CN115418311A - A sample pretreatment device and method - Google Patents
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Abstract
Translated fromChinese
Description
Translated fromChinese技术领域technical field
本发明涉及自动化技术领域，尤其涉及一种样本预处理装置及其方法。The invention relates to the field of automation technology, in particular to a sample preprocessing device and a method thereof.
背景技术Background technique
近年来，新、突发传染病呈现来源多、传播快、波及广等特点，给传染病防控和社会稳定带来了巨大挑战。2019年以来，新冠肺炎疫情的频繁暴发及全球大流行更是将重大传染病的监控预警提升到一个新高度。随着国外“自然”群体免疫策略的实行，国内防控面临前所未有的挑战。但随着新冠病毒不断变异、传染力增强，疫情防控的难度也不断攀升，尤其是对于海关、基层医疗机构这类场所，建立健全重大传染病病原体核酸检测体系变得尤为关键。In recent years, new and sudden infectious diseases have shown the characteristics of multiple sources, rapid spread, and wide spread, which have brought huge challenges to the prevention and control of infectious diseases and social stability. Since 2019, the frequent outbreaks of the new crown pneumonia epidemic and the global pandemic have raised the monitoring and early warning of major infectious diseases to a new level. With the implementation of foreign "natural" herd immunity strategies, domestic prevention and control is facing unprecedented challenges. However, as the new coronavirus continues to mutate and its infectivity increases, the difficulty of epidemic prevention and control continues to increase. Especially for places such as customs and primary medical institutions, it is particularly critical to establish and improve a nucleic acid detection system for major infectious disease pathogens.
然而，现有核酸检测体系仍有较大提升空间，核酸检测主要依托专业机构，多采用大型、高通量、自动化设备，且样品预处理步骤繁琐、耗时长，难以适用于现场快速诊断。However, the existing nucleic acid detection system still has a lot of room for improvement. Nucleic acid detection mainly relies on professional institutions, mostly using large-scale, high-throughput, and automated equipment, and the sample pretreatment steps are cumbersome and time-consuming, making it difficult to apply for on-site rapid diagnosis.
近年来，已有一系列具备自动化“样品进-结果出”特征的病原核酸检测平台出现，但或成本高昂(需酶促扩增)、或通量有限(大多单一靶标)、或关键检测性能不足(如灵敏度达不到单拷贝/测试)，尚不能完全满足现场快速实时诊断的需求。In recent years, a series of pathogenic nucleic acid detection platforms with the characteristics of automatic "sample in-result out" have emerged, but they are either expensive (enzymatic amplification is required), or the throughput is limited (mostly a single target), or the key detection performance is insufficient (such as the sensitivity can not reach single copy/test), can not fully meet the needs of on-site rapid real-time diagnosis.
新型冠状病毒(2019-nCoV)全球范围内大规模爆发，使“核酸检测”进入了公共视野。在全球新冠诊断方法中，核酸检测是公认的“金标准”。目前，常规的核酸检测包括采样及前处理、核酸提取、PCR扩增和数据分析这4个流程，且必须依赖专业的实验室、精密的PCR设备和专业的操作人员，但仍不可避免出现医护人员感染、病毒/试剂交叉污染、检测流程试剂多个独立空间以及检测结果一致性不理想等问题，使得核酸快速检测一体机的研发迫在眉睫。The large-scale outbreak of the new coronavirus (2019-nCoV) around the world has brought "nucleic acid testing" into the public eye. Among the global new crown diagnostic methods, nucleic acid testing is recognized as the "gold standard". At present, routine nucleic acid detection includes four processes: sampling and pretreatment, nucleic acid extraction, PCR amplification, and data analysis, and must rely on professional laboratories, sophisticated PCR equipment, and professional operators. Problems such as personnel infection, virus/reagent cross-contamination, multiple independent spaces for detection process reagents, and unsatisfactory consistency of test results make the development of an all-in-one nucleic acid rapid detection machine imminent.
现有核酸检测一体机主要分为以下三类：流水线自动化系统、卡盒式一体化机器以及其他型式一体化机器(免扩增、免提取核酸等)。流水线自动化系统是最成熟的一体化核酸检测仪，开发主要是基于用机械自动化替换人工的理念，将人工操作的部分缩减至仅需放置试剂耗材和样本管，由样品导入、样品转移、样品分离提纯扩增以及扩增检测这4个模块组成。能实现从样本移液、样本准备、扩增检测、结果计算和上传全流程的自动化，有效提高操作人员的防护力和避免外源污染，但设备体积限制了其POCT应用的潜力。Existing nucleic acid detection integrated machines are mainly divided into the following three categories: assembly line automation systems, cassette-type integrated machines, and other types of integrated machines (free of amplification, free of nucleic acid extraction, etc.). The assembly line automation system is the most mature integrated nucleic acid detector. Its development is mainly based on the concept of replacing manual labor with mechanical automation, reducing the manual operation to only placing reagent consumables and sample tubes, including sample introduction, sample transfer, and sample separation. It consists of four modules: purification amplification and amplification detection. It can realize the automation of the whole process from sample pipetting, sample preparation, amplification detection, result calculation and uploading, effectively improving the protection of operators and avoiding external contamination, but the size of the equipment limits its potential for POCT applications.
国外代表性产品Roche cobas 8800，其24h检测通量高达2880；国内以上海之江的“青耕一号”为代表，24小时连续工作只需4次人工耗材移放，能大幅节省专业检测人力，每日单管检测通量达4500。卡盒式一体化机器将流水线式系统的所有功能集成在一个卡盒内，大大缩减了设备体积，加速了检测流程和提高了便携性。The representative foreign product, Roche cobas 8800, has a 24h detection throughput of up to 2880; domestically, Shanghai Zhijiang's "Qinggeng No. 1" is representative, and it only needs 4 times of manual consumables to be moved and placed for 24 hours of continuous work, which can greatly save professional testing manpower. The daily single-tube detection throughput reaches 4500. The cartridge-type integrated machine integrates all the functions of the assembly line system in a cartridge, which greatly reduces the volume of the equipment, speeds up the testing process and improves portability.
