WO2014139194A1 - 柔性心外膜心电电极芯片及其制备方法 - Google Patents

柔性心外膜心电电极芯片及其制备方法 Download PDF

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Publication number
WO2014139194A1
WO2014139194A1 PCT/CN2013/074306 CN2013074306W WO2014139194A1 WO 2014139194 A1 WO2014139194 A1 WO 2014139194A1 CN 2013074306 W CN2013074306 W CN 2013074306W WO 2014139194 A1 WO2014139194 A1 WO 2014139194A1
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electrode
flexible
flexible substrate
lead
connection point
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PCT/CN2013/074306
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English (en)
French (fr)
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于喆
谢雷
张红治
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深圳先进技术研究院
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Publication of WO2014139194A1 publication Critical patent/WO2014139194A1/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
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6867—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive specially adapted to be attached or implanted in a specific body part
    • A61B5/6869—Heart
    • 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
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • 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
    • A61B2562/02—Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0209—Special features of electrodes classified in A61B5/24, A61B5/25, A61B5/283, A61B5/291, A61B5/296, A61B5/053
    • A61B2562/0215—Silver or silver chloride containing
    • 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
    • A61B2562/16—Details of sensor housings or probes; Details of structural supports for sensors
    • A61B2562/166—Details of sensor housings or probes; Details of structural supports for sensors the sensor is mounted on a specially adapted printed circuit board

Definitions

  • the invention relates to the field of medical equipment, in particular to a flexible epicardial electrocardiographic electrode chip, and to a preparation method of a flexible epicardial electrocardiographic electrode chip.
  • ECG examinations are used to locate macroscopic surface ECG signals from 9 locations such as the hand, foot, and chest to analyze the heart disease.
  • the electrical signals generated by the heart have attenuation, distortion and filtering effects during conduction to the outside of the body.
  • the ECG signal of the body surface is significantly different in amplitude and phase from the potential distribution on the surface of the heart.
  • Many electrophysiological events are not necessarily observed on the body surface. If multiple excitatory points occur at the same time in the myocardium, the superposition of multiple maps will make the body surface potential difficult to determine.
  • the surface electrocardiogram can only be qualitatively observed, and the precise location of the lesion cannot be performed, thus leading to a limited correct rate of diagnosis.
  • a direct examination of the heart is required to locate the characterization and to perform targeted treatment.
  • Epicardial electrocardiogram is a method for accurately measuring and observing the electrical activity of the heart. Unlike conventional electrocardiography, it can not only macroscopically determine the diagnosis, but also determine the precise location of the lesion, providing an objective basis for targeted treatment. . It uses a multi-electrode system to cover the epicardial surface for simultaneous multi-point recording of cardiac electrical excitation. Due to the direct contact between the electrode array and the epicardium, and the simultaneous sampling of the ECG signals, the origin and propagation of ECG excitation can be objectively and accurately reflected.
  • the epicardial multi-channel ECG system provides asymmetric ventricular repolarization information compared to surface ECG recording and is useful for monitoring changes in ECG during cardiac regeneration.
  • foreign epicardial ECG research seeks to obtain more accurate myocardial activation sequences and distribution data with more electrode points. Due to the large number of electrodes and the large amount of data, most of them are electrophysiological studies using off-line analysis methods, which are difficult to apply to clinical practice.
  • the electrode acts as a transducer that directs the bioelectrical changes produced by the living organism, and the ionizing current is an electron current.
  • the earliest used for ECG acquisition was the needle electrode, but the needle electrode was limited to local recording. Later, with the deepening of research, the epicardial electrocardiogram mainly used a sheet electrode that is easy to operate.
  • the main base materials currently used for epicardial electrode sheets are silicone rubber and thermoplastics, which facilitate multi-site detection.
  • the base material of the electrode should have good flexibility and compliance, and can adapt to the contraction and relaxation of the heart.
  • the size and relative spacing of the electrodes must meet the measurement requirements while preventing damage to the epicardium.
  • the silicone rubber and the thermoplastic substrate can meet the above requirements, as the number of electrodes increases, the electrode leads are easily chaotic and broken, which increases the difficulty in fabrication and use, and also affects the adhesion of the electrode points to the epicardium.
  • the material of the commonly used electrode points is generally silver (diameter 0.2 mm silver). Wire) or stainless steel (1.5mm diameter stainless steel wire), the distance between the existing epicardial electrodes is generally 1-5.6mm. But the same problem will
  • electrodes are designed to uniformly distribute electrode dots on a flexible printed circuit board, and the surface of the electrode dots is exposed to copper foil and subjected to electroless gold plating.
  • the lead wire of each electrode is formed integrally with the flexible sheet, and the raw material of the electrode sheet is made of polyimide, and the abutting line is enhanced by reducing the thickness to the micrometer scale.
  • the electrode points are plated with gold on the outside of the copper to achieve long-term placement and are not easily oxidized, while ensuring good contact.
  • the polyimide film cannot be stretched and folded, and the degree of local tolerance is less than 1%.
  • a flexible epicardial electrocardiographic electrode chip comprising: a flexible substrate, an electrode unit, an electrode lead, a lead connection point and an insulating layer, wherein the electrode unit, the electrode lead and the lead connection point together constitute an electrode assembly, and the electrode assembly is provided On the flexible substrate, the electrode unit is connected to a lead connection point via an electrode lead for electrical connection, the insulating layer is disposed on the flexible substrate and covers the electrode lead, and the electrode unit is used for electrical connection
  • the surface of the heart, the flexible substrate and the insulating layer are made of polydimethylsiloxane.
