CN1106865C - 自包装生物电极及其制作方法 - Google Patents

自包装生物电极及其制作方法 Download PDF

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CN1106865C
CN1106865C CN96199418A CN96199418A CN1106865C CN 1106865 C CN1106865 C CN 1106865C CN 96199418 A CN96199418 A CN 96199418A CN 96199418 A CN96199418 A CN 96199418A CN 1106865 C CN1106865 C CN 1106865C
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CN1206352A (zh
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萨默尔G·耐特利
斯考特A·布顿
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3M Co
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • 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
    • A61B5/25—Bioelectric electrodes therefor
    • 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
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/251—Means for maintaining electrode contact with the body
    • A61B5/257—Means for maintaining electrode contact with the body using adhesive means, e.g. adhesive pads or tapes
    • 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
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/263—Bioelectric electrodes therefor characterised by the electrode materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/24—Hygienic packaging for medical sensors; Maintaining apparatus for sensor hygiene
    • A61B2562/242—Packaging, i.e. for packaging the sensor or apparatus before use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00—Electrotherapy; Circuits therefor
    • A61N1/02—Details
    • A61N1/04—Electrodes
    • A61N1/0404—Electrodes for external use
    • A61N1/0472—Structure-related aspects
    • A61N1/0492—Patch electrodes

Abstract

本发明提供一种生物电极(10)，它包含背衬(12)、与背衬(12)接触的导电层(28，30)和与导电层(28，30)接触的导电粘合剂层(36，38)。这种生物电极(10)被设计成具有两种结构。最初制成品处于第一种结构状态，其背衬(12)构成密封的保护外罩以保护导电粘合剂层(36，38)。当医生准备将电极(10)粘附到病人身上时，电极(10)被方便地转换为第二种结构状态，由此露出导电粘合剂层(36，38)使生物电极(10)与病人身体接触并粘合上去。