国外代表性产品cepheid infinity80-80，其定义了“样本进，结果出”的分子POCT产品概念，基于特殊的微流控试剂卡盒和积木式累加的反应模块组成，样本的处理、核酸提取纯化、体系配置和扩增检测都在特殊的试剂盒中完成，24h 检测通量可达768，且能实现随到随检；Foreign representative product cepheid infinity80-80, which defines the concept of molecular POCT products of "sample in, result out", based on special microfluidic reagent cartridges and building block cumulative reaction modules, sample processing, nucleic acid extraction and purification , System configuration and amplification detection are all completed in a special kit, the 24h detection throughput can reach 768, and can realize anytime inspection;
国内Automolec 3000是当前国产分子诊断一体机的巅峰，不仅把核酸提取、纯化、扩增、检测集成到了一台机器上，还做到了“样本随来随检”。突破了以前高通量一体机只能按批量检测的限制。The domestic Automolec 3000 is the pinnacle of the current domestic molecular diagnostic all-in-one machine. It not only integrates nucleic acid extraction, purification, amplification, and detection into one machine, but also achieves "sample inspection at any time". It breaks through the limitation that the previous high-throughput all-in-one machine can only detect in batches.
随着对检测速度和便携式要求的不断提高，免扩增型和免提取型核酸一体化检测设备不断涌现，通过优化裂解流程和后端扩增试剂，清华大学研发出免核酸提取的一体集成化微流控卡盒，可在30分钟内实现“样本入，结果出”；基于CRISPR-Cas13a体系靶标特异性识别并激活非特异性切割功能的特性，日本开发出9分钟内自动检测新冠病毒装置。With the continuous improvement of detection speed and portable requirements, integrated detection equipment for nucleic acid without amplification and extraction is emerging. By optimizing the lysis process and back-end amplification reagents, Tsinghua University has developed an integrated nucleic acid extraction-free The microfluidic cartridge can realize "sample in, result out" within 30 minutes; based on the characteristics of CRISPR-Cas13a system target-specific recognition and activation of non-specific cleavage function, Japan has developed an automatic detection device for the new coronavirus within 9 minutes.
综上，国内外相关产品层出不穷，国外产品在机械精度控制和新技术开发应用方面略有优势，但大多停留在研发层面，市面上缺少大规模应用的相关资料和实践，提示还有很大的改进空间。国内产品在PCR扩增模块、通量扩展和防护模块进行了更多的思考，尤其是在基层可实际推广应用的自动化一体机还需要投入更多的研究。To sum up, related products at home and abroad are emerging one after another. Foreign products have slight advantages in mechanical precision control and new technology development and application, but most of them stay at the research and development level. The market lacks relevant materials and practices for large-scale applications, suggesting that there are still great opportunities room for improvement. For domestic products, more thinking has been done on the PCR amplification module, throughput expansion and protection modules, especially the automatic all-in-one machine that can be practically promoted and applied at the grassroots level needs more research.
针对新、突发感染性疾病频繁爆发的趋势，核酸快速检测一体机的发展趋势将由大体积流水线式自动化转向微型自动化卡盒式检测装置，最后融合检测新方法和新技术推动其向快速、精准、高通量、一体化、全自动化、微型化分子诊断设备发展。In response to the trend of frequent outbreaks of new and sudden infectious diseases, the development trend of the nucleic acid rapid detection all-in-one machine will shift from large-volume assembly line automation to micro-automatic cartridge detection devices, and finally integrate new detection methods and technologies to promote rapid and accurate detection. , high-throughput, integrated, fully automated, and miniaturized molecular diagnostic equipment development.
发明内容Contents of the invention
有鉴于此，本发明提供一种样本预处理装置及方法，至少部分解决现有技术中存在的问题。In view of this, the present invention provides a sample preprocessing device and method, which at least partially solve the problems existing in the prior art.
一种样本预处理装置，包括机架以及设置在其上的：A sample preprocessing device, including a rack and the following:
样本富集装置，用于处理含有受检样本和纳米级磁性颗粒富集管，将受检样本中的目标成分富集起来；The sample enrichment device is used for processing the enrichment tube containing the tested sample and nano-scale magnetic particles, and enriches the target components in the tested sample;
样本裂解装置，用于将富集的受检样本置入含有裂解液的裂解管中，得到核酸提取管。The sample lysing device is used for placing the enriched test sample into the lysing tube containing the lysing solution to obtain the nucleic acid extraction tube.
优选的，还包括设置于所述样本裂解装置后方的试管料仓，所述试管料仓用于提供存有裂解液的裂解管以及存放含有受检样本的核酸提取管。Preferably, it also includes a test tube bin arranged behind the sample lysing device, and the test tube bin is used to provide lysing tubes containing lysate and store nucleic acid extraction tubes containing tested samples.
优选的，所述样本富集装置，包括其中设置的：Preferably, the sample enrichment device includes:
置物台，用于安放所述富集管；A storage table for placing the enrichment tube;
翻转机械手，用于将置物台上的富集管倒置于所述倒置架；Overturning manipulator, used for inverting the enrichment tube on the storage table to the inversion rack;
倒置架，用于倒置安放所述富集管。An inversion frame for placing the enrichment tube upside down.
优选的，所述置物台为台架结构，设置有驱动其沿所述机架左右方向移动的X轴驱动器一。Preferably, the storage table is a gantry structure, and is provided with an
优选的，所述置物台还包括用于夹持所述富集管的夹爪一，以及用于将富集管的富集盖拧紧的旋转爪一。Preferably, the storage table further includes clamping claw one for clamping the enrichment tube, and rotating claw one for tightening the enrichment cap of the enrichment tube.
优选的，所述置物台上部还设置有图像识别装置，用于检测所述富集管是否安装有所述富集盖。Preferably, an image recognition device is provided on the upper part of the storage table for detecting whether the enrichment cap is installed on the enrichment tube.
优选的，所述翻转机械手包括：Preferably, the turning manipulator includes:
用于驱动其沿所述机架左右方向移动的X轴驱动器二；An X-axis driver 2 for driving the rack to move left and right;
用于驱动其沿所述机架上下方向移动的Z轴驱动器二；A second Z-axis driver for driving the frame to move up and down;
用于夹持所述富集管的夹爪二；Clamping
用于驱动所述夹爪二沿重力方向翻转的旋转驱动器一。The first rotary driver is used to drive the second jaw to turn over in the direction of gravity.