  • the electrode assembly includes an electrode layer, and the electrode layer is made of one of gold, titanium, and copper.
  • the electrode assembly further includes a primer layer, the electrode layer is disposed on the primer layer, and the underlayer is made of titanium, chromium, or one of the two elements or Two alloys.
  • the electrode unit further includes a modifying layer disposed on a surface of the electrode unit facing away from the flexible substrate, the modifying layer being made of platinum, rhodium, or both One or two of the alloys or compounds, or one of polypyrrole, poly(3,4-ethylenedioxythiophene), and polyaniline.
  • the flexible substrate is located at a portion of the electrode unit portion that is much thicker than other regions of the flexible substrate.
  • the flexible substrate has a rectangular cross section
  • the electrode unit and the lead connection point are in one-to-one correspondence
  • the electrode assembly includes two columns that are axisymmetric about a vertical axis of the rectangle, the electrode The unit and the corresponding lead connection point are located on the same side of the vertical line, the electrode unit is disposed near the center line, and the corresponding lead connection point is located near a side of the rectangle parallel to the mid-perpendicular line.
  • the central portion of the flexible epicardial electrocardiographic electrode chip forms an inward depression on a side facing away from the insulating layer.
  • a method for preparing a flexible nerve bundle electrode comprising the steps of: step one, providing polydimethylsiloxane on a rigid substrate to form a flexible substrate; and step 2, forming an electrode assembly on the flexible substrate, the electrode assembly a lead connection point, an electrode unit for electrically connecting the surface of the heart, and an electrode lead electrically connecting the lead connection point and the electrode unit; and step 3, providing a polydimethyl group covering the electrode assembly on the flexible substrate
  • the siloxane forms an insulating layer, and forms an opening at a position of the electrode unit and the lead connection point of the insulating layer to expose the electrode unit and the lead connection point; and step 4, separating the flexible substrate from the rigid substrate to obtain The flexible epicardial electrocardiographic electrode chip.
  • the second step comprises: preparing a mask formed with a hollow pattern of the shape of the electrode assembly; attaching the mask to the flexible substrate; Depositing a primer layer on the flexible substrate of the mask; depositing an electrode layer on the primer layer; and removing the mask from the flexible substrate.
  • the step 3 further comprises the step of plating a surface of the electrode unit with a finishing layer, the modifying layer is made of platinum, rhodium, or one of the two elements or Two alloys or compounds, or one of polypyrrole, poly(3,4-ethylenedioxythiophene), and polyaniline.
  • the modifying layer is made of platinum, rhodium, or one of the two elements or Two alloys or compounds, or one of polypyrrole, poly(3,4-ethylenedioxythiophene), and polyaniline.
  • the rigid substrate is a glass boss.
  • the flexible epicardial electrocardiographic electrode chip has good flexibility and deformability, and the recording part is accurate, the contact is tight, and the repeatability is good.
  • 90% one-dimensional deformation and 20% two-dimensional deformation can be realized, and a good conformal effect can be realized without greatly reducing the thickness of the substrate.
  • the microelectrode array is adhered to the surface of the heart to improve sensitivity.
  • good flexibility matching with the heart can effectively reduce the risk of damage to the epicardium caused by the chip.
  • the chip maintains good electrical properties under folding, twisting and stretching conditions, thereby improving the fit to the heart.
  • FIG. 1 is a schematic structural view of a flexible epicardial electrocardiographic electrode chip according to an embodiment
  • Figure 2 is a cross-sectional view taken along the dotted line 6 of Figure 1;
  • FIG. 3 is a flow chart showing a method of preparing a flexible epicardial electrocardiographic electrode chip in an embodiment
  • FIG. 4 is a flow chart showing a method of preparing a flexible epicardial electrocardiographic electrode chip of Embodiment 1;
  • FIG. 5 is a schematic structural view of a flexible epicardial electrocardiographic electrode chip of Embodiment 2;
  • Figure 6 is a cross-sectional view taken along the dotted line 12 shown in Figure 5;
  • FIG. 7 is a schematic view showing the application of the flexible epicardial electrocardiographic electrode chip of Embodiment 2;
  • FIG. 8 is a flow chart showing a method of preparing a flexible epicardial electrocardiographic electrode chip of Example 2.
  • FIG. 1 is a schematic structural view of a flexible epicardial electrocardiographic electrode chip of Embodiment 1, the flexible epicardial electrocardiographic electrode chip comprising a flexible substrate 1, an insulating layer 2, an electrode unit 3, an electrode lead 4, and a lead connection point 5.
  • the electrode lead 4 is electrically connected to the electrode unit 3 and the lead pad 5, and one electrode unit 3, one electrode lead 4, and one lead pad 5 together constitute one electrode assembly.
  • the electrode assembly is disposed on the flexible substrate 1, and the insulating layer 2 is disposed on the flexible substrate 1 and covers the electrode leads 4.
  • the electrode unit 3 is for electrically connecting the heart, and the lead connection point 5 is for connecting the electrocardiographic electrode to an external circuit.
  • Fig. 2 is a cross-sectional view taken along the broken line 6 shown in Fig. 1.
  • the electrode unit 3 and the lead connection point 5 are exposed to the outside without an insulating layer on the surface.
