CN111785414A - Wire for ECG electrode, ECG electrode and ECG monitoring device - Google Patents
Wire for ECG electrode, ECG electrode and ECG monitoring device Download PDFInfo
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Abstract
Description
技术领域technical field
本发明属于心电测量设备领域,尤其是一种用于感应身体电信号的心电电极片用导线、心电电极片及心电监测装置。The invention belongs to the field of electrocardiogram measurement equipment, in particular to a lead wire for electrocardiogram electrode sheets, an electrocardiogram electrode sheet and an electrocardiogram monitoring device used for inducing body electrical signals.
背景技术Background technique
随着中国社会的发展,经济水平的提升,心脑血管疾病迅速成为威胁都市人群生命健康的主要疾病之一。2018年初,国家心血管病中心发布《中国心血管病报告2017(概要)》。据推算,我国心血管病患人数2.9亿,心血管病死亡占居民疾病死亡构成40%以上,居首位,高于肿瘤及其他疾病。对心脑血管病人来说,时刻对心电信号进行检测,以便及时发现异常、及时就医显得尤为重要。With the development of Chinese society and the improvement of economic level, cardiovascular and cerebrovascular diseases have rapidly become one of the major diseases that threaten the life and health of urban populations. At the beginning of 2018, the National Cardiovascular Disease Center released the "China Cardiovascular Disease Report 2017 (Summary)". It is estimated that the number of cardiovascular disease patients in my country is 290 million, and cardiovascular disease deaths account for more than 40% of residents' disease deaths, ranking first, higher than tumors and other diseases. For cardiovascular and cerebrovascular patients, it is particularly important to detect ECG signals at all times in order to detect abnormalities in time and seek medical treatment in time.
常规即时心电检测设备包括主机、导联线和电极片,其中电极片为一次性用品,主机和导联线可重复使用。Conventional instant ECG detection equipment includes a host, lead wires and electrode pads, wherein the electrode pads are disposable, and the host and lead wires are reusable.
典型的常规即时心电检测设备如CN200720125633.0号、名称为《一次性电极片型常规心电图导联线》的发明专利所公开的:一次性电极片型常规心电图导联线,属于一种用于常规心电图监测和描记的导联线,电缆(5)经过固定联结分线器(4)连接屏蔽胶合线(3),屏蔽胶合线(3)末端联结接头(1),接头(1)工作面粘接一次性粘贴电极(2)。本发明的优点在于:将现有技术中的夹子式和吸球式金属电极,改为一次性贴式电极片可有效增强和保证电极与所对应部位皮肤的稳定接触,提高了心电图检查的成功率和描记质量等,同时将电极的连续使用改为一次性使用后,也符合公共卫生的要求,本发明结构简便有效,易于实施。其结构如图1所示。Typical conventional real-time ECG detection equipment such as CN200720125633.0, the invention patent named "disposable electrode pad type conventional ECG lead wire" disclosed: the disposable electrode pad type conventional ECG lead wire belongs to a kind of For the lead wire for routine ECG monitoring and tracing, the cable (5) is connected to the shielded glued wire (3) through the fixed connection splitter (4), and the end of the shielded glued wire (3) is connected to the connector (1), and the connector (1) works The surface is bonded to the disposable paste electrode (2). The advantages of the present invention lie in that: the clip-type and suction-ball-type metal electrodes in the prior art are changed into disposable stick-type electrode sheets, which can effectively enhance and ensure the stable contact between the electrodes and the skin of the corresponding part, and improve the success of the electrocardiogram examination. At the same time, after the continuous use of the electrode is changed to one-time use, it also meets the requirements of public health, and the invention has a simple and effective structure and is easy to implement. Its structure is shown in Figure 1.
然而,普通心电图只能记录某一段短时间内的心电活动,而心脏异常情况的发生,往往是阵发性的、一过性的、偶发性的。也就是说,当一个人的心脏发生异常状况,即便他马上去医院做检查,那短短十几秒的静态心电图,往往是不能够抓到异常情况的,所以就需要进行全程连续24小时,甚至48小时的监测,去捕获到心脏的异常状况。However, ordinary ECG can only record the electrical activity of the heart for a short period of time, and the occurrence of cardiac abnormalities is often paroxysmal, transient, and occasional. That is to say, when a person's heart is abnormal, even if he goes to the hospital for an examination immediately, the static ECG in just ten seconds is often unable to catch the abnormal situation, so it needs to be carried out for 24 consecutive hours. Even 48 hours of monitoring to capture abnormal conditions of the heart.
因此,动态心电图检测设备应运而生,其可以对24甚至48小时的心电信号进行检测。Therefore, the dynamic electrocardiogram detection equipment came into being, which can detect the ECG signal for 24 or even 48 hours.
典型的动态心电图检测设备如CN94213324.2号、名称为《标准12导联瞬时动态心电图机》的发明专利所公开的:标准12导联瞬时动态心电图机由机壳及装在该机壳上打印机、带有操作键盘、显示器和回放机电路的回放机、有记录盒电路的心电图记录盒组成,回放机和记录盒通过通讯口连接。回放机电路为单片微机电路,记录盒电路为含采集、放大、模数转换及数据储存的单片微机电路。回放机通过键盘向记录盒输入初始化信息,病人随身携带记录盒,按键后便将探头测取的12导联异常心电信号记录在存贮器内,该信号再由回放机显示或打印。其电路结构如图2所示。Typical Holter monitoring equipment such as CN94213324.2, the invention patent named "Standard 12-Lead Instantaneous Holter" is disclosed: The standard 12-lead Instantaneous Holter consists of a casing and a printer mounted on the casing. , It is composed of a playback machine with an operating keyboard, a display and a playback machine circuit, and an electrocardiogram recording box with a recording box circuit. The playback machine and the recording box are connected through a communication port. The playback machine circuit is a single-chip microcomputer circuit, and the record box circuit is a single-chip microcomputer circuit including acquisition, amplification, analog-to-digital conversion and data storage. The playback machine inputs initialization information to the recording box through the keyboard. The patient carries the recording box with them. After pressing the button, the abnormal 12-lead ECG signal measured by the probe is recorded in the memory, and the signal is displayed or printed by the playback machine. Its circuit structure is shown in Figure 2.
