CN218793374U - Closed-loop control system and closed-loop system for insulin injection - Google Patents

Abstract

The embodiment of the application provides a closed-loop control system and insulin closed-loop system for injection, belongs to the field of biochemical medicine, and comprises: the system comprises an electrochemical micro pump, a sensor and a control module; the electrochemical micropump comprises a pump body, wherein the pump body is provided with an accommodating area, a medium solution and an electrode layer connected with the inner wall of the pump body are arranged in the accommodating area, and an expansion film covering the accommodating area is arranged on the pump body; the sensor comprises a substrate, a microneedle array and an electrode covered on the substrate, wherein the microneedle array and the substrate are integrally formed, the microneedle array comprises a plurality of hollow microneedles, and an injection channel is arranged in each hollow microneedle; the input end of the control module is connected with the output end of the sensor, and the output end of the control module is connected with the input end of the electrochemical micropump. Through the closed-loop control system and the closed-loop system for insulin injection provided by the embodiment of the application, the blood glucose concentration of a patient can be measured by using the biosensor, and the insulin injection is controlled according to the signal of the biosensor.

Description

Translated fromChinese

一种闭环控制系统及胰岛素注射用闭环系统A closed-loop control system and a closed-loop system for insulin injection

技术领域technical field

本申请实施例涉及生化医药技术领域，具体而言，涉及一种闭环控制系统及胰岛素注射用闭环系统。The embodiments of the present application relate to the technical field of biochemical medicine, and specifically, to a closed-loop control system and a closed-loop system for insulin injection.

背景技术Background technique

糖尿病是一种基于代谢异常的疾病，其因胰脏分泌的一种激素——胰岛素不足而引起。糖尿病患者可以将胰岛素注射到体内，作为积极的治疗方法之一。可以通过使用胰岛素注射装置，以使根据患者血糖的变化，将胰岛素适当地注射到体内。Diabetes is a disease based on metabolic abnormalities caused by insufficient insulin, a hormone secreted by the pancreas. Diabetics can have insulin injected into their body as part of their active treatment. Insulin injection devices can be used to properly inject insulin into the body according to changes in the patient's blood sugar.

目前，相关技术中已有利用闭环控制系统可以根据患者的血糖浓度控制胰岛素注射的装置，但是，相关技术中的闭环控制系统体积较大且成本高，使用不便。At present, there is a closed-loop control system in the related art that can control insulin injection according to the patient's blood sugar concentration. However, the closed-loop control system in the related art has a large volume and high cost, and is inconvenient to use.

实用新型内容Utility model content

本申请实施例在于提供一种闭环控制系统及胰岛素注射用闭环系统，旨在减小闭环控制系统的体积并降低成本。The embodiment of the present application is to provide a closed-loop control system and a closed-loop system for insulin injection, aiming at reducing the volume and cost of the closed-loop control system.

本申请实施例第一方面提供一种闭环控制系统，包括：The first aspect of the embodiment of the present application provides a closed-loop control system, including:

电化学微泵、传感器和控制模块；Electrochemical micropumps, sensors and control modules;

其中，所述电化学微泵包括泵体，所述泵体具有容纳区域，所述容纳区域内具有介质溶液以及与所述泵体的内壁连接的电极层，且所述泵体上设置有覆盖所述容纳区域的扩张膜；Wherein, the electrochemical micropump includes a pump body, the pump body has an accommodation area, the accommodation area has a medium solution and an electrode layer connected to the inner wall of the pump body, and the pump body is provided with a cover an expansion membrane of the containment area;

传感器，所述传感器包括基底、微针阵列和覆盖在所述基底上的电极，所述微针阵列与所述基底一体成型，所述微针阵列包括多个空心微针，所述空心微针内部具有注射通道；A sensor, the sensor includes a base, a microneedle array and electrodes covered on the base, the microneedle array is integrally formed with the base, the microneedle array includes a plurality of hollow microneedles, the hollow microneedles There is an injection channel inside;

所述扩张膜与所述传感器的基底连接，且所述空心微针的尖端朝向远离所述扩张膜的一侧；The expansion membrane is connected to the base of the sensor, and the tip of the hollow microneedle faces the side away from the expansion membrane;

所述控制模块的输入端与所述传感器的输出端连接，所述控制模块的输出端与所述电化学微泵的输入端连接；所述控制模块用于接收所述传感器输出的电信号，并根据所述电信号，控制所述电化学微泵的开启或关闭。The input end of the control module is connected to the output end of the sensor, and the output end of the control module is connected to the input end of the electrochemical micropump; the control module is used to receive the electrical signal output by the sensor, And according to the electric signal, control the opening or closing of the electrochemical micropump.

可选地，所述控制模块包括第一转换子单元、控制子单元和第二转换子单元；Optionally, the control module includes a first conversion subunit, a control subunit and a second conversion subunit;

所述第一转换子单元的输入端与所述传感器的输出端连接，所述第一转换子单元的输出端与所述控制子单元的输入端连接，所述第一转换子单元用于接收并转换所述传感器输出的电信号；The input end of the first conversion subunit is connected to the output end of the sensor, the output end of the first conversion subunit is connected to the input end of the control subunit, and the first conversion subunit is used to receive and convert the electrical signal output by the sensor;

所述控制子单元，用于接收所述第一转换子单元转换后的电信号，并根据所述电信号发送命令给所述第二转换子单元；The control subunit is configured to receive the electrical signal converted by the first conversion subunit, and send a command to the second conversion subunit according to the electrical signal;

所述第二转换子单元的输入端与所述控制子单元的输出端连接，所述第二转换子单元的输出端与所述电化学微泵的输入端连接，所述第二转换子单元用于接收并转换所述控制子单元输出的命令，并将转换后的命令信号传输至所述电化学微泵，以控制所述电化学微泵的开启或关闭。The input end of the second conversion subunit is connected to the output end of the control subunit, the output end of the second conversion subunit is connected to the input end of the electrochemical micropump, and the second conversion subunit It is used for receiving and converting the command output by the control subunit, and transmitting the converted command signal to the electrochemical micropump, so as to control the opening or closing of the electrochemical micropump.