  • the number of electrode units is 10, which is a matrix distribution of 2*5. It can be understood that the size, spacing and number of the electrode units 3 can be adjusted according to actual application requirements.
  • the line width, the pitch, and the wiring pattern of the electrode lead 4 can be adjusted while sufficiently considering the rationality of the wiring.
  • the size and spacing of the lead connection points 5 can be adjusted according to actual application requirements.
  • the lead connection points 5 are in one-to-one correspondence with the electrode units 3, and the number is the same.
  • the material of the flexible substrate 1 and the insulating layer 2 is polydimethylsiloxane.
  • Polydimethylsiloxane has good flexibility and deformation ability and good biocompatibility, and can ensure the processing precision and spatial resolution of the flexible epicardial electrocardiographic electrode chip.
  • the flexible epicardial electrocardiographic electrode chip is arranged by a plurality of electrode units 3 to form an electrode array, which can achieve spatial resolution down to the micrometer scale, has good softness and deformation ability, can be attached to the surface of the heart, and adapts to the surface of the heart.
  • the change of the contour can ensure the good adhesion of the electrode to the target area of the heart surface, and can effectively avoid the damage caused by the electrode caused by the extrusion and scratch during the movement of the heart. It can be used for qualitative diagnosis of heart disease and precise location of lesions to provide an objective basis for targeted treatment.
  • FIG. 3 is a flow chart of a method for preparing a flexible epicardial electrocardiographic electrode chip according to an embodiment, comprising the following steps:
  • the rigid substrate can be made of glass, silicon wafer, etc., and mainly serves as a support.
  • the rigid substrate is made of a silicon wafer (which may be in any crystal orientation), and the polydimethylsiloxane is disposed on the surface of the silicon wafer by spin coating.
  • spin coating speed There are two main methods for changing the thickness of the flexible substrate 1: one is to change the spin coating speed, and the other is to change the concentration of the polydimethylsiloxane.
  • the microfabrication process (including a film preparation process, a photolithography process, an etching process, etc.) is performed on the flexible substrate 1.
  • One electrode unit 3, one electrode lead 4, and one lead connection point 5 constitute one electrode assembly, and the electrode lead 4 electrically connects the electrode unit 3 and the lead connection point 5.
  • the electrode assembly includes at least an electrode layer, and the electrode layer is made of one of gold, titanium, and copper.
  • the electrode assembly further includes a primer layer, the electrode layer is disposed on the primer layer, and the underlayer is made of titanium, chromium, or an alloy containing one or both of the two elements.
  • the electrode unit 3 further includes a modifying layer disposed on the surface of the electrode unit 3 facing away from the flexible substrate 1.
  • the decorative layer is made of platinum, rhodium, or one of the two elements or Two alloys or compounds, or one of polypyrrole, poly(3,4-ethylenedioxythiophene), and polyaniline.
  • a polydimethylsiloxane covering the electrode assembly is disposed on the flexible substrate 1 to form an insulating layer 2, and an opening is formed at a position of the electrode unit 3 and the lead connection point 5 of the insulating layer 2, and the electrode unit 3 and the lead are connected Point 5 is exposed.
  • the insulating layer 2 can also be provided by a spin coating method, and the thickness of the insulating layer 2 can also be adjusted by changing the spin coating speed or changing the concentration of the polydimethylsiloxane.
  • the flexible nerve beam electrode prepared by the above preparation method of the flexible nerve beam electrode has good dimensional adaptability and is easy to realize the normalized design of the device.
  • a method for preparing a flexible epicardial electrocardiographic electrode chip of Embodiment 1 is provided. Referring to FIG. 4, the following steps are included:
  • the underlying layer and the electrode layer are limited by the hollow pattern of the mask to form the shape of the electrode assembly.
  • photolithography is performed using a thick photoresist, and a sacrificial layer of photoresist is prepared at a position of the electrode unit 3 and a position of the lead connection point 5.
  • the thickness of the insulating layer 2 should be much lower than the thickness of the thick photoresist sacrificial layer.
  • the electrode unit 3 is surface-modified.
  • a surface of the exposed electrode unit 3 is plated with a layer of platinum black or ruthenium oxide as a finishing layer to reduce the impedance.
  • the material of the modifying layer may be platinum, rhodium, or an alloy or compound containing one or both of these two elements, or polypyrrole, poly(3,4-ethylenedioxythiophene), One of polyaniline.
  • FIG. 5 is a schematic structural view of a flexible epicardial electrocardiographic electrode chip according to Embodiment 2, wherein the flexible epicardial electrocardiographic electrode chip is also composed of a flexible substrate 7, an insulating layer 8, an electrode unit 9, an electrode lead 10, and a lead connection point 11 Part of the composition.
  • This embodiment differs from the electrode structure of Embodiment 1 in that it adopts a stepped electrode structure, and the thickness of the flexible substrate 7 is stepped.
  • polydimethylsiloxane itself has good elastic properties, its dynamic stretchability, softness and adhesion are closely related to its thickness.
  • the flexible substrate 7 of the electrode attached to the heart (mainly concentrated in the electrode unit array and part of the wiring area) can be thinned. .
  • the thickness of the flexible substrate 7 under the electrode unit 9 is much smaller than the thickness of other regions of the flexible substrate 7, much less than one tenth of the general reference.
  • the flexible substrate 7 at the position where the electrode is attached to the heart is locally thinned to 5 ⁇ m or less, and the peripheral lead connection point 11 portion can be maintained at a relatively thick level of 50-500 ⁇ m, which is ensured.