然而,这种动态心电仪体积较大,病人带在身上甚为不便,完全无法进行运动或洗澡。因此,需要一种体积较小、携带方便的动态心电仪器结构。However, this kind of Holter monitor is quite bulky, and it is inconvenient for the patient to carry, and it is completely impossible to exercise or take a bath. Therefore, there is a need for a dynamic electrocardiographic instrument structure with a small volume and convenient portability.
因此,又有人发明了贴片式动态心电图记录仪,其结构相对于普通心电图减小了非常多,其便携性能较好。典型的例如201811082281.4号、名称为《一种贴片式动态心电图记录器》的发明专利所公开的:一种贴片式动态心电图记录器,包括底盖组件和主机,所述底盖组件包括可拆卸的安装在主机上的底盖本体、设于底盖本体上的第一电路板,所述第一电路板包括第一电路板本体和连接在第一电路板本体上的三个电极座,每个电极座上可拆卸的安装有一个一次性电极片。这样将底盖本体可拆卸的安装在主机上,在底盖本体的底面上单独设置电路板,将主机上的电路板与底盖本体上的电路板分开了,同时使得电路与一次性电极片分开,每检测完一个病人后,只需要更换安装在底盖本体上的一次性电极片即可,而这种一次性电极片一个只要几毛钱,相对于现有技术中来说大大降低了一次性电极片的成本。其结构可参考图3。图3中102指代贴片式动态心电图记录器,1021指代主体,1033系主机上的孔隙。Therefore, another person invented a patch-type dynamic electrocardiogram recorder, the structure of which is much smaller than that of ordinary electrocardiograms, and its portability is better. A typical invention patent, for example, No. 201811082281.4, titled "A Patch Holter Electrocardiogram Recorder" discloses: a patch Holter Electrocardiogram Recorder, including a bottom cover assembly and a host, the bottom cover assembly includes a The disassembled bottom cover body installed on the host, and the first circuit board provided on the bottom cover body, the first circuit board includes a first circuit board body and three electrode seats connected to the first circuit board body, A disposable electrode pad is detachably mounted on each electrode holder. In this way, the bottom cover body is detachably installed on the main body, and the circuit board is separately arranged on the bottom surface of the bottom cover body, the circuit board on the main body is separated from the circuit board on the bottom cover body, and the circuit and the disposable electrode sheet are separated at the same time. Separately, after each patient is detected, it is only necessary to replace the disposable electrode pad installed on the bottom cover body, and this disposable electrode pad only costs a few cents, which is greatly reduced compared to the prior art. Cost of disposable pads. Its structure can refer to Figure 3. In Fig. 3, 102 refers to the patch-type Holter monitor, 1021 refers to the main body, and 1033 refers to the aperture on the main body.
然而,这种心电胸贴都是主机和传统扣式电极相连,几个电极扣之间的距离不能随着人体胸腔的运动而相应的发生变化,导致贴附于人体之后,皮肤因为人体活动而导致的牵拉感强烈,舒适度大大降低。However, this kind of ECG chest stickers are all connected to the host and traditional button electrodes, and the distance between several electrode buttons cannot be changed correspondingly with the movement of the human chest, resulting in the skin being attached to the human body. As a result, the pulling feeling is strong and the comfort is greatly reduced.
因此,有必要设计一种电极片结构,其能够适应人体运动时电极片上的电极相对位置发生变化,在确认电极片性能的基础上提高人体舒适度。Therefore, it is necessary to design an electrode pad structure, which can adapt to the changes in the relative positions of the electrodes on the electrode pads when the human body moves, and improve the comfort of the human body on the basis of confirming the performance of the electrode pads.
发明内容SUMMARY OF THE INVENTION
本发明的主要目的是提供一种心电电极片用导线、心电电极片及心电监测装置,其能解决上述的问题。The main purpose of the present invention is to provide a lead wire for an ECG electrode pad, an ECG electrode pad and an ECG monitoring device, which can solve the above problems.
本发明首先公开的是一种心电电极片用导线,包括绝缘层和氧化还原层,所述氧化还原层铺设于所述绝缘层之上,所述氧化还原层的纵向截面宽度不大于所述绝缘层,所述绝缘层的纵向截面厚度大于所述氧化还原层,所述绝缘层为柔性非导体材料制成,所述氧化还原层具有导电能力。通过设置绝缘层将氧化还原层隔离、保护起来。本发明的进一步技术方案是:所述绝缘层为聚酰亚胺、聚酯、聚碳酸酯中的一种或多种的组合。这些材料具有较好的柔性,同时让氧化还原层能够牢固的贴附其表面。氧化还原层的印刷属于较为成熟的现有技术,在此不再赘述。The present invention firstly discloses a lead wire for an ECG electrode sheet, which includes an insulating layer and a redox layer, the redox layer is laid on the insulating layer, and the longitudinal cross-sectional width of the redox layer is not greater than the width of the redox layer. An insulating layer, the longitudinal section thickness of the insulating layer is greater than that of the redox layer, the insulating layer is made of a flexible non-conductor material, and the redox layer has electrical conductivity. The redox layer is isolated and protected by arranging an insulating layer. A further technical solution of the present invention is: the insulating layer is one or a combination of polyimide, polyester and polycarbonate. These materials have good flexibility, while allowing the redox layer to adhere firmly to its surface. The printing of the redox layer belongs to a relatively mature prior art, and will not be repeated here.