可选地，所述第一转换子单元为第一信号转换器；Optionally, the first converting subunit is a first signal converter;

所述控制子单元为微控制器；The control subunit is a microcontroller;

所述第二转换子单元为第二信号转换器。The second conversion subunit is a second signal converter.

可选地，所述扩张膜的材料至少包括以下之一：聚四氟乙烯、聚二甲基硅氧烷、聚丙烯酸酯、硅胶、橡胶、乳胶、聚氨酯、聚对二甲苯和聚酰亚胺。Optionally, the material of the expansion membrane includes at least one of the following: polytetrafluoroethylene, polydimethylsiloxane, polyacrylate, silicone, rubber, latex, polyurethane, parylene and polyimide .

可选地，所述电极层的材料包括硬质膜材或柔性膜材。Optionally, the material of the electrode layer includes a hard film material or a flexible film material.

可选地，所述电极包括工作电极和电源电极。Optionally, the electrodes include working electrodes and power electrodes.

可选地，所述电源电极为作用电极；Optionally, the power electrode is an active electrode;

或者，所述电源电极为对电极和参比电极。Alternatively, the power supply electrode is a counter electrode and a reference electrode.

本申请实施例第二方面提供一种胰岛素注射用闭环系统，包括如本申请实施例第一方面提供的一种闭环控制系统。The second aspect of the embodiment of the present application provides a closed-loop system for insulin injection, including the closed-loop control system as provided in the first aspect of the embodiment of the present application.

有益效果：Beneficial effect:

本申请提供一种闭环控制系统，通过设置电化学微泵、传感器和控制模块，并使电化学微泵的扩张膜与传感器的基底连接，使控制模块的输入端与传感器的输出端连接，使控制模块的输出端与电化学微泵的输入端连接；利用传感器可以检测患者的皮下组织液的葡萄糖浓度，由于组织液葡萄糖浓度与血糖浓度具有很强的相关性，因此传感器输出的信号能够反应血糖浓度的大小；同时传感器可以输出信号给控制模块，控制模块根据传感器输出的电信号进而控制电化学微泵的开启或关闭，从而使得电化学微泵可以实时地根据患者的血糖浓度进行胰岛素的注射。The application provides a closed-loop control system. By setting an electrochemical micropump, a sensor and a control module, and connecting the expansion membrane of the electrochemical micropump to the substrate of the sensor, the input end of the control module is connected to the output end of the sensor, so that The output terminal of the control module is connected to the input terminal of the electrochemical micropump; the glucose concentration of the patient's subcutaneous tissue fluid can be detected by using the sensor. Since the glucose concentration of the tissue fluid has a strong correlation with the blood glucose concentration, the signal output by the sensor can reflect the blood glucose concentration. At the same time, the sensor can output signals to the control module, and the control module controls the opening or closing of the electrochemical micropump according to the electrical signal output by the sensor, so that the electrochemical micropump can inject insulin according to the patient's blood sugar concentration in real time.

附图说明Description of drawings

为了更清楚地说明本申请实施例的技术方案，下面将对本申请实施例的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性的前提下，还可以根据这些附图获得其他的附图。In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following will briefly introduce the accompanying drawings that need to be used in the description of the embodiments of the present application. Obviously, the accompanying drawings in the following description are only some embodiments of the present application , for those skilled in the art, other drawings can also be obtained according to these drawings without paying creative labor.

图1是本申请一实施例提出的一种闭环控制系统的结构示意图；Fig. 1 is a schematic structural diagram of a closed-loop control system proposed by an embodiment of the present application;

图2是本申请一实施例提出的另一种闭环控制系统的结构示意图；Fig. 2 is a schematic structural diagram of another closed-loop control system proposed by an embodiment of the present application;

图3是本申请一实施例提出的电极层为叉指电极的结构示意图；Fig. 3 is a schematic diagram of the structure of an electrode layer proposed by an embodiment of the present application as an interdigital electrode;

图4是本申请一实施例提出的基板为锯齿状的电化学微泵的结构示意图；Fig. 4 is a schematic structural view of an electrochemical micropump with a serrated substrate proposed in an embodiment of the present application;

图5是本申请一实施例提出的基板为曲线状的电化学微泵的结构示意图；5 is a schematic structural view of an electrochemical micropump with a curved substrate proposed in an embodiment of the present application;

图6是本申请一实施例提出的一种包含第一转换子单元、控制子单元和第二转换子单元的闭环控制系统的结构示意图；Fig. 6 is a schematic structural diagram of a closed-loop control system including a first conversion subunit, a control subunit and a second conversion subunit proposed by an embodiment of the present application;

图7是本申请一实施例提出的一种闭环控制系统中电源电极为作用电极的传感器的结构示意图；Fig. 7 is a schematic structural diagram of a sensor in which the power supply electrode is the active electrode in a closed-loop control system proposed by an embodiment of the present application;

图8是本申请一实施例提出的一种闭环控制系统中电源电极为参比电极和对电极的传感器的结构示意图；Fig. 8 is a schematic structural diagram of a sensor in which the power supply electrode is a reference electrode and a counter electrode in a closed-loop control system proposed by an embodiment of the present application;

图9是本申请一实施例提出的一种闭环控制系统中空心微针为圆锥状的传感器的结构示意图。FIG. 9 is a schematic structural diagram of a sensor with a hollow microneedle in the shape of a cone in a closed-loop control system proposed by an embodiment of the present application.

