturing method comprises the following steps:
  • the flexible PCB substrate includes the PI layer and the Cu attached to the upper and lower sides of the PI layer.
  • a dry film is laid on the surface of the layer, and a groove is formed on the dry film after exposure and development, and the groove includes a conductive groove facing each through hole and an array groove for forming an array of electrode microneedles;
  • a second dry film is laid on the surface of the dry film, and after exposure and development, a second array of grooves is formed on the second dry film to interface with the array grooves, and the diameter of the second array groove is smaller than that of the array groove caliber;
  • an embodiment provides a disposable skin surface dry electrode comprising a flexible PCB substrate and respectively disposed on a flexible PCB Electrode microneedle array and metal snaps on the upper and lower surfaces of the substrate, penetrating the flexible PCB
  • the substrate is provided with a conductive medium for conducting the electrode microneedle array and the metal snap, and the metal snap is for transmitting the electrical signal collected by the electrode microneedle array.
  • the flexible PCB substrate comprises a PI layer and Cu attached to the upper and lower sides of the PI layer.
  • the layer, the electrode microneedle array comprises a plurality of copper pillars densely packed on the upper Cu layer on the PI layer.
  • the copper pillar includes the flexible PCB
  • the base portion to which the substrate is attached and the needle portion provided at the top end of the base portion have a diameter larger than a diameter of the needle portion, and a tip end surface of the needle portion forms a dome.
  • a conductive layer is provided on the surface of the Cu layer on the upper side of the copper pillar and the flexible PCB substrate.
  • the present invention uses a mature electroplating process instead of a micromachining process to fabricate an electrode microneedle array, which is low-cost and suitable for mass production; and secondly, the present invention is in a flexible PCB
  • the board is fabricated instead of a substrate such as silicon or metal, so that the electrode has flexibility and is directly attached to the surface of the user's skin during use. It is painless and does not see blood, and can improve user comfort and stable signal acquisition. Sexuality, reduce skin electrode contact noise; in addition, no high-risk acid such as hydrofluoric acid is used, and skin pretreatment is not required relative to the wet electrode, which is more convenient and quicker to use.
  • Figure 1 is a cross-sectional view showing an embodiment of the present invention
  • Figure 2 is a front plan view of an embodiment of the present invention.
  • FIG. 3 is a flow chart of a manufacturing process of an embodiment of the present invention.
  • PI Polymide
  • the present invention provides a disposable skin surface dry electrode comprising a flexible PCB substrate 1 and an electrode microneedle array 2 and a metal respectively disposed on the upper and lower surfaces of the flexible PCB substrate 1.
  • the flexible PCB substrate 1 includes a PI layer 11 and a Cu layer 12 attached to the upper and lower sides of the PI layer 11, and the Cu layers 12 on both sides have the same thickness, ranging from 10 ⁇ m to 14 ⁇ m.
  • the thickness of the PI layer 11 is between 20 ⁇ m and 30 ⁇ m.
  • the electrode microneedle array 2 includes a plurality of copper pillars 4 densely packed on the upper Cu layer 12 of the PI layer 11, and the copper pillars 4 have a pitch of 200 ⁇ m to 1000 ⁇ m.
  • Copper column 4 The base portion 41 connected to the flexible PCB substrate 1 and the needle portion 42 disposed at the top end of the base portion 41 form a dome end surface of the needle segment 42 having a diameter of 100-200 ⁇ m and a height of 40-50 ⁇ m.
  • the needle segment 42 has a diameter of 50-100 ⁇ m and a height of 20-30 ⁇ m.
  • a conductive layer 13 is attached to the surface of the Cu layer 12 on the upper side of the copper pillar 4 and the flexible PCB substrate 1.
  • Penetrating the flexible PCB substrate 1 is provided with a conductive medium of the conductive electrode microneedle array 2 and the metal snap (the electrode microneedle array 2 and the metal snap on the back side are perforated on the flexible PCB substrate 1) , inject conductive metal for conductive connection).
  • the metal snap is used to transmit the electrical signal collected by the electrode microneedle array.
  • the metal snap is also used for detachable connection with the external wire, thereby realizing the detachable connection between the dry electrode and the external wire to be dry.
  • the electrical signals of the electrodes are transmitted to instruments, devices and/or mobile terminals to which the external conductors are connected.
  • Metal snaps can also be replaced with other devices that transmit electrical signals and have a fastening function.
  • the present invention also provides a method for fabricating a disposable skin surface dry electrode based on a flexible PCB, comprising the following steps:
  • the copper is plated in the groove, the copper in the array groove 52 forms the copper pillar 4, the copper in the conductive groove 51 forms the conductive medium of the conductive electrode microneedle array 2 and the metal snap, and the top end surface of the copper pillar 4 is plated.
  • the dome is naturally formed during the process;
  • a second dry film 6 having a thickness of 30 ⁇ m is deposited on the surface of the dry film 5. After exposure and development, a second array of grooves 61 is formed on the second dry film 6 to interface with the array grooves 52.
  • the second array Groove 61 The aperture is smaller than the aperture of the array groove 52;
  • Copper is electroplated in the second array of grooves 61 to extend the copper post 4, the copper post 4 including a base segment 41 located within the array recess 52 and a needle segment 42 located within the second array recess 61, the diameter of the base segment 41 It is larger than the diameter of the needle segment 42 and thus relatively close to the shape of the needle tip, and the tip end surface of the needle segment 42 naturally forms a dome during the electroplating process;
  • the dry film 5 and the second dry film 6 are removed using an alkaline release film liquid, and silver, gold or titanium is sputtered on the surface of the upper Cu layer 12 and the copper pillar 4 on the flexible PCB substrate 1 using a sputtering apparatus.
  • Conductive layer 13 is