本发明的进一步技术方案是:所述氧化还原层包括中间层和反应层。其中中间层的目的主要是为了加强反应层与绝缘层的结合。A further technical solution of the present invention is that: the redox layer includes an intermediate layer and a reaction layer. The purpose of the intermediate layer is mainly to strengthen the combination of the reaction layer and the insulating layer.
采用本方案获得的心电电极片用导线,在具备最基本的导电性能的基础上,具有一定的柔性,能够适应贴附于人体表面的需求。当使用者运动时,身体表层肌肉发生形变折弯的过程中,心电电极片用导线随之一起发生折弯,从而不会影响电信号传输,同时也不会让使用者感到不适。On the basis of having the most basic electrical conductivity, the lead wire for the electrocardiographic electrode sheet obtained by this scheme has certain flexibility and can adapt to the needs of being attached to the surface of the human body. When the user is exercising, during the deformation and bending of the body surface muscles, the wires used for the ECG electrode pads are also bent together, so that the electrical signal transmission will not be affected, and the user will not feel uncomfortable.
本发明同时公开的是一种心电电极片,包括基材层,铺设于所述基材层之上的至少一条如前所述的心电电极片用导线,输入电极,输出电极,所述输入电极、输出电极的数量与所述心电电极片用导线相同,每条所述心电电极片用导线分别对应一个输入电极及一个输出电极,其中所述输入电极与所述心电电极片用导线的一端相连,所述输出电极与所述心电电极片用导线的另一端相连。The invention also discloses an electrocardiographic electrode sheet, comprising a base material layer, at least one lead wire for electrocardiographic electrode sheet as described above laid on the base material layer, an input electrode, an output electrode, and the The number of input electrodes and output electrodes is the same as the lead wire for the ECG electrode sheet, and each lead wire for the ECG electrode sheet corresponds to an input electrode and an output electrode respectively, wherein the input electrode and the ECG electrode sheet have the same numbers. One end of the wire is connected, and the output electrode is connected to the other end of the wire for the ECG electrode sheet.
基材层直接与人体接触,人体的心电信号被基材层之上的输入电极感应到,通过前述的心电电极片用导线传输至基材层之上的输出电极,实现人体心电信号的感应。至于输入电极、输出电极设置的位置;心电电极片用导线如何与输入电极、输出电极相连并实现导通等,均不是本专利保护的重点,且现有技术中已经存在可以实现的方案,故本专利中不再赘述。The substrate layer is in direct contact with the human body, and the human body's ECG signal is sensed by the input electrode on the substrate layer, and is transmitted to the output electrode above the substrate layer through the aforementioned ECG electrode sheet with wires to realize the human body's ECG signal. induction. As for the positions of the input electrodes and the output electrodes; how the wires of the ECG electrode pads are connected to the input electrodes and the output electrodes to achieve conduction, etc., are not the focus of the protection of this patent, and there are already solutions that can be realized in the prior art. Therefore, it is not repeated in this patent.
本发明的进一步技术方案是:所述基材层为柔性材料,并具有弹性。基材层直接与人体接触,当人体皮肤发生形变时基材层随之发生相同形变。A further technical solution of the present invention is that: the base material layer is a flexible material and has elasticity. The substrate layer is in direct contact with the human body, and when the human skin is deformed, the substrate layer undergoes the same deformation.
本发明的进一步技术方案是:所述心电电极片用导线非线性的铺设于所述基材层上。通过非线性的设置,确保基材层发生形变时导线一同发生形变、但不影响电信号的传输。A further technical solution of the present invention is that the wires for the ECG electrode sheet are non-linearly laid on the base material layer. Through the non-linear setting, it is ensured that when the substrate layer is deformed, the wires are deformed together, but the transmission of electrical signals is not affected.
本发明的进一步技术方案是:所述心电电极片用导线包括至少一个延长部与至少一个折弯部,所述延长部与所述折弯部相互连接。虽然心电电极片用导线在局部是非线性的,但在宏观上依然具有方向性,其中延长部是心电电极片用导线中沿着直线延伸的部分,而折弯部是心电电极片用导线中转角的部分。A further technical solution of the present invention is that: the lead wire for the ECG electrode sheet includes at least one extension portion and at least one bending portion, and the extension portion and the bending portion are connected to each other. Although the lead wire for ECG electrode pads is locally nonlinear, it is still directional on a macroscopic scale. The extension part is the part that extends along a straight line in the lead wire for ECG The part of the wire that turns the corner.
本发明的进一步技术方案是:所述延长部具有至少两个第一非线性重复单元,每个所述第一非线性重复单元首尾相连。A further technical solution of the present invention is that: the extension part has at least two first nonlinear repeating units, and each of the first nonlinear repeating units is connected end to end.
本发明的进一步技术方案是:所述折弯部具有一个第二非线性重复单元或至少两个相互连接的第二非线性重复单元。通过重复单元的设置,使得生产尽可能便利。但由于延长部和折弯部延伸方向不同,其形变时受力不同,所以重复单元的结构也有所不同。重复单元可以是任何形状,例如方波形,“M”字形、波浪形等,只要能够实现重复的生产即可。A further technical solution of the present invention is that: the bent portion has one second nonlinear repeating unit or at least two second nonlinear repeating units connected to each other. The production is made as convenient as possible by the arrangement of repeating units. However, due to the different extension directions of the extension part and the bending part, the force during deformation is different, so the structure of the repeating unit is also different. The repeating unit can be in any shape, such as square wave, "M" shape, wave shape, etc., as long as it can achieve repeated production.
