WO2014019254A1 - Vacuum blood collection pipe capable of directly separating plasma and method thereof - Google Patents

Vacuum blood collection pipe capable of directly separating plasma and method thereof Download PDF

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Publication number
WO2014019254A1
WO2014019254A1 PCT/CN2012/079961 CN2012079961W WO2014019254A1 WO 2014019254 A1 WO2014019254 A1 WO 2014019254A1 CN 2012079961 W CN2012079961 W CN 2012079961W WO 2014019254 A1 WO2014019254 A1 WO 2014019254A1
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WO
WIPO (PCT)
Prior art keywords
blood collection
plasma
collection tube
filter element
blood
Prior art date
Application number
PCT/CN2012/079961
Other languages
French (fr)
Chinese (zh)
Inventor
朱德新
Original Assignee
上海科华检验医学产品有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 上海科华检验医学产品有限公司 filed Critical 上海科华检验医学产品有限公司
Publication of WO2014019254A1 publication Critical patent/WO2014019254A1/en

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Classifications

    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483Physical analysis of biological material
    • G01N33/487Physical analysis of biological material of liquid biological material
    • G01N33/49Blood
    • G01N33/491Blood by separating the blood components
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150206Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150251Collection chamber divided into at least two compartments, e.g. for division of samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150755Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/153Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/154Devices using pre-evacuated means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/15003Source of blood for venous or arterial blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150351Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel

Definitions

  • Vacuum blood collection tube capable of directly separating plasma and method thereof
  • the present invention relates to the field of clinical medical device technology, and in particular to a vacuum blood collection tube capable of directly separating plasma and a method thereof.
  • the detection of blood specimens is a conventional technical means for clinical examination of medical institutions, and blood specimens for in vitro diagnosis are mainly divided into arterial blood and venous blood, clinically, arterial blood specimens are mainly used for blood gas index analysis, and venous blood specimens.
  • the detection range is widely used, such as for detecting biochemical indicators, hemagglutination indicators, blood rheology indicators, routine blood analysis, trace element and ionic composition analysis, nutrient detection, drug concentration detection, genetic testing, infectious disease pathogens. Learning, microbiological testing, etc. Due to the differences in the detection instruments used in different detection indicators, venous blood specimens are classified into plasma, serum and whole blood according to their uses.
  • the plasma specimens have traditionally been obtained mainly by centrifugation. After the blood is ex vivo, the anticoagulant is treated by anticoagulant, and the plasma specimen is separated by a centrifuge under a certain centrifugal force.
  • the vacuum blood collection tube commonly used in the prior art is composed of a blood collection tube body, a rubber stopper and a head cover, an additive, a label, etc., and does not have the function of directly separating plasma. If it is necessary to separate plasma, it must be centrifuged after blood collection. To complete, the anticoagulated blood needs to be centrifuged to separate the plasma.
  • centrifugation conditions are not well controlled, hemolysis may occur, or the collection container may be damaged during the centrifugation process, resulting in leakage or complete damage of the specimen;
  • the plasma and other components of the blood are mixed together. Under the action of centrifugal force or during storage, the substances in the red blood cells are released into the plasma, which affects the final test result. , not safe and reliable.
  • a vacuum blood collection tube publication number CN 202173399 U
  • the blood is quantitatively absorbed by the adsorption material built in the sampling component, and then added into the blood sample storage container containing the liquid anticoagulant, fully well mixed.
  • the top of the plasma separation component is a hollow elastic piston, and the outer part of the piston forms a slightly sealed closed cavity with the inner wall of the blood sample preservation container, and the hollow piston is provided with a filter element inside.
  • the plasma portion of the anticoagulant can pass through the filter element and is in the upper part of the filter element, and the blood that cannot pass through the filter element is formed. It is still in the lower part of the filter element.
  • the operation method of the vacuum collecting tube is complicated, and the operation technology of the operator is required in the process of collecting the plasma sample, and the time spent in the collecting process is also long, the efficiency is not high, and it is not practical enough.
  • a vacuum blood collection tube capable of directly separating plasma which comprises a blood collection tube body, an inner tube, a rubber stopper and a filter element, wherein the top of the blood collection tube body is provided with a rubber stopper and a rubber stopper.
  • the structure is approximately plug shape, and the upper center of the rubber plug structure is provided with a semi-circular groove, and the left and right ends of the rubber plug are embedded and connected with the blood collection tube and the inner tube of the blood collection tube, and the inner tube of the blood collection tube is used.
  • a plasma outlet is arranged in the middle of the bottom, a plasma collection chamber is arranged in the lower part of the plasma outlet, a filter membrane is arranged on the upper part of the plasma outlet of the blood collection tube, a filter element is arranged on the upper part of the filtration membrane, and a buffer sheet is arranged on the filter element.
  • a blood collection chamber is formed in the inner tube of the blood collection tube from the upper portion of the filter element to the top of the inner tube of the blood collection tube, and an anticoagulant is disposed on the inner wall of the inner tube of the blood collection tube, and the anticoagulant includes heparin sodium, lithium heparin, and lemon.
  • the anticoagulant includes heparin sodium, lithium heparin, and lemon.
  • the blood collection tube body is made of one or more of glass, polyester plastic, and polymer material.
  • the inner tube of the blood collection tube is mainly made of a polymer material, including high density polyethylene, low density polyethylene, polypropylene, polystyrene, polycarbonate, polyethylene, terephthalate.