优选的，所述样本裂解装置，包括其中设置的：Preferably, the sample cracking device includes:
双位旋转台，设置有两个试管安置位，用于分别安放富集管和装有裂解液的裂解管；The double-position rotary table is equipped with two test tube placement positions, which are used to respectively place the enrichment tube and the lysis tube containing the lysate;
裂解机械手，用于在所述双位旋转台上，将富集管的富集盖盖入盛有裂解液的裂解管上，得到核酸提取管并将其移至试管料仓。The lysing manipulator is used to cover the enrichment cap of the enrichment tube on the lysate tube containing the lysate on the double-position rotary platform to obtain the nucleic acid extraction tube and move it to the test tube hopper.
优选的，所述双位旋转台为台架结构，其上分别设置有两个试管安置位，每个试管安置位下均设置有夹持试管并旋转的旋转爪二。Preferably, the double-position rotary table is a bench structure, on which two test tube placement positions are arranged respectively, and a rotating
优选的，所述双位旋转台包括：Preferably, the two-position rotary table includes:
试管架，其上分别设置有两个试管安置位，用于安放富集管和裂解管；The test tube rack is respectively provided with two test tube placement positions for placing the enrichment tube and the cracking tube;
两个夹爪三，分别用于夹紧所述富集管和裂解管；Two
两个旋转爪二，分别用于旋转所述富集管和裂解管的管身；Two rotating
X轴驱动器三，用于驱动所述两个旋转爪二沿所述机架左右方向移动。The
优选的，所述裂解机械手包括：Preferably, the cracking manipulator includes:
用于驱动其沿所述机架左右方向移动的X轴驱动器四；An X-axis driver four used to drive it to move along the left and right directions of the frame;
用于驱动其沿所述机架前后方向移动的Y轴驱动器四；A Y-axis driver for driving it to move along the front and rear directions of the rack;
用于驱动其沿所述机架上下方向移动的Z轴驱动器四；A Z-axis driver for driving it to move up and down along the frame;
用于夹持所述富集管的夹爪四；Jaw four for clamping the enrichment tube;
用于驱动所述夹爪四沿重力方向翻转的旋转驱动器二，The second rotary driver for driving the four jaws to turn over in the direction of gravity,
用于夹持所述裂解管的夹爪五。Jaw five for clamping the cracking tube.
优选的，所述夹爪四上设置有磁性装置。Preferably, a magnetic device is provided on the four jaws.
优选的，还包括识别验证装置，所述识别验证装置包括用于识别所述富集管上条码信息的扫码装置，和/或，用于识别受检人身份信息的身份认证装置，和/或，用于识别受检人操作是否规范的图像识别装置。Preferably, it also includes an identification verification device, the identification verification device includes a code scanning device for identifying the barcode information on the enrichment tube, and/or, an identity verification device for identifying the identity information of the examinee, and/or Or, an image recognition device used to identify whether the subject's operation is normal.
优选的，还包括消杀装置，用于在检测前、检测后进行消杀动作，以避免受检样本受到污染或泄漏。Preferably, a sterilizing device is also included, which is used to perform sterilizing actions before and after the test, so as to avoid contamination or leakage of the tested sample.
优选的，还包括隔离门装置，设置在所述样本富集装置前方，用于封闭所述样本富集装置，以避免受检样受到污染。Preferably, an isolation door device is also included, which is arranged in front of the sample enrichment device, and is used to close the sample enrichment device, so as to prevent the tested sample from being polluted.
优选的，还包括废料收集装置，所述废料收集装置装有消毒剂，用于存放所述裂解管的管盖以及所述富集管的管身。Preferably, it also includes a waste material collection device, the waste material collection device is equipped with a disinfectant, and is used to store the cap of the cracking tube and the tube body of the enrichment tube.
优选的，所述X轴驱动器一、X轴驱动器二、X轴驱动器三、X轴驱动器四、Y轴驱动器四、Z轴驱动器二、Z轴驱动器四均为直线驱动机构，其驱动方式为电动、气动或液压驱动方式，具体不再赘述。Preferably, the
一种通过上述样本预处理装置进行样本预处理的方法，包括样本富集环节和样本裂解环节，其中：A method for sample pretreatment by the above-mentioned sample pretreatment device, including a sample enrichment link and a sample cracking link, wherein:
所述样本富集环节，主要是通过翻转机械手，将含有受检样本和纳米级磁性颗粒富集管倒置，以使受检样本中的目标成分富集与所述富集管的富集盖；The sample enrichment link is mainly to invert the enrichment tube containing the test sample and nano-scale magnetic particles by turning over the manipulator, so that the target components in the test sample are enriched with the enrichment cover of the enrichment tube;
所述样本裂解环节，主要是通过裂解机械手，将所述富集盖盖入含有裂解液的裂解管中，得到核酸提取管。The sample lysing step is mainly to cover the enrichment cap into the lysing tube containing the lysing solution through the lysing manipulator to obtain the nucleic acid extraction tube.