本发明的进一步技术方案是:所述第一非线性重复单元上没有应力集中点,所述第二非线性重复单元上没有应力集中点。由于形变时不同位置受力不同,若存在应力集中点,极有可能发生断裂或接触不良,导致信号传输中断。A further technical solution of the present invention is that: there is no stress concentration point on the first nonlinear repeating unit, and no stress concentration point on the second nonlinear repeating unit. Due to the different forces at different positions during deformation, if there is a stress concentration point, it is very likely that fracture or poor contact will occur, resulting in interruption of signal transmission.
本发明的进一步技术方案是:所述第一非线性重复单元正弦波形、余弦波形中的一种,所述第一非线性重复单元正弦波形的函数表达式为所述第一非线性重复单元余弦波形的函数表达式为所述第二非线性重复单元为正弦波形、余弦波形中的一种,所述第二非线性重复单元正弦波形的函数表达式为所述第一非线性重复单元余弦波形的函数表达式为其中A1为所述第一非线性重复单元的波幅,A2为所述第二非线性重复单元的波幅,ω1为所述第一非线性重复单元角频率,ω2为所述第二非线性重复单元角频率,x为所述第一非线性重复单元或所述第二非线性重复单元的横轴量,为所述第一非线性重复单元或所述第二非线性重复单元的横相偏移,b为所述第一非线性重复单元或所述第二非线性重复单元的竖相偏移。A further technical solution of the present invention is: one of a sine waveform and a cosine waveform of the first nonlinear repeating unit, and the function expression of the first nonlinear repeating unit sine waveform is: The functional expression of the cosine waveform of the first nonlinear repeating unit is: The second nonlinear repeating unit is one of a sine waveform and a cosine waveform, and the function expression of the sine waveform of the second nonlinear repeating unit is: The functional expression of the cosine waveform of the first nonlinear repeating unit is: where A 1 is the amplitude of the first nonlinear repeating unit, A 2 is the amplitude of the second nonlinear repeating unit, ω 1 is the angular frequency of the first nonlinear repeating unit, and ω 2 is the second nonlinear repeating unit the angular frequency of the nonlinear repeating unit, x is the horizontal axis quantity of the first nonlinear repeating unit or the second nonlinear repeating unit, is the transverse phase shift of the first nonlinear repeating unit or the second nonlinear repeating unit, and b is the vertical phase shift of the first nonlinear repeating unit or the second nonlinear repeating unit.
本发明的进一步技术方案是:所述ω2大于所述ω1,所述A2大于所述A1。由于折弯部发生了折弯,若其与延伸部的角频率及波幅相同,则折弯部单位长度线路受到的应力可能会高于延伸部,造成受力不均。A further technical solution of the present invention is: the ω 2 is greater than the ω 1 , and the A 2 is greater than the A 1 . Since the bending part is bent, if it has the same angular frequency and amplitude as the extension part, the stress per unit length of the bending part may be higher than that of the extension part, resulting in uneven stress.
本发明的进一步技术方案是:所述A2小于或等于2π/ω2的数值。2π/ω2即是该波函数的周期的具体数值,换句话说,折弯部的高度不大于其每周期的长度。这样可以保证折弯部足够平滑,确保应力较小。A further technical solution of the present invention is: the A 2 is less than or equal to the value of 2π/ω 2 . 2π/ω 2 is the specific value of the period of the wave function, in other words, the height of the bent portion is not greater than the length of each period. This ensures that the bend is smooth enough to ensure less stress.
本发明的进一步技术方案是:所述心电电极片用导线的宽度不大于A1的一半。导线宽度越宽,其电阻率越低,越有利于信号传输,但导线宽度越大电极片的便携性能就越差,同时导线宽度大于一定波幅的一半时,较难实现形变。A further technical solution of the present invention is: the width of the lead wire for the ECG electrode sheet is not greater than half of A1. The wider the wire width is, the lower the resistivity is, which is more conducive to signal transmission, but the larger the wire width, the worse the portability of the electrode sheet.
本发明的进一步技术方案是:每条所述心电电极片用导线之间平行放置,所述心电电极片用导线之间的距离大于A1的一半。每条所述心电电极片用导线之间的距离过近,在人体发生移动时可能会导致导线相互接触,但距离越远又不利于便携性能。A further technical solution of the present invention is that each of the wires for the ECG electrode pads is placed in parallel, and the distance between the wires for the ECG electrode pads is greater than half of A1. The distance between the wires for each of the ECG electrode sheets is too close, which may cause the wires to contact each other when the human body moves, but the farther the distance is, the worse the portability is.
本发明同时公开的是一种心电监测装置,包括主机,如权利要求4-15所述的心电电极片,所述主机与所述心电电极片可分离的相连,所述主机上设有至少一个感应电极,所述感应电极与所述心电电极片上的输出电极一一对应并可分离的相连。The present invention also discloses an ECG monitoring device, comprising a host, an ECG electrode sheet according to claims 4-15, the host and the ECG electrode sheet are detachably connected, and the host is provided with There is at least one sensing electrode, and the sensing electrode is in a one-to-one correspondence with the output electrodes on the ECG electrode sheet and can be detachably connected.
本方案中的心电监测装置之包括主机和心电电极片,大大减小了传统心电仪的体积,同时由于电极片具有拉伸和柔韧性能,可以随着人体一起发生形变,人体在运动过程中不会因为电极片而感到不适,电极片也不会因为人体发生形变而传输不畅。The ECG monitoring device in this solution includes the host and the ECG electrode pads, which greatly reduces the volume of the traditional ECG instrument. At the same time, because the electrode pads have stretching and flexibility properties, they can deform together with the human body, and the human body is moving. During the process, there will be no discomfort due to the electrode pads, and the electrode pads will not be transmitted poorly due to the deformation of the human body.