  • the filter core is made of ultrafine plant fiber, synthetic fiber, polyester sintered product, filter paper, preferably polypropylene synthetic fiber, polyethylene synthetic fiber, polyethylene terephthalate synthetic fiber, carboxymethyl fiber. , microcrystalline cellulose, processed plant fibers.
  • the material of the rubber stopper includes natural rubber, halogenated butyl rubber, synthetic rubber, and thermoplastic elastomer.
  • a buffer sheet is disposed above the filter element, and the buffer material of the buffer sheet comprises a lyophilized anticoagulant tablet, a nylon membrane, a filter paper, a synthetic cellulose membrane, and a buffered anticoagulant is further disposed on the buffer sheet.
  • the filter membrane is a microporous membrane, and the manufacturing materials thereof include cellulose acetate, nitrocellulose, mixed cellulose ester, nylon 6, nylon 66, polyvinylidene fluoride, polytetrafluoroethylene, polyethersulfone, polypropylene. material.
  • a method for directly separating plasma vacuum blood collection tubes characterized in that the method utilizes a different physical form of plasma and blood formation, and an inner tube equipped with a filter element is installed inside the blood collection tube to separate the blood collection tube into blood collection.
  • the filter element flows into the lower part of the blood collection tube, ie the plasma collection chamber, thereby allowing plasma to The formation of the blood is separated, and the blood collection gel plug connected to the upper end of the inner tube is discarded.
  • the entire inner tube can be used to use the plasma sample of the plasma collection chamber for various tests; the filter membrane, the filter element and the filter tube are sequentially loaded in the inner tube. Spraying the filter paper buffer sheet with anticoagulant, spraying the anticoagulant on the inner tube wall, loading the prepared inner tube into the blood collection tube body, placing the rubber plug on the upper part of the blood collection tube body, and placing it in the vacuum machine After the vacuum is placed, the plug is pressed.
  • the blood collection tube body is made of borate glass
  • the blood collection tube rubber is made of chlorinated butyl rubber
  • the blood collection tube is made of high density polyethylene
  • the filtration membrane is an asymmetric polysulfone filtration membrane.
  • the filter element is a polyethylene terephthalate fiber filter
  • the buffer sheet is a filter paper buffer sheet sprayed with an anticoagulant of ethylenediaminetetraacetate
  • the inner tube wall is sprayed with ethylenediamine four.
  • Dipotassium acetate anticoagulant The invention has the advantages of utilizing the physical form difference of blood forming component and plasma component, and rapidly separating plasma by the principle of simple filtering method, and has the characteristics of simple, safe and rapid, and can be directly separated and qualified without using a conventional centrifugal machine. Plasma for clinical testing.
  • the material used is not only made into a transparent tube body but also can effectively ensure the negative pressure of the vacuum blood collection tube, the material is easy to obtain, the cost is low, the effect is good, economical and practical, safe and reliable.
  • FIG. 1 is a schematic view showing the main structure of a vacuum blood collection tube of the present invention
  • Figure 2 is a partial enlarged view of a portion of Figure 1 of the present invention.
  • Plasma outflow As shown in the figure, in the figure: 1. Blood collection tube 2. Plasma collection chamber 3. Filter membrane 4. Filter element 5. Buffer sheet 6. Blood collection tube 7. Anticoagulant 8. Blood collection chamber 9. Rubber stopper 10. Plasma outflow;
  • the invention provides a vacuum blood collection tube capable of directly separating plasma and a method thereof, which can obtain qualified plasma without using other equipment, and the principle is that the physical form of plasma and blood formation is different, and the blood vessel is installed inside the blood collection tube.
  • An inner tube equipped with a filter element separates the inside of the blood collection tube into a blood collection chamber and a plasma collection chamber. The anticoagulant and the filter element built into the inner tube prevent the blood flowing into the blood collection chamber from coagulating, and the blood is formed into a filter element.
  • Plasma samples from the plasma collection chamber can be used for various tests by discarding the entire inner tube.
  • the tube body is made of glass, plastic or other polymer material. It is a round bottom or a pointed bottom, flat bottom tube structure with one end closed and the other end open.
  • the inner part of the blood collection tube body is filled with an inner tube filled with a filter element.
  • the inner tube is made of plastic or other polymer material, and one end is open to the upper opening and is connected with the rubber plug, the other end is hollow ⁇ -shaped structure, and the lower part is opened with a plasma flow outlet;
  • the outer diameter of the inner tube is slightly smaller than the inner diameter of the blood vessel tube body, and is closely adhered to the inner wall of the blood collection tube after assembly;
  • the filter element is made of plant fiber, synthetic fiber or polyester sintered material, filter paper material, and the pore diameter is smaller than the blood forming component.
  • the inner wall of the inner tube is coated with an anticoagulant, and the anticoagulant can also be sprayed on the other material on the upper part of the filter element; the upper part of the filter element can be placed with a buffer material as an anti-coagulant
  • the coagulant carrier, the filter element can be placed on the lower part of the filter element, and the liquid flowing out of the filter element is further filtered to ensure the quality of the plasma.
  • the blood collection rubber plug is made of elastic material, which can completely seal the open end of the blood collection tube body, ensure that a certain negative pressure can be preset inside the vacuum blood collection tube, and maintain the vacuum degree inside the tube for a certain period of time.