优选的，所述样本富集环节包括以下步骤：Preferably, the sample enrichment link includes the following steps:
步骤一，将含有漱口液和纳米级磁性颗粒的富集管放入置物台；
步骤二，通过翻转机械手将所述富集管沿重力方向翻转，倒置于所述倒置架，并静置预设时长；
步骤三，通过在所述富集管的富集盖和/或所述翻转机械手的夹爪四上设置磁性装置，使吸附有受检样本目标成分的纳米级磁性颗粒富集于所述富集盖。
优选的，所述样本裂解环节包括以下步骤：Preferably, the sample lysis link includes the following steps:
步骤一，通过所述裂解机械手的夹爪五，从所述试管料仓取出一个含有裂解液的裂解管置入所述双位旋转台的一个试管安置位，并取下所述裂解管的管盖；
步骤二，通过所述裂解机械手的夹爪四，从所述倒置架上取下富集管，沿重力方向翻转之后，将其置入所述双位旋转台的另一个试管安置位，并取下所述富集管的富集盖；
步骤三，通过所述裂解机械手的移动，将所述富集盖盖入所述裂解管，得到核酸提取管并将其移至试管料仓。
优选的，所述样本裂解环节包括以下步骤：Preferably, the sample lysis link includes the following steps:
步骤一，通过所述裂解机械手的夹爪五，从所述试管料仓取出一个含有裂解液的裂解管置入所述双位旋转台的一个试管安置位，且所述夹爪五保持夹住所述裂解管的管盖，该试管安置位对应的夹爪三夹住所述裂解管的管身，该试管安置位对应的旋转爪二驱动所述裂解管的管身旋转，以取下所述裂解管的管盖；
步骤二，通过所述裂解机械手的夹爪四，从所述倒置架上取下富集管，沿重力方向翻转之后，将其置入所述双位旋转台的另一个试管安置位，且所述夹爪四保持夹住所述富集管的富集盖，该试管安置位对应的夹爪三夹住所述富集管的管身，该试管安置位对应的旋转爪二驱动所述富集管的管身旋转，以取下所述富集管的富集盖；
步骤三，通过X轴驱动器三驱动两个旋转爪二沿所述机架左右方向移动，使所述裂解管的管身移动至所述富集盖下方，所述裂解管对应的旋转爪二驱动管身旋转，以使所述富集盖盖入裂解管，得到核酸提取管。
优选的，所述样本裂解环节包括以下步骤：Preferably, the sample lysis link includes the following steps:
步骤四，所述裂解机械手的夹爪四，从所述双位旋转台取出所述核酸提取管，并通过所述旋转驱动器二翻转所述核酸提取管预定次数，以使所述富集盖上的受检样本充分裂解；
步骤五，所述裂解机械手将所述核酸提取管正置放入试管料仓。
优选的，还包括废料收集环节，其包括以下动作之一：Preferably, it also includes a waste collection link, which includes one of the following actions:
动作一，通过所述裂解机械手的夹爪五，将取下的所述裂解管的管盖盖入已被取走富集盖的富集管，得到废料管，再通过所述裂解机械手的移动，将所述废料管投入装有消毒剂的废料收集装置；Action 1: Cover the removed tube cap of the lysis tube into the enrichment tube whose enrichment cap has been removed through the gripper five of the cracking manipulator to obtain a waste tube, and then through the movement of the cracking manipulator , putting the waste pipe into a waste collection device equipped with a disinfectant;
动作二，通过X轴驱动器三驱动两个旋转爪二沿所述机架左右方向移动，使所述富集管的管身移动至所述裂解管的管盖下方，所述富集管对应的旋转爪二驱动管身旋转，以使所述所述裂解管的管盖盖入富集管，得到废料管，再通过所述裂解机械手的移动，将所述废料管投入装有消毒剂的废料收集装置。
优选的，还包括识别验证环节，其包括以下步骤：Preferably, it also includes an identification and verification link, which includes the following steps:
步骤一，通过身份认证装置，识别受检人的身份信息，认证通过后，打开隔离门，并提示受检人将所述富集管放入置物台；Step 1: Identify the identity information of the examinee through the identity authentication device. After passing the authentication, open the isolation door and prompt the examinee to put the enrichment tube into the storage table;
步骤二，通过扫码装置，识别放在置物台上的富集管的条码信息，识别成功后，关闭隔离门并发出提示。Step 2: Use the code scanning device to identify the barcode information of the enrichment tube placed on the storage table. After the identification is successful, close the isolation door and issue a reminder.
优选的，所述样本富集环节的步骤一，还包括以下动作：Preferably,
通过设置在置物台上方的图像识别装置，识别所述富集管是否盖有富集盖，若有，则通过所述夹爪一和旋转爪一的配合，将所述富集盖拧紧，若没有，则中断操作并发出警报。Through the image recognition device arranged above the storage table, identify whether the enrichment tube is covered with an enrichment cap, and if so, tighten the enrichment cap through the cooperation of the clamping claw one and the rotating claw one, if If not, interrupt operation and sound an alarm.
优选的，还包括消杀环节，即在进行样本预处理之前和之后，通过紫外线、高温蒸汽、消毒剂中至少一种方式，对样本预处理装置性进行消杀。Preferably, it also includes a sterilization link, that is, before and after the sample pretreatment, the sample pretreatment device is sterilized by at least one of ultraviolet light, high-temperature steam, and disinfectant.
本发明所述的样本预处理装置及方法，相对于现有技术，具有以下优点：Compared with the prior art, the sample pretreatment device and method described in the present invention have the following advantages:
(1)全自动机械操作，节约医疗资源，降低专业人员需求。本发明所述的样本预处理装置，集身份验证、样品信息采集、样本富集、样本裂解等一系列功能，全自动机械化操作，可大大降低相关专业人员需求，节约医疗资源，降低防疫成本。(1) Fully automatic mechanical operation saves medical resources and reduces the need for professionals. The sample preprocessing device described in the present invention integrates a series of functions such as identity verification, sample information collection, sample enrichment, and sample cracking, and fully automatic mechanized operation, which can greatly reduce the needs of relevant professionals, save medical resources, and reduce epidemic prevention costs.
(2)封闭空间的操作，完备的消杀措施，避免交叉感染。本发明所述的样本预处理装置，皆在机架内相对密闭的空间中完成，且具备一系列的如高温灭菌、紫外灯灭菌等符合国家标准的杀菌、灭菌措施，可有效防止避免交叉污染，极大的提高疫情防控效率，降低人群感染风险。(2) Operation in a closed space, complete disinfection measures to avoid cross-infection. The sample pretreatment device described in the present invention is completed in a relatively closed space in the rack, and has a series of sterilization and sterilization measures in line with national standards such as high temperature sterilization and ultraviolet lamp sterilization, which can effectively prevent Avoid cross-contamination, greatly improve the efficiency of epidemic prevention and control, and reduce the risk of crowd infection.
(3)结构紧凑，可实现多多节点、多层次、快速部署。本发明所述的样本预处理装置，结构紧凑、占地面积小、轻量化、布置灵活，可组成全自动无人化核酸采样及检测系统，系统模块化程度高，极易部署，可快速推广至城市社区、学校、园区、酒店、工地、交通入口、大型商超、城乡接合部以及广大农村地区，筑牢基层疫情防控的坚强堡垒。(3) The structure is compact, and it can realize multi-node, multi-level, and rapid deployment. The sample pretreatment device of the present invention has a compact structure, a small footprint, light weight, and flexible layout, and can form a fully automatic unmanned nucleic acid sampling and detection system. The system has a high degree of modularity, is easy to deploy, and can be quickly promoted To urban communities, schools, parks, hotels, construction sites, traffic entrances, large supermarkets, urban-rural junctions and vast rural areas, build a strong fortress for grassroots epidemic prevention and control.