本发明的进一步技术方案是:所述感应电极具有磁性。通过设置磁性,使得感应电极更好的与输出电极定位并连接。A further technical solution of the present invention is: the induction electrode has magnetism. By setting the magnetism, the sensing electrode is better positioned and connected with the output electrode.
本发明的有益效果是:本方案提供的心电电极片用导线本身具有一定的折弯性能和拉伸性能,能够适应人体运动时导线发生形变的需求。进一步的,本方案提供的心电电极片中非线性重复单元的排列,为导线的拉伸进一步提供了空间,最终使得采用本方案心电电极片的心电监测装置可以较好的与人体接触,人体在运动过程中不会因为电极片而感到不适,电极片也不会因为人体发生形变而传输不畅。The beneficial effect of the present invention is that the lead wire for the electrocardiographic electrode sheet provided by the solution has certain bending performance and tensile performance, and can meet the requirements of the deformation of the lead wire when the human body moves. Further, the arrangement of the nonlinear repeating units in the ECG electrode pads provided by this solution provides further space for the stretching of the wires, and finally enables the ECG monitoring device using the ECG electrode pads of this solution to better contact the human body. , the human body will not feel uncomfortable because of the electrode pads during the movement, and the electrode pads will not be transmitted poorly due to the deformation of the human body.
附图说明Description of drawings
为了更清楚地说明本申请实施例或现有技术中的技术方案,下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍,显而易见地,下面描述中的附图仅仅是本申请中记载的一些实施例,对于本领域普通技术人员来讲,在不付出创造性劳动的前提下,还可以根据这些附图获得其他的附图。In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the following briefly introduces the accompanying drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some embodiments described in this application. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without any creative effort.
图1是现有技术1提供的心电检测设备示意图。FIG. 1 is a schematic diagram of an electrocardiogram detection device provided by the
图2是现有技术2提供的心电检测设备示意图。FIG. 2 is a schematic diagram of an ECG detection device provided by the
图3是现有技术3提供的心电检测设备示意图。FIG. 3 is a schematic diagram of an electrocardiogram detection device provided by the
图4是本发明实施例1提供的心电电极片用导线的堆叠示意图。FIG. 4 is a schematic diagram of stacking of wires for ECG electrode pads provided in
图5是本发明实施例1提供的心电电极片基材示意图。FIG. 5 is a schematic diagram of an ECG electrode sheet substrate provided in Example 1 of the present invention.
图6是本发明实施例1提供的心电电极片用导线结构图。6 is a structural diagram of a lead wire for an ECG electrode sheet provided in
图7是本发明实施例1提供的心电电极片示意图。FIG. 7 is a schematic diagram of the ECG electrode sheet provided in
图例:1-接头;2-一次性粘贴电;3-屏蔽胶合线;4-分线器;5-电缆;102-贴片式动态心电图记录器;1021-主体;1033-主机上的孔隙;123-反应层;124-中间层;125-绝缘层;11-基材层;12-心电电极片用导线;121-延长部;122-折弯部;13-输出电极;14-输入电极。Legend: 1-connector; 2-disposable paste electric; 3-shielded glue line; 4-split; 5-cable; 102-patch Holter; 1021-body; 1033-hole on the host; 123-reaction layer; 124-intermediate layer; 125-insulation layer; 11-substrate layer; 12-lead wire for ECG electrode sheet; 121-extension part; 122-bending part; 13-output electrode; .
具体实施方式Detailed ways
下面将结合本发明实施例中的附图,对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明的一部分实施例,而不是全部的实施例。基于木发明中的实施例,本领域普通技术人员在没有做出创造性劳动的前提下所获得的所有其它实施例,都属于本发明保护的范围。The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments in the wooden invention, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present invention.
此外,以下各实施例的说明是参考附加的图示,用以例示本发明可用以实施的特定实施例。本发明中所提到的方向用语,例如,“上”、“下”、“前”、“后”、“左”、“右”、“内”、“外”、“侧面”等,仅是参考附加图式的方向,因此,使用的方向用语是为了更好、更清楚地说明及理解本发明,而不是指示或暗指所指的装置或元件必须具有特定的方位、以特定的方位构造和操作,因此不能理解为对本发明的限制。Furthermore, the following descriptions of the various embodiments refer to the accompanying drawings to illustrate specific embodiments in which the invention may be practiced. Directional terms mentioned in the present invention, such as "up", "down", "front", "rear", "left", "right", "inside", "outside", "side", etc., only Reference is made to the directions of the accompanying drawings, therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, in a specific orientation construction and operation, and therefore should not be construed as limiting the invention.
在本发明的描述中,需要说明的是,除非另有明确的规定和限定,术语“安装”、“相连”、“连接”等应做广义理解,例如,可以是固定连接,也可以是可拆卸地连接,或者一体地连接;可以是机械连接;可以是直接相连,也可以通过中间媒介间接相连,可以是两个元件内部的连通。对于本领域的普通技术人员而言,可以具体情况理解上述术语在本发明中的具体含义。In the description of the present invention, it should be noted that the terms "installed", "connected", "connected" and the like should be understood in a broad sense, unless otherwise expressly specified and limited, for example, it may be a fixed connection or a Removably connected, or integrally connected; it can be a mechanical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the internal communication of the two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood in specific situations.