  • the crown of the rubber plug is bulged or the safety head cover is placed outside, and is easily pulled out after use.
  • the tube cover has a circular groove in the middle to facilitate the puncture of the blood collection needle during blood collection; the rubber plug has two contact parts with the tube body.
  • Level, upper level The outer diameter matches the inner diameter of the blood vessel tube to ensure the vacuum inside the tube.
  • the outer diameter of the next layer matches the inner diameter of the inner tube, and there is a certain interference. It can ensure that the rubber plug together with the whole inner tube after the plasma is filtered out. The blood vessel tube is pulled out.
  • the material for manufacturing the blood vessel tube body includes silicate glass, borate glass, soda lime glass, polyester plastic material, polymer material, preferably borate glass, polyethylene terephthalate, polyethylene glycol. Modified polyethylene terephthalate, polycarbonate, polyethylene naphthalate or polyethylene terephthalate and polyethylene naphthalate composite. Because the above materials are not only made into a transparent tube body but also can effectively ensure the vacuum pressure of the vacuum blood collection tube, the material is easy to obtain and the cost is relatively low.
  • Materials for manufacturing the inner tube body include high density polyethylene, low density polyethylene, polypropylene, polystyrene, polycarbonate, polyethylene terephthalate or other high molecular materials, preferably high density polyethylene,
  • the inner tube is relatively transparent and soft, and can be attached to the inner wall of the blood collection tube on the one hand, and easily removed from the blood collection tube after plasma filtration on the other hand.
  • Anticoagulant sprayed on the inner wall of the inner tube includes sodium heparin, lithium heparin, sodium citrate, dipotassium edetate, tripotassium edetate, disodium edetate, potassium oxalate, sodium oxalate, leeches
  • stabilizers such as sodium fluoride and sodium iodide may be added as long as they do not affect the subsequent detection of plasma.
  • the material for manufacturing the filter element includes ultrafine plant fiber, synthetic fiber, polyester sintered product, filter paper, preferably polypropylene synthetic fiber, polyethylene synthetic fiber, polyethylene terephthalate synthetic fiber, carboxymethyl cellulose, micro Crystalline cellulose, processed plant fibers, such as defatted cotton, the pore size of the ultrafine fibers is preferably a micron-sized product, preferably a polyethylene terephthalate synthetic fiber, which does not form hemolysis and does not bind to blood.
  • Target detection component preferably a micron-sized product, preferably a polyethylene terephthalate synthetic fiber, which does not form hemolysis and does not bind to blood.
  • Materials for manufacturing vascular rubber plugs include natural rubber, halogenated butyl rubber, synthetic rubber, thermoplastic elastomer, preferably halogenated butyl rubber, which is not only easy to mold, but also has sufficient elasticity to ensure effective The preset vacuum of the blood collection tube is also easy to pull out after use.
  • a cushioning material may be attached to the filter element, and the material is coated with an anticoagulant or an additive, so that the blood flowing into the blood collection tube first can be quickly mixed with the anticoagulant and does not solidify.
  • the cushioning material comprises a tablet of a freeze-dried anticoagulant, a nylon membrane, a filter paper, a synthetic cellulose membrane, etc., preferably a filter paper sheet coated with an anticoagulant, and the buffer material prevents the blood from being in contact with the spray when initially flowing into the blood collection chamber.
  • the anticoagulant on the tube wall directly flows into the filter to form a solid, forming a tiny clot, which causes the separated plasma to fail.
  • a filter membrane can be added under the filter element.
  • the filter membrane has a circular sheet shape, and the outer diameter is equal to the inner diameter of the inner tube. It is made of microporous inert hydrophobic material, and the pore diameter is smaller than the blood cell component, which can effectively block the formation of blood. Does not itself react with any components of the blood, nor does it adsorb any components of the blood.
  • Such materials include microporous membranes made of materials such as cellulose acetate, nitrocellulose, mixed cellulose ester, nylon 6, nylon 66, polyvinylidene fluoride, polytetrafluoroethylene, polyethersulfone, polypropylene, and the like.
  • An asymmetric polysulfone membrane is preferred, and the asymmetric structure of the membrane captures cellular components in the blood without cleavage, does not form hemolysis, and does not adsorb critical biomarkers.
  • the invention can realize the direct separation of qualified blood plasma without using a centrifuge after blood collection by the above design.
  • the blood vessel tube is made of borate glass
  • the vascular rubber plug is made by chlorinated butyl rubber
  • the blood collection tube is made of high density polyethylene
  • the inner tube is sequentially filled with asymmetric polysulfone filter membrane and polyethylene terephthalate.
  • a fiber filter core and a filter paper buffer sheet sprayed with an anticoagulant of ethylenediaminetetraacetic acid dipotassium, and an anti-coagulant of ethylenediaminetetraacetate is sprayed on the inner tube wall, and the prepared inner tube is loaded into the blood collection tube body.
  • Place the rubber stopper on top of the blood collection tube body, put it into the vacuum machine and preset the vacuum and then press it.
  • the vascular tube body is made of polyethylene terephthalate
  • the vascular rubber plug is made of chlorinated butyl rubber
  • the blood collection tube is made of high density polyethylene
  • the inner tube is loaded with asymmetric polysulfone filter membrane and polyethylene benzene.
