CN111420164A - Novel insulin pump infusion system with noninvasive insulin injection part induration eliminating equipment - Google Patents

Abstract

Translated fromChinese

本发明公开了一种带无创消除胰岛素注射部位硬结系统的新型胰岛素泵输注系统，此系统由胰岛素输注主机和耗材部分组成一个智能控制系统的硬件和软件，其中泵端由控制系统、显示系统、传动系统组成，耗材端由输注管路、控制连接头、控制连接线、发热极片、温度传感器组成，输注管路由鲁尔接头、导管、针座、输液针组成；泵端和耗材端，通过输注管路鲁尔接头连接，完成不同状态下输注胰岛素的基本功能。本发明解决了以往胰岛素泵使用者在使用胰岛素的过程中，先输注，后消硬结的滞后性，避免了硬结的形成，更有效的胰岛素吸收，能显著的改善血糖控制状况。

The invention discloses a novel insulin pump infusion system with a non-invasive system for eliminating induration at the insulin injection site. The system consists of an insulin infusion host and consumables to form the hardware and software of an intelligent control system, wherein the pump end is composed of a control system, a display System and transmission system. The consumable end is connected through the luer connector of the infusion pipeline to complete the basic function of insulin infusion in different states. The invention solves the hysteresis of the previous insulin pump users in the process of using insulin, first infusion, and then eliminating induration, avoiding the formation of induration, more effective insulin absorption, and can significantly improve blood sugar control.

Description

Translated fromChinese

一种带无创消除胰岛素注射部位硬结设备的新型胰岛素泵输注系统A new type of insulin pump with a non-invasive device for eliminating induration at the insulin injection siteNote system

技术领域technical field

本发明涉及胰岛素泵智能控制系统领域，更具体地说涉及一种带无创消除胰岛素输注部位硬结设备的新型胰岛素泵输注系统。The invention relates to the field of intelligent control systems for insulin pumps, and more particularly to a novel insulin pump infusion system with a non-invasive device for eliminating induration at the insulin infusion site.

背景技术Background technique

糖尿病是一种危害社会人类健康的慢性疾病，其危害程度在所有疾病中目前已位列第三位，并且在继续提高。控制血糖的波动范围可以防止各种严重并发症的产生，现在公认注射胰岛素是控制血糖最为有效的方式。传统的注射方式为人工注射，最新的方式是程序控制型胰岛素泵注射胰岛素，其给药量与时间可以通过程序控制，连续输注。但是在同一个部位的反复输注刺激，由于吸收不及时，会导致胰岛素在局部皮下脂肪长时间残留，造成输注部位皮下脂肪肥大，纤维组织增生，从而造成皮下硬结的出现；另外硬结部位微血管比较少，注射在硬结部位的胰岛素，吸收通常比较缓慢，胰岛素的吸收不彻底，起效就会延迟，同时吸收也不稳定，这一次吸收快，下一次吸收慢，这样同样的胰岛素量，同样的饮食、运动量，而血糖却不一样，会打乱你的治疗计划，也会严重影响血糖的控制情况，从而造成高低血糖并发症的危险。Diabetes is a chronic disease that endangers the health of society and human beings, and its degree of harm is currently the third among all diseases, and it continues to increase. Controlling the fluctuation range of blood sugar can prevent the occurrence of various serious complications, and it is now recognized that insulin injection is the most effective way to control blood sugar. The traditional injection method is manual injection. The latest method is a program-controlled insulin pump to inject insulin. The dosage and time can be controlled by the program and continuously infused. However, repeated infusion stimulation at the same site will cause insulin to remain in the local subcutaneous fat for a long time due to untimely absorption, resulting in hypertrophy of subcutaneous fat and fibrous tissue proliferation at the infusion site, resulting in the appearance of subcutaneous induration; Less insulin is injected into the induration part, and the absorption is usually slow. If the insulin is not absorbed completely, the onset of action will be delayed, and the absorption will be unstable. The absorption is fast this time, and the absorption is slow the next time, so the same amount of insulin, the same Depending on your diet and exercise, your blood sugar will be different, which will disrupt your treatment plan and seriously affect your blood sugar control, resulting in the risk of high and low blood sugar complications.

