CN115590508A - Miniature Analyte Sensors - Google Patents
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Abstract
Translated fromChinese
Description
Translated fromChinese技术领域technical field
本发明主要涉及医疗器械领域，特别涉及一种微型分析物传感器。The invention mainly relates to the field of medical equipment, in particular to a miniature analyte sensor.
背景技术Background technique
正常人身体中的胰腺可自动监测人体血液中的葡萄糖含量，并自动分泌所需的胰岛素/胰高血糖素。而糖尿病患者胰腺的功能出现异常状况，无法正常分泌人体所需胰岛素。因此糖尿病是人体胰腺功能出现异常而导致的代谢类疾病，糖尿病为终身疾病。目前医疗技术尚无法根治糖尿病，只能通过稳定血糖来控制糖尿病及其并发症的发生和发展。The pancreas in a normal human body can automatically monitor the glucose content in the human blood and automatically secrete the required insulin/glucagon. The function of the pancreas in diabetic patients is abnormal and cannot normally secrete the insulin needed by the human body. Therefore, diabetes is a metabolic disease caused by abnormal pancreatic function, and diabetes is a lifelong disease. At present, medical technology is still unable to cure diabetes, and the occurrence and development of diabetes and its complications can only be controlled by stabilizing blood sugar.
糖尿病患者在向体内注射胰岛素之前需要检测血糖。目前多数的检测手段可以对血糖连续检测，并将血糖数据实时发送至远程设备，便于用户查看，这种检测方法称为连续葡萄糖检测(Continuous Glucose Monitoring，CGM)法。该方法需要检测装置贴在皮肤表面，将其携带的探头刺入皮下的组织液完成检测。但是，目前传感器电极的电子传导层大多为光滑结构，电子传导层与基底、膜层之间的粘附力较小，在使用过程中电极容易脱落，膜层容易移位，影响传感器的使用可靠性和寿命。在某些改进技术方案中，为了增加电子传导层与膜层之间的黏合力，在电子传导层上加工一层铂黑，但铂黑与基底间的黏合力仍较小，而且铂黑加工工艺复杂，成本较高。Diabetics need to check their blood sugar before injecting insulin into their body. At present, most detection methods can continuously detect blood glucose, and send the blood glucose data to a remote device in real time, which is convenient for users to view. This detection method is called Continuous Glucose Monitoring (CGM) method. This method requires the detection device to be attached to the skin surface, and the probe carried by it is inserted into the subcutaneous interstitial fluid to complete the detection. However, at present, the electronic conductive layer of the sensor electrode is mostly smooth, and the adhesion between the electronic conductive layer and the substrate and the film layer is small. During use, the electrode is easy to fall off, and the film layer is easy to shift, which affects the reliability of the sensor. sex and longevity. In some improved technical solutions, in order to increase the adhesion between the electron conduction layer and the film layer, a layer of platinum black is processed on the electron conduction layer, but the adhesion between platinum black and the substrate is still small, and platinum black processing The process is complex and the cost is high.
因此，现有技术亟需一种电极的黏合力强的微型分析物传感器。Therefore, there is an urgent need in the prior art for a miniature analyte sensor with strong electrode adhesion.
发明内容Contents of the invention
鉴于以上现有技术存在的缺点，本发明实施例第一方面公开了一种微型分析物传感器，包括至少一个电极组，电极组包括至少一个工作电极和至少一个附加电极，工作电极和/或附加电极电子传导层的至少一个表面设置有微型结构，可以提高电子传导层与基底、膜层间的黏合力，而且加工成本较低。In view of the above disadvantages of the prior art, the first aspect of the embodiment of the present invention discloses a miniature analyte sensor, including at least one electrode set, the electrode set includes at least one working electrode and at least one additional electrode, the working electrode and/or additional At least one surface of the electron conduction layer of the electrode is provided with a microstructure, which can improve the adhesion between the electron conduction layer and the substrate and the film layer, and the processing cost is low.
本发明公开了一种微型分析物传感器，包括：基底，基底包括体内部分和体外部分；至少一个电极组，位于体内部分的表面，电极组包括至少一个工作电极和至少一个附加电极；在体外部分设置有与各电极对应的引脚(PAD)，引脚分别与工作电极和附加电极通过导线电连接；工作电极和/或附加电极的至少一个表面设置有微型结构。The invention discloses a miniature analyte sensor, comprising: a base, the base includes an internal part and an external part; at least one electrode group, located on the surface of the internal part, the electrode group includes at least one working electrode and at least one additional electrode; the external part A pin (PAD) corresponding to each electrode is provided, and the pin is electrically connected to the working electrode and the additional electrode through a wire; at least one surface of the working electrode and/or the additional electrode is provided with a microstructure.
根据本发明的一个方面，附加电极包括对电极。According to an aspect of the invention, the additional electrode comprises a counter electrode.
根据本发明的一个方面，附加电极还包括参比电极。According to an aspect of the invention, the additional electrode also includes a reference electrode.
根据本发明的一个方面，工作电极、参比电极、对电极至少包括电子传导层、抗干扰层、酶层、调节层和生物相容层。According to one aspect of the present invention, the working electrode, the reference electrode and the counter electrode at least include an electron conduction layer, an anti-interference layer, an enzyme layer, an adjustment layer and a biocompatible layer.
根据本发明的一个方面，工作电极和对电极的电子传导层为石墨、玻碳或贵金属中的一种。According to one aspect of the present invention, the electron conducting layer of the working electrode and the counter electrode is one of graphite, glassy carbon or noble metal.
根据本发明的一个方面，工作电极和对电极的电子传导层为铂。According to one aspect of the invention, the electron conducting layers of the working and counter electrodes are platinum.