  • the flexibility of the device also ensures operability during packaging and surgery.
  • the thickness of the portion of the flexible substrate 7 below the lead connection point 11 is much larger than the thickness of the portion of the flexible substrate 7 below the electrode unit 9 and the electrode lead 10, and the flexible substrate 7 is provided with one side of the electrode assembly as a flat surface.
  • Figure 6 is a cross-sectional view taken along the dotted line 12 of Figure 5.
  • Fig. 7 is a schematic view of the application thereof, including a heart 13, a wire 14, and a wire 14 for effecting the connection of the lead connection point 11 to an external circuit.
  • the flexible substrate 7 has a rectangular cross section, and the electrode unit 9 and the lead connection point 11 are in one-to-one correspondence.
  • the electrode assembly includes two columns that are axisymmetric about a vertical axis of the rectangle, the electrode unit 9 and its corresponding wire connection point 11 are located on the same side of the center line, and the electrode unit 9 is disposed near the center line, and the corresponding wire connection point 11 is located near the side of the rectangle parallel to the vertical line.
  • the central portion of the flexible epicardial electrocardiographic electrode chip forms an inward depression on one side of the back insulating layer 8.
  • a method for preparing a flexible epicardial electrocardiographic electrode chip of Embodiment 2 is provided. Referring to FIG. 8, the following steps are included:
  • a polydimethylsiloxane flexible substrate 7 having a stepped structure is prepared on a glass substrate having a stud structure.
  • the boss structure is a right angle boss, and in other embodiments, it may be a bevel boss.
  • a reverse photoresist pattern of the desired electrode unit 9, the electrode lead 10, and the lead connection point 11 is prepared on the flexible substrate 7 by a lift-off technique.
  • a layer of polydimethylsiloxane is spin-coated on the flexible substrate on which the electrode unit 9, the electrode lead 10, and the lead connection point 11 are prepared as the insulating layer 8.
  • the electrode unit 9 and the lead connection point 11 are cut at the corresponding positions by the laser cutting method, and the insulating layer on the surface of the electrode unit 9 and the lead connection point 11 is removed to realize the opening.
  • the electrode unit 9 is surface-modified.
  • a surface of the electrode unit 9 is exposed with a layer of platinum black or ruthenium oxide as a finishing layer to reduce the impedance.