经查询，现有专利文献中有一些相关专利文献的报道，主要有以下这些：After inquiry, there are some relevant patent literature reports in the existing patent literature, mainly including the following:

1、授权公告号CN201341983Y 名称为“一种加压消除糖尿病人皮下硬结装置”实用新型专利，属于医疗器械装置技术领域。该专利为充气加压囊的两端加上腰围系带，充气管的另一端与挤压充气囊固定连接相通，环套固定在充气加压囊上，然后把切好的土豆片一一排列将两边塞入环套中固定，利用充气挤压使土豆片长时间贴在皮肤上，达到消除硬结的目的；1. The authorized announcement number CN201341983Y is a utility model patent named "a pressurized device for eliminating subcutaneous induration of diabetic patients", which belongs to the technical field of medical devices. In this patent, the two ends of the inflatable pressure bag are added with waist belts, the other end of the inflatable tube is fixedly connected with the extrusion inflatable bag, the ring sleeve is fixed on the inflatable pressure bag, and then the cut potato slices are arranged one by one. Put the two sides into the ring to fix it, and use the inflation and squeeze to make the potato chips stick to the skin for a long time to achieve the purpose of eliminating induration;

2、授权公告号 CN202620351U名称为“一种内分泌疾病注射用辅助装置”实用新型专利，属于一种内分泌疾病注射用辅助装置。该装置包括吸盘、设置在吸盘下端面的加热圈及设置在加热圈内部的无菌垫，通过外接电源加热圈加热的方式，有效防止皮下产生硬结；2. The authorized announcement number CN202620351U is a utility model patent named "Auxiliary device for injection of endocrine diseases", which belongs to an auxiliary device for injection of endocrine diseases. The device comprises a suction cup, a heating ring arranged on the lower end face of the suction cup, and a sterile pad arranged inside the heating ring, and is heated by an external power supply heating ring to effectively prevent subcutaneous induration;

上述两种专利是现有的代表性的解决方案，基本都存在以下问题：①需要繁琐的操作步骤，需要特定的固定方式来固定治疗器械；②药物输注和消除硬结是分离的，硬结消除过程中没办法智能控制；③在硬结已经形成的情况下去消除，有滞后性；④设备都需要单独购买，增加使用者经济负担。The above two patents are the existing representative solutions, and basically have the following problems: ① It requires tedious operation steps and requires a specific fixing method to fix the therapeutic device; ② The drug infusion and the elimination of induration are separated, and the induration is eliminated. There is no way to intelligently control it in the process; ③If the induration is already formed, there is a lag to eliminate it; ④The equipment needs to be purchased separately, which increases the economic burden of the user.

发明内容SUMMARY OF THE INVENTION

为了克服上述现有技术的不足，本发明提供了一种带无创消除胰岛素输注部位硬结设备的新型胰岛素泵输注系统；In order to overcome the above-mentioned deficiencies of the prior art, the present invention provides a novel insulin pump infusion system with a non-invasive device for eliminating induration at the insulin infusion site;

本发明所采用的技术方案是：由胰岛素输注主机和耗材部分组成一个智能控制系统的硬件和软件，其中泵端由控制系统、显示系统、传动系统组成，耗材端由输注管路、控制连接头、控制连接线、发热极片、温度传感器组成，输注管路由鲁尔接头、导管、针座、输液针组成；The technical scheme adopted in the present invention is: the hardware and software of an intelligent control system are composed of an insulin infusion host and consumables, wherein the pump end is composed of a control system, a display system and a transmission system, and the consumable end is composed of an infusion pipeline, a control system, and a control system. It consists of a connector, a control cable, a heating pole piece, and a temperature sensor, and the infusion tube is composed of a Luer connector, a catheter, a needle seat, and an infusion needle;

泵端和耗材端，通过输注管路鲁尔接头连接，完成不同状态下输注胰岛素的基本功能；The pump end and the consumable end are connected through the luer connector of the infusion pipeline to complete the basic function of insulin infusion in different states;