附图标记说明：1、电化学微泵；11、泵体；12、介质溶液；13、电极层；14、扩张膜；2、传感器；21、基底；22、微针阵列；221、空心微针；23、电极；231、工作电极；232、作用电极；233、对电极；234、参比电极；3、控制模块；31、第一转换子单元；32、控制子单元；33、第二转换子单元；A、容纳区域；B、注射通道。Explanation of reference signs: 1. electrochemical micropump; 11. pump body; 12. medium solution; 13. electrode layer; 14. expansion membrane; 2. sensor; 21. substrate; 22. microneedle array; 221. hollow microneedle needle; 23, electrode; 231, working electrode; 232, active electrode; 233, counter electrode; 234, reference electrode; 3, control module; 31, first conversion subunit; 32, control subunit; 33, second Conversion subunit; A, containment area; B, injection channel.

具体实施方式Detailed ways

下面将结合本申请实施例中的附图，对本申请实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。The following will clearly and completely describe the technical solutions in the embodiments of the present application with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of them. Based on the embodiments in this application, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the scope of protection of this application.

参照图1所示，为本申请实施例公开的的一种闭环控制系统，该闭环控制系统包括电化学微泵1、传感器2和控制模块3。Referring to FIG. 1 , it is a closed-loop control system disclosed in the embodiment of the present application. The closed-loop control system includes anelectrochemical micropump 1 , asensor 2 and acontrol module 3 .

具体地，参照图1所示，电化学微泵1包括泵体11，泵体11具有容纳区域A，容纳区域A内设置有介质溶液12和电极层13，其中，电极层13位于泵体11的内壁上，并且泵体11上设置有覆盖容纳区域A的扩张膜14。在一种可选的实施方式中，泵体11整体可以为一个圆柱形或者半球形，电极层13可以为铂材料制成的叉指电极，介质溶液12可以为去离子水或盐溶液，扩张膜14可以为聚四氟乙烯膜。Specifically, as shown in FIG. 1 , theelectrochemical micropump 1 includes apump body 11, thepump body 11 has an accommodation area A, and amedium solution 12 and anelectrode layer 13 are arranged in the accommodation area A, wherein theelectrode layer 13 is located in thepump body 11 and thepump body 11 is provided with anexpansion film 14 covering the accommodation area A. In an optional embodiment, thepump body 11 as a whole can be cylindrical or hemispherical, theelectrode layer 13 can be an interdigitated electrode made of platinum material, themedium solution 12 can be deionized water or saline solution, and theexpansion Membrane 14 may be a polytetrafluoroethylene membrane.

其中，如图3所示，叉指电极包括交叉配料的铂电极片，铂电极片的宽度可以为1μm-500μm。叉指电极通过导线连接到泵体11的外部，用于通过导线接收电流。此外，电极层13的材料还可以选用金、银、铝、碳等。电极层13的面积可以为1mm²-1cm²，电极层13的厚度可以为50nm-100μm。在电极层13为其他形状的电极，例如平板电极时，平板电极的宽度可以在毫米到厘米范围内。电极层13可以通过微纳加工的溅射或蒸镀工艺形成在基板上，也可以通过丝网印刷的方式形成在基板上。Wherein, as shown in FIG. 3 , the interdigitated electrodes include platinum electrode sheets cross-proportioned, and the width of the platinum electrode sheets can be 1 μm-500 μm. The interdigital electrodes are connected to the outside of thepump body 11 through wires, and are used to receive current through the wires. In addition, the material of theelectrode layer 13 can also be selected from gold, silver, aluminum, carbon and the like. The area of theelectrode layer 13 may be 1 mm² -1 cm² , and the thickness of theelectrode layer 13 may be 50 nm-100 μm. When theelectrode layer 13 is an electrode of other shapes, such as a flat plate electrode, the width of the flat plate electrode can be in the range of millimeters to centimeters. Theelectrode layer 13 can be formed on the substrate by sputtering or evaporation process of micro-nano processing, and can also be formed on the substrate by screen printing.

电极层13所在的泵体11的内壁作为电极层13的基板，其中，如图1、图4和图5所示，基板的形状可以为平面形状、锯齿形状或曲面形状。基板的材料可以选用柔性材料，例如，聚对苯二甲酸乙二醇酯(PET)、聚酰亚胺(Polyimide)、聚对二甲苯(Parylene)、聚氨酯(Polyurethane)、聚碳酸酯、聚酯、热塑性聚氨酯弹性体(TPU)、聚氯乙烯(PVC)、壳聚糖、聚乳酸、硅胶、橡胶、乳胶、热塑性弹性体(TPE)、全氟乙烯丙烯共聚物(FEP)和聚四氟乙烯(PTFE)；基板的材料也可以选用玻璃等硬质材料。The inner wall of thepump body 11 where theelectrode layer 13 is located serves as the substrate of theelectrode layer 13, wherein, as shown in Fig. 1 , Fig. 4 and Fig. 5 , the shape of the substrate can be planar, zigzag or curved. The material of the substrate can be selected from flexible materials, such as polyethylene terephthalate (PET), polyimide (Polyimide), parylene (Parylene), polyurethane (Polyurethane), polycarbonate, polyester , thermoplastic polyurethane elastomer (TPU), polyvinyl chloride (PVC), chitosan, polylactic acid, silicone, rubber, latex, thermoplastic elastomer (TPE), perfluoroethylene propylene copolymer (FEP) and polytetrafluoroethylene (PTFE); the material of the substrate can also be selected from hard materials such as glass.