附图说明Description of drawings
为了更清楚地说明本发明实施例的技术方案，下面将对实施例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发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其它的附图。In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the accompanying drawings used in the embodiments will be briefly introduced below. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. Those of ordinary skill in the art can also obtain other drawings based on these drawings without any creative effort.
为了更清楚地说明本发明实施例的技术方案，下面将对实施例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发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其它的附图。In order to illustrate the technical solutions of the embodiments of the present invention more clearly, the accompanying drawings used in the embodiments will be briefly introduced below. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. Those of ordinary skill in the art can also obtain other drawings based on these drawings without any creative effort.
图1为本发明实施例所述样本预处理装置安装于整机的结构示意图；Fig. 1 is a schematic structural diagram of the sample pretreatment device installed in the whole machine according to the embodiment of the present invention;
图2为图1置隐藏机架上的封板的结构示意图；Fig. 2 is the structural representation of the sealing plate on the hidden frame of Fig. 1;
图3为图2隐藏机架底部结构的示意图一；Fig. 3 is a schematic diagram 1 of the bottom structure of the hidden rack in Fig. 2;
图4为图3另一个角度的示意图二；Fig. 4 is a schematic diagram 2 from another angle of Fig. 3;
图5为本发明实施例所述样本预处理装置的结构示意图一；Fig. 5 is a schematic structural diagram of the sample preprocessing device according to the embodiment of the present invention;
图6为本发明实施例所述预处理装置的结构示意图二；FIG. 6 is a second structural schematic diagram of the pretreatment device according to the embodiment of the present invention;
图7为本发明实施例所述样本预处理装置中样本富集装置的结构示意图一；Fig. 7 is a schematic diagram of the structure of the sample enrichment device in the sample preprocessing device according to the embodiment of the present invention;
图8为本发明实施例所述样本预处理装置中样本富集装置的结构示意图二；Fig. 8 is a second structural schematic diagram of the sample enrichment device in the sample preprocessing device according to the embodiment of the present invention;
图9为本发明实施例样本预处理装置中样本裂解装置的结构示意图一；FIG. 9 is a schematic structural diagram of the sample cracking device in the sample pretreatment device according to the embodiment of the present invention;
图10为本发明实施例样本预处理装置中样本裂解装置的结构示意图二；Fig. 10 is the second structural schematic diagram of the sample cracking device in the sample pretreatment device according to the embodiment of the present invention;
附图标记说明：Explanation of reference signs:
1-机架；1 - Rack;
11-废料收集装置；11 - waste collection device;
12-消杀装置；12-disinfecting device;
13-识别验证装置；13 - identification verification device;
14-隔离门装置；14-isolation door device;
2-样本预处理装置；2-sample pretreatment device;
21-样本富集装置；21 - sample enrichment device;
211-置物台；211-storage table;
2111-X轴驱动器一；2111-X-axis driver one;
2112-夹爪一；2112-jaw one;
2113-旋转爪一；2113-rotating claw one;
2114-图像识别装置；2114-image recognition device;
212-翻转机械手；212-Flip manipulator;
2121-X轴驱动器二；2121-X axis drive two;
2122-Z轴驱动器二；2122-Z axis drive two;
2123-夹爪二；2123-jaw two;
2124-旋转驱动器一；2124 - Rotary drive one;
213-倒置架；213 - inversion frame;
22-样本裂解装置；22-sample cracking device;
221-双位旋转台；221-double rotary table;
2211-试管架；2211-test tube rack;
2212-夹爪三；2212-jaw three;
2213-旋转爪二；2213-rotating claw two;
2214-X轴驱动器三；2214-X axis drive three;
222-裂解机械手；222-cracking manipulator;
2221-X轴驱动器四；2221-X axis drive four;
2222-Y轴驱动器四；2222-Y axis drive four;
2223-Z轴驱动器四；2223-Z axis drive four;
2224-夹爪四；2224-jaw four;
2225-旋转驱动器二；2225-rotary drive two;
2226-夹爪五；2226-jaw five;
5-试管料仓；5-Test tube silo;
51-富集管；51 - enrichment tube;
511-富集盖；511 - enrichment cover;
52-裂解管；52-cracking tube;
53-核酸提取管；53-nucleic acid extraction tube;
6-升降装置。6- Lifting device.
具体实施方式Detailed ways
下面结合附图对本发明实施例进行详细描述。Embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings.
需说明的是，在不冲突的情况下，以下实施例及实施例中的特征可以相互组合；并且，基于本公开中的实施例，本领域普通技术人员在没有作出创造性劳动前提下所获得的所有其他实施例，都属于本公开保护的范围。It should be noted that, in the case of no conflict, the following embodiments and the features in the embodiments can be combined with each other; and, based on the embodiments in the present disclosure, those of ordinary skill in the art obtained without creative work All other embodiments belong to the protection scope of the present disclosure.
需要说明的是，下文描述在所附权利要求书的范围内的实施例的各种方面。应显而易见，本文中所描述的方面可体现于广泛多种形式中，且本文中所描述的任何特定结构及/或功能仅为说明性的。基于本公开，所属领域的技术人员应了解，本文中所描述的一个方面可与任何其它方面独立地实施，且可以各种方式组合这些方面中的两者或两者以上。举例来说，可使用本文中所阐述的任何数目个方面来实施设备及/或实践方法。另外，可使用除了本文中所阐述的方面中的一或多者之外的其它结构及/或功能性实施此设备及/或实践此方法。It is noted that the following describes various aspects of the embodiments that are within the scope of the appended claims. It should be apparent that the aspects described herein may be embodied in a wide variety of forms and that any specific structure and/or function described herein is illustrative only. Based on the present disclosure one skilled in the art should appreciate that an aspect described herein may be implemented independently of any other aspects and that two or more of these aspects may be combined in various ways. For example, any number of the aspects set forth herein can be used to implement an apparatus and/or practice a method. In addition, such an apparatus may be implemented and/or such a method practiced using other structure and/or functionality than one or more of the aspects set forth herein.