泵端和耗材端，通过控制连接头和泵端主板连接，通过泵端控制系统形成完整的胰岛素输注部位消硬结控制系统，所述胰岛素输注部位消硬结控制控制系统，可以通过识别泵端输注状态（基础输/大剂量输注），反馈到主控端，主控智能调节供电电流，通过发热极片上附带的温度传感器实时反馈发热极片的温度，从而控制发热极片的工作状态，促进输注部位组织间液的流动，从而促进胰岛素的高效吸收，避免在皮下长时间残留，形成硬结。其中泵端控制系统不仅包括泵端胰岛素的正常输注管理和输注过程中对输注状态的实时监控、反馈，还包括消硬结设备的温度控制系统，系统可以实时接收发热极片上附带的温度传感器通过控制连接线传输过来的温度数据，并通过显示系统呈现在显示屏上，方便使用者查看。其中，发热极片的初始化温度可以根据不同的人体组织对温度的感知敏感度不同而在泵端控制系统中被设置和调整，调整后的温度可以被记忆保存，方便后续使用。默认状态下，泵端在执行基础率输注时，系统会关闭发热极片的电源，在泵端执行大剂量输注时，才会开启发热极片的电源，升温到所需温度，然后保持，同时，这两种状态下的温度和开关状态是可以在泵端控制系统中根据个人使用情况手动调整。在大剂量输注完成后，发热极片会持续工作一段时间，以达到最佳的吸收效果，输注完成后发热极片工作时间可根据人体吸收速度的差异，在泵端控制系统进行调整。The pump end and the consumable end are connected to the main board of the pump end through the control connector, and a complete insulin infusion site control system is formed through the pump end control system. The infusion status (basic infusion/large-dose infusion) is fed back to the main control terminal, the main control intelligently adjusts the power supply current, and feeds back the temperature of the heating pole piece in real time through the temperature sensor attached to the heating pole piece, thereby controlling the working state of the heating pole piece , to promote the flow of interstitial fluid at the infusion site, thereby promoting the efficient absorption of insulin, avoiding long-term residues under the skin and forming induration. The pump-end control system includes not only the normal infusion management of the pump-end insulin and the real-time monitoring and feedback of the infusion state during the infusion process, but also the temperature control system of the induration device. The system can receive the temperature attached to the heating pole piece in real time. The temperature data transmitted by the sensor through the control connection line is presented on the display screen through the display system, which is convenient for users to view. Among them, the initialization temperature of the heating pole piece can be set and adjusted in the pump-end control system according to the different sensitivity of different human tissues to temperature, and the adjusted temperature can be stored in memory, which is convenient for subsequent use. By default, when the pump side performs basal rate infusion, the system will turn off the power of the heating pole piece, and when the pump side performs large-dose infusion, the power supply of the heating pole piece will be turned on, heated to the required temperature, and then maintained , At the same time, the temperature and switch state in these two states can be manually adjusted in the pump-side control system according to individual usage. After the large-dose infusion is completed, the heating pole piece will continue to work for a period of time to achieve the best absorption effect. After the infusion is completed, the working time of the heating pole piece can be adjusted in the pump-side control system according to the difference in the absorption rate of the human body.

与现有技术相比，本发明的有益效果是：Compared with the prior art, the beneficial effects of the present invention are:

1、解决了以往胰岛素泵使用者在使用胰岛素的过程中，先输注，后消硬结的滞后性，本发明直接在输注同时改变局部组织液流动速度，加速胰岛素吸收，避免了硬结的形成，有实时性；1. Solve the hysteresis of the previous insulin pump users in the process of using insulin, first infusion, and then eliminate induration, the present invention directly changes the flow speed of local tissue fluid at the same time of infusion, accelerates insulin absorption, and avoids the formation of induration, have real-time;

2、解决了以往发明设备操作的复杂性，本发明不需要额外操作，不需要加装辅助设备设施，也不需要频繁的安装和拆卸，通过先进工艺，导线直接和管路融合挤出，二次加工就可直接连接泵端使用；2. The complexity of the operation of the equipment invented in the past is solved. The present invention does not require additional operations, does not need to install auxiliary equipment, and does not require frequent installation and disassembly. Through advanced technology, the wire is directly fused with the pipeline. It can be directly connected to the pump end for use after processing;

3、本发明可以根据使用人群、体质的不同情况，进行针对性的智能调节，从而促进胰岛素的吸收。更有效的胰岛素吸收，能显著的改善血糖控制状况，提高2型糖尿病患者的糖化血红蛋白水平，控制血糖效果，更显著，有效避免并发症的产生；3. The present invention can carry out targeted intelligent adjustment according to the different conditions of the user population and physique, thereby promoting the absorption of insulin. More effective insulin absorption can significantly improve blood sugar control, increase the level of glycosylated hemoglobin in patients with type 2 diabetes, and control blood sugar more significantly, effectively avoiding complications;

4、本发明采用先进设计理念和工艺，有效的控制设备体积，做到便携、无创方便使用者随时操作，并且成本没有显著的升高，社会效益更显著。4. The present invention adopts advanced design concept and technology, effectively controls the volume of the equipment, is portable, non-invasive and convenient for users to operate at any time, and the cost does not increase significantly, and the social benefit is more significant.