扩张膜14还可以选用聚二甲基硅氧烷(PDMS)、聚丙烯酸酯、硅胶(例如Ecoflex、Dragon Skin)、橡胶(例如NBR、IIR)、乳胶、聚氨酯、聚对二甲苯(Parylene)、聚亚酰胺(Polyimide)等材料。Theexpansion film 14 can also be selected from polydimethylsiloxane (PDMS), polyacrylate, silica gel (such as Ecoflex, Dragon Skin), rubber (such as NBR, IIR), latex, polyurethane, parylene (Parylene), Materials such as polyimide.

参照图1所示，传感器2包括基底21、微针阵列22和覆盖在基底21上的电极23，微针阵列22与基底21一体成型。微针阵列22包括多个空心微针221，空心微针221的内部具有注射通道B，并且空心微针221的尖端上具有注射孔，将传感器2与扩张膜14连接后，可以朝向空心微针221内部的注射通道B注入胰岛素溶液。需要说明的是，空心微针221尖端的注射孔的孔径较小，进而在毛细管力的作用下，空心微针221内部的胰岛素溶液不会通过注射孔流出。Referring to FIG. 1 , thesensor 2 includes asubstrate 21 , amicroneedle array 22 andelectrodes 23 covering thesubstrate 21 , and themicroneedle array 22 and thesubstrate 21 are integrally formed. Themicroneedle array 22 includes a plurality ofhollow microneedles 221. The interior of thehollow microneedles 221 has an injection channel B, and the tips of thehollow microneedles 221 have injection holes. Injection channel B inside 221 injects insulin solution. It should be noted that the diameter of the injection hole at the tip of thehollow microneedle 221 is small, and under the action of capillary force, the insulin solution inside thehollow microneedle 221 will not flow out through the injection hole.

具体地，微针阵列22中空心微针221的高度可以为500μm-2000μm，空心微针221在基底21的直径可以为100μm-500μm，空心微针221侧壁的厚度可以为30μm-300μm。电极23的厚度可以为50nm-20μm。Specifically, the height of thehollow microneedles 221 in themicroneedle array 22 can be 500 μm-2000 μm, the diameter of thehollow microneedles 221 on thesubstrate 21 can be 100 μm-500 μm, and the thickness of the side walls of thehollow microneedles 221 can be 30 μm-300 μm. The thickness of theelectrode 23 may be 50 nm-20 μm.

而在对电化学微泵1通电后，电极层13会将水电解并产生氢气气泡和氧气气泡，这些气泡会朝向扩张膜14所在的位置移动，并且在这些气泡的作用下，扩张膜14会发生变形膨胀，并对空心微针221内部的胰岛素溶液产生挤压力，使得胰岛素溶液通过注射孔流出，再将传感器2作用于患者时，便可以将胰岛素溶液注射至患者体内。而在电化学微泵1不通电时，氢气和氧气会通过电极层13的催化重新结合会水，此时扩张膜14便会收缩，使得胰岛素溶液不再从空心微针221尖端的注射孔流出。After theelectrochemical micropump 1 is energized, theelectrode layer 13 will electrolyze the water and generate hydrogen bubbles and oxygen bubbles, and these bubbles will move towards the position where theexpansion membrane 14 is located, and under the action of these bubbles, theexpansion membrane 14 will Deformation and expansion occur, and squeeze the insulin solution inside thehollow microneedle 221, so that the insulin solution flows out through the injection hole, and when thesensor 2 acts on the patient, the insulin solution can be injected into the patient. When theelectrochemical micropump 1 is not energized, hydrogen and oxygen will recombine water through the catalysis of theelectrode layer 13, and theexpansion membrane 14 will shrink at this time, so that the insulin solution no longer flows out from the injection hole at the tip of thehollow microneedle 221 .

控制模块3的输入端与传感器2的输出端连接，输出端与电化学微泵1的输入端连接。因此，控制模块3可以接收传感器2输出的电信号，由于传感器2上的空心微针221进入患者体内，并接触到患者的皮下组织液，因此可以检测到患者的皮下组织液的葡萄糖浓度，同时，组织液葡萄糖浓度与血糖浓度具有很强的相关性，因此传感器2输出的电信号能够反应血糖浓度的大小。示例性地，传感器2可以在恒定电压下检测电流，且电流信号的大小与葡萄糖浓度的大小成正比。The input end of thecontrol module 3 is connected to the output end of thesensor 2 , and the output end is connected to the input end of theelectrochemical micropump 1 . Therefore, thecontrol module 3 can receive the electrical signal output by thesensor 2. Since thehollow microneedle 221 on thesensor 2 enters the patient's body and contacts the patient's subcutaneous tissue fluid, the glucose concentration of the patient's subcutaneous tissue fluid can be detected. At the same time, the tissue fluid The glucose concentration has a strong correlation with the blood glucose concentration, so the electrical signal output by thesensor 2 can reflect the magnitude of the blood glucose concentration. Exemplarily, thesensor 2 can detect current at a constant voltage, and the magnitude of the current signal is proportional to the magnitude of the glucose concentration.