此外,在本发明的描述中,除非另有说明,“多个”的含义是两个或两个以上。若本说明书中出现“工序”的用语,其不仅是指独立的工序,在与其它工序无法明确区别时,只要能实现该工序所预期的作用则也包括在本用语中。另外,本说明书中用“~”表示的数值范围是指将“~”前后记载的数值分别作为最小值及最大值包括在内的范围。在附图中,结构相似或相同的用相同的标号表示。Also, in the description of the present invention, unless otherwise specified, "plurality" means two or more. If the term "process" appears in this specification, it not only refers to an independent process, but also includes in this term as long as the intended function of the process can be achieved when it cannot be clearly distinguished from other processes. In addition, the numerical range represented by "-" in this specification means the range which includes the numerical value described before and after "-" as a minimum value and a maximum value, respectively. In the drawings, structures that are similar or identical are denoted by the same reference numerals.
本发明提供一种电极片装置。以下结合附图及实施例对本发明进行详细说明。The invention provides an electrode sheet device. The present invention will be described in detail below with reference to the accompanying drawings and embodiments.
本发明首先公开的是一种心电电极片用导线,参考图4。The present invention firstly discloses a lead wire for an ECG electrode sheet, with reference to FIG. 4 .
该心电电极片用导线包括绝缘层125和氧化还原层,所述氧化还原层铺设于所述绝缘层之上,所述氧化还原层的纵向截面宽度不大于所述绝缘层,所述绝缘层的纵向截面厚度大于所述氧化还原层,所述绝缘层为柔性非导体材料制成,所述氧化还原层具有导电能力。通过设置绝缘层将氧化还原层隔离、保护起来。The wire for ECG electrode sheet includes an insulating
从图4中可以看出,所述氧化还原层包括中间层124和反应层123。在本实施例中,中间层为Ag层,其可以使得作为反应层的Ag\AgCl更好的附着在绝缘层上,从而更好的反应。It can be seen from FIG. 4 that the redox layer includes an
其中,所述绝缘层为聚酰亚胺、聚酯、聚碳酸酯中的一种或多种的组合。这些材料具有较好的柔性,同时让氧化还原层能够牢固的贴附其表面。氧化还原层的印刷属于较为成熟的现有技术,在此不再赘述。Wherein, the insulating layer is one or a combination of polyimide, polyester and polycarbonate. These materials have good flexibility, while allowing the redox layer to adhere firmly to its surface. The printing of the redox layer belongs to a relatively mature prior art, and will not be repeated here.
在本实施例中,我们选用PET作为绝缘层的基材,PET具有较好的柔韧性能和力学性能,同时成本较低。In this embodiment, we choose PET as the base material of the insulating layer. PET has good flexibility and mechanical properties, and at the same time, the cost is low.
采用本方案获得的心电电极片用导线,在具备最基本的导电性能的基础上,具有一定的柔性,能够适应贴附于人体表面的需求。当使用者运动时,身体表层肌肉发生形变折弯的过程中,心电电极片用导线随之一起发生折弯,从而不会影响电信号传输,同时也不会让使用者感到不适。On the basis of having the most basic electrical conductivity, the lead wire for the electrocardiographic electrode sheet obtained by this scheme has certain flexibility and can adapt to the needs of being attached to the surface of the human body. When the user is exercising, during the deformation and bending of the body surface muscles, the wires used for the ECG electrode pads are also bent together, so that the electrical signal transmission will not be affected, and the user will not feel uncomfortable.
本具体实施例同时公开的是一种心电电极片,其结构可以参考图5-7。This specific embodiment also discloses an ECG electrode sheet, the structure of which can be referred to FIGS. 5-7 .
该心电电极片包括基材层11,铺设于所述基材层之上的至少一条权利前述心电电极片用导线12,输入电极14,输出电极13,所述输入电极、输出电极的数量与所述心电电极片用导线相同,每条所述心电电极片用导线分别对应一个输入电极及一个输出电极,其中所述输入电极与所述心电电极片用导线的一端相连,所述输出电极与所述心电电极片用导线的另一端相连。The ECG electrode sheet includes a
心电监测又可以分为多导和单导。多导采集到心电的信息更加丰富,能够监测到心肌缺血、心梗等等。单导对于心律失常这一大类心脏疾病的筛查,尤其对房颤筛查,具有现实意义。ECG monitoring can be divided into multi-lead and single-lead. The information collected by polyconductive ECG is more abundant, and it can monitor myocardial ischemia, myocardial infarction and so on. Single lead has practical significance for the screening of arrhythmia, a large category of heart diseases, especially for atrial fibrillation.
本具体实施例中的电极片为单导电极片,其上具有三对相互独立的电极,因此也有三根导线。可以预见,多导电极片的导线数量会更多,但其原理与单导相同。The electrode sheet in this specific embodiment is a single-conductive electrode sheet, which has three pairs of electrodes independent of each other, and therefore also has three wires. It is foreseeable that the number of wires in the multi-conductor electrode sheet will be more, but the principle is the same as that of the single lead.
基材层直接与人体接触,人体的心电信号被基材层之上的输入电极感应到,通过本专利中的心电电极片用导线传输至基材层之上的输出电极,实现人体心电信号的感应。至于输入电极、输出电极设置的位置;心电电极片用导线如何与输入电极、输出电极相连并实现导通等,均不是本专利保护的重点,且现有技术中已经存在可以实现的方案,故本专利中不再赘述。The substrate layer is in direct contact with the human body, and the ECG signal of the human body is sensed by the input electrode on the substrate layer, and is transmitted to the output electrode above the substrate layer through the ECG electrode sheet in this patent with wires, so as to realize the human heart. Induction of electrical signals. As for the positions of the input electrodes and the output electrodes; how the wires of the ECG electrode pads are connected to the input electrodes and the output electrodes to achieve conduction, etc., are not the focus of the protection of this patent, and there are already solutions that can be realized in the prior art. Therefore, it is not repeated in this patent.