Description

自包装生物电极及其制作方法
发明领域
本发明通常涉及生物电极，具体而言涉及最大程度地减少包装浪费的生物电极。
背景技术
为了将医院内传播感染的危险降低到最低限度，许多直接接触病人的制品都是一次性使用的。使用这种一次性制品的一个问题是不仅制品本身而且包装制品的材料都是大量的废弃物。第二个问题是包装成本；消费者实际上必须为丢弃的制品和包装材料本身支付费用。
这两个问题在生物电极包装领域特别突出。生物电极的大量使用使得其在医院废弃物中所占的比重越来越大。而且，为了保护生物电极完好无损，它的包装体积臃肿而且价格昂贵。这是因为不管生物电极是为诊断目的而检测人体生物电还是为治疗目的而向人体释放电流，都需要一层特殊的人体接触物质来传递电流。近年来，这种物质一直采用柔软而导电的粘合剂制成，它具有向人体输送电流和使电极粘附在人体上的双重功能。许多最为人们熟知的导电粘合剂都是“亲水性的”，它们包含或者吸收一定的水份。因此生物电极的包装必须保护导电粘合剂免受物理损坏或者沾污，并且还要避免水份的蒸发流失。显然，现有技术需要一种最大程度减小包装材料体积的生物电极。
发明内容
本发明通过向生物电极提供能够使其基本担负起自包装功能的外层部分来解决上述问题。这些生物电极的外层部分是抗冲击和防水蒸发的。它们可以被设计成一方面在装运和搬运时保护脆弱的导电粘合剂，而另一方面在使用中使导电粘合剂显露出与人体之间传送电流的功能。
本发明至少包括两个方面。本发明的第一方面提供了一种生物电极，其特征在于包含：包含第一侧面的背衬，第一侧面的外围部分包含第一和第二区域，其中背衬被涂敷了一块皮肤粘合剂；通过皮肤粘合剂固定在背衬第一侧面上的导电层；以及与导电层相邻的导电粘合剂层；其中生物电极处于第一种结构状态，此时背衬构成密封的保护外罩以保护导电粘合剂层，并且适于成为第二种结构，此时导电粘合剂层露出与病人身体接触，并且当生物电极处于第一种结构状态时，背村本身折叠起来使得外围部分的某一区域与另一区域密封从而形成密封的保护外罩。
这种生物电极被设计成具有两种结构。最初被制成第一种即“封闭”结构，其背衬构成密封的保护外罩以保护导电粘合剂层。当医生准备将电极粘附到病人身上时，电极很方便地转换为第二种即“开放”结构，由此露出导电粘合剂层使生物电极与病人身体接触并粘合上去。
通过将背衬折叠为自密封袋囊来提供这两种结构最为方便。一般的平坦背衬包含两个面：(1)外罩内部面朝导电层和导电粘合剂的面，它被称为“内面”；以及(2)外罩外部的面，它被称为“外面”。靠近背衬内面边缘的是外围部分。当折叠生物电极时，该外围部分的一部分区域与其另一部分区域接触。当这样的一部分区域与另一部分区域密封在一起时就构成了密封的保护外罩。
在较佳实施例中，生物电极具有基本对称的轴，当生物电极处于其第一种结构状态时沿该轴折叠背衬。当生物电极是用来在电外科手术中传输电流的分立电极时，为了使生物电极适于同“CQM”型(“接触质量监控”)发生器联用，通常把导电层做成两个分立的导电部分。当生物电极处于第一种结构状态时，两个导电部分位于折叠轴的相对两侧。
为了能使医生将生物电极转换为第二种的“开放”结构，外围部分两个区域之间的密封必须很容易拆开。一种便捷的实现方式是用可释放的粘合剂密封两个区域。在其它实施例中，背衬的外围部分可以与背衬其它部分分开。这可以通过划开或穿孔不费力地做到。
本发明的第二方面提供了制作生物电极的方法，所述生物电极在使用前要装运，其特征在于，所述方法包括下列步骤：提供一种生物电极，包括下列步骤：提供包含第一侧面的背衬，所述第一侧面的外围部分包含第一和第二区域，其中所述背衬被涂敷了一块皮肤粘合剂；通过这块皮肤粘合剂，将导电层固定在背衬的第一侧面上；以及涂敷与导电层相邻的导电粘合剂层；和折叠所述生物电极，使其外围部分的某一区域与另一区域密封在一起从而形成密封的保护外罩。
附图的简要说明
以下将借助附图对本发明作进一步的描述，附图中相同的部分用相同的标号表示，附图包括：
图1为按照本发明较佳实施例的生物电极在第一种结构状态下的平面示意图；
图2为图1生物电极开封后的透视图；
图3为图2生物电极打开变为第二种结构状态时的底视图；以及
图4为沿图3中剖面线4-4剖取的剖面图。
实施发明的较佳方式
现在参见图1和2，它们示出了按照本发明的生物电极10在第一种结构状态下的顶视图。图中所见的是沿着折线14折叠的背衬12。背衬12包括外围部分16，它的第一区域18示于图中，而第二区域20在示意图的远侧。在该实施例中，外围部分16包括划痕线22。在图2中，外围部分16已经被医生沿划痕线22撕开。外围部分16不再使用而被丢弃；由于它的体积较小，所以并没有增加多少医院废弃物。
现在参见图3，它示出了图2的生物电极10被打开成第二种结构时的底视图。通过沿折线14打开生物电极10使它转换为这种结构。在图3中现在可以看到生物电极10朝图1和2内部折叠的部分。背衬12的内面除了区域26以外，都被涂敷上皮肤粘合剂24。皮肤粘合剂24使一对导电片28和30固定到背衬12上。一对导电搭接片32和34从导电片28和30一端开始延伸，这些导电的搭接片起着连接生物电极与例如电外科发生器的作用。由于导电搭接片32和34延伸入区域26，所以可以在一定范围内自由抬离背衬并且起连接作用。
导电粘合剂的两个区域36和38被涂敷在导电片28和30的顶部并且在电外科手术中从人体传输电流。许多适用于导电粘合剂两个区域36和38的材料是透明或者至少是半透明的，并且它们按照通常提供的示意图画法示出。将会注意到的是，当生物电极10折叠时，背衬12两个半部分上的皮肤粘合剂和导电粘合剂是互相面对着的。有些可用的粘合剂自身之间没有明显的粘合作用，在打开生物电极10时很容易剥离开来。其它可用的粘合剂不大容易剥离开来，因此当生物电极处于折叠状态时需要有所保护。当采用这些粘合剂时，按照类似于用书签将书中面对的书页隔开的方法，可以利用内衬40将生物电极10两个半部分上的层隔开，而在其两个表面上的内衬对皮肤粘合剂和导电粘合剂都没有粘合性。在图3中，内衬40按照通常提供的示意图画法被画成是透明的。
现在参见图4，它示出了沿图3中剖线4-4剖取的生物电极10的剖面图。所看到的内衬40仍然粘合在生物电极10画出的半部分。内衬40在使用前从生物电极上剥离并被丢弃。背衬
背衬12可以是电绝缘的，并且比较好的是与人体配合得非常完美。正如本领域内技术人员显而易见的，许多材料可以适合于这种用途。在一个较佳实施例中，封闭单元泡沫被认为特别适合；其中一种这样的材料就是Massachusetts州的Voltek股份有限公司提供的Volara泡沫。背衬的厚度大约介于O.75mm(O.03英寸)-1.5mm(0.06英寸)之间，比较好的是1.0mm(0.04英寸)。导电层
对于上述电外科所用的分立电极，生物电极的导电层一般由层叠在聚乙烯lerephthalate(PET)薄膜上的铝薄片制成。PET薄膜的厚度一般0.05mm(0.002英寸)左右，而铝层厚度一般介于0.0075mm(0。0003英寸)-0.025mm(0.001英寸)之间，比较好的是0.012mm(0.0005英寸)。在考虑到非极化性的诊断应用中，导电层一般由非导电塑料片构成，在其靠近导电粘合剂的表面附近涂敷银/氯化银。这样的涂层可以采用银/氯化银墨水；Massachusetts州Waltham的Ercon公司提供了一种货号为R-301的合适墨水。另外，导电层可以用PCT公开文本WO94/26950和WO 95/20350中揭示的材料构成。不仅如此，导电层还可以由美国专利5,215,087中揭示的石墨材料构成。导电粘合剂
本发明所用导电粘合剂的非限定性实例包括以下文献揭示的材料：美国专利Nos.4,524,087(Engel)、4,539,996(Engel)、4,848,353(Engel)、5,225,473(Duan)、5,276,079(Duan等人)、5,338,490(Dietz等人)、5,362,420(Itoch等人)、5,385,679(Uy等人)、5,133,356(Bryan等人)；共同待批和共同转让的PCT公开文本Nos.WO 95/20634和WO 94/12585；以及PCT专利申请Nos.US95/17079、US95/16993和US95/16996。内衬
内衬40可以是当生物电极10处于第一种结构状态时任何适于保护导电粘合剂和/或皮肤粘合剂自粘合的构造。一种合适的内衬是0.05mm(0.002英寸)厚的双轴定向聚丙烯内衬片，Illinois州Dixon的Daubert有限公司提供了货号为Daubert 1-2 BOPPL-164Z的内衬。皮肤粘合剂
本发明所用皮肤粘合剂24的非限定性实例包括丙烯酸酯粘合剂，特别是丙烯酸酯共聚物粘合剂。这种粘合剂在下列文献中都有概括介绍：美国专利Nos.2,924,906、2,933,353、3,389827、4,112,213、4,310,509、4,323,557、4,732,808、4,917,928、4,917,929和欧洲专利公开0 051 935。
由于本领域内技术人员在不偏离本发明范围和精神的前提下很容易对本发明作各种修改和改动，所以应该理解的是，上述示例性的实施例并不对本发明有限定作用。