然后，控制模块3可以根据电信号，控制电化学微泵1的开启或关闭，即给电化学微泵1通电或不通电。示例性地，控制模块3内可以设置一个预设值，若电信号的值大于或等于该预设值，则给电化学微泵1通电，若电信号的值小于该预设值，则不给电化学微泵1通电。Then, thecontrol module 3 can control theelectrochemical micropump 1 to be turned on or off according to the electrical signal, that is, to energize or not energize theelectrochemical micropump 1 . Exemplarily, a preset value can be set in thecontrol module 3, if the value of the electrical signal is greater than or equal to the preset value, theelectrochemical micropump 1 will be energized, if the value of the electrical signal is smaller than the preset value, then no Power up theelectrochemical micropump 1.

这样，便可以根据患者实时的血糖浓度对电化学微泵1进行控制。In this way, theelectrochemical micropump 1 can be controlled according to the real-time blood glucose concentration of the patient.

进一步地，传感器2的基底21与微针阵列22可以选用带有微针阵列形状的模具进行制作。在具体制作时，将液态聚合物材料铸造在该带有微针阵列22形状的模具上，并在干燥后脱模，便可以形成基底21。其中，液态聚合物材料可以为生物可降解材料，如壳聚糖、聚乳酸、丝素蛋白；也可以为生物兼容性材料，如热塑性聚氨酯；在采用生物可降解材料时，使得微针传感器2具有可降解能力，在使用后可以自然分解；而采用生物兼容性材料，则使得微针传感器2的生物兼容性较强，在使用时可以避免对人体造成损害。Further, thesubstrate 21 and themicroneedle array 22 of thesensor 2 can be manufactured using a mold with the shape of the microneedle array. During specific fabrication, thebase 21 can be formed by casting the liquid polymer material on the mold with the shape of themicroneedle array 22 and demoulding after drying. Among them, the liquid polymer material can be a biodegradable material, such as chitosan, polylactic acid, silk fibroin; it can also be a biocompatible material, such as thermoplastic polyurethane; when using a biodegradable material, themicroneedle sensor 2 It has degradability and can be decomposed naturally after use; and the use of biocompatible materials makes themicroneedle sensor 2 have strong biocompatibility and can avoid damage to the human body during use.

在一种可选的实施方式中，传感器2的基底与微针阵列22还可以通过3D打印的方式制作，具体地，传感器2的材料可以选择环氧树脂、陶瓷、金属、生物兼容性材料、生物可降解材料等。In an optional embodiment, the substrate of thesensor 2 and themicroneedle array 22 can also be made by 3D printing. Specifically, the material of thesensor 2 can be selected from epoxy resin, ceramics, metal, biocompatible materials, biodegradable materials, etc.

进一步地，参照图7和图9所示，微针阵列22中的空心微针221的形状可以是棱锥，也可以是圆锥，在本申请实施例中不做具体限定。而空心微针221尖端的注射孔可以通过金属针阵列穿透来形成。具体地，可以选用不锈钢针阵列来穿透微针阵列22中每个空心微针221的尖端，从而使每个空心微针221的尖端获得明显的孔洞作为注射孔使用。Further, referring to FIG. 7 and FIG. 9 , the shape of thehollow microneedles 221 in themicroneedle array 22 may be a pyramid or a cone, which is not specifically limited in this embodiment of the present application. The injection hole at the tip of thehollow microneedle 221 can be formed by piercing through the metal needle array. Specifically, the stainless steel needle array can be selected to penetrate the tip of eachhollow microneedle 221 in themicroneedle array 22, so that the tip of eachhollow microneedle 221 obtains an obvious hole as an injection hole.

在一种可选的实施方式中，参照图2所示，为本申请实施例提供的另一种闭环控制系统，在该闭环控制系统中，传感器2位于扩张膜14的左侧(也可以为右侧)，且在该实施方式中，传感器2与扩张膜14的空间可以用于存储更多的胰岛素溶液，从而进一步方便闭环控制系统的使用。In an optional embodiment, as shown in FIG. 2 , another closed-loop control system provided by the embodiment of the present application, in this closed-loop control system, thesensor 2 is located on the left side of the expansion membrane 14 (also can be Right side), and in this embodiment, the space between thesensor 2 and theexpansion membrane 14 can be used to store more insulin solution, thereby further facilitating the use of the closed-loop control system.

在一种可选的实施方式中，参照图6所示，控制模块3包括第一转换子单元31、控制子单元32和第二转换子单元33。In an optional implementation manner, as shown in FIG. 6 , thecontrol module 3 includes afirst conversion subunit 31 , acontrol subunit 32 and asecond conversion subunit 33 .