  • the flexible epicardial electrocardiographic electrode chip is different from the conventional electrocardiographic electrode in that it can not only macroscopically determine the diagnosis, but also determine the precise position of the lesion, which can be targeted sexual treatment provides an objective basis, and it can also be more intuitive to observe the efficacy of the drug.
  • the present invention has the following beneficial effects:
  • the flexible epicardial ECG electrode chip is prepared from a material with good biocompatibility with the organism and can be used for a long time in the body.
  • the electrode chip is made of flexible material, which can adapt to different contours of the heart surface and can flex and retract with the movement of the heart without displacement.
  • the electrode chip is automatically attached, which avoids the wounding caused by the suture on the myocardium and generates a damage potential, which affects the accuracy of signal acquisition.
  • the flexible connection of the lead connection point ensures that the contact between the electrode points and the epicardium is good, and the phenomenon that the rigid material electrode contacts are caused by the on-time breakage is avoided.
  • the electrode chip can change the spatial resolution as needed.
  • the interference between the electrode arrays is small, easy to use, and no stitching is required.
  • the recording chip style applied to different parts can be placed at a large position, the dislocation rate is low, and no complications occur.
  • the electrode chip still maintains good electrical properties under the conditions of folding, twisting and stretching, which improves the operability of the implant and reduces the risk of surgery.
  • This electrode chip can also be used to visually observe the efficacy of the drug.

Abstract

一种柔性心外膜心电电极芯片及其制备方法，所述电极芯片包括柔性基底、电极单元、电极引线、引线连接点和绝缘层，电极单元、电极引线、引线连接点均设于柔性基底上，三者实现电连接，绝缘层设于柔性基底上并覆盖电极引线，电极单元和引线连接点表面不设绝缘层。上述电极芯片由多个电极单元排列形成电极阵列，可实现最小到微米尺度的空间分辨率，具良好的柔软度和形变能力，可贴附在心脏表面，适应心脏表面轮廓的变化，既能保证电极与心脏表面目标区域形成良好的贴附，又能有效避免心脏运动过程中由电极造成的挤压和划伤等损害。可用于心脏疾病的定性诊断以及对病灶进行精确定位，为针对性治疗提供客观依据。

Description

柔性心外膜心电电极芯片及其制备方法
【技术领域】
本发明涉及医疗设备领域，特别是涉及一种柔性心外膜心电电极芯片，还涉及一种柔性心外膜心电电极芯片的制备方法。
【背景技术】
常规心电检查从手、足、胸前等9个位置安置电极获取宏观体表心电信号加以分析来判断心脏疾病。但是由于身体组织的非对称、非规则、非均匀性，心脏产生的电信号在向体外传导过程中存在衰减、失真和滤波效应。另外体表的心电信号在幅度和相位上与心脏表面的电位分布都有明显的差异，许多电生理事件并不一定能在体表观察到。如心肌同时出现多个激动点时，多幅映射的叠加将使体表电位难以确定。体表心电只能定性观察，不能进行病灶的精确定位，因而导致诊断的正确率受限。而对于心律失常、心肌缺血等复杂的心脏疾病则需要对心脏进行直接的检查才能定位定性，从而进行针对性治疗。
心外膜心电作为一种精确测量和观察分析心脏电活动的方法，与常规心电图检查不同，它不仅能宏观地得出诊断，还能确定出病变的精确位置，为针对性治疗提供客观依据。它是利用多电极系统覆盖心外膜表面对心脏电兴奋进行多点同步记录。由于电极阵列与心外膜的直接接触，以及对心电信号的同步采样，因此能客观而精确的反应心电兴奋的起源及传播的过程。