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Measurement And Recording Of Electrical Phenomena And Electrical Characteristics Of The Living Body (AREA)

Abstract

一种用于医疗器械领域的一次性皮肤表面干电极及其制作方法，该干电极包括挠性PCB基材（1）以及分别设于挠性PCB基材（1）上表面和下表面的电极微针阵列（2）和金属按扣，穿透挠性PCB基材（1）设有导通电极微针阵列（2）和金属按扣的导电介质。采用成熟的电镀工艺而不是微机械加工工艺来在挠性PCB基材（1）上制作电极微针阵列（2），成本低，不使用氢氟酸，适合大批量生产；在挠性PCB板而不是硅、金属等衬底上进行制作，使得该干电极具有柔性，使用时直接贴附于使用者的皮肤表面，无痛且不见血，可以提高使用者的舒适度和采集信号的稳定性，降低皮肤电极接触噪声；同时相对于湿电极，该干电极不需要皮肤的预处理，使用更加方便、快捷。

Description

一次性皮肤表面干电极及其制作方法 技术领域
本发明涉及医疗器械领域，特别是涉及一种一次性皮肤表面干电极及其制作方法。
 背景技术
心电信号、脑电信号、肌电信号等生物电势信号对于诊断人体疾病和检测人体健康状况非常重要。这些生物电势的采集主要通过电极与人体皮肤接触获得，良好的电极对于提高采集信号质量的作用不言而喻。
如今，市场上主要的电极是湿电极，即商用的Ag/AgCl 电极。因为皮肤最外层的角质层无法进行导电，湿电极在使用的时候需要做皮肤的预处理，将角质层腐蚀掉或者让高浓度的导电离子穿透角质层。预处理的方式有涂抹导电溶液、涂抹导电膏和在电极上使用导电胶等。皮肤预处理的存在使得电极不能长期使用，同时可能造成皮肤溃烂或者过敏等副作用。
目前，国内外存在科研单位在研制干电极，来解决湿电极需要皮肤预处理的问题。这些干电极可分为接触式电导干电极和非接触式电容干电极。譬如接触式干电极有柔性薄膜干电极、导电泡沫干电极、导电纤维干电极、碳纳米管干电极等。其中，导电泡沫干电极体积大，且接触稳定性不好。柔性薄膜干电极、导电纤维干电极和碳纳米管干电极目前的技术尚不成熟。此外，现有技术中，通常采用金属、硅作为基材，金属缺乏韧性，弯折后不易恢复且可能折断，而硅则更脆，更易折断
目前，干电极的主流工艺是微机械加工工艺。加工时，也往往需要用深度等离子体刻蚀机等昂贵设备，使用氢氟酸等高危险性酸，不具备柔性、噪声大的缺点。
 发明内容
依据本发明的第一方面，一种实施方式提供一种一次性皮肤表面干电极的制作方法，用于制作基于挠性PCB 的一次性皮肤表面干电极的制作，，制作方法包括以下步骤：
A. 准备挠性PCB 基材，并清洗干净，挠性PCB 基材包括PI 层以及贴附于PI 层上、下两侧的Cu 层；
B. 在挠性PCB 基材的边沿位置打若干通孔；
C. 在挠性PCB 基材上侧Cu 层的表面铺设干膜，曝光、显影后在干膜上制作出凹槽，凹槽包括正对各通孔的导电凹槽和用于制作电极微针阵列的阵列凹槽；
D. 在凹槽内电镀铜，以形成铜柱，铜柱的顶端端面在电镀过程中形成圆顶；
E. 在干膜的表面铺设第二层干膜，曝光、显影后在第二层干膜上制作出与各阵列凹槽对接的第二阵列凹槽，第二阵列凹槽的口径小于阵列凹槽的口径；
F. 在第二阵列凹槽内电镀铜，以延长铜柱，铜柱包括位于阵列凹槽内的基段和位于第二阵列凹槽内的针段，针段的顶端端面在电镀过程中形成圆顶；
G. 去膜后在挠性PCB 基材上侧Cu 层以及铜柱的表面溅射银、金或钛作为导电层。
依据本发明的第二方面，一种实施方式提供一种一次性皮肤表面干电极，包括挠性PCB 基材以及分别设于挠性PCB 基材上表面和下表面的电极微针阵列和金属按扣，穿透于挠性PCB 基材设有导通电极微针阵列和金属按扣的导电介质，金属按扣用于传输电极微针阵列所采集的电信号。