具体地，第一转换子单元31的输入端与传感器2的输出端连接，第一转换子单元31的输出端与控制子单元32的输入端连接，第一转换子单元31用于接收并转换传感器2输出的电信号。示例性地，传感器2在检测到患者体内的葡萄糖浓度后，输出对应的电流信号，第一转换子单元31便可以检测到电流信号，并将该电流信号转换后传输给控制子单元32；同时第一转换子单元31也可以为传感器2提供恒定电压，恒定电压可以是0.1V，-0.1V，或者0.6V等不同电压。Specifically, the input end of thefirst conversion subunit 31 is connected to the output end of thesensor 2, the output end of thefirst conversion subunit 31 is connected to the input end of thecontrol subunit 32, and thefirst conversion subunit 31 is used to receive and convert The electrical signal output bysensor 2. Exemplarily, after thesensor 2 detects the glucose concentration in the patient's body, it outputs a corresponding current signal, and thefirst conversion subunit 31 can detect the current signal, convert the current signal and transmit it to thecontrol subunit 32; at the same time Thefirst conversion subunit 31 can also provide a constant voltage for thesensor 2, and the constant voltage can be 0.1V, -0.1V, or 0.6V and other different voltages.

第二转换子单元33的输入端与控制子单元32的输出端连接，第二转换子单元33的输出端与电化学微泵1的输入端连接。其中，控制子单元32在接收第一转换子单元31转换后的电信号后，会根据电信号发送命令给第二转换子单元33，第二转换子单元33可以接收控制子单元32输出的命令，并将该命令转换为对应的命令信号，再将该命令信号传输给电化学微泵1，以控制电化学微泵1的开启或关闭。The input end of thesecond conversion subunit 33 is connected to the output end of thecontrol subunit 32 , and the output end of thesecond conversion subunit 33 is connected to the input end of theelectrochemical micropump 1 . Wherein, after thecontrol subunit 32 receives the electrical signal converted by thefirst conversion subunit 31, it will send a command to thesecond conversion subunit 33 according to the electrical signal, and thesecond conversion subunit 33 can receive the command output by thecontrol subunit 32 , and convert the command into a corresponding command signal, and then transmit the command signal to theelectrochemical micropump 1 to control theelectrochemical micropump 1 to be turned on or off.

示例性地，控制子单元32接收的电信号为大于预设值的电信号，因此控制子单元32会输出通电命令给第二转换子单元33，第二转换子单元33会接收通电命令，并将通电命令转换为通电命令信号，而后电化学微泵1接收通电命令信号后实现通电。同时，第二转换子单元33可以提供恒定电压或恒定电流以驱动电化学微泵1并且通过控制电压的大小和持续时间，进而控制胰岛素的注射量，电压大小可以在0.1到20V，电流的大小可以为0.1mA到10mA。Exemplarily, the electrical signal received by thecontrol subunit 32 is an electrical signal greater than a preset value, so thecontrol subunit 32 will output a power-on command to thesecond conversion sub-unit 33, and the second conversion sub-unit 33 will receive the power-on command, and The power-on command is converted into a power-on command signal, and then theelectrochemical micropump 1 realizes power-on after receiving the power-on command signal. At the same time, thesecond conversion subunit 33 can provide a constant voltage or constant current to drive theelectrochemical micropump 1 and control the magnitude and duration of the voltage, thereby controlling the injection amount of insulin. The voltage can be from 0.1 to 20V, and the magnitude of the current Can be 0.1mA to 10mA.

这样，在传感器2检测患者体内的葡萄糖浓度并产生电信号后，第一转换子单元31会接收并转换电信号，再将转换后的电信号发送给控制子单元32，控制子单元32接收第一转换子单元31转换的电信号后，会根据电信号的不同生成不同的命令，同时控制子单元32将生成的命令发送给第二转换子单元33，第二转换子单元33再将接收的命令转换为对应的命令信号，并依据命令信号控制电化学微泵1的开启或关闭，如此便实现了依据患者实时的血糖浓度对电渗泵1进行控制。In this way, after thesensor 2 detects the glucose concentration in the patient's body and generates an electrical signal, the first convertingsubunit 31 will receive and convert the electrical signal, and then send the converted electrical signal to thecontrol subunit 32, and thecontrol subunit 32 will receive the second electrical signal. After the electrical signal converted by thefirst conversion subunit 31, different commands will be generated according to the difference of the electrical signal, and thecontrol subunit 32 will send the generated command to thesecond conversion subunit 33, and thesecond conversion subunit 33 will receive the received command again. The command is converted into a corresponding command signal, and theelectrochemical micropump 1 is controlled to be turned on or off according to the command signal, so that theelectroosmotic pump 1 is controlled according to the patient's real-time blood glucose concentration.

在一种可选的实施方式中，第一转换子单元31为第一信号转换器；控制子单元32为微控制器；第二转换子单元33为第二信号转换器。In an optional implementation manner, thefirst conversion subunit 31 is a first signal converter; thecontrol subunit 32 is a microcontroller; and thesecond conversion subunit 33 is a second signal converter.

具体地，本领域技术人员可以依据相关技术中的器件作为第一信号转换器和第二信号转换器，只需要通过控制模块3可以达到控制电化学微泵1开启或关闭的效果即可，因此，在本实施例中对此不做具体限定，也不再赘述相关技术的具体内容。Specifically, those skilled in the art can use the devices in the related art as the first signal converter and the second signal converter, and only need to achieve the effect of controlling theelectrochemical micropump 1 to be turned on or off through thecontrol module 3, so , which is not specifically limited in this embodiment, and specific content of related technologies will not be repeated here.

在一种可选的实施方式中，闭环控制系统还包括云端服务器，控制子单元32与云端服务器电连接。In an optional implementation manner, the closed-loop control system further includes a cloud server, and thecontrol subunit 32 is electrically connected to the cloud server.