需要说明的是，下文中所述的步骤，其后缀的数字，只是为了区分不同的步骤，并不代表步骤的顺序。It should be noted that the numbers suffixed by the steps described below are only used to distinguish different steps, and do not represent the order of the steps.
图1为本实施例所述样本预处理装置安装于整机的整体结构示意图，图2 为图1去除机架1上的蒙板的结构示意图，图3、图4为图2去除机架1底部结构的两个示意图，如图中所示，样本预处理装置2的核心即为样本富集裂解装置，其主要包括设置在机架1上的样本富集装置和样本裂解装置22。Figure 1 is a schematic diagram of the overall structure of the sample preprocessing device in this embodiment installed on the whole machine, Figure 2 is a schematic structural diagram of removing the mask on the
在机架1后部还封闭设置有升降装置6，用于在该样本预处理装置2和该待检样本预制装置3之间传送该试管料仓5，该试管料仓5用于提供存有裂解液的裂解管52以及存放含有受检样本的核酸提取管53。There is also a
上述的样本富集装置，是用于处理含有受检样本和纳米级磁性颗粒富集管 51，将受检样本中的目标成分富集起来；样本裂解装置22，是用于将富集的受检样本置入含有裂解液的裂解管52中，得到核酸提取管53，并将该核酸提取管 53送至试管料仓5；移管装置31，用于将该试管料仓5内装有裂解样本的核酸提取管53移送至取液台311并开盖；移液装置32，用于将该核酸提取管53内的受检样本移液至八连管3221，得到待检样本并送入该PCR仪4。The above-mentioned sample enrichment device is used to process the test sample and the nano-scale magnetic
图5、图6为本实施例样本预处理装置2的两个结构示意图，如图中所示，该样本富集装置21，包括由前至后依序设置的置物台211、翻转机械手212和倒置架213，置物台211用于正常安放该富集管51，倒置架213用于倒置安放该富集管51。翻转机械手212设置在所述置物台211和倒置架213上方，用于将置物台211上的富集管51倒置于该倒置架213。5 and 6 are two structural schematic diagrams of the
该样本裂解装置22，包括由前至后依序设置的双位旋转台221和裂解机械手222，双位旋转台221设置有两个试管安置位，用于分别安放富集管51和装有裂解液的裂解管52；该裂解机械手222，用于在该双位旋转台221上，将富集管51的富集盖511盖入盛有裂解液的裂解管52上，得到核酸提取管53并将其移至试管料仓5。The
图7、图8为本实施例中样本富集装置21的两个结构示意图，如图中所示，该置物台211为台架结构，在台架下方设置有驱动其沿该机架1左右方向移动的X轴驱动器一2111，该置物台211还包括用于夹持该富集管51的夹爪一2112，以及用于将富集管51的富集盖511拧紧的旋转爪一2113，该置物台211上部还设置有图像识别装置2114，用于检测该富集管51是否安装有该富集盖511。7 and 8 are two structural schematic diagrams of the
在本实施例中，该图像识别装置2114为一摄像头，当受检人将富集管51 放在置物台211上时，该摄像头开始工作用于识别富集管51上有没有富集盖 511，若有，则夹爪一2112夹紧富集管51，并通过X轴驱动器一2111将置物台 211沿机架1的左右方向，驱动到旋转爪一2113的下方，旋转爪一2113夹住富集管51的富集盖511，旋转拧紧；若摄像头识别到富集管51上没有富集盖511，则中断操作并发出警报。In this embodiment, the
该翻转机械手212包括：X轴驱动器二2121、Z轴驱动器二2122、夹爪二 2123、旋转驱动器一2124，其中X轴驱动器二2121用于驱动其沿该机架1左右方向移动，Z轴驱动器二2122用于驱动其沿该机架1上下方向移动，夹爪二 2123用于夹持该富集管51，旋转驱动器一2124用于驱动该夹爪二2123沿重力方向翻转180°。The
具体工作时，该翻转机械手212通过X轴驱动器二2121驱动其沿左右方向移动，使夹爪二2123移动到富集管51的位置并夹住富集管51，然后通过旋转驱动器驱动夹爪二2123沿重力方向翻转180°，再通过Z轴驱动器二2122带动夹爪二2123沿机架1上下方向移动，使富集管51倒置安放在倒置架213上，使受检样本中的目标成分沉积于富集盖511上，为了加快这一过程，还可以在富集盖511上或者裂解机械手222的夹爪四2224上设置磁性装置，或者在这两者上都设置磁性装置，使得被纳米级磁性颗粒吸附的受检样本加速富集于富集盖511上。During specific work, the
图9、图10为样本裂解装置22的两个结构示意图，如图中所示，该双位旋转台221包括：试管架2211、两个夹爪三2212、两个旋转爪二2213和X轴驱动器三2214。其中，试管架2211上分别设置有两个试管安置位，用于安放富集管51和裂解管52；两个夹爪三2212，分别用于夹紧该富集管51和裂解管52；两个旋转爪二2213，分别用于旋转该富集管51和裂解管52的管身；X轴驱动器三2214，用于驱动该两个旋转爪二2213沿该机架1左右方向移动。Figure 9 and Figure 10 are two schematic diagrams of the structure of the
该裂解机械手222包括：X轴驱动器四2221、Y轴驱动器四2222、Z轴驱动器四2223、夹爪四2224、旋转驱动器二2225和夹爪五2226。其中X轴驱动器四2221用于驱动其沿该机架1左右方向移动，Y轴驱动器四2222用于驱动其沿该机架1前后方向移动，Z轴驱动器四2223用于驱动其沿该机架1上下方向移动，夹爪四2224用于夹持该富集管51，旋转驱动器二2225用于驱动该夹爪四2224沿重力方向翻转，夹爪五2226用于夹持该裂解管52，The cracking
具体工作时，有两种实施方式，具体如下：When working specifically, there are two implementation methods, as follows:
实施方式一
裂解机械手222的夹爪五2226，从试管料仓5取出一个含有裂解液的裂解管52置入双位旋转台221的一个试管安置位，且夹爪五2226保持夹住该裂解管52的管盖，该试管安置位对应的夹爪三2212夹住该裂解管52的管身，该试管安置位对应的旋转爪二2213驱动该裂解管52的管身旋转，以取下该裂解管 52的管盖；The five
该裂解机械手222的夹爪四2224，从该倒置架213上取下富集管51，沿重力方向翻转180°之后，将其置入该双位旋转台221的另一个试管安置位，且该夹爪四2224保持夹住该富集管51的富集盖511，该试管安置位对应的夹爪三 2212夹住该富集管51的管身，该试管安置位对应的旋转爪二2213驱动该富集管51的管身旋转，以取下该富集管51的富集盖511；The jaw four 2224 of the cracking
最后通过X轴驱动器三2214驱动两个旋转爪二2213沿该机架1左右方向移动，使该裂解管52的管身移动至该富集盖511下方，该裂解管52对应的旋转爪二2213驱动管身旋转，以使该富集盖511盖入裂解管52，得到核酸提取管 53。Finally, the
这种富集盖511保持不动而移动裂解管52的管身来得到核酸提取管53的方式，最主要的优点是，因保持富集盖511不动，尽量避免了受检样本可能的掉落、受污染等干扰因素，以确保核酸检测结果的真实性。The main advantage of this way of obtaining the nucleic acid extraction tube 53 by keeping the
实施方式二Implementation mode two