本具体实施例的进一步方案为:所述基材层为柔性材料,并具有弹性。基材层直接与人体接触,当人体皮肤发生形变时基材层随之发生相同形变。A further solution of this specific embodiment is: the base material layer is a flexible material and has elasticity. The substrate layer is in direct contact with the human body, and when the human skin is deformed, the substrate layer undergoes the same deformation.
在本实施例中,基材层的选择为PU,但是本领域技术人员可知,任何具有一定力学性能,同时具有较好生物相容性的材料,例如PCL等,据可用于作为基材层的原料。In this embodiment, the choice of the substrate layer is PU, but those skilled in the art know that any material with certain mechanical properties and good biocompatibility, such as PCL, etc., can be used as the substrate layer. raw material.
在本实施例中,所述心电电极片用导线非线性的铺设于所述基材层上,参考图6。通过非线性的设置,确保基材层发生形变时导线一同发生形变、但不影响电信号的传输。In this embodiment, the conductive wires for the ECG electrode sheet are non-linearly laid on the base material layer, referring to FIG. 6 . Through the non-linear setting, it is ensured that when the substrate layer is deformed, the wires are deformed together, but the transmission of electrical signals is not affected.
本具体实施例的进一步方案为:所述心电电极片用导线包括至少一个延长部121与至少一个折弯部122,所述延长部与所述折弯部相互连接。虽然心电电极片用导线在局部是非线性的,但在宏观上依然具有方向性,其中延长部是心电电极片用导线中沿着直线延伸的部分,而折弯部是心电电极片用导线中转角的部分。A further solution of this specific embodiment is: the lead wire for the ECG electrode sheet includes at least one
本具体实施例的进一步方案为:所述延长部具有至少两个第一非线性重复单元,每个所述第一非线性重复单元首尾相连。A further solution of this specific embodiment is: the extension part has at least two first nonlinear repeating units, and each of the first nonlinear repeating units is connected end to end.
本具体实施例的进一步方案为:所述折弯部具有一个第二非线性重复单元或至少两个相互连接的第二非线性重复单元。通过重复单元的设置,使得生产尽可能便利。但由于延长部和折弯部延伸方向不同,其形变时受力不同,所以重复单元的结构也有所不同。重复单元可以是任何形状,例如方波形,“M”字形、波浪形等,只要能够实现重复的生产即可。A further solution of this specific embodiment is: the bending portion has one second nonlinear repeating unit or at least two second nonlinear repeating units connected to each other. The production is made as convenient as possible by the arrangement of repeating units. However, due to the different extension directions of the extension part and the bending part, the force during deformation is different, so the structure of the repeating unit is also different. The repeating unit can be in any shape, such as square wave, "M" shape, wave shape, etc., as long as it can achieve repeated production.
在本实施例中,第一重复单元和第二重复单元都是正弦波,但是本专利并没有限定第一重复单元和第二重复单元一定要相同,一种可行的方式是:第一重复单元采用方波,第二重复单元采用正弦波,甚至第一重复单元可以包括多种不同的波形,例如一个正弦波和一个方波结合。In this embodiment, the first repeating unit and the second repeating unit are both sine waves, but this patent does not limit the first repeating unit and the second repeating unit must be the same, a feasible way is: the first repeating unit A square wave is used, a sine wave is used for the second repeating unit, and even the first repeating unit can include a variety of different waveforms, such as a combination of a sine wave and a square wave.
本具体实施例的进一步方案为:所述第一非线性重复单元上没有应力集中点,所述第二非线性重复单元上没有应力集中点。由于形变时不同位置受力不同,若存在应力集中点,极有可能发生断裂或接触不良,导致信号传输中断。A further solution of this specific embodiment is: there is no stress concentration point on the first nonlinear repeating unit, and no stress concentration point on the second nonlinear repeating unit. Due to the different forces at different positions during deformation, if there is a stress concentration point, it is very likely that fracture or poor contact will occur, resulting in interruption of signal transmission.
本具体实施例的进一步方案为:所述第一非线性重复单元正弦波形、余弦波形中的一种,所述第一非线性重复单元正弦波形的函数表达式为所述第一非线性重复单元余弦波形的函数表达式为所述第二非线性重复单元为正弦波形、余弦波形中的一种,所述第二非线性重复单元正弦波形的函数表达式为所述第一非线性重复单元余弦波形的函数表达式为其中A1为所述第一非线性重复单元的波幅,A2为所述第二非线性重复单元的波幅,ω1为所述第一非线性重复单元角频率,ω2为所述第二非线性重复单元角频率,x为所述第一非线性重复单元或所述第二非线性重复单元的横轴量,为所述第一非线性重复单元或所述第二非线性重复单元的横相偏移,b为所述第一非线性重复单元或所述第二非线性重复单元的竖相偏移。A further solution of this specific embodiment is: one of a sine waveform and a cosine waveform of the first nonlinear repeating unit, and the function expression of the first nonlinear repeating unit sine waveform is: The functional expression of the cosine waveform of the first nonlinear repeating unit is: The second nonlinear repeating unit is one of a sine waveform and a cosine waveform, and the function expression of the sine waveform of the second nonlinear repeating unit is: The functional expression of the cosine waveform of the first nonlinear repeating unit is: where A 1 is the amplitude of the first nonlinear repeating unit, A 2 is the amplitude of the second nonlinear repeating unit, ω 1 is the angular frequency of the first nonlinear repeating unit, and ω 2 is the second nonlinear repeating unit the angular frequency of the nonlinear repeating unit, x is the horizontal axis quantity of the first nonlinear repeating unit or the second nonlinear repeating unit, is the transverse phase shift of the first nonlinear repeating unit or the second nonlinear repeating unit, and b is the vertical phase shift of the first nonlinear repeating unit or the second nonlinear repeating unit.