云端服务器用于接收并存储控制子单元32发送的信息，控制子单元32发送的信息可以包括患者体内的葡萄糖浓度。The cloud server is used to receive and store the information sent by thecontrol subunit 32, and the information sent by thecontrol subunit 32 may include the glucose concentration in the patient's body.

在一种可选的实施方式中，闭环控制系统还包括显示模块，显示模块与控制子单元32电连接，同时显示模块还可以与云端服务器连接。In an optional implementation manner, the closed-loop control system further includes a display module, which is electrically connected to thecontrol subunit 32, and meanwhile, the display module can also be connected to a cloud server.

显示模块用于接收并显示所述控制子单元32发送的信息。在具体应用时，显示模块可以是计算机、显示器、平板电脑等。The display module is used to receive and display the information sent by thecontrol subunit 32 . In a specific application, the display module may be a computer, a monitor, a tablet computer, and the like.

在一种可选的实施方式中，电极23可以包括工作电极231和电源电极。In an optional embodiment, theelectrode 23 may include a workingelectrode 231 and a power electrode.

具体地，在制作工作电极231和电源电极时，可以在基底21上微针阵列22凸出的一侧制作；工作电极231和电源电极也可以在基底21上微针阵列22内凹的一侧制作；并且在微针阵列22凸出的一侧制作工作电极231和电源电极时，可以选择不穿透空心微针221阵列22，因为此时只需将微针与被检测溶液接触即可，无需被检测溶液流入微针阵列22内部。Specifically, when making the workingelectrode 231 and the power supply electrode, it can be made on the protruding side of themicroneedle array 22 on thesubstrate 21; the workingelectrode 231 and the power supply electrode can also be made on the concave side of themicroneedle array 22 on thesubstrate 21 making; and when making the workingelectrode 231 and the power supply electrode on the protruding side of themicroneedle array 22, you can choose not to penetrate thehollow microneedle 221array 22, because at this time it is only necessary to contact the microneedle with the solution to be detected. There is no need for the solution to be detected to flow into the interior of themicroneedle array 22 .

同时，工作电极231包括层叠设置在基底21上的电极层、普鲁士蓝层、试剂酶层和生物兼容性聚合物层，其中电极层可以选用金、铂或碳，而电源电极一般则包括电极层。At the same time, the workingelectrode 231 includes an electrode layer, a Prussian blue layer, a reagent enzyme layer and a biocompatible polymer layer stacked on thesubstrate 21, wherein the electrode layer can be selected from gold, platinum or carbon, and the power electrode generally includes an electrode layer. .

通过在试剂酶层上覆盖液态的生物兼容性聚合物，再对液态的生物兼容性聚合物进行加热干燥，从而形成生物兼容性聚合物层。生物兼容性聚合物层可以选用全氟磺酸，生物兼容性聚合物层可以避免普鲁士蓝层对人体造成损害。The biocompatible polymer layer is formed by covering the liquid biocompatible polymer on the reagent enzyme layer, and then heating and drying the liquid biocompatible polymer. The biocompatible polymer layer can be selected from perfluorosulfonic acid, and the biocompatible polymer layer can prevent the Prussian blue layer from causing damage to the human body.

这样，在工作电极231接触到被检测溶液时，试剂酶可以与被检测溶液中的对应分析物发生反应，并通过试剂酶反应产生产物，产物会在工作电极231上进行氧化或者还原反应产生电信号的变化。In this way, when the workingelectrode 231 contacts the detected solution, the reagent enzyme can react with the corresponding analyte in the detected solution, and produce a product through the reagent enzyme reaction, and the product will undergo oxidation or reduction reaction on the workingelectrode 231 to generate electricity. Signal changes.

在具体应用时，如图7所示，电源电极可以只包括一个作用电极232，此时作用电极232可以同时起到连通电路和稳定电压的作用，作用电极232的材料可以选用银/氯化银；如图8所示，电源电极也可以包括一个参比电极234和一个对电极233，此时参比电极234起到稳定电压的作用，对电极233起到连通电路的作用；对电极233的材料可以选用金、铂或碳；参比电极234的材料可以选用银/氯化银。In specific applications, as shown in Figure 7, the power supply electrode can only include oneactive electrode 232. At this time, theactive electrode 232 can play the role of connecting the circuit and stabilizing the voltage at the same time, and the material of theactive electrode 232 can be selected from silver/silver chloride. ; As shown in Figure 8, the power electrode can also include areference electrode 234 and acounter electrode 233, and now thereference electrode 234 plays the role of stabilizing voltage, and thecounter electrode 233 plays the role of a connected circuit; thecounter electrode 233 The material can be selected from gold, platinum or carbon; the material of thereference electrode 234 can be selected from silver/silver chloride.

基于同一发明构思，本申请实施例还公开一种胰岛素注射用闭环系统，包括如本申请任一实施例所提供的闭环控制系统。Based on the same inventive concept, the embodiment of the present application also discloses a closed-loop system for insulin injection, including the closed-loop control system provided in any embodiment of the present application.

具体地，该胰岛素注射用闭环系统还包括胰岛素传输装置，所述胰岛素传输装置用于传输胰岛素，并且胰岛素传输装置的输出端位于传感器2与扩张膜14之间的区域内，从而使得电化学微泵1可以根据传感器2检测的患者的血糖浓度，来控制胰岛素的精确注射。Specifically, the closed-loop system for insulin injection also includes an insulin delivery device, the insulin delivery device is used to deliver insulin, and the output end of the insulin delivery device is located in the area between thesensor 2 and theexpansion membrane 14, so that the electrochemical micro Thepump 1 can control the precise injection of insulin according to the blood glucose concentration of the patient detected by thesensor 2 .