  • a diester fiber filter element and a filter paper buffer sheet coated with heparin sodium, a heparin sodium anticoagulant sprayed on the inner tube wall, the inner tube prepared above is loaded into the blood collection tube body, and the rubber stopper is placed on the blood collection tube body Above, put it into the vacuum machine and preset the vacuum and then press it.
  • the vascular tube body is made of polyethylene glycol modified polyethylene terephthalate
  • the vascular rubber plug is made by chlorinated butyl rubber
  • the blood collection tube is made of high density polyethylene
  • the inner tube is sequentially filled with asymmetric polysulfone filtration.
  • Membrane, polyethylene terephthalate fiber filter and filter paper buffer coated with lithium heparin, sprayed with heparin lithium anticoagulant on the inner tube wall, the inner tube prepared above is loaded into the blood collection tube body, and the rubber stopper is inserted Place it on top of the blood collection tube body, put it into the vacuum machine and preset the vacuum and then press it.
  • the vascular tube body is made of polyethylene terephthalate
  • the vascular rubber plug is made of bromobutyl rubber
  • the inner tube of the blood collection tube is made of polypropylene
  • the inner tube is sequentially filled with asymmetric polysulfone filter membrane and polyethylene terephthalic acid.
  • the acid ester fiber filter element and the filter paper buffer paper coated with the tripotassium EDTA, the inner tube wall is sprayed with the anti-coagulant of ethylenediaminetetraacetic acid, and the prepared inner tube is loaded into the blood collection tube body. Place the rubber stopper on top of the blood collection tube body, put it into the vacuum machine and preset the vacuum and then press it.
  • the blood vessel tube is made of borate glass
  • the vascular rubber plug is made of bromobutyl rubber
  • the blood collection tube is made of high transparent polypropylene
  • the inner tube is sequentially filled with asymmetric polysulfone filter membrane and polyethylene terephthalate.
  • a fiber filter and a filter paper coated with sodium citrate anticoagulant spraying a sodium citrate anticoagulant on the inner tube wall, loading the prepared inner tube into the blood collection tube body, and placing the rubber plug on the blood collection tube body Above, put vacuum After the vacuum is preset in the machine, the plug is pressed.
  • Polyethylene terephthalate modified polyethylene terephthalate is used to make blood vessel tube
  • halogenated butyl rubber is used to make blood vessel rubber plug
  • low density polyethylene is used to make blood collection tube
  • inner tube is loaded with asymmetric polysulfone filtration.
  • a buffer sheet made of a film, a polyethylene terephthalate fiber filter and a polyester film coated with a hirudin anticoagulant, and a hydroquinone anticoagulant is sprayed on the inner tube wall, and the prepared inner tube is loaded into the tube.
  • the rubber stopper is placed above the blood collection tube body, and placed in a vacuum machine to preset a vacuum and then tamped.
  • the valve tube is made of polyethylene terephthalate
  • the vascular rubber plug is made of halogenated butyl rubber
  • the inner tube of blood collection tube is made of high density polyethylene
  • the inner tube is loaded with asymmetric polysulfone filter membrane and polyethylene terephthalate.
  • a buffer sheet made of a polyesterate fiber filter and a polyester film coated with potassium oxalate anticoagulant and sodium fluoride stabilizer, sprayed with potassium oxalate anticoagulant and sodium fluoride stabilizer on the inner tube wall, which is prepared as described above.
  • the inner tube is loaded into the blood collection tube body, and the rubber stopper is placed above the blood collection tube body, and placed in a vacuum machine to preset a vacuum and then pressed.
  • the vacuum blood collection tube was prepared, and the vein was punctured with a venous puncture needle, and blood was collected separately. After the blood collection, the blood was placed upright for 15 minutes, and the blood collection rubber plug and the inner tube were discarded. Observe that the blood collected in the blood collection tube is a pale yellow, transparent or translucent liquid.

Abstract

A vacuum blood collection pipe capable of directly separating plasma and a preparation method thereof. The vacuum blood collection pipe comprises a blood collection pipe body (1), a blood collection inner pipe (6), a rubber plug (9), and a filter element (4). The blood collection inner pipe (6) is disposed in the blood collection pipe body (1), and the rubber plug (9) is disposed at the top of the blood collection pipe body (1). The structure of the rubber plug (9) is similar to a plug shape. A semicircular groove is disposed in the center of the upper portion in the structure of the rubber plug (9). Left and right ends at the lower portion of the rubber plug (9) are embedded into the blood collection pipe body (1) and connected to the blood collection inner pipe (6). A plasma outlet (10) is disposed in the middle of the bottom of the blood collection inner pipe (6), and a lower portion of the plasma outlet (10) is a plasma collection chamber (2). A filtering film (3) is disposed at the upper portion of the plasma outlet (10) in the blood collection inner pipe (6). The filter element (4) is disposed at the upper portion of the filtering film (3). A buffer plate (5) is further disposed on the filter element (4). Therefore, a blood collection chamber (8) is formed in the blood collection inner pipe (6), and a layer of anticoagulants (7) is disposed on an inner wall of the blood collection inner pipe (6). According to the present invention, by using a difference between physical forms of a visible component and a plasma composite of blood, the plasma can be rapidly separated, having the features of simpleness and convenience, safety and rapidness.