根据本发明的一个方面，参比电极的电子传导层为Ag/AgCl或甘汞中的一种。According to one aspect of the present invention, the electron-conducting layer of the reference electrode is one of Ag/AgCl or calomel.
根据本发明的一个方面，微型结构设置在电子传导层上。According to one aspect of the invention, microstructures are provided on the electron conducting layer.
根据本发明的一个方面，微型结构包括微型凹槽或者微型凸起。According to one aspect of the present invention, the microstructures include microgrooves or microprotrusions.
根据本发明的一个方面，微型凹槽包括微型通孔或者微型盲孔或者微型刻痕中的一种或者多种。According to one aspect of the present invention, the micro-grooves include one or more of micro-through holes, micro-blind holes, or micro-scores.
根据本发明的一个方面，微型结构的直径为0.01～100um。According to one aspect of the present invention, the microstructures have a diameter of 0.01-100 um.
根据本发明的一个方面，微型结构的密度为1*102～1*1010/cm2。According to one aspect of the present invention, the density of the microstructure is 1*102 -1*1010 /cm2 .
根据本发明的一个方面，基底的材料选自聚四氟乙烯、聚乙烯、聚氯乙烯、丙烯腈-丁二烯-苯乙烯共聚物、聚甲基丙烯酸甲酯、聚碳酸酯、聚酰亚胺中的一种或多种的组合。According to one aspect of the present invention, the material of the substrate is selected from polytetrafluoroethylene, polyethylene, polyvinyl chloride, acrylonitrile-butadiene-styrene copolymer, polymethyl methacrylate, polycarbonate, polyimide One or more combinations of amines.
与现有技术相比，本发明的技术方案具备以下优点：Compared with the prior art, the technical solution of the present invention has the following advantages:
本发明公开的微型分析物传感器，在基底上的体内部分设置有工作电极和附加电极，所有电极通过导线与设置在体外部分相对应的PAD电连接。工作电极和/或附加电极电子传导层的至少一个表面设置有微型结构，增加电子传导层表面积的同时，还增加了表面的粗糙度，因此可以增加电子传导层与基底、膜层之间的粘附力，降低了在使用过程中电极以及膜层发生移位或者脱落的可能性，提高了传感器的可靠性。In the miniature analyte sensor disclosed by the present invention, a working electrode and an additional electrode are arranged on the body part on the base, and all the electrodes are electrically connected to the corresponding PAD arranged on the body part through wires. At least one surface of the electron conduction layer of the working electrode and/or the additional electrode is provided with a microstructure, while increasing the surface area of the electron conduction layer, the roughness of the surface is also increased, so the adhesion between the electron conduction layer and the substrate and the film layer can be increased. Adhesion reduces the possibility of displacement or falling off of electrodes and film layers during use, and improves the reliability of the sensor.
进一步的，本发明公开的微型分析物传感器可分为三电极体系和两电极体系，其中三电极体系为一个对电极、一个参比电极和至少一个工作电极，两电极体系则为一个对电极和至少一个工作电极。此外，本发明按照工作电极的数量，也可分为两种情况：1)单工作电极：工作电极只有一个；2)双工作电极：工作电极有两个，其中一个与分析物发生电氧化还原反应，产生电信号，称为“工作电极”，另一个则通常负责检测干扰物或者背景溶液的响应信号，称之为“辅助电极”。上述各种电极组成方式均有其独特的优势，其中三电极体系因为多出一个参比电极，可以有效的控制检测电位，防止出现电位漂移的情况，提高了检测分析物参数信息的可靠性；而两电极体系则结构简单，制作成本更低。Further, the miniature analyte sensor disclosed in the present invention can be divided into a three-electrode system and a two-electrode system, wherein the three-electrode system is a counter electrode, a reference electrode and at least one working electrode, and the two-electrode system is a counter electrode and a at least one working electrode. In addition, the present invention can also be divided into two cases according to the number of working electrodes: 1) single working electrode: there is only one working electrode; The reaction generates an electrical signal, which is called the "working electrode", and the other is usually responsible for detecting the response signal of the interfering substance or the background solution, called the "auxiliary electrode". The above-mentioned various electrode composition methods have their unique advantages. Among them, the three-electrode system can effectively control the detection potential due to the addition of a reference electrode, prevent potential drift, and improve the reliability of the detection of analyte parameter information; The two-electrode system has a simple structure and lower manufacturing cost.
进一步的，各个电极的电子传导层采用具有良好导电性和强化学惰性的材料作为电极材料。优选的工作电极和对电极为石墨、玻碳或贵金属中的一种，参比电极为Ag/AgCl或甘汞中的一种。考虑到良好的延展性和表面结构稳定性的要求，贵金属材料如金、铂、银等成为较好的选择。更优选的，工作电极和对电极均为铂电极。Further, the electron conducting layer of each electrode adopts a material with good electrical conductivity and strong chemical inertness as the electrode material. The preferred working electrode and counter electrode are one of graphite, glassy carbon or noble metal, and the reference electrode is one of Ag/AgCl or calomel. Considering the requirements of good ductility and surface structure stability, noble metal materials such as gold, platinum, silver, etc. have become better choices. More preferably, both the working electrode and the counter electrode are platinum electrodes.
进一步的，电子传导层表面的微型结构可以是微型凹槽，也可以是微型凸起，当微型结构是微型凹槽时，可以是微型通孔或者微型盲孔或者微型刻痕中的一种或者多种，即微型结构不限于其自身的具体形状，能增加电极表面积及粗糙度均可，降低了对加工工艺的要求以及加工成本。Further, the microstructure on the surface of the electron conducting layer can be a microgroove, or a microprotrusion, and when the microstructure is a microgroove, it can be one of a micro through hole, a micro blind hole, or a micro scratch or Various, that is, the microstructure is not limited to its own specific shape, and can increase the surface area and roughness of the electrode, which reduces the requirements for processing technology and processing costs.