进一步作为本发明技术方案的改进，挠性PCB 基材包括PI 层以及贴附于PI 层上、下两侧的Cu 层，电极微针阵列包括若干密布于PI 层上侧Cu 层上的铜柱。
进一步作为本发明技术方案的改进，铜柱包括与挠性PCB 基材连接的基段和设于基段顶端的针段，基段的直径大于针段的直径，针段的顶端端面形成圆顶。
进一步作为本发明技术方案的改进，贴附于铜柱以及挠性PCB 基材上侧Cu 层表面设有导电层。
本发明的有益效果：首先，本发明使用成熟的电镀工艺而不是微机械加工工艺来制作电极微针阵列，低成本，适合大批量生产；其次，本发明在挠性PCB 板上进行制作，而不是硅、金属等衬底，使得本电极具有柔性，使用时直接贴附于使用者的皮肤表面，无痛且不见血，可以提高使用者的舒适度和采集信号的稳定性，降低皮肤电极接触噪声；再者，没有使用氢氟酸等高危险性酸，同时相对于湿电极不需要皮肤的预处理，使用更加方便、快捷。
附图说明
图1 是本发明实施例的剖面图；
图2 是本发明实施例的正面俯视图；
图3 是本发明实施例的制作工艺流程图。
具体实施方式
首先对本实施中的技术术语进行解释：
PI，聚酰亚胺（Polymide），是一种有机高分子材料，耐高温，具有较好的柔软性。
实施例1：
参照图1、图2，本发明提供了一种一次性皮肤表面干电极，包括挠性PCB基材1以及分别设于挠性PCB基材1上表面和下表面的电极微针阵列2和金属按扣，挠性PCB基材1包括PI层11以及贴附于PI层11上、下两侧的Cu层12，两侧Cu层12的厚度相同，范围在10μm-14μm 间，PI层11厚度在20μm-30μm 间。电极微针阵列2包括若干密布于PI层11上侧Cu层12上的铜柱4，各铜柱4间距为200μm-1000μm。铜柱4 包括与挠性PCB基材1连接的基段41和设于基段41顶端的针段42，针段42的顶端端面形成圆顶，基段41的直径为100-200μm，高40-50μm，针段42的直径为50-100μm，高为20-30μm。贴附于铜柱4以及挠性PCB基材1上侧Cu层12表面设有导电层13。穿透于挠性PCB基材1设有导通电极微针阵列2和金属按扣的导电介质（电极微针阵列2和背面的金属按扣之间通过在挠性PCB基材1上打孔，灌入导电金属进行导电连接）。金属按扣用于传输电极微针阵列所采集的电信号，在具体实施例中，金属按扣还用于与外界导线可拆卸连接，从而实现干电极与外界导线的可拆卸连接，以将干电极的电信号传输至外界导线所连接的仪器、设备和/或移动终端。金属按扣也可以采用其它具备传输电信号以及附带紧固功能的器件代替。
参照图3，本发明还提供一种基于挠性PCB的一次性皮肤表面干电极的制作方法，包括以下步骤：
A. 选择一块挠性PCB基材1，清洗干净；
B. 使用钻孔设备在挠性PCB基材1的边沿位置打若干通孔14；
C. 在挠性PCB基材1上侧Cu层12的表面铺设50μm 厚的干膜5，曝光、显影后在干膜5上制作出凹槽，凹槽包括正对各通孔14 的导电凹槽51和用于制作电极微针阵列2的阵列凹槽52；
D. 在凹槽内电镀铜，阵列凹槽52内的铜形成铜柱4，导电凹槽51内的铜形成导通电极微针阵列2和金属按扣的导电介质，铜柱4的顶端端面在电镀过程中自然形成圆顶；
E. 在干膜5的表面铺设厚度为30μm的第二层干膜6，曝光、显影后在第二层干膜6上制作出与各阵列凹槽52对接的第二阵列凹槽61，第二阵列凹槽61 的口径小于阵列凹槽52 的口径；
F. 在第二阵列凹槽61内电镀铜，以延长铜柱4，铜柱4包括位于阵列凹槽52内的基段41和位于第二阵列凹槽61内的针段42，基段41的直径大于针段42的直径，因此比较接近针尖形状，针段42的顶端端面在电镀过程中自然形成圆顶；
G. 使用碱性脱离膜液去除掉干膜5和第二层干膜6，并使用溅射设备在挠性PCB基材1上侧Cu层12以及铜柱4的表面溅射银、金或钛作为导电层13。
当然，本发明创造并不局限于上述实施方式，熟悉本领域的技术人员在不违背本发明精神的前提下还可作出等同变形或替换，这些等同的变型或替换均包含在本申请权利要求所限定的范围内。