Claims (7)

1.一种生物电极，其特征在于包含：
包含第一侧面的背衬(12)，第一侧面的外围部分(16)包含第一和第二区域(18和20)，其中背衬被涂敷了一块皮肤粘合剂(24)；
通过皮肤粘合剂固定在背衬第一侧面上的导电层(28或30)；以及
与导电层相邻的导电粘合剂层(36或38)；其中
生物电极处于第一种结构状态，此时背衬构成密封的保护外罩以保护导电粘合剂层，并且适于成为第二种结构，此时导电粘合剂层露出与病人身体接触，并且
当生物电极处于第一种结构状态时，背村本身折叠起来使得外围部分的某一区域(1)与另一区域(2)密封从而形成密封的保护外罩。
2.如权利要求1所述的生物电极，其特征在于生物电极具有基本对称的轴(14)，并且
当生物电极处于第一种结构状态时沿该轴折叠背衬。
3.如权利要求2所述的生物电极，其特征在于导电层包含两个分立的导电部分(28和30)。
4.如权利要求1所述的生物电极，其特征在于当生物电极处于第一种结构状态时，第一与第二区域用可释放的粘合剂密封。
5.如权利要求1所述的生物电极，其特征在于当生物电极处于第一种结构状态时，第一与第二区域用不可释放的粘合剂密封，并且背衬的外围部分适于与背衬其它部分分开。
6.如权利要求3所述的生物电极，其特征在于导电粘合剂层包括两个分立的导电粘合剂区域，并且生物电极进一步包括内衬(4)，从而当生物电极处于第一结构状态时，内材将导电粘合剂的区域分离开来。
7.一种生物电极(10)制作方法，所述生物电极在使用前要装运，其特征在于，所述方法包括下列步骤：
提供一种生物电极，包括下列步骤：
提供包含第一侧面的背衬(12)，所述第一侧面的外围部分(16)包含第一和第二区域(18和20)，其中所述背衬被涂敷了一块皮肤粘合剂(24)；
通过这块皮肤粘合剂，将导电层(28或30)固定在背衬的第一侧面上；以及
涂敷与导电层相邻的导电粘合剂层(36或38)；和
折叠所述生物电极，使其外围部分的某一区域与另一区域密封在一起从而形成密封的保护外罩。
CN96199418A 1995-12-29 1996-04-26 自包装生物电极及其制作方法 Expired - Fee Related CN1106865C (zh)

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DE69627539D1 (de) 2003-05-22
US5827184A (en) 1998-10-27
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CN1206352A (zh) 1999-01-27
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