进一步的，传感器基底的材料选自聚四氟乙烯(Teflon)、聚乙烯(PE)、聚氯乙烯(PVC)、丙烯腈-丁二烯-苯乙烯共聚物(ABS)、聚甲基丙烯酸甲酯(PMMA)、聚碳酸酯(PC)、聚酰亚胺(PI)等中的一种或多种的组合，上述材料均具有优异的绝缘性能、不透水性和较高的机械强度，能延长传感器的使用寿命。Further, the material of the sensor substrate is selected from polytetrafluoroethylene (Teflon), polyethylene (PE), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene copolymer (ABS), polymethacrylate One or more combinations of ester (PMMA), polycarbonate (PC), polyimide (PI), etc., all of the above materials have excellent insulation properties, water impermeability and high mechanical strength, and can Extend the life of the sensor.
本发明实施例第二方面公开了一种连续分析物监测装置，包括：底壳，底壳用于安装在宿主皮肤表面；传感器单元，所述传感器单元包括底座和至少一个如前文所述的微型分析物传感器，微型分析物传感器固定在底座上，传感器单元通过底座安装在底壳上，用于检测宿主体内分析物参数信息；发射器，发射器与传感器单元电连接，用于将分析物参数信息发送至外界；电池，电池用于提供电能；和接收器，接收器用于接收分析物参数信息，并向用户指示。The second aspect of the embodiment of the present invention discloses a continuous analyte monitoring device, comprising: a bottom case, the bottom case is used to be installed on the skin surface of the host; a sensor unit, the sensor unit includes a base and at least one miniature sensor as described above Analyte sensor, the miniature analyte sensor is fixed on the base, the sensor unit is installed on the bottom shell through the base, and is used to detect the analyte parameter information in the host; The information is sent to the outside world; the battery is used to provide electrical power; and the receiver is used to receive the analyte parameter information and indicate it to the user.
传感器的可靠性往往是限制连续分析物监测装置可靠性的关键因素，现通过在电极电子传导层表面设置微型结构，增强电子传导层与基底、膜层间的黏合力，提高了传感器的可靠性，因此也提高了连续分析物监测装置的可靠性。The reliability of the sensor is often the key factor that limits the reliability of the continuous analyte monitoring device. Now, the reliability of the sensor is improved by setting a microstructure on the surface of the electron conducting layer of the electrode to enhance the adhesion between the electron conducting layer and the substrate and the film layer. , thus also improving the reliability of the continuous analyte monitoring device.
附图说明Description of drawings
图1为根据本发明实施例传感器的结构示意图；Fig. 1 is a schematic structural diagram of a sensor according to an embodiment of the present invention;
图2为图1实施例传感器的侧视图；Fig. 2 is the side view of Fig. 1 embodiment sensor;
图3为电极的断面剖视图；Fig. 3 is the sectional view of electrode;
图4为根据本发明实施例电子传导层表面微型结构的示意图；4 is a schematic diagram of the surface microstructure of the electron conducting layer according to an embodiment of the present invention;
图5为图4的V-V’剖面图；Fig. 5 is the V-V ' sectional view of Fig. 4;
图6为根据本发明实施例连续分析物监测装置的示意图。6 is a schematic diagram of a continuous analyte monitoring device according to an embodiment of the present invention.
具体实施方式detailed description
如前所述，现有技术的分析物传感器电极电子传导层与基底、膜层间的粘附力较弱，在使用过程中电极及膜层容易移位或者脱落，影响传感器的使用可靠性。As mentioned above, the analyte sensor electrodes in the prior art have weak adhesion between the electronic conductive layer and the substrate and film layer, and the electrodes and film layers are easy to shift or fall off during use, which affects the reliability of the sensor.
为了解决该问题，本发明提供了一种微型分析物传感器，在基底上的体内部分表面设置有至少一个电极组，电极组包括至少一个工作电极和至少一个附加电极，所有电极通过导线与设置在体外部分相对应的PAD电连接。工作电极和附加电极电子传导层表面都设置有微型结构，增加电子传导层表面积的同时，还增加了表面的粗糙度，因此可以增加电子传导层与基底、膜层之间的黏合力，降低了在使用过程中电极以及膜层发生移位或者脱落的可能性，提高了传感器的可靠性。In order to solve this problem, the present invention provides a kind of miniature analyte sensor, at least one electrode group is arranged on the surface of the body part on the substrate, the electrode group includes at least one working electrode and at least one additional electrode, and all electrodes are connected to the Corresponding PADs in vitro are electrically connected. The surface of the electron conduction layer of the working electrode and the additional electrode is provided with a microstructure, which not only increases the surface area of the electron conduction layer, but also increases the roughness of the surface, so that the adhesion between the electron conduction layer and the substrate and the film layer can be increased, reducing the The possibility of displacement or falling off of the electrode and the film layer during use improves the reliability of the sensor.
现在将参照附图来详细描述本发明的各种示例性实施例。应理解，除非另外具体说明，否则在这些实施例中阐述的部件和步骤的相对布置、数字表达式和数值不应被理解为对本发明范围的限制。Various exemplary embodiments of the present invention will now be described in detail with reference to the accompanying drawings. It should be understood that the relative arrangements of components and steps, numerical expressions and values set forth in these embodiments should not be construed as limiting the scope of the present invention unless specifically stated otherwise.
此外，应当理解，为了便于描述，附图中所示出的各个部件的尺寸并不必然按照实际的比例关系绘制，例如某些单元的厚度、宽度、长度或距离可以相对于其他结构有所放大。In addition, it should be understood that for the convenience of description, the dimensions of the various components shown in the drawings are not necessarily drawn according to the actual scale relationship, for example, the thickness, width, length or distance of some units may be enlarged relative to other structures .