与实施方式一相比，本实施方式的核心就是试管不动而管盖动，具体的，就是裂解机械手222分别从试管料仓5和倒置架213上取出裂解管52和富集管 51放置于双位旋转台221之后，通过夹爪三2212和旋转爪二2213的配合分别拧掉管盖，最后通过裂解机械手222的移动将富集盖511盖入裂解管52，得到核酸提取管53。Compared with
在通过上述两种方式之一得到核酸提取管53之后，裂解机械手222还要通过夹爪四2224和旋转驱动器二2225，将核酸提取管53来回翻转多次，使受检样本充分裂解之后，再正置放入试管料仓5。After the nucleic acid extraction tube 53 is obtained by one of the above two methods, the cracking
对于剩下的富集管51的管身和裂解管52的管盖，也是通过上述两种方式之一，将裂解管52的管盖盖入富集管51的管身以得到废料管，然后再通过该裂解机械手222的移动，将该废料管投入装有消毒剂的废料收集装置11。For the tube body of the remaining
如图1、图2所示，本实施例所述的核酸检测装置还包括识别验证装置13 和隔离门装置14，该识别验证装置13包括用于识别该富集管51上条码信息的扫码装置，和/或，用于识别受检人身份信息的身份认证装置，和/或，用于识别受检人操作是否规范的图像识别装置2114。本实施例中，包括全部上述识别验证装置13，在其他实施例中，也可以只设置其中的一个或两个。As shown in Fig. 1 and Fig. 2, the nucleic acid detection device described in this embodiment also includes an
该隔离门装置14设置在该样本富集装置21前方，用于封闭该样本富集装置21，以避免受检样受到污染。The
如图5-8所示，本实施例所述的核酸检测装置还包消杀装置12，用于在检测前、检测后进行消杀动作，以避免受检样本受到污染或泄漏。在本实施例中，该消杀装置12主要为222纳米新型紫外线准分子智能消杀灯，不仅设置于机架 1下层，在机架1上层内也设有多处(图中未示出)。在其他实施例中，消杀装置12还可以包括高温蒸汽消杀设备、消毒剂喷洒设备等。As shown in Figures 5-8, the nucleic acid detection device described in this embodiment also includes a
在本实施例所述的核酸检测装置中，所述X轴驱动器一、X轴驱动器二、X 轴驱动器三、X轴驱动器四、Y轴驱动器四、Z轴驱动器二2122、Z轴驱动器四 2223均为直线驱动机构，其驱动方式为电动、气动或液压驱动方式，具体不再赘述。In the nucleic acid detection device described in this embodiment, the first X-axis driver, the second X-axis driver, the third X-axis driver, the fourth X-axis driver, the fourth Y-axis driver, the second Z-
本实施例还公开了一种根据上述样本预处理装置进行样本预处理的方法，主要包括以下环节：This embodiment also discloses a method for sample preprocessing according to the above-mentioned sample preprocessing device, which mainly includes the following links:
样本富集环节，主要是通过翻转机械手212，将含有受检样本和纳米级磁性颗粒富集管51倒置，以使受检样本中的目标成分富集与该富集管51的富集盖 511；In the sample enrichment process, the
样本裂解环节，主要是通过裂解机械手222，将该富集盖511盖入含有裂解液的裂解管52中，得到核酸提取管53；In the sample lysis step, the
该样本富集环节包括以下步骤：The sample enrichment link includes the following steps:
步骤一，将含有漱口液和纳米级磁性颗粒的富集管51放入置物台211，通过设置在置物台211上方的图像识别装置2114，识别该富集管51是否盖有富集盖511，若有，则通过该夹爪一2112和旋转爪一2113的配合，将该富集盖511 拧紧，若没有，则中断操作并发出警报；
步骤二，通过翻转机械手212将该富集管51沿重力方向翻转，倒置于该倒置架213，并静置预设时长，本实施例中，预设时长为3分钟；Step 2: Flip the
步骤三，通过在该富集管51的富集盖511和/或该翻转机械手212的夹爪四 2224上设置磁性装置，使吸附有受检样本目标成分的纳米级磁性颗粒富集于该富集盖511。
该样本裂解环节有两种实施方式，具体如下：There are two ways to implement the sample cracking link, as follows:
实施方式一包括以下步骤：Embodiment one includes the following steps:
步骤一，通过该裂解机械手222的夹爪五2226，从该试管料仓5取出一个含有裂解液的裂解管52置入该双位旋转台221的一个试管安置位，并取下该裂解管52的管盖；
步骤二，通过该裂解机械手222的夹爪四2224，从该倒置架213上取下富集管51，沿重力方向翻转之后，将其置入该双位旋转台221的另一个试管安置位，并取下该富集管51的富集盖511；
步骤三，通过该裂解机械手222的移动，将该富集盖511盖入该裂解管52，得到核酸提取管53并将其移至试管料仓5。
实施方式二包括以下步骤：
步骤一，通过该裂解机械手222的夹爪五2226，从该试管料仓5取出一个含有裂解液的裂解管52置入该双位旋转台221的一个试管安置位，且该夹爪五 2226保持夹住该裂解管52的管盖，该试管安置位对应的夹爪三2212夹住该裂解管52的管身，该试管安置位对应的旋转爪二2213驱动该裂解管52的管身旋转，以取下该裂解管52的管盖；
步骤二，通过该裂解机械手222的夹爪四2224，从该倒置架213上取下富集管51，沿重力方向翻转之后，将其置入该双位旋转台221的另一个试管安置位，且该夹爪四2224保持夹住该富集管51的富集盖511，该试管安置位对应的夹爪三2212夹住该富集管51的管身，该试管安置位对应的旋转爪二2213驱动该富集管51的管身旋转，以取下该富集管51的富集盖511；
步骤三，通过X轴驱动器三2214驱动两个旋转爪二2213沿该机架1左右方向移动，使该裂解管52的管身移动至该富集盖511下方，该裂解管52对应的旋转爪二2213驱动管身旋转，以使该富集盖511盖入裂解管52，得到核酸提取管53。
本实施方式相对于实施方式一，富集盖511保持不动而移动裂解管52的管身来得到核酸提取管53，最主要的优点是，因保持富集盖511不动，尽量避免了受检样本可能的掉落、受污染等干扰因素，以确保核酸检测结果的真实性。Compared with
在上述两种实施方式之后，该样本裂解环节还包括以下步骤：After the above two implementations, the sample cracking link also includes the following steps:
步骤四，该裂解机械手222的夹爪四2224，从该双位旋转台221取出该核酸提取管53，并通过该旋转驱动器二2225翻转该核酸提取管53预定次数，以使该富集盖511上的受检样本充分裂解，本实施例中，预定次数为5次；Step four, the gripper four 2224 of the lysing
步骤五，该裂解机械手222将该核酸提取管53正置放入试管料仓5。Step five, the lysing
该样本裂解环节还包括废料收集环节，其包括以下动作之一：The sample lysis link also includes a waste collection link, which includes one of the following actions:
动作一，通过该裂解机械手222的夹爪五2226，将取下的该裂解管52的管盖盖入已被取走富集盖511的富集管51，得到废料管，再通过该裂解机械手222 的移动，将该废料管投入装有消毒剂的废料收集装置11；Action one, through the jaw five 2226 of the cracking