在美国，有将近五百万心脏衰竭患者，而且每年新增确诊患者数高达55万。以当前情况来看，在美国等发达国家以心脏衰竭作为主要原因的疾病，其发病率和死亡率主要来自替代干细胞介导的心肌梗死不足。
相比于体表心电图记录，心外膜多道心电图系统能够提供非对称性的心室复极信息，而且在心脏再生中对监测心电图的变化非常有用。目前国外的心外膜心电研究都力求以更多的电极点获取更精确的心肌激动顺序和分布的资料。由于电极数目的众多，数据量大，因而大多都是采用离线分析的方法进行电生理研究，难以应用于临床。
在生物医学信息提取中，电极起到换能器的作用，它可将生物机体产生的生物电变化引导出来，变离子电流为电子电流。最早用于心电采集的是针状电极，但是针状电极仅限于局部记录，后来随着研究深入，心外膜心电主要采用方便操作的片状电极。
目前用于心外膜电极片的主要基底材料多为硅橡胶和热塑性塑料，便于实现多位点检测。电极的基底材料应该具有良好的柔韧性和顺应性，能适应心脏的收缩和舒张，电极的尺寸以及相对间距必须满足测量的要求，同时还要防止对心外膜造成损伤。虽然硅橡胶和热塑性塑料为基底可以满足上述的要求，但是随着电极的增多，电极引线容易混乱、折断，增加制作和使用的难度，同时也会影响电极点与心外膜的贴附性。另外还有人用生理盐水浸透的医用纱布作为电极的基底材料，术前将电极均匀缝合在纱布上，电极的直径达到1mm，间距为3mm，常用的电极点的材料一般采用银（直径0.2mm银丝）或不锈钢（直径1.5mm的不锈钢丝），现有心外膜电极的极间距一般为1-5.6mm。但在使用中也会存在同样的问题。
最近还有研究将电极设计为电极点均匀分布制作在柔性印刷电路板上，电极点表面暴露铜箔并做化学镀金处理。每个电极的引出线和柔性板形成一个整体，电极片的原材料采用聚酰亚胺，通过降低厚度到微米尺度来增强贴靠行。而电极点采用铜质外面镀金来达到长时间放置不易氧化，同时保证良好的接触性。然而，受到材料本身性能的制约，聚酰亚胺薄膜不能拉伸和折叠，局部容忍应变程度小于1%。即使可以通过不断降低聚酰亚胺薄膜的厚度来提高微电极阵列的柔韧性，但是这样做增加了电极的加工难度，由于受到工艺的制约不得不增大电极的加工尺寸，从而导致电极的分辨率下降，另外聚酰亚胺基底厚度减薄，也使微电极阵列的机械强度和可操作性随之下降。
【发明内容】
基于此，有必要针对传统的心外膜电极片存在的问题，提供一种柔性心外膜心电电极芯片。
一种柔性心外膜心电电极芯片，包括：柔性基底、电极单元、电极引线、引线连接点和绝缘层，所述电极单元、电极引线及引线连接点共同组成电极组件，所述电极组件设于所述柔性基底上，所述电极单元经由电极引线连接到引线连接点，实现电连接，所述绝缘层设于所述柔性基底上并覆盖所述电极引线，所述电极单元用于电连接心脏表面，所述柔性基底和绝缘层的材质为聚二甲基硅氧烷。
在其中一个实施例中，所述电极组件包括电极层，所述电极层的材质为金、钛、铜中的一种。
在其中一个实施例中，所述电极组件还包括打底层，所述电极层设于所述打底层上，所述打底层的材质为钛、铬，或包含这两种元素中的一种或两种的合金。
在其中一个实施例中，所述电极单元还包括修饰层，所述修饰层设于电极单元背向所述柔性基底的表面，所述修饰层的材质为铂、铱，或包含这两种元素中的一种或两种的合金或化合物，或者聚吡咯、聚（3,4-乙烯二氧噻吩）、聚苯胺中的一种。
在其中一个实施例中，所述柔性基底位于电极单元部分的厚度远小于柔性基底其它区域的厚度。
在其中一个实施例中，所述柔性基底的横截面为长方形，所述电极单元和引线连接点一一对应，所述电极组件包括关于所述长方形的中垂线轴对称的两列，所述电极单元和对应的引线连接点位于中垂线的同一侧，所述电极单元设于靠近所述中垂线的位置，对应的引线连接点位于靠近长方形与所述中垂线平行的一边的位置，所述柔性心外膜心电电极芯片中部于背向所述绝缘层的一面形成向内的凹陷。
还有必要提供一种柔性心外膜心电电极芯片的制备方法。
一种柔性神经束电极的制备方法，包括下列步骤：步骤一，在刚性基底上设置聚二甲基硅氧烷形成柔性基底；步骤二，在所述柔性基底上形成电极组件，所述电极组件包括引线连接点、用于电连接心脏表面的电极单元、及电连接所述引线连接点和电极单元的电极引线；步骤三，在所述柔性基底上设置覆盖所述电极组件的聚二甲基硅氧烷形成绝缘层，并在所述绝缘层的电极单元和引线连接点位置处形成开口，露出所述电极单元和引线连接点；步骤四，将所述柔性基底从刚性基底上分离，得到所述柔性心外膜心电电极芯片。
在其中一个实施例中，所述步骤二包括：制备一块形成有所述电极组件形状的镂空图案的掩膜；将所述掩膜紧密贴附于所述柔性基底上；在贴附有所述掩膜的柔性基底上淀积打底层；在所述打底层上淀积一层电极层；将所述掩膜自柔性基底上移除。
在其中一个实施例中，所述步骤三之后还包括在所述电极单元表面镀一层修饰层的步骤，所述修饰层的材质为铂、铱，或包含这两种元素中的一种或两种的合金或化合物，或者聚吡咯、聚（3,4-乙烯二氧噻吩）、聚苯胺中的一种。
在其中一个实施例中，所述刚性基底为玻璃凸台。
上述柔性心外膜心电电极芯片具有良好的柔韧性和形变能力，记录部位准确、接触严密、重复性好。另外在保证电极阵列的微米尺度加工精度和空间分辨率的同时，可以实现90%的一维形变和20%的二维形变，不需要大幅度降低基底厚度就可以实现很好的共形效果，实现微电极阵列与心脏表面的吻合贴附，提高灵敏度。同时，与心脏良好的柔性匹配性能，能有效降低芯片对心外膜造成损伤的风险。另外，芯片在折叠、扭曲和拉伸条件下仍能保持良好的电学性能，从而提高了与心脏的匹配性。
【附图说明】
图1是一实施例中柔性心外膜心电电极芯片的结构示意图；
图2是沿图1所示虚线6的剖视图；
图3是一实施例中柔性心外膜心电电极芯片的制备方法的流程图；
图4是实施例1中柔性心外膜心电电极芯片的制备方法的流程图；
图5是实施例2中柔性心外膜心电电极芯片的结构示意图；
图6是沿图5所示虚线12的剖视图；
图7是实施例2中柔性心外膜心电电极芯片的应用示意图；