Description

一种可直接分离血浆的真空采血管及其方法  Vacuum blood collection tube capable of directly separating plasma and method thereof
[技术领域] 本发明涉及临床医疗器械技术领域, 具体是一种可直接分离血浆的真空采 血管及其方法。 [Technical Field] The present invention relates to the field of clinical medical device technology, and in particular to a vacuum blood collection tube capable of directly separating plasma and a method thereof.
[背景技术] 血液标本的检测是医疗机构临床检验的常规技术手段, 用于体外诊断的血 液标本主要分为动脉血和静脉血, 临床上动脉血液标本主要用于血气指标分析, 而静脉血液标本的检测应用范围相当广泛, 如用于检测生化指标、 血凝学指标、 血液流变学指标、 血液常规分析、 微量元素及离子成分分析、 营养成分检测、 药物浓度检测、 基因检测、 传染病病原学检测、 微生物检测等等。 由于不同检 测指标所使用检测仪器的差异, 静脉血液标本按照用途又被分为血浆、 血清和 全血三类。 血浆标本的获得传统上主要是通过离心分离的途径, 血液离体以后 经过抗凝剂抗凝处理, 通过离心机在达到一定离心力的条件下分离出血浆标本。 现有技术中市场上常见的真空采血管由采血管管体、 胶塞及头盖、 添加剂、 标签等组成, 本身并不具备直接分离血浆的功能, 若需要分离血浆必须在采血 后借助离心机来完成, 经过抗凝处理的血液需要经过离心才能分离出血浆, 一 方面如果离心条件掌握不好可能会形成溶血, 或者离心过程中引起采集容器的 破损, 导致标本渗漏或完全损坏; 另一方面在离心过程中及分离以后, 血浆与 血液的其他有形成分混合在一起, 在受到离心力的作用下或在存放过程中, 红 细胞内的物质会释放到血浆中, 对最终的检测结果造成影响, 不够安全可靠。 现有技术中还有一种可直接分离血浆的真空采血管 (公开号 CN 202173399 U) , 血液由内置在采样组件内的吸附材料定量吸取后加入盛有液体抗凝剂的血 样保存容器内, 充分混合均匀。 将装有滤芯的血浆分离组件插入血样保存容器, 血浆分离组件的顶端是一个中空的弹性活塞, 活塞的外部与血样保存容器的内 壁形成一个略有过盈的密闭腔, 中空活塞内部装有滤芯, 通过活塞的自上而下 的运动, 在活塞通过采集的抗凝血液标本时, 由于压力作用, 抗凝血液的血浆 部分可以通过滤芯而处于滤芯的上部, 而不能通过滤芯的血液有形成分则仍然 处于滤芯的下部。 但是这种真空采集管的操作方法较为复杂, 且采集血浆样本 的过程中对操作人员的操作技术有一定的要求, 采集过程中花费的时间也较长, 效率不高, 不够实用。 [Background Art] The detection of blood specimens is a conventional technical means for clinical examination of medical institutions, and blood specimens for in vitro diagnosis are mainly divided into arterial blood and venous blood, clinically, arterial blood specimens are mainly used for blood gas index analysis, and venous blood specimens. The detection range is widely used, such as for detecting biochemical indicators, hemagglutination indicators, blood rheology indicators, routine blood analysis, trace element and ionic composition analysis, nutrient detection, drug concentration detection, genetic testing, infectious disease pathogens. Learning, microbiological testing, etc. Due to the differences in the detection instruments used in different detection indicators, venous blood specimens are classified into plasma, serum and whole blood according to their uses. The plasma specimens have traditionally been obtained mainly by centrifugation. After the blood is ex vivo, the anticoagulant is treated by anticoagulant, and the plasma specimen is separated by a centrifuge under a certain centrifugal force. The vacuum blood collection tube commonly used in the prior art is composed of a blood collection tube body, a rubber stopper and a head cover, an additive, a label, etc., and does not have the function of directly separating plasma. If it is necessary to separate plasma, it must be centrifuged after blood collection. To complete, the anticoagulated blood needs to be centrifuged to separate the plasma. On the one hand, if the centrifugation conditions are not well controlled, hemolysis may occur, or the collection container may be damaged during the centrifugation process, resulting in leakage or complete damage of the specimen; In the process of centrifugation and after separation, the plasma and other components of the blood are mixed together. Under the action of centrifugal force or during storage, the substances in the red blood cells are released into the plasma, which affects the final test result. , not safe and reliable. There is also a vacuum blood collection tube (publication number CN 202173399 U) which can directly separate plasma, and the blood is quantitatively absorbed by the adsorption material built in the sampling component, and then added into the blood sample storage container containing the liquid anticoagulant, fully well mixed. Inserting the plasma separation component equipped with the filter element into the blood sample preservation container, the top of the plasma separation component is a hollow elastic piston, and the outer part of the piston forms a slightly sealed closed cavity with the inner wall of the blood sample preservation container, and the hollow piston is provided with a filter element inside. Through the top-down movement of the piston, when the piston passes the collected anticoagulant sample, due to the pressure, the plasma portion of the anticoagulant can pass through the filter element and is in the upper part of the filter element, and the blood that cannot pass through the filter element is formed. It is still in the lower part of the filter element. However, the operation method of the vacuum collecting tube is complicated, and the operation technology of the operator is required in the process of collecting the plasma sample, and the time spent in the collecting process is also long, the efficiency is not high, and it is not practical enough.