Claims (6)

  1. 一种一次性皮肤表面干电极的制作方法，用于制作基于挠性PCB 的一次性皮肤表面干电极的制作，其特征在于，包括以下步骤：
    A.准备挠性PCB 基材，并清洗干净，所述挠性PCB 基材包括PI 层以及贴附于所述PI 层上、下两侧的Cu 层；
    B.在所述挠性PCB 基材的边沿位置打若干通孔；
    C.在所述挠性PCB 基材上侧Cu 层的表面铺设干膜，曝光、显影后在所述干膜上制作出凹槽，所述凹槽包括正对各所述通孔的导电凹槽和用于制作电极微针阵列的阵列凹槽；
    D.在所述凹槽内电镀铜，以形成铜柱，所述铜柱的顶端端面在电镀过程中形成圆顶；
    G.去膜后在所述挠性PCB 基材上侧Cu 层以及所述铜柱的表面溅射银、金或钛作为导电层。
  2. 根据权利要求1所述的制作方法，其特征在于，所述步骤D与步骤G间还包括以下步骤：
    E.在所述干膜的表面铺设第二层干膜，曝光、显影后在所述第二层干膜上制作出与各所述阵列凹槽对接的第二阵列凹槽，所述第二阵列凹槽的口径小于所述阵列凹槽的口径；
    F.在所述第二阵列凹槽内电镀铜，以延长所述铜柱，所述铜柱包括位于所述阵列凹槽内的基段和位于所述第二阵列凹槽内的针段，所述针段的顶端端面在电镀过程中形成圆顶。
  3. 一种一次性皮肤表面干电极，其特征在于：包括挠性PCB 基材以及分别设于所述挠性PCB 基材上表面和下表面的电极微针阵列和金属按扣，穿透于所述挠性PCB 基材设有导通所述电极微针阵列和金属按扣的导电介质，所述金属按扣用于传输所述电极微针阵列所采集的电信号。
  4. 根据权利要求3 所述的一次性皮肤表面干电极，其特征在于：所述挠性PCB 基材包括PI 层以及贴附于所述PI 层上、下两侧的Cu 层，所述电极微针阵列包括若干密布于所述PI 层上侧Cu 层上的铜柱。
  5. 根据权利要求4 所述的一次性皮肤表面干电极，其特征在于：所述铜柱包括与所述挠性PCB 基材连接的基段和设于所述基段顶端的针段，所述基段的直径大于所述针段的直径，所述针段的顶端端面形成圆顶。
  6. 根据权利要求4 所述的一次性皮肤表面干电极，其特征在于：贴附于所述铜柱以及挠性PCB 基材上侧Cu 层表面设有导电层。
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