具体实施方式：下面将结合附图对本发明进步一说明；DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below with reference to the accompanying drawings;

附图说明：Description of drawings:

图1一种便携式无创消除胰岛素注射部位硬结的系统Figure 1 A portable non-invasive system for eliminating induration at the insulin injection site

1-胰岛素泵主机 2-耗材1-Insulin pump host 2-Consumables

图2 局部示意图Figure 2 Partial schematic diagram

1-胰岛素泵主机 2- 耗材1- Insulin pump host 2- Consumables

2-1 输注管路2-1 Infusion Line

2-2 控制线路2-2 Control circuit

2-3 针座敷贴2-3 Needle application

2-4 温度传感器2-4 Temperature sensor

2-5 发热片2-5 Heater

具体实施实例：Specific implementation examples:

在1 胰岛素泵主机里面装入胰岛素，正常设置基础率输注和大剂量输注值。并设置泵端控制系统，设置发热片默认温度，首次设置可根据后续的使用情况，反向动态调节。设置完成后，输注管路接入胰岛素泵主机储药仓端；控制线路，接入胰岛素泵主机控制窗口端，然后按照正常的使用，插入在人体合适部位，进行输注。当胰岛素泵在进行基础输注的时候，胰岛素泵控制系统会识别到输注状态，并断开控制窗口的电源供给，如果实际输注过程中，发现个人基础输注也有硬结出现的症状，可以选择在控制系统菜单中，打开发热片开关。当胰岛素泵在进行大剂量输注时，胰岛素泵控制系统识别到输注状态，默认开启控制窗口的电源供给，如果实际输注过程中，个人大剂量输注并没有出现硬结的症状，可以选在在控制系统菜单中，关闭发热片开关。大剂量输注的胰岛素，会有延迟吸收的情况，所以，在大剂量输注完成后，发热片还根据设置的时间，会持续工作，在此过程中，也可以手动关闭。在发热片工作的时候，温度传感器会感知发热片的温度，通过控制线路，反馈到泵的控制系统，如果有超出默认预设温度的状况出现，泵端会马上关闭发热片的开关，并在泵端报警提示，使用者可以查看是否有使用异常的情况存在。Load insulin into the main body of the 1 insulin pump, and set the basal rate infusion and bolus infusion values normally. And set the pump end control system, set the default temperature of the heating element, the first setting can be reversed and dynamically adjusted according to the subsequent usage. After the setting is completed, the infusion pipeline is connected to the drug storage end of the main body of the insulin pump; the control line is connected to the control window end of the main body of the insulin pump, and then inserted into the appropriate part of the human body for infusion according to normal use. When the insulin pump is performing basal infusion, the insulin pump control system will recognize the infusion state and disconnect the power supply of the control window. Select in the control system menu, turn on the heating plate switch. When the insulin pump is performing large-dose infusion, the insulin pump control system recognizes the infusion state and turns on the power supply of the control window by default. If there is no induration during the actual infusion process, you can choose In the control system menu, turn off the heater switch. High-dose infusion of insulin may delay absorption. Therefore, after the large-dose infusion is completed, the heating pad will continue to work according to the set time, and it can also be manually turned off during this process. When the heating element is working, the temperature sensor will sense the temperature of the heating element, and feed it back to the control system of the pump through the control circuit. The pump end alarm prompts, the user can check whether there is any abnormal use.