以下对示例性实施例的描述仅仅是说明性的，在任何意义上都不作为对本发明及其应用或使用的任何限制。这里对于相关领域普通技术人员已知的技术、方法和装置可能不作详细讨论，但在适用这些技术、方法和装置情况下，这些技术、方法和装置应当被视为本说明书的一部分。The following description of the exemplary embodiments is illustrative only and is not intended to limit the invention and its application or use in any way. Techniques, methods and devices known to persons of ordinary skill in the related art may not be discussed in detail here, but when applicable, these techniques, methods and devices should be regarded as a part of this specification.
应注意，相似的标号和字母在下面的附图中表示类似项，因此，一旦某一项在一个附图中被定义或说明，则在随后的附图说明中将不需要对其进行进一步讨论。It should be noted that like numerals and letters denote like items in the following figures, therefore, once an item is defined or illustrated in one figure, it will not require further discussion in subsequent figure descriptions .
此外应理解，本发明中提到的一个或多个方法步骤并不排斥在所述组合步骤前后还可以存在其他方法步骤或在这些明确提到的步骤之间还可以插入其他方法步骤，除非另有说明；还应理解，本发明中提到的一个或多个设备/装置之间的组合连接关系并不排斥在所述组合设备/装置前后还可以存在其他设备/装置或在这些明确提到的两个设备/装置之间还可以插入其他设备/装置，除非另有说明。而且，除非另有说明，各方法步骤的编号仅为鉴别各方法步骤的便利工具，而非为限制各方法步骤的排列次序或限定本发明可实施的范围，其相对关系的改变或调整，在无实质变更技术内容的情况下，当亦视为本发明可实施的范畴。In addition, it should be understood that one or more method steps mentioned in the present invention do not exclude that there may be other method steps before and after the combined steps or other method steps may be inserted between these explicitly mentioned steps, unless otherwise There are descriptions; it should also be understood that the combined connection relationship between one or more devices/devices mentioned in the present invention does not exclude that there may be other devices/devices before and after the combined devices/devices or those explicitly mentioned Other devices/apparatus can also be interposed between the two devices/apparatus, unless otherwise stated. Moreover, unless otherwise stated, the numbering of each method step is only a convenient tool for identifying each method step, and is not intended to limit the sequence of each method step or limit the scope of the present invention. The change or adjustment of its relative relationship is in In the case of no substantive change in the technical content, it shall also be regarded as the applicable scope of the present invention.
图1为本发明实施例传感器的结构示意图；图2为图1实施例传感器的侧视图。Fig. 1 is a schematic structural diagram of the sensor of the embodiment of the present invention; Fig. 2 is a side view of the sensor of the embodiment of Fig. 1 .
传感器11包括基底111，以图1所示虚线为分界线，基底111分为体外部分X和体内部分Y。体内部分Y上铺设有电极，包括至少一个工作电极1131和至少一个附加电极，明显的，在本实施例中，附加电极包括对电极1231和参比电极1331，从而构成三电极体系，对电极1231是相对于工作电极1131的另一极，与工作电极1131构成闭合回路，使得电极上的电流能正常导通，参比电极1331用于提供工作电极1131的参考电位，因此可以有效的控制检测电位。在本发明另一个实施例中，附加电极也可仅包括对电极1231，从而构成双电极体系，相比于三电极体系，可以在体内部分Y有限的面积上增加工作电极1131和对电极1231的有效面积，从而延长电极的使用寿命，而且因为减少了一个电极，加工工艺也更为简单，但是工作电极1131没有了参比电极的检测电位作为参考，分析物的检测信息可靠性会有所降低。在本发明再一个实施例中，工作电极1131存在至少两个，其中一个与待检测分析物发生电氧化还原反应，产生电信号，另一个用于检测宿主体液中干扰物或者背景溶液的响应信号，这一个电极为辅助电极。The
继续参考图1和图2，体外部分X上铺设有PAD(引脚)，PAD与电极一一对应，并通过导线电连接，即与工作电极1131对应的第一PAD1111，通过导线1121电连接；与对电极1231对应的第二PAD1211，通过导线1221电连接；和与参比电极1331对应的第三PAD1311，通过导线1321电连接。不同的PAD、导线和电极之间彼此绝缘，防止电信号出现窜扰。Continuing to refer to FIG. 1 and FIG. 2, PAD (pins) are laid on the in vitro part X, and the PAD corresponds to the electrodes one by one, and is electrically connected through a wire, that is, the
由于传感器11为平面结构，因此存在相对的两个面，即A面和B面。工作电极1131、对电极1231和参比电极1331作为一个电极组铺设在传感器的A面上，相对的，在传感器的B面上，铺设有另一个电极组，该电极组可以是双电极体系，也可以是三电极体系，也可以是双工作电极，优选的，与A面一致，即包括工作电极1132、对电极1232和参比电极1332，同样的，在B面上也铺设有PAD，PAD与B面上的电极一一对应，并通过导线电连接，即与工作电极1132对应的第四PAD1112，通过导线1122电连接；与对电极1232对应的第五PAD1212，通过导线1222电连接；和与参比电极1332对应的第六PAD1312，通过导线1322电连接。这样在A面任一电极寿命终止或者提前失效的情况下，B面的同名电极可以接替进入工作状态，提高检测分析物的参数数据可靠性，延长传感器使用寿命。Since the