[发明内容] 本发明就是为了解决现有技术中血液采集容器无法直接分离血浆的不足和 缺陷, 提供一种结构新颖、 安全可靠的可直接分离血浆的真空采血管及其方法。 为实现上述目的, 提供一种可直接分离血浆的真空采血管, 包括采血管管 体、 内管、 胶塞、 滤芯, 其特征在于所述的采血管管体的顶部设有胶塞, 胶塞 的结构近似为插头形状, 胶塞结构的上部中央设有半圆形凹槽, 胶塞下部左右 两端嵌入连接采血管管体与采血管管体中的采血管内管相连接, 采血管内管的 底部中间设有血浆流出口, 血浆流出口的下部为血浆收集室, 在采血管内管血 浆流出口的上部设有过滤膜, 过滤膜的上部设有滤芯, 所述的滤芯上还设有缓 冲片, 由此在采血管内管内构成由滤芯上部至采血管内管顶部之间的采血室, 在采血管内管的内壁上设有一层抗凝剂, 所述的抗凝剂包括肝素钠、 肝素锂、 柠檬酸钠、 乙二胺四乙酸二钾、 乙二胺四乙酸三钾、 乙二胺四乙酸二钠、 草酸 钾、 草酸钠、 水蛭素及目标检测物的稳定剂。 所述的采血管管体由玻璃、 聚酯塑胶、 高分子材料中的一种或一种以上复 合制成。 所述的采血管内管其管体的制造材料主要为高分子材料, 包括高密度聚乙 烯、 低密度聚乙烯、 聚丙烯、 聚苯乙烯、 聚碳酸酯、 聚乙烯、 对苯二甲酸酯。 所述的滤芯的制造材料包括超细植物纤维、 人工合成纤维、 聚酯烧结产物、 滤纸, 优选聚丙烯合成纤维、 聚乙烯合成纤维、 聚乙烯对苯二甲酸酯合成纤维、 羧甲基纤维素、 微晶纤维素、 经加工的植物纤维。 所述的胶塞的材料包括天然橡胶、 卤化丁基橡胶、 合成橡胶、 热塑性弹性 体。 所述的滤芯上方设有一层缓冲片, 缓冲片的缓冲材料包括冻干的抗凝剂压 片、 尼龙膜、 滤纸、 合成纤维素膜, 缓冲片上还设有一层涂布的抗凝剂。 所述的过滤膜为微孔滤膜, 其制造材料包括醋酸纤维素、 硝酸纤维素、 混 合纤维素酯、 尼龙 6、 尼龙 66、 聚偏氟乙烯、 聚四氟乙烯、 聚醚砜、 聚丙烯材 料。 一种可直接分离血浆的真空采血管的方法, 其特征在于该方法利用血浆与 血液有形成分的物理形态不同, 在采血管内部安装一个装有滤芯的内管, 把采 血管内部分隔成采血室和血浆收集室, 通过内置在内管的抗凝剂和滤芯, 使流 入采血室的血液不会凝固, 血液的有形成分被滤芯挡在其上部, 即采血室, 而 血浆成分可以顺利通过滤芯流入采血管的下部, 即血浆收集室, 从而使血浆与 血液的有形成分分开, 拔出连接在内管上端的采血管胶塞弃去整个内管即可使 用血浆收集室的血浆标本用于各种检测; 在内管中依次装填过滤膜、 滤芯和喷 有抗凝剂的滤纸缓冲片, 内管管壁喷涂抗凝剂, 将上述制作好的内管装入采血 管管体, 将胶塞置于采血管管体上方, 放入真空机内预置真空后压塞。 所述的采血管管体以硼酸盐玻璃制作, 采血管胶塞以氯化丁基橡胶制作, 采血管内管以高密度聚乙烯制作, 所述的过滤膜为不对称聚砜过滤膜, 所述的 滤芯为聚乙烯对苯二甲酸酯纤维滤芯, 所述的缓冲片为喷有乙二胺四乙酸二钾 抗凝剂的滤纸缓冲片, 所述的内管管壁喷涂乙二胺四乙酸二钾抗凝剂。 本发明的优点在于利用血液有形成分与血浆组分的物理形态差异, 利用简 单的过滤法的原理快速分离血浆, 具有简便、 安全、 快速的特点, 无需借助传 统的离心机械而直接分离出合格的血浆, 供临床检测使用。 其采用的材料不仅 制成后为透明管体而且可以有效保证真空采血管的负压, 材料易于取得, 成本 低, 效果好, 经济实用, 安全可靠。 SUMMARY OF THE INVENTION The present invention is to solve the defects and defects in the prior art that the blood collection container cannot directly separate plasma, and provides a vacuum blood collection tube and a method thereof, which can directly separate plasma, which is novel in structure, safe and reliable. In order to achieve the above object, a vacuum blood collection tube capable of directly separating plasma is provided, which comprises a blood collection tube body, an inner tube, a rubber stopper and a filter element, wherein the top of the blood collection tube body is provided with a rubber stopper and a rubber stopper. The structure is approximately plug shape, and the upper center of the rubber plug structure is provided with a semi-circular groove, and the left and right ends of the rubber plug are embedded and connected with the blood collection tube and the inner tube of the blood collection tube, and the inner tube of the blood collection tube is used. a plasma outlet is arranged in the middle of the bottom, a plasma collection chamber is arranged in the lower part of the plasma outlet, a filter membrane is arranged on the upper part of the plasma outlet of the blood collection tube, a filter element is arranged on the upper part of the filtration membrane, and a buffer sheet is arranged on the filter element. Thus, a blood collection chamber is formed in the inner tube of the blood collection tube from the upper portion of the filter element to the top of the inner tube of the blood collection tube, and an anticoagulant is disposed on the inner wall of the inner tube of the blood collection tube, and the anticoagulant includes heparin sodium, lithium heparin, and lemon. Sodium, dipotassium edetate, tripotassium edetate, disodium edetate, oxalic acid Potassium, sodium oxalate, hirudin and stabilizers for target analytes. The blood collection tube body is made of one or more of glass, polyester plastic, and polymer material. The inner tube of the blood collection tube is mainly made of a polymer material, including high density polyethylene, low density polyethylene, polypropylene, polystyrene, polycarbonate, polyethylene, terephthalate. The filter core is made of ultrafine plant fiber, synthetic fiber, polyester sintered product, filter paper, preferably polypropylene synthetic fiber, polyethylene synthetic fiber, polyethylene terephthalate synthetic fiber, carboxymethyl fiber. , microcrystalline cellulose, processed plant fibers. The material of the rubber stopper includes natural rubber, halogenated butyl rubber, synthetic rubber, and thermoplastic elastomer. A buffer sheet is disposed above the filter element, and the buffer material of the buffer sheet comprises a lyophilized