可以理解的是，本发明已以较佳实施实例披露如上，然而上述实施实例并非限定本发明。对于任何熟悉本领域的技术人员而言，在不脱离本发明技术方案范围情况下，都可以利用上述揭示的技术内容对本发明技术方案做出许多可能的变动和修饰，或修改为等同变化的等效实例。因此，凡是未脱离本发明技术方案的内容，依据本发明的技术实质对以上实施实例所做的任何简单修改、等同变化及修饰，均仍属于本发明技术方案保护的范围内。It should be understood that the present invention has been disclosed above with preferred embodiments, but the above embodiments do not limit the present invention. For any person skilled in the art, without departing from the scope of the technical solution of the present invention, many possible changes and modifications can be made to the technical solution of the present invention by using the technical content disclosed above, or modified to equivalent changes, etc. Valid instance. Therefore, any simple modification, equivalent change and modification made to the above embodiment according to the technical essence of the present invention without departing from the content of the technical solution of the present invention still fall within the protection scope of the technical solution of the present invention.

Claims (8)

Translated fromChinese

1.一种带无创消除胰岛素注射部位硬结设备的新型胰岛素泵输注系统，其特征在于：包括了泵端和耗材端；所述泵端由控制系统、显示系统、传动系统组成，所述耗材端由输注管路、控制连接头、控制连接线、发热极片、温度传感器组成，所述输注管路由鲁尔接头、导管、针座、输液针组成；所述泵端和耗材端，通过输注管路鲁尔接头连接，完成不同状态下输注胰岛素的基本功能；所述泵端和耗材端，通过控制连接头和泵端主板连接，通过泵端控制系统形成完整的胰岛素输注部位消硬结控制系统；所述胰岛素输注部位消硬结控制控制系统，可以通过识别泵端输注状态，反馈到主控端，通过主控智能调节供电电流，通过发热极片上附带的温度传感器实时反馈发热极片的温度，从而控制发热极片的工作状态。1. a novel insulin pump infusion system with non-invasive elimination of insulin injection site induration equipment, is characterized in that: comprise pump end and consumables end; Described pump end is made up of control system, display system, transmission system, described consumables The end is composed of an infusion pipeline, a control connector, a control connection line, a heating pole piece, and a temperature sensor. The infusion pipeline is composed of a Luer connector, a catheter, a needle seat, and an infusion needle; The basic functions of insulin infusion in different states are completed through the connection of the luer connector of the infusion pipeline; the pump end and the consumable end are connected to the main board of the pump end through the control connector, and the complete insulin infusion is formed through the pump end control system The control system for eliminating induration at the site; the control system for eliminating induration at the insulin infusion site can identify the infusion status of the pump end, feed it back to the main control end, intelligently adjust the power supply current through the main control, and real-time through the temperature sensor attached to the heating pole piece. Feedback the temperature of the heating pole piece to control the working state of the heating pole piece.2.根据权利要求1所述一种带无创消除胰岛素输注部位硬结设备的新型胰岛素泵输注系统其特征在于：泵端控制系统不仅包括泵端胰岛素的正常输注管理和输注过程中对输注状态的实时监控、反馈，还包括消硬结设备的温度控制系统。2. a kind of novel insulin pump infusion system with non-invasive eliminating insulin infusion site induration device according to claim 1 is characterized in that: the pump-end control system not only includes the normal infusion management of the pump-end insulin and the control of the infusion process. Real-time monitoring, feedback of infusion status, and temperature control system for induration devices.3.根据权利要求1所述的一种带无创消除胰岛素输注部位硬结设备的新型胰岛素泵输注系统，其特征在于：泵端控制系统可以实时接收发热极片上附带的温度传感器通过控制连接线传输过来的温度数据，并通过显示系统呈现在显示屏上，方便使用者查看和实时调节，若有超出设置温度的异常情况，则泵端控制系统会切断供电，发出蜂鸣报警，并在显示屏上闪烁提示。3. a kind of novel insulin pump infusion system with non-invasive eliminating insulin infusion site induration device according to claim 1, is characterized in that: the pump end control system can receive the temperature sensor attached on the heating pole piece in real time by controlling the connecting line The transmitted temperature data is displayed on the display screen through the display system, which is convenient for users to view and adjust in real time. If there is an abnormal situation exceeding the set temperature, the pump end control system will cut off the power supply, issue a buzzer alarm, and display it on the display. A prompt flashes on the screen.4.