图8是实施例2中柔性心外膜心电电极芯片的制备方法的流程图。
【具体实施方式】
为使本发明的目的、特征和优点能够更为明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。
实施例1：
图1是实施例1中柔性心外膜心电电极芯片的结构示意图，柔性心外膜心电电极芯片包括柔性基底1、绝缘层2、电极单元3、电极引线4以及引线连接点5。电极引线4电连接电极单元3和引线焊点5，一个电极单元3、一根电极引线4及一个引线焊点5共同组成一个电极组件。电极组件设于柔性基底1上，绝缘层2设于柔性基底1上并覆盖电极引线4。电极单元3用于电连接心脏，引线连接点5用于实现心电电极与外部电路的连接。图2是沿图1所示虚线6的剖视图，在该实施例中，电极单元3和引线连接点5曝露在外界，表面不设绝缘层。电极单元数量为10个，成2*5的矩阵分布。可以理解的，电极单元3的尺寸、间距、数量根据实际应用要求可以进行调整。电极引线4的线宽、间距、走线方式可以在充分考虑布线合理性的情况下进行调整。引线连接点5的尺寸和间距根据实际应用要求可以进行调整。引线连接点5与电极单元3一一对应，数量相同。
柔性基底1和绝缘层2的材质为聚二甲基硅氧烷（polydimethylsiloxane）。聚二甲基硅氧烷具有良好的柔韧性和形变能力及良好的生物相容性，并能保证柔性心外膜心电电极芯片的加工精度和空间分辨率。
上述柔性心外膜心电电极芯片由多个电极单元3排列形成电极阵列，可以实现最小到微米尺度的空间分辨率，具有良好的柔软度和形变能力，可以贴附在心脏表面，适应心脏表面轮廓的变化，既能保证电极与心脏表面目标区域形成良好的贴附，又能有效避免心脏运动过程中由电极造成的挤压和划伤等损害。可用于心脏疾病的定性诊断以及对病灶进行精确定位，为针对性治疗提供客观依据。
图3是一实施例中柔性心外膜心电电极芯片的制备方法的流程图，包括下列步骤：
S110，在刚性基底上设置聚二甲基硅氧烷形成柔性基底1。
刚性基底可以选用玻璃、硅片等，主要起支撑的作用。在本实施例中，刚性基底采用硅片（可以为任意晶向），并采用旋涂的方式将聚二甲基硅氧烷设置在硅片表面。其中改变柔性基底1厚度的方法主要有两种：一种是改变旋涂速度，另外一种是改变聚二甲基硅氧烷的浓度。
S120，在柔性基底1上形成电极单元3、电极引线4以及引线连接点5。
采用微加工工艺（包括薄膜制备工艺、光刻工艺、刻蚀工艺等）在柔性基底1上进行制作。一个电极单元3、一根电极引线4以及一个引线连接点5组成一个电极组件，电极引线4将电极单元3和引线连接点5电连接。在其中一个实施例中，电极组件至少包括电极层，电极层的材质为金、钛、铜中的一种。在其中一个实施例中，电极组件还包括打底层，电极层设于打底层上，打底层的材质为钛、铬，或包含这两种元素中的一种或两种的合金。在其中一个实施例中，电极单元3还包括修饰层，修饰层设于电极单元3背向柔性基底1的表面，修饰层的材质为铂、铱，或包含这两种元素中的一种或两种的合金或化合物，或者聚吡咯、聚（3,4-乙烯二氧噻吩）、聚苯胺中的一种。
S130，在柔性基底1上设置覆盖电极组件的聚二甲基硅氧烷形成绝缘层2，并在绝缘层2的电极单元3和引线连接点5位置处形成开口，将电极单元3和引线连接点5露出。
绝缘层2同样可以通过旋涂的方法进行设置，绝缘层2的厚度也可以通过改变旋涂速度或改变聚二甲基硅氧烷的浓度的方法进行调整。
S140，将柔性基底1从刚性基底上分离，得到柔性心外膜心电电极芯片。
采用上述柔性神经束电极的制备方法制备的柔性神经束电极，具有良好的尺寸适应性，易于实现器件的归一化设计。
再提供一种实施例1中的柔性心外膜心电电极芯片的制备方法，参见图4，包括下列步骤：
S210，在任意晶向的硅片上旋涂一层聚二甲基硅氧烷作为柔性基底1。
S220，制备一块掩膜，在掩膜上形成电极组件的镂空图案，将掩膜置于柔性基底1上，形成紧密贴附。
S230，采用电子束蒸发的方法首先在柔性基底1上沉积一层钛膜作为打底层，然后再采用热蒸发的方法在打底层上沉积一层金膜作为电极层。
打底层和电极层受到掩膜的镂空图案限制，形成电极组件的形状。
S240，移除掩膜。
S250，采用厚型光刻胶进行光刻，在电极单元3的位置和引线连接点5的位置上制备出光刻胶牺牲层。
S260，旋涂一层聚二甲基硅氧烷作为绝缘层2。
其中绝缘层2的厚度应远低于厚型光刻胶牺牲层的厚度。
S270，去除光刻胶牺牲层，在牺牲层的位置形成绝缘层开口，将相应位置的电极组件暴露出来。
S280，对电极单元3进行表面修饰。
即在电极单元3露出的表面镀一层铂黑或氧化铱作为修饰层，以降低阻抗。
在其它实施例中，修饰层的材质可以为铂、铱，或包含这两种元素中的一种或两种的合金或化合物，或者聚吡咯、聚（3,4-乙烯二氧噻吩）、聚苯胺中的一种。
实施例2：
图5是实施例2中柔性心外膜心电电极芯片的结构示意图，柔性心外膜心电电极芯片同样由柔性基底7、绝缘层8、电极单元9、电极引线10以及引线连接点11五部分组成。该实施例中与实施例1中的电极结构不同之处在于其采用了一种阶梯式的电极结构，柔性基底7的厚度呈阶梯状设计。虽然聚二甲基硅氧烷本身具有良好的弹性性能，但是其动态可拉伸的能力、柔软度及其贴附性还是与其厚度息息相关。为了更好的适应心脏的收缩和舒张，避免对心外膜产生损伤，可以对电极贴附在心脏上的位置处（主要集中在电极单元阵列和部分走线区域）的柔性基底7进行减薄。具体的，在一个实施例中，位于电极单元9下方的柔性基底7的厚度远小于柔性基底7其它区域的厚度，远小于一般指十分之一以下。在本实施例中，对电极贴附在心脏上的位置处的柔性基底7局部减薄至5μm以下，而外围引线连接点11部分可以保持在一个较厚的水平50-500μm，这样既能保证器件的柔性，同时也保证了其封装和手术过程中的可操作性。
在实施例2中，柔性基底7位于引线连接点11下方的部分的厚度远大于柔性基底7位于电极单元9和电极引线10的下方的部分的厚度，柔性基底7设有电极组件的一面为平面。图6是沿图5所示虚线12的剖视图。图7是其应用示意图，其中包括心脏13，导线14，导线14用于实现引线连接点11与外部电路的连接。