通常情况下,不需要有横相偏移或竖相偏移,即和b都为0。另需要说明的是,本函数的零点设置在导线的起点。Under normal circumstances, there is no need for a horizontal phase offset or a vertical phase offset, i.e. and b are both 0. It should be noted that the zero point of this function is set at the starting point of the wire.
本具体实施例的进一步方案为:所述ω2大于所述ω1,所述A2大于所述A1。由于折弯部发生了折弯,若其与延长部的角频率及波幅相同,则折弯部单位长度线路受到的应力可能会高于延伸部,造成受力不均。A further solution of this specific embodiment is: the ω 2 is greater than the ω 1 , and the A 2 is greater than the A 1 . Since the bending part is bent, if the angular frequency and amplitude of the extension part are the same, the stress per unit length of the bending part may be higher than that of the extension part, resulting in uneven stress.
本具体实施例的进一步方案为:所述A2小于或等于2π/ω2的数值。2π/ω2即是该波函数的周期的具体数值,换句话说,折弯部的高度不大于其每周期的长度。这样可以保证折弯部足够平滑,确保应力较小。A further solution of this specific embodiment is: the A 2 is less than or equal to the value of 2π/ω 2 . 2π/ω 2 is the specific value of the period of the wave function, in other words, the height of the bent portion is not greater than the length of each period. This ensures that the bend is smooth enough to ensure less stress.
本具体实施例的进一步方案为:所述心电电极片用导线的宽度不大于A1的一半。导线宽度越宽,其电阻率越低,越有利于信号传输,但导线宽度越大电极片的便携性能就越差,同时导线宽度大于一定波幅的一半时,较难实现形变。A further solution of this specific embodiment is: the width of the lead wire for the ECG electrode sheet is not greater than half of A 1 . The wider the wire width is, the lower the resistivity is, which is more conducive to signal transmission, but the larger the wire width, the worse the portability of the electrode sheet.
在本实施例中,每条所述心电电极片用导线之间平行放置,所述心电电极片用导线之间的距离大于A1的一半。可以参考图7。每条所述心电电极片用导线之间的距离过近,在人体发生移动时可能会导致导线相互接触,但距离越远又不利于便携性能。In this embodiment, each lead wire for the ECG electrode sheet is placed in parallel, and the distance between the lead wires for the ECG electrode sheet is greater than half of A1. Refer to Figure 7. The distance between the wires for each of the ECG electrode sheets is too close, which may cause the wires to contact each other when the human body moves, but the farther the distance is, the worse the portability is.
本发明同时公开的是一种心电监测装置(图中未示出),包括主机,如本具体实施例所述的心电电极片,所述主机与所述心电电极片可分离的相连,所述主机上设有至少一个感应电极,所述感应电极与所述心电电极片上的输出电极一一对应并可分离的相连。The present invention also discloses an ECG monitoring device (not shown in the figure), which includes a host, such as the ECG electrode sheet described in this specific embodiment, the host is detachably connected to the ECG electrode sheet , the host is provided with at least one sensing electrode, and the sensing electrode is in a one-to-one correspondence with the output electrodes on the ECG electrode sheet and can be connected separately.
本方案中的心电监测装置之包括主机和心电电极片,大大减小了传统心电仪的体积,同时由于电极片具有拉伸和柔韧性能,可以随着人体一起发生形变,人体在运动过程中不会因为电极片而感到不适,电极片也不会因为人体发生形变而传输不畅。The ECG monitoring device in this solution includes the host and the ECG electrode pads, which greatly reduces the volume of the traditional ECG instrument. At the same time, because the electrode pads have stretching and flexibility properties, they can deform together with the human body, and the human body is moving. During the process, there will be no discomfort due to the electrode pads, and the electrode pads will not be transmitted poorly due to the deformation of the human body.
本具体实施例的进一步方案为:所述感应电极具有磁性。通过设置磁性,使得感应电极更好的与输出电极定位并连接。A further solution of this specific embodiment is: the sensing electrode has magnetism. By setting the magnetism, the sensing electrode is better positioned and connected with the output electrode.
本发明的有益效果是:本方案提供的心电电极片用导线本身具有一定的折弯性能和拉伸性能,能够适应人体运动时导线发生形变的需求。进一步的,本方案提供的心电电极片中非线性重复单元的排列,为导线的拉伸进一步提供了空间,最终使得采用本方案心电电极片的心电监测装置可以较好的与人体接触,人体在运动过程中不会因为电极片而感到不适,电极片也不会因为人体发生形变而传输不畅。The beneficial effect of the present invention is that the lead wire for the electrocardiographic electrode sheet provided by the solution has certain bending performance and tensile performance, and can meet the requirements of the deformation of the lead wire when the human body moves. Further, the arrangement of the nonlinear repeating units in the ECG electrode pads provided by this solution provides further space for the stretching of the wires, and finally enables the ECG monitoring device using the ECG electrode pads of this solution to better contact the human body. , the human body will not feel uncomfortable because of the electrode pads during the movement, and the electrode pads will not be transmitted poorly due to the deformation of the human body.
以上所述仅为本发明的较佳实施例而已,并不用以限制本发明,凡在本发明的精神和原则之内所作的任何修改、等同替换和改进等,均应包含在本发明的保护范围之内。The above descriptions are only preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements and improvements made within the spirit and principles of the present invention shall be included in the protection of the present invention. within the range.
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