根据权利要求1所述的一种带无创消除胰岛素输注部位硬结设备的新型胰岛素输注系统，其特征在于：耗材的输注管路和控制连接线，是通过热熔同步挤出机器，缠绕而成，在前后端分别开叉，前端通过二次加工，分别加装鲁尔接头和控制连接头，后端加装针座、输液针、温度传感器和发热极片，做成方便使用高性价比的一次性耗材。4. a kind of novel insulin infusion system with a non-invasive device for eliminating induration of insulin infusion site according to claim 1, it is characterized in that: the infusion pipeline and the control connection line of consumables are made by hot-melt synchronous extrusion machine , wound, split forks at the front and rear ends respectively, the front end is processed by the second time, the Luer connector and the control connector are respectively installed, and the back end is equipped with a needle seat, an infusion needle, a temperature sensor and a heating pole piece to make it easy to use. Cost-effective disposable consumables.5.根据权利要求1或2所述的一种带无创消除胰岛素输注部位硬结设备的新型胰岛素输注系统，其特征在于：发热极片的初始化温度可以根据不同的人体组织对温度的感知敏感度不同而在泵端控制系统中被设置和调整，调整后的温度可以被记忆保存。5. The novel insulin infusion system with a non-invasive device for eliminating induration at the insulin infusion site according to claim 1 or 2, characterized in that: the initialization temperature of the heating pole piece can be sensitive to the perception of temperature according to different human tissues Different degrees are set and adjusted in the pump end control system, and the adjusted temperature can be stored in memory.6.根据权利要求1、3和权利要求4 所述的一种带无创消除胰岛素输注部位硬结设备的新型胰岛素输注系统，其特征在于，泵端处于基础率输注（胰岛素泵的一种低剂量，间歇性输注状态）时，由于输注剂量小且间歇输注，正常组织间吸收就可以完成，不会形成硬结，此时控制系统默认关闭发热片电源，当泵端处理大剂量输注（胰岛素泵的一种高流速，持续性输注状态）时，由于输注剂量大且连续性输注，正常组件间吸收可能完不成，会形成硬结，此时控制系统会根据输注状态，打开发热极片电源，发热极片升温至预设温度，并保持在预设温度，提高输注部位组织液的流动，促进胰岛素的快速吸收，避免硬结形成。6. A novel insulin infusion system with a non-invasive device for eliminating induration at the insulin infusion site according to claims 1, 3 and 4, wherein the pump end is in a basal rate infusion (a type of insulin pump). In low-dose, intermittent infusion state), due to the small infusion dose and intermittent infusion, the absorption between normal tissues can be completed, and no induration will be formed. At this time, the control system turns off the power of the heating plate by default, and when the pump side processes large doses During infusion (a high flow rate of insulin pump, continuous infusion state), due to the large infusion dose and continuous infusion, the absorption between normal components may not be completed, and induration will form. At this time, the control system will state, turn on the power of the heating pole piece, the heating pole piece is heated to the preset temperature, and kept at the preset temperature, which improves the flow of tissue fluid at the infusion site, promotes the rapid absorption of insulin, and avoids the formation of induration.7.根据权利要求2、5、6所述的一种无创消除胰岛素输注部位硬结设备的新型胰岛素输注系统，其特征在于：泵端控制系统所包含的消硬结温度控制系统应有物理开关可以人为选择开启或者关闭发热极片电源，以应对不同人群在使用过程中的实际情况。7. The novel insulin infusion system of a non-invasive device for eliminating induration at an insulin infusion site according to claims 2, 5, and 6, wherein the induration temperature control system included in the pump end control system should have a physical switch You can manually choose to turn on or off the power of the heating pole piece to deal with the actual situation of different groups of people in the process of use.8.根据权利要求6所述的一种无创消除胰岛素输注部位硬结设备的新型胰岛素输注系统，其特征在于，当泵端完成大剂量输注后，由于胰岛素的吸收具有滞后性，发热极片会持续工作一段时间，以达到最佳吸收效果，降低硬结形成的概率，此工作时间可根据不同人群、体质吸收情况，自行调节。8. The novel insulin infusion system for non-invasively eliminating induration at the insulin infusion site according to claim 6, wherein when the pump end completes the large-dose infusion, due to the hysteresis of the absorption of insulin, the fever is extremely high. The tablet will continue to work for a period of time to achieve the best absorption effect and reduce the probability of induration. This working time can be adjusted according to the absorption situation of different people and physiques.

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