anticoagulant tablet, a nylon membrane, a filter paper, a synthetic cellulose membrane, and a buffered anticoagulant is further disposed on the buffer sheet. The filter membrane is a microporous membrane, and the manufacturing materials thereof include cellulose acetate, nitrocellulose, mixed cellulose ester, nylon 6, nylon 66, polyvinylidene fluoride, polytetrafluoroethylene, polyethersulfone, polypropylene. material. A method for directly separating plasma vacuum blood collection tubes, characterized in that the method utilizes a different physical form of plasma and blood formation, and an inner tube equipped with a filter element is installed inside the blood collection tube to separate the blood collection tube into blood collection. The chamber and the plasma collection chamber, through the anticoagulant and the filter element built into the inner tube, the blood flowing into the blood collection chamber will not solidify, and the formed part of the blood is blocked by the filter element in the upper part thereof, that is, the blood collection chamber, and the plasma component can pass smoothly. The filter element flows into the lower part of the blood collection tube, ie the plasma collection chamber, thereby allowing plasma to The formation of the blood is separated, and the blood collection gel plug connected to the upper end of the inner tube is discarded. The entire inner tube can be used to use the plasma sample of the plasma collection chamber for various tests; the filter membrane, the filter element and the filter tube are sequentially loaded in the inner tube. Spraying the filter paper buffer sheet with anticoagulant, spraying the anticoagulant on the inner tube wall, loading the prepared inner tube into the blood collection tube body, placing the rubber plug on the upper part of the blood collection tube body, and placing it in the vacuum machine After the vacuum is placed, the plug is pressed. The blood collection tube body is made of borate glass, the blood collection tube rubber is made of chlorinated butyl rubber, and the blood collection tube is made of high density polyethylene, and the filtration membrane is an asymmetric polysulfone filtration membrane. The filter element is a polyethylene terephthalate fiber filter, the buffer sheet is a filter paper buffer sheet sprayed with an anticoagulant of ethylenediaminetetraacetate, and the inner tube wall is sprayed with ethylenediamine four. Dipotassium acetate anticoagulant. The invention has the advantages of utilizing the physical form difference of blood forming component and plasma component, and rapidly separating plasma by the principle of simple filtering method, and has the characteristics of simple, safe and rapid, and can be directly separated and qualified without using a conventional centrifugal machine. Plasma for clinical testing. The material used is not only made into a transparent tube body but also can effectively ensure the negative pressure of the vacuum blood collection tube, the material is easy to obtain, the cost is low, the effect is good, economical and practical, safe and reliable.
[附图说明] 图 1是本发明真空采血管的主要结构示意图; BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic view showing the main structure of a vacuum blood collection tube of the present invention;
图 2是本发明图 1中 a部分的局部放大图;  Figure 2 is a partial enlarged view of a portion of Figure 1 of the present invention;
如图所示, 图中: 1.采血管管体 2.血浆收集室 3.过滤膜 4.滤芯 5. 缓冲片 6.采血管内管 7.抗凝剂 8.采血室 9.胶塞 10.血浆流出口;  As shown in the figure, in the figure: 1. Blood collection tube 2. Plasma collection chamber 3. Filter membrane 4. Filter element 5. Buffer sheet 6. Blood collection tube 7. Anticoagulant 8. Blood collection chamber 9. Rubber stopper 10. Plasma outflow;
指定图 1为本发明的摘要附图。  BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a summary drawing of the present invention.
[具体实施方式]  [detailed description]
下面结合附图对本发明作进一步说明, 这种装置的结构和原理对本专业的 人来说是非常清楚的。 应当理解, 此处所描述的具体实施例仅用于解释本发明, 并不用于限定本发明。 The present invention will be further described below in conjunction with the accompanying drawings. The structure and principle of such a device are People are very clear. It is understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.