本领域技术人员应当理解的是，无论是传感器的A面、B面，其上铺设的PAD、导线和电极的顺序、位置并不做限制。两个面上的PAD、导线和电极可以是对称布置，也可以是非对称布置。对应的PAD、导线和电极铺设在同一面上，也可以铺设在不同的面上，优选的，对应的PAD、导线和电极铺设在同一面上，便于导线走线。例如，A面上的工作电极1131可以与对电极1231更换位置，或者A面上的对电极1231可以与B面上的参比电极1332更换位置，无论A面和B面上的PAD、导线和电极的顺序、位置如何变化，只需使得PAD、导线和电极存在一一对应、彼此绝缘的关系即可。Those skilled in the art should understand that no matter whether it is the A surface or the B surface of the sensor, the sequence and position of the PADs, wires and electrodes laid thereon are not limited. The PADs, wires and electrodes on the two surfaces can be arranged symmetrically or asymmetrically. Corresponding PADs, wires and electrodes are laid on the same surface, or they can be laid on different surfaces. Preferably, the corresponding PADs, wires and electrodes are laid on the same surface to facilitate wire routing. For example, the working
在本发明其他实施例中，尽管平面结构传感器仅存在相对的A面和B面，但是也可通过增加传感器面积或者减小电极面积，以增加电极组的数量，从而进一步增加传感器的使用寿命。然而过大的传感器面积可能会增加宿主的排异反应，引起宿主的不适感；过小的电极面积会减小电极的灵敏度，降低检测参数的可靠性。数量过多的电极组也会增加加工工艺的复杂程度，如导线的走线会变得非常密集。因此，优选的，电极组的数量为两个。In other embodiments of the present invention, although the planar sensor only has opposing surfaces A and B, it is also possible to increase the sensor area or reduce the electrode area to increase the number of electrode groups, thereby further increasing the service life of the sensor. However, too large sensor area may increase the host's rejection reaction and cause host discomfort; too small electrode area will reduce the sensitivity of the electrode and reduce the reliability of the detection parameters. An excessive number of electrode groups will also increase the complexity of the processing technology, such as the wiring of the wires will become very dense. Therefore, preferably, the number of electrode groups is two.
在本发明其他实施例中，各个电极组也可以分布在传感器的同一面上，如A面或者B面，在此不作限制。In other embodiments of the present invention, each electrode group may also be distributed on the same surface of the sensor, such as surface A or surface B, which is not limited here.
在本发明实施例中，基底111为具有优异绝缘性能的材料，主要来自无机非金属陶瓷、氧化硅玻璃和有机高聚物等，同时考虑到植入式电极的应用环境，还要求基底材料具有较高的不透水性和机械强度。优选的，基底的材料选自聚四氟乙烯(Teflon)、聚乙烯(PE)、聚氯乙烯(PVC)、丙烯腈-丁二烯-苯乙烯共聚物(ABS)、聚甲基丙烯酸甲酯(PMMA)、聚碳酸酯(PC)、聚酰亚胺(PI)等中的一种或多种的组合。In the embodiment of the present invention, the
图3为电极的断面剖视图。在本发明的一个实施例中，工作电极(辅助电极)、对电极和参比电极至少包括电子传导层a、抗干扰层b、酶层c、调节层d和生物相容层e，上述抗干扰层b、酶层c、调节层d和生物相容层e统称为膜层。Fig. 3 is a cross-sectional view of an electrode. In one embodiment of the present invention, the working electrode (auxiliary electrode), the counter electrode and the reference electrode at least include an electron conduction layer a, an anti-interference layer b, an enzyme layer c, an adjustment layer d and a biocompatible layer e. Interference layer b, enzyme layer c, regulation layer d and biocompatible layer e are collectively referred to as film layers.
电子传导层：Electron conducting layer:
电子传导层a采用具有良好导电性和强化学惰性的材料。优选的，工作电极和对电极选自石墨电极、玻碳电极、贵金属等材料中的一种，参比电极选自Ag/AgCl或甘汞中的一种。考虑到良好的延展性和表面结构的稳定性的要求，贵金属电极如金电极、铂电极、银电极等成为较好的选择，进一步优选的，工作电极和对电极均为铂电极。The electron conducting layer a is made of a material with good electrical conductivity and strong chemical inertness. Preferably, the working electrode and the counter electrode are selected from materials such as graphite electrodes, glassy carbon electrodes, and noble metals, and the reference electrode is selected from one of Ag/AgCl or calomel. Considering the requirements of good ductility and stability of the surface structure, noble metal electrodes such as gold electrodes, platinum electrodes, silver electrodes, etc. have become better choices, and further preferably, both the working electrode and the counter electrode are platinum electrodes.
在本专利技术方案中，微型结构即设置在电子传导层a。In the technical solution of this patent, the microstructure is arranged on the electron conducting layer a.
抗干扰层：Anti-interference layer:
抗干扰层b位于酶层和电子传导层之间。干扰物是这样一类分子或物质，它们在电极表面会直接地或通过电子转移剂间接地发生电化学还原或电化学氧化，从而产生了一个干扰分析物检测的错误信号。例如，对于分析物为葡萄糖的测定来说，体内的常见干扰物有尿素、抗坏血酸、对乙酰氨基酚等等。The anti-interference layer b is located between the enzyme layer and the electron-conducting layer. Interfering substances are molecules or substances that undergo electrochemical reduction or electrochemical oxidation at the electrode surface, either directly or indirectly through electron transfer agents, thereby producing a false signal that interferes with the detection of the analyte. For example, for an assay where the analyte is glucose, common interfering substances in the body are urea, ascorbic acid, acetaminophen, and others.