在实施例2中，柔性基底7的横截面为长方形，电极单元9和引线连接点11一一对应。电极组件包括关于长方形的中垂线轴对称的两列，电极单元9和其对应的引线连接点11位于中垂线的同一侧，电极单元9设于靠近中垂线的位置，对应的引线连接点11位于靠近长方形与中垂线平行的一边的位置。柔性心外膜心电电极芯片中部于背向绝缘层8的一面形成向内的凹陷。
再提供一种实施例2中的柔性心外膜心电电极芯片的制备方法，参见图8，包括下列步骤：
S310，在带有凸台结构的玻璃基底上制备有台阶结构的聚二甲基硅氧烷柔性基底7。
在本实施例中凸台结构为直角凸台，在其它实施例中也可以为斜角凸台。
S320，采用剥离（lift-off）技术，在柔性基底7上面制备所需要电极单元9、电极引线10和引线连接点11的反转光刻胶图案。
S330，采用电子束蒸发的方式在柔性基底7上沉积一层金属钛膜。
S340，去除光刻胶及其上的金属钛膜，直接形成所需要的电极单元9、电极引线10和引线连接点11。
S350，在制备好电极单元9、电极引线10及引线连接点11的柔性基底上旋涂一层聚二甲基硅氧烷作为绝缘层8。
S360，采用激光切割的方法在电极单元9以及引线连接点11对应位置进行切割，去除电极单元9以及引线连接点11表面的绝缘层，实现开口。
S370，对电极单元9进行表面修饰。
即在电极单元9露出的表面镀一层铂黑或氧化铱作为修饰层，以降低阻抗。
作为一种精确测量和观察分析心脏电活动的电极芯片，柔性心外膜心电电极芯片与常规心电图电极不同，它不仅能宏观地得出诊断，还能确定出病变的精确位置，可为针对性治疗提供客观依据，还可以更为直观的观察药物的疗效。
与现有技术相比，本发明具有如下有益的效果：
1. 此柔性心外膜心电电极芯片采用与生物体具有良好生物相容性的材料制备，可以在体内长时间使用。
2. 电极芯片采用柔性材料制成，更能适应心脏表面的不同轮廓并能随心脏运动而同步伸缩且不发生移位。
3. 电极芯片采用自动贴附，避免了缝合在心肌上造成伤口而产生损伤电位，影响信号采集精度。
4. 引线连接点采用柔性设计，保证各电极点与心外膜接触良好，避免了刚性材质电极触点造成时通时断的现象出现。
5. 电极芯片可以根据需要改变空间分辨率，电极阵列之间干扰小，使用方便，无需缝合。
6. 可以根据心脏结构设计应用于不同部位的记录芯片样式，可放置位置多、脱位率低，不会产生并发症。
7. 电极芯片在折叠、扭曲和拉伸的条件下仍然保持良好的电学性能，提高了植入的可操作性，降低手术风险。
8. 此电极芯片还可以用来直观的观察药物疗效。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对本发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种柔性心外膜心电电极芯片，其特征在于，包括：柔性基底、电极单元、电极引线、引线连接点和绝缘层，所述电极单元、电极引线及引线连接点共同组成电极组件，所述电极组件设于所述柔性基底上，所述电极单元经由电极引线连接到引线连接点，实现电连接，所述绝缘层设于所述柔性基底上并覆盖所述电极引线，所述电极单元用于电连接心脏表面，所述柔性基底和绝缘层的材质为聚二甲基硅氧烷。
  2. 根据权利要求1所述的柔性心外膜心电电极芯片，其特征在于，所述电极组件包括电极层，所述电极层的材质为金、钛、铜中的一种。
  3. 根据权利要求2所述的柔性心外膜心电电极芯片，其特征在于，所述电极组件还包括打底层，所述电极层设于所述打底层上，所述打底层的材质为钛、铬，或包含这两种元素中的一种或两种的合金。
  4. 根据权利要求2或3所述的柔性心外膜心电电极芯片，其特征在于，所述电极单元还包括修饰层，所述修饰层设于电极单元背向所述柔性基底的表面，所述修饰层的材质为铂、铱，或包含这两种元素中的一种或两种的合金或化合物，或者聚吡咯、聚（3,4-乙烯二氧噻吩）、聚苯胺中的一种。
  5. 根据权利要求1所述的柔性心外膜心电电极芯片，其特征在于，所述柔性基底位于电极单元部分的厚度远小于柔性基底其它区域的厚度。
  6. 根据权利要求5所述的柔性心外膜心电电极芯片，其特征在于，所述柔性基底的横截面为长方形，所述电极单元和引线连接点一一对应，所述电极组件包括关于所述长方形的中垂线轴对称的两列，所述电极单元和对应的引线连接点位于中垂线的同一侧，所述电极单元设于靠近所述中垂线的位置，对应的引线连接点位于靠近长方形与所述中垂线平行的一边的位置，所述柔性心外膜心电电极芯片中部于背向所述绝缘层的一面形成向内的凹陷。
  7. 一种柔性心外膜心电电极芯片的制备方法，包括下列步骤：
    步骤一，在刚性基底上设置聚二甲基硅氧烷形成柔性基底；
    步骤二，在所述柔性基底上形成电极组件，所述电极组件包括引线连接点、用于电连接心脏表面的电极单元、及电连接所述引线连接点和电极单元的电极引线；
    步骤三，在所述柔性基底上设置覆盖所述电极组件的聚二甲基硅氧烷形成绝缘层，并在所述绝缘层的电极单元和引线连接点位置处形成开口，露出所述电极单元和引线连接点；
    步骤四，将所述柔性基底从刚性基底上分离，得到所述柔性心外膜心电电极芯片。
  8. 根据权利要求7所述的柔性心外膜心电电极芯片的制备方法，其特征在于，所述步骤二包括：
    制备一块形成有所述电极组件形状的镂空图案的掩膜；
    将所述掩膜紧密贴附于所述柔性基底上；
    在贴附有所述掩膜的柔性基底上淀积打底层；
    在所述打底层上淀积一层电极层；
    将所述掩膜自柔性基底上移除。
  9. 根据权利要求7所述的柔性心外膜心电电极芯片的制备方法，其特征在于，所述步骤三之后还包括在所述电极单元表面镀一层修饰层的步骤，所述修饰层的材质为铂、铱，或包含这两种元素中的一种或两种的合金或化合物，或者聚吡咯、聚（3,4-乙烯二氧噻吩）、聚苯胺中的一种。
  10. 根据权利要求7所述的柔性心外膜心电电极芯片的制备方法，其特征在于，所述刚性基底为玻璃凸台。
PCT/CN2013/074306 2013-03-14 2013-04-17 柔性心外膜心电电极芯片及其制备方法 WO2014139194A1 (zh)

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