需要说明的是，本说明书中的各个实施例均采用递进的方式描述，每个实施例重点说明的都是与其他实施例的不同之处，各个实施例之间相同相似的部分互相参见即可。It should be noted that each embodiment in this specification is described in a progressive manner, and each embodiment focuses on the differences from other embodiments. For the same and similar parts in each embodiment, refer to each other, that is, Can.

还需要说明的是，在本文中，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示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申请的限制。此外，诸如“第一”和“第二”之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来，而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序，也不能理解为指示或暗示相对重要性。而且，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者终端设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者终端设备所固有的要素。在没有更多限制的情况下，由语句“包括一个……”限定的要素，并不排除在包括要素的过程、方法、物品或者终端设备中还存在另外的相同要素。It should also be noted that, in this document, the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" etc. indicate The orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, and is only for the convenience of describing the application and simplifying the description, rather than indicating or implying that the referred device or element must have a specific orientation, be configured in a specific orientation, and operation and therefore should not be construed as limiting the application. Furthermore, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another and do not necessarily require or imply any such relationship between the entities or operations. no actual relationship or order, nor should it be construed as indicating or implying relative importance. Furthermore, the term "comprises", "comprises" or any other variation thereof is intended to cover a non-exclusive inclusion such that a process, method, article, or terminal equipment comprising a set of elements includes not only those elements, but also includes elements not expressly listed. other elements identified, or also include elements inherent in such a process, method, article, or end-equipment. Without further limitations, an element defined by the phrase "comprising a ..." does not preclude the presence of additional identical elements in the process, method, article or terminal device comprising the element.

以上对本申请所提供的技术方案进行了详细介绍，本文中应用了具体个例对本申请的原理及实施方式进行了阐述，以上实施例的说明只是用于帮助理解本申请，本说明书内容不应理解为对本申请的限制。同时，对于本领域的一般技术人员，依据本申请，在具体实施方式及应用范围上均会有不同形式的改变之处，这里无需也无法对所有的实施方式予以穷举，而由此所引伸出的显而易见的变化或变动仍处于本申请的保护范围之中。The technical solutions provided by this application have been introduced in detail above, and specific examples have been used in this paper to illustrate the principles and implementation methods of this application. The descriptions of the above examples are only used to help understand this application, and the content of this specification should not be understood For the limitation of this application. At the same time, for those of ordinary skill in the art, according to the present application, there will be changes in different forms in the specific implementation methods and application ranges, and it is not necessary and impossible to exhaustively list all the implementation methods here. Obvious changes or modifications are still within the protection scope of the present application.

Claims (8)

1. A closed loop control system, comprising:

the system comprises an electrochemical micro pump, a sensor and a control module;

the electrochemical micropump comprises a pump body, wherein the pump body is provided with a containing area, a medium solution and an electrode layer connected with the inner wall of the pump body are arranged in the containing area, and an expansion film covering the containing area is arranged on the pump body;

a sensor comprising a substrate, a microneedle array and an electrode covering the substrate, wherein the microneedle array is integrally formed with the substrate and comprises a plurality of hollow microneedles, and an injection channel is formed in the hollow microneedles;

the expanding membrane is connected with the base of the sensor, and the tips of the hollow microneedles face to the side far away from the expanding membrane;

the input end of the control module is connected with the output end of the sensor, and the output end of the control module is connected with the input end of the electrochemical micropump; the control module is used for receiving the electric signal output by the sensor and controlling the opening or closing of the electrochemical micro pump according to the electric signal.

2. The closed-loop control system of claim 1, wherein:

the control module comprises a first conversion subunit, a control subunit and a second conversion subunit;

the input end of the first conversion subunit is connected with the output end of the sensor, the output end of the first conversion subunit is connected with the input end of the control subunit, and the first conversion subunit is used for receiving and converting the electric signal output by the sensor;

the control subunit is configured to receive the electrical signal converted by the first conversion subunit, and send a command to the second conversion subunit according to the electrical signal;

the input end of the second conversion subunit is connected with the output end of the control subunit, the output end of the second conversion subunit is connected with the input end of the electrochemical micropump, and the second conversion subunit is used for receiving and converting the command output by the control subunit and transmitting the converted command signal to the electrochemical micropump so as to control the opening or closing of the electrochemical micropump.

3. The closed-loop control system of claim 2, wherein:

the first conversion subunit is a first signal converter;

the control subunit is a microcontroller;

the second converting subunit is a second signal converter.

4. The closed-loop control system of claim 1, wherein:

the material of the expansion film comprises at least one of the following materials: polytetrafluoroethylene, polydimethylsiloxane, polyacrylate, silicone, rubber, latex, polyurethane, parylene, and polyimide.

5. The closed-loop control system of claim 1, wherein:

the material of the electrode layer comprises a hard film material or a flexible film material.

6. The closed-loop control system of claim 1, wherein:

the electrodes include a working electrode and a power supply electrode.

7. The closed-loop control system of claim 6, wherein:

the power supply electrode is an action electrode;

alternatively, the power supply electrode is a counter electrode and a reference electrode.

8. A closed loop system for insulin injection, characterized by:

comprising a closed loop control system as claimed in any one of claims 1-7.

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