在优选实例中，抗干扰层b可以防止一个或多个干扰物渗透到电极周围的电解质中。比如，抗干扰层b会允许要在电极上测量的分析物(例如，过氧化氢)通过，而同时又可以防止其它物质(如潜在的干扰物质)的通过。在一个优选方案中，抗干扰层b可以是一层很薄的膜，旨在限制那些分子量大于34Da的物质的扩散。In a preferred embodiment, the anti-interference layer b prevents one or more interfering substances from penetrating into the electrolyte surrounding the electrodes. For example, the anti-interference layer b will allow the passage of the analyte to be measured on the electrode (eg hydrogen peroxide) while at the same time prevent the passage of other substances (eg potentially interfering substances). In a preferred solution, the anti-interference layer b can be a very thin film designed to limit the diffusion of substances with a molecular weight greater than 34Da.
在另一个优选的实例中，抗干扰层b可以是有机聚合物，它可以由有机硅烷和一种亲水性共聚物来制备。亲水性共聚物，更优选的是，聚乙二醇(PEG)，聚甲基丙烯酸2-羟乙基酯和聚赖氨酸。在优选的实施方案中，抗干扰层b的厚度范围可以是0.1微米或更小至10微米或更大。更优选的厚度范围是0.5微米到5微米。In another preferred example, the anti-interference layer b can be an organic polymer, which can be prepared from organosilane and a hydrophilic copolymer. Hydrophilic copolymers, more preferably polyethylene glycol (PEG), poly 2-hydroxyethyl methacrylate and polylysine. In a preferred embodiment, the thickness of the anti-interference layer b may range from 0.1 micrometer or less to 10 micrometers or more. A more preferred thickness range is 0.5 microns to 5 microns.
酶层：Enzyme layer:
酶层c上涂覆有活性酶，根据待检测分析物的种类，涂覆相应的活性酶。活性酶可以使待检测分析物产生某些化学反应，产生电子，根据不同的待检测分析物浓度，产生的电子数量不同，电子被电子传导层收集，从而形成不同的电流强度，因此电流强度信息可以用于表征分析物参数信息。Enzyme layer c is coated with active enzymes, and corresponding active enzymes are coated according to the type of analyte to be detected. The active enzyme can cause the analyte to be detected to produce certain chemical reactions and generate electrons. According to different concentrations of the analyte to be detected, the number of electrons generated is different, and the electrons are collected by the electron-conducting layer, thereby forming different current intensities, so the current intensity information Can be used to characterize analyte parameter information.
优选的，酶层c上涂覆有葡萄糖氧化酶(GOx)。Preferably, the enzyme layer c is coated with glucose oxidase (GOx).
调节层：Adjustment layer:
调节层d位于酶层的上面。在本发明实施例中，酶层上涂覆葡萄糖氧化酶时，调节层d主要用来调控传递到酶层上的氧和葡萄糖的透过率。体液中葡萄糖含量(摩尔浓度)比氧的含量高出一个量级。然而，对于需要氧气参与的酶基传感器来说，需要供给过量的氧气以确保氧气不成为限制性物质，从而使传感器可以对葡萄糖浓度的变化线性响应，而不受氧分压的影响。也就是说，当氧气含量成为限制性因素时，葡萄糖氧监测反应的线性范围达不到预期的浓度范围。在酶层上面没有半透膜来调控氧和葡萄糖的透过时，传感器对葡萄糖线性响应的上限仅可达到约40mg/dL。然而，在临床情况下，血糖水平的线性响应上限需要到达约500mg/dL。The regulation layer d is located on the top of the enzyme layer. In the embodiment of the present invention, when glucose oxidase is coated on the enzyme layer, the regulating layer d is mainly used to regulate the permeability of oxygen and glucose delivered to the enzyme layer. The glucose content (molar concentration) in body fluids is an order of magnitude higher than the oxygen content. However, for enzyme-based sensors that require oxygen to participate, an excess of oxygen needs to be supplied to ensure that oxygen does not become a limiting species, so that the sensor can respond linearly to changes in glucose concentration without being affected by oxygen partial pressure. That is, the glucose oxygen monitoring response was not linear over the expected concentration range when the oxygen content became the limiting factor. When there is no semipermeable membrane on the enzyme layer to regulate the permeation of oxygen and glucose, the upper limit of the linear response of the sensor to glucose can only reach about 40 mg/dL. However, in clinical situations, the upper limit of the linear response of blood glucose levels needs to reach about 500 mg/dL.
调节层d主要起半透膜的作用，用来调控传递到酶层上的氧和葡萄糖的透过量，更明确地说，使氧过量成为非限制性因素。和不含调节层相比，含有调节层的传感器对葡萄糖线性响应的上限可以达到一个更高的水平。在一个优选实例中，调节层d的氧-葡萄糖透过率的比例可以到达为200:1，这样就可以保证，对于皮下可能出现的各种葡萄糖和氧气浓度，都有足够的氧用于酶基反应的进行。Regulatory layer d mainly functions as a semipermeable membrane to regulate the permeation of oxygen and glucose delivered to the enzyme layer, more specifically, to make excess oxygen a non-limiting factor. The upper limit of the linear response of the sensor with the regulating layer to glucose can reach a higher level than that without the regulating layer. In a preferred example, the ratio of the oxygen-glucose permeability of the regulating layer d can reach 200:1, so that it can be ensured that there is enough oxygen for the enzymes for various glucose and oxygen concentrations that may occur in the subcutaneous tissue. The progress of the base reaction.
在一个优选实例中，调节层d可以是有机聚合物，它可以由有机硅烷和一种亲水性共聚物来制备。亲水性共聚物，更优选的是，共聚或接枝的聚乙二醇(PEG)。其他可能用到的亲水性共聚物，包括但不限于其他的二醇，如丙二醇，酯，酰胺，碳酸酯和聚丙二醇。利用有机硅聚合物，可以明显地提高氧的传输，同时有效地控制葡萄糖的透过。在优选的实施方案中，调节层d的厚度范围可以是1微米或更小至50微米或更大，更优选的厚度范围是1微米到10微米。In a preferred example, the conditioning layer d may be an organic polymer, which may be prepared from organosilane and a hydrophilic copolymer. A hydrophilic copolymer, more preferably, a copolymerized or grafted polyethylene glycol (PEG). Other hydrophilic copolymers that may be used include, but are not limited to, other glycols such as propylene glycol, esters, amides, carbonates and polypropylene glycol. Utilizing silicone polymers, oxygen transport can be significantly enhanced while glucose penetration is effectively controlled. In a preferred embodiment, the adjustment layer d may have a thickness ranging from 1 micrometer or less to 50 micrometers or more, more preferably a thickness ranging from 1 micrometer to 10 micrometers.