动作二，通过X轴驱动器三2214驱动两个旋转爪二2213沿该机架1左右方向移动，使该富集管51的管身移动至该裂解管52的管盖下方，该富集管51 对应的旋转爪二2213驱动管身旋转，以使该该裂解管52的管盖盖入富集管51，得到废料管，再通过该裂解机械手222的移动，将该废料管投入装有消毒剂的废料收集装置11。
本实施例所述的样本预处理方法，还包括识别验证环节，其包括以下步骤：The sample preprocessing method described in this embodiment also includes an identification verification link, which includes the following steps:
步骤一，通过身份认证装置，识别受检人的身份信息，认证通过后，打开隔离门，并提示受检人将该富集管51放入置物台211；Step 1: Identify the identity information of the examinee through the identity authentication device. After passing the authentication, open the isolation door and prompt the examinee to put the
步骤二，通过扫码装置，识别放在置物台211上的富集管51的条码信息，识别成功后，关闭隔离门并发出提示。Step 2: Use the code scanning device to identify the barcode information of the
本实施例所述的样本预处理方法，还包括消杀环节，即在进行样本预处理之前和之后，通过紫外线、高温蒸汽、消毒剂中至少一种方式，对样本预处理装置2性进行消杀。The sample pretreatment method described in this embodiment also includes a sterilization link, that is, before and after the sample pretreatment, the sample pretreatment device is sterilized by at least one of ultraviolet rays, high-temperature steam, and disinfectants. disinfect.
本实施例所述的样本预处理装置及方法，相对于现有技术，具有以下优点：Compared with the prior art, the sample preprocessing device and method described in this embodiment have the following advantages:
(1)全自动机械操作，节约医疗资源，降低专业人员需求。本发明所述的样本预处理装置，集身份验证、样品信息采集、样本富集、样本裂解等一系列功能，全自动机械化操作，可大大降低相关专业人员需求，节约医疗资源，降低防疫成本。(1) Fully automatic mechanical operation saves medical resources and reduces the need for professionals. The sample preprocessing device described in the present invention integrates a series of functions such as identity verification, sample information collection, sample enrichment, and sample cracking, and fully automatic mechanized operation, which can greatly reduce the needs of relevant professionals, save medical resources, and reduce epidemic prevention costs.
(2)封闭空间的操作，完备的消杀措施，避免交叉感染。本发明所述的样本预处理装置，皆在机架内相对密闭的空间中完成，且具备一系列的如高温灭菌、紫外灯灭菌等符合国家标准的杀菌、灭菌措施，可有效防止避免交叉污染，极大的提高疫情防控效率，降低人群感染风险。(2) Operation in a closed space, complete disinfection measures to avoid cross-infection. The sample pretreatment device described in the present invention is completed in a relatively closed space in the rack, and has a series of sterilization and sterilization measures in line with national standards such as high temperature sterilization and ultraviolet lamp sterilization, which can effectively prevent Avoid cross-contamination, greatly improve the efficiency of epidemic prevention and control, and reduce the risk of crowd infection.
(3)结构紧凑，可实现多多节点、多层次、快速部署。本发明所述的样本预处理装置，结构紧凑、占地面积小、轻量化、布置灵活，可组成全自动无人化核酸采样及检测系统，系统模块化程度高，极易部署，可快速推广至城市社区、学校、园区、酒店、工地、交通入口、大型商超、城乡接合部以及广大农村地区，筑牢基层疫情防控的坚强堡垒。(3) The structure is compact, and it can realize multi-node, multi-level, and rapid deployment. The sample pretreatment device of the present invention has a compact structure, a small footprint, light weight, and flexible layout, and can form a fully automatic unmanned nucleic acid sampling and detection system. The system has a high degree of modularity, is easy to deploy, and can be quickly promoted To urban communities, schools, parks, hotels, construction sites, traffic entrances, large supermarkets, urban-rural junctions and vast rural areas, build a strong fortress for grassroots epidemic prevention and control.
以上所述，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以权利要求的保护范围为准。The above is only a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Anyone skilled in the art can easily think of changes or substitutions within the technical scope disclosed in the present invention. All should be covered within the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.
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