生物相容层：Biocompatible layer:
生物相容层e位于电极的最外面，旨在消除机体对异物的排斥反应并减少植入电极周围屏蔽细胞层的形成。The biocompatible layer e is located on the outermost part of the electrode, and is designed to eliminate the body's rejection of foreign substances and reduce the formation of a shielding cell layer around the implanted electrode.
在一个优选实例中，生物相容层e可以由有机硅烷和一种亲水性共聚物来制备。亲水性共聚物，更优选的是，共聚或接枝的聚乙二醇(PEG)。其他可能用到的亲水性共聚物，包括但不限于其他的二醇，如丙二醇，酯，酰胺，碳酸酯和聚丙二醇。In a preferred example, the biocompatible layer e can be prepared from organosilane and a hydrophilic copolymer. A hydrophilic copolymer, more preferably, a copolymerized or grafted polyethylene glycol (PEG). Other hydrophilic copolymers that may be used include, but are not limited to, other glycols such as propylene glycol, esters, amides, carbonates and polypropylene glycol.
在优选的实施方案中，生物相容层e的厚度范围可以是1微米或更小至100微米或更大。更优选的厚度范围是10微米到30微米。In preferred embodiments, the thickness of the biocompatible layer e may range from 1 micron or less to 100 microns or more. A more preferred thickness range is 10 microns to 30 microns.
在本发明实施例中，基底111的厚度为0.01～0.8mm，各电极为长方形，各电极宽度为0.01～1mm，面积为0.1～2mm2。In the embodiment of the present invention, the
图4为本发明实施例电极表面微型结构的示意图，图5为图4的V-V’剖面图。Fig. 4 is a schematic diagram of the microstructure of the electrode surface according to an embodiment of the present invention, and Fig. 5 is a V-V' cross-sectional view of Fig. 4 .
在本发明实施例中，以工作电极1131为例，电极的电子传导层a分为A面和B面，一面与传感器基底11贴合，另一面与膜层(b\c\d\e)贴合，两面上均有微型结构，微型结构一方面可以增大电子传导层表面积，从而增加电流密度，另一方面可以增加表面的粗糙度，以增强电子传导层a与基底11、膜层间(b\c\d\e)的黏合力，防止在使用时，电极在基底上或膜层之间出现移位或者脱落，同时还可以增强电极与聚合物，如体内葡萄糖的结合力，提高传感器检测的可靠性和稳定性。In the embodiment of the present invention, taking the working
向电子传导层a表面外部突出的微型结构形成微型凸起，如微型凸起11311a、11311b、11311c等，微型凸起没有具体的形状限制，可以是类三棱柱形，可以是类球形，可以是类长方体形，也可以是无规则形状，其直径为0.001～100um，优选的，直径为10～50um。The microstructure protruding to the outside of the surface of the electron conducting layer a forms micro-protrusions, such as
相应的，向电子传导层a表面内部凹进的微型结构形成微型凹槽，如微型凹槽11311d、11311e、11311f，微型凸起没有具体的形状限制，可以是类三棱柱形，可以是类球形，可以是类长方体形，也可以是无规则形状，如长条的刻痕(图中未示出)等形状。微型凹槽的直径为0.001～100um，微型凸起的高度或微型凹槽的深度为0.001～50um。优选的，直径为10～50um，微型凸起的高度或微型凹槽的深度为10～30um。Correspondingly, the micro-structures recessed into the surface of the electron conducting layer a form micro-grooves, such as micro-grooves 11311d, 11311e, 11311f, and the micro-protrusions have no specific shape restrictions, and can be triangular prism-like or spherical-like , can be a quasi-cuboid shape, and can also be an irregular shape, such as a long strip of notch (not shown in the figure) and other shapes. The diameter of the micro-groove is 0.001-100um, and the height of the micro-protrusion or the depth of the micro-groove is 0.001-50um. Preferably, the diameter is 10-50um, and the height of the micro-protrusions or the depth of the micro-grooves is 10-30um.
在本发明实施例中，无论是微型凸起或是微型凹槽，在电子传导层a的任意一面上，可以按照等高或者等宽的间隔均匀排列，也可以是随机排列，在此不做限制。但是其密度需要限制在一定范围之类，例如为1*102～1*1010/cm2，过大或者过小的微型结构密度都无法达到理想的增加黏合力的效果。In the embodiment of the present invention, whether it is micro-protrusions or micro-grooves, on any side of the electronic conduction layer a, they can be uniformly arranged at intervals of equal height or width, or randomly arranged, which are not described here. limit. However, its density needs to be limited within a certain range, such as 1*102 -1*1010 /cm2 , too large or too small a microstructure density cannot achieve the ideal effect of increasing the adhesion.
在本发明实施例中，微型凸起或者微型凹槽可以通过化学腐蚀的方法得到。例如通过清洗-化学液(HCl/C2H2O2/NH4Cl/FeCl3)腐蚀-清洗-光亮化处理-清洗-烘干处理的工艺步骤，可以得到直径约1～50um、密度5*102～3*103/cm2、厚度1～10um的微型凸起或者微型凹槽。再例如，也可以通过激光刻蚀的工艺，控制激光的行程及能量，得到如上述参数的微型凸起或者微型凹槽。相比于加工得到铂黑，加工得到微型凹槽或者微型凸起的工艺更为简单，而且更节省成本。In the embodiment of the present invention, the micro-protrusions or micro-grooves can be obtained by chemical etching. For example, through the process steps of cleaning-chemical solution (HCl/C2 H2 O2 /NH4 Cl/FeCl3 ) corrosion-cleaning-brightening treatment-cleaning-drying treatment, you can get a diameter of about 1 ~ 50um, a density of 5 *102 ~3*103 /cm2 , micro-protrusions or micro-grooves with a thickness of 1-10um. For another example, the laser etching process can also be used to control the stroke and energy of the laser to obtain micro-protrusions or micro-grooves with the above parameters. Compared with platinum black, the process of processing micro-grooves or micro-protrusions is simpler and more cost-effective.
通过化学腐蚀方法得到的微型结构呈不规则形状，根据化学液的用量及相应的处理工艺可以分别得到通孔或者盲孔或者刻痕，孔径尺寸在一定范围内变化，每个孔洞的直径在不同方向上也有所变化，这种不规则形状的孔洞更有利于提高电子传导层与基底、膜层间的黏合力。The microstructure obtained by the chemical etching method is irregular in shape. According to the amount of chemical liquid and the corresponding treatment process, through holes or blind holes or notches can be obtained respectively. The diameter of the holes varies within a certain range. The direction is also changed, and the irregularly shaped holes are more conducive to improving the adhesion between the electron conducting layer and the substrate and the film layer.
本领域技术人员可以理解的是，加工得到上述微型凹槽或者微型凸起的工艺并不限于上述已提及到的工艺流程，任何可以通过微加工得到微型凹槽或者微型凸起的工艺均可以使用。It will be understood by those skilled in the art that the process for obtaining the above-mentioned micro-grooves or micro-protrusions is not limited to the above-mentioned process flow, and any process that can obtain micro-grooves or micro-protrusions through micromachining can be use.
在本发明的其他实施例中，电子传导层a表面还设有碳纳米管修饰层(图中未示出)。利用碳纳米管特有的机械强度、高比表面积、快速电子传递效应和化学稳定性，在已成型的电子传导层a表面，通过物理吸附、包埋或者共价键和等方式，将碳纳米管修饰到电子传导层a表面以提高电子传递速度，同时由于其比表面积大能够作为一种优良的催化剂(酶)载体。所述碳纳米管层修饰层可通过Nafion溶液分散法、共价固定法等固定于电子传导层a表面。In other embodiments of the present invention, a carbon nanotube modification layer (not shown in the figure) is further provided on the surface of the electron conduction layer a. Utilizing the unique mechanical strength, high specific surface area, fast electron transfer effect and chemical stability of carbon nanotubes, carbon nanotubes are deposited on the surface of the formed electron conducting layer a through physical adsorption, embedding or covalent bonding. Modified to the surface of the electron conducting layer a to increase the electron transfer speed, and at the same time, it can be used as an excellent catalyst (enzyme) carrier due to its large specific surface area. The carbon nanotube layer modification layer can be fixed on the surface of the electron conducting layer a by Nafion solution dispersion method, covalent immobilization method and the like.
图6为本发明实施例连续分析物监测装置100的示意图。连续分析物监测装置100包括底壳101，底壳用于安装在宿主皮肤表面；传感器单元102，传感器单元102包括底座1021和如前文所述的微型分析物传感器11，微型分析物传感器11固定在所述底座上，传感器单元102通过底座安装在底壳101上；发射器单元103，发射器单元103包括内部电路1031、发射器1032和电连接区1033，电连接区1033和传感器单元102电连接，内部电路1031储存有前文所述切换电极的预定条件，发射器1032用于将分析物参数信息发送至外界；电池104，电池104用于提供电能；接收器105，接收器105用于接收分析物参数信息，并向用户指示。FIG. 6 is a schematic diagram of a continuous
综上所述，本发明公开了一种微型分析物传感器，在基底上的体内部分表面设置有至少一个电极组，电极组包括至少一个工作电极和至少一个附加电极，所有电极通过导线与设置在体外部分相对应的PAD电连接。工作电极和附加电极的电子传导层表面都设置有微型结构，增加电子传导层表面积的同时，还增加了表面的粗糙度，因此可以增加电子传导层与基底、膜层之间的黏合力，降低了在使用过程中电极以及膜层发生移位或者脱落的可能性，提高了传感器使用的可靠性。In summary, the present invention discloses a miniature analyte sensor. At least one electrode group is arranged on the surface of the body part on the substrate. The electrode group includes at least one working electrode and at least one additional electrode. Corresponding PADs in vitro are electrically connected. The surface of the electron conduction layer of the working electrode and the additional electrode is provided with a microstructure, which not only increases the surface area of the electron conduction layer, but also increases the roughness of the surface, so that the adhesion between the electron conduction layer and the substrate and the film layer can be increased, reducing the It eliminates the possibility of displacement or falling off of the electrode and the film layer during use, and improves the reliability of the sensor.
虽然已经通过示例对本发明的一些特定实施例进行了详细说明，但是本领域的技术人员应该理解，以上示例仅是为了进行说明，而不是为了限制本发明的范围。本领域的技术人员应该理解，可在不脱离本发明的范围和精神的情况下，对以上实施例进行修改。本发明的范围由所附权利要求来限定。Although some specific embodiments of the present invention have been described in detail through examples, those skilled in the art should understand that the above examples are for illustration only, rather than limiting the scope of the present invention. Those skilled in the art will appreciate that modifications can be made to the above embodiments without departing from the scope and spirit of the invention. The scope of the invention is defined by the appended claims.
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