本发明提供了一种可直接分离血浆的真空采血管及其方法, 不需要借助其 他设备就可以得到合格的血浆, 其原理是利用血浆与血液有形成分的物理形态 不同, 在采血管内部安装一个装有滤芯的内管, 把采血管内部分隔成采血室和 血浆收集室, 通过内置在内管的抗凝剂和滤芯, 使流入采血室的血液不会凝固, 血液的有形成分被滤芯挡在其上部, 即采血室, 而血浆成分可以顺利通过滤芯 流入采血管的下部, 即血浆收集室, 从而使血浆与血液的有形成分分开, 拔出 连接在内管上端的采血管胶塞弃去整个内管即可使用血浆收集室的血浆标本用 于各种检测。  The invention provides a vacuum blood collection tube capable of directly separating plasma and a method thereof, which can obtain qualified plasma without using other equipment, and the principle is that the physical form of plasma and blood formation is different, and the blood vessel is installed inside the blood collection tube. An inner tube equipped with a filter element separates the inside of the blood collection tube into a blood collection chamber and a plasma collection chamber. The anticoagulant and the filter element built into the inner tube prevent the blood flowing into the blood collection chamber from coagulating, and the blood is formed into a filter element. Blocked in the upper part, that is, the blood collection chamber, and the plasma component can smoothly pass through the filter element into the lower part of the blood collection tube, that is, the plasma collection chamber, thereby separating the plasma from the blood formation, and pulling out the blood collection tube plug connected to the upper end of the inner tube. Plasma samples from the plasma collection chamber can be used for various tests by discarding the entire inner tube.
采血管管体由玻璃、 塑料或其他高分子材料制成, 为圆底或尖底、 平底管 状结构, 一端封闭, 另一端开口。 采血管管体内部有一个填有滤芯的内管, 内 管由塑胶或其他高分子材料制成, 一端朝上开口与胶塞连接, 另一端为中空 τ 形结构, 下部开有血浆流出口; 内管的外径略小于采血管管体的内径, 组装后 与采血管内壁紧密贴合; 滤芯由植物纤维、 合成纤维或聚酯烧结材料、 滤纸材 料制成, 其孔径小于血液有形成分, 只能滤过血浆, 不能通过其他血液有形成 分; 内管的内壁涂有抗凝剂, 抗凝剂也可以喷涂在另外的材料上置于滤芯上部; 滤芯的上部可以置放缓冲材料作为抗凝剂载体, 滤芯的下部可以置放滤膜, 进 一步对滤芯流出的液体再过滤, 以保证血浆的质量。  The tube body is made of glass, plastic or other polymer material. It is a round bottom or a pointed bottom, flat bottom tube structure with one end closed and the other end open. The inner part of the blood collection tube body is filled with an inner tube filled with a filter element. The inner tube is made of plastic or other polymer material, and one end is open to the upper opening and is connected with the rubber plug, the other end is hollow τ-shaped structure, and the lower part is opened with a plasma flow outlet; The outer diameter of the inner tube is slightly smaller than the inner diameter of the blood vessel tube body, and is closely adhered to the inner wall of the blood collection tube after assembly; the filter element is made of plant fiber, synthetic fiber or polyester sintered material, filter paper material, and the pore diameter is smaller than the blood forming component. Only the plasma can be filtered and cannot be formed by other blood; the inner wall of the inner tube is coated with an anticoagulant, and the anticoagulant can also be sprayed on the other material on the upper part of the filter element; the upper part of the filter element can be placed with a buffer material as an anti-coagulant The coagulant carrier, the filter element can be placed on the lower part of the filter element, and the liquid flowing out of the filter element is further filtered to ensure the quality of the plasma.
采血管胶塞由弹性材料制成, 能够完全密封采血管管体的开口端, 保证真 空采血管内部能够预置一定的负压, 并且在一定时间内保持管内真空度。 胶塞 的冠部膨出或在外部置放安全头盖, 在使用后易于拔出, 管盖的中间开有圆形 凹槽, 便于采血时采血针穿刺; 胶塞与管体接触部分有两个层面, 上一层面的 外径与采血管管体内径匹配, 可以保证管内真空度, 下一层面的外径与内管内 径匹配, 并有一定过盈, 能够保证在血浆滤出后将胶塞连同整个内管一起从采 血管管体拔出。 The blood collection rubber plug is made of elastic material, which can completely seal the open end of the blood collection tube body, ensure that a certain negative pressure can be preset inside the vacuum blood collection tube, and maintain the vacuum degree inside the tube for a certain period of time. The crown of the rubber plug is bulged or the safety head cover is placed outside, and is easily pulled out after use. The tube cover has a circular groove in the middle to facilitate the puncture of the blood collection needle during blood collection; the rubber plug has two contact parts with the tube body. Level, upper level The outer diameter matches the inner diameter of the blood vessel tube to ensure the vacuum inside the tube. The outer diameter of the next layer matches the inner diameter of the inner tube, and there is a certain interference. It can ensure that the rubber plug together with the whole inner tube after the plasma is filtered out. The blood vessel tube is pulled out.
制造采血管管体的材料包括硅酸盐玻璃、 硼酸盐玻璃、 钠钙玻璃、 聚酯塑 胶材料、 高分子材料, 优选硼酸盐玻璃、 聚乙烯对苯二甲酸酯、 聚乙二醇改性 聚乙烯对苯二甲酸酯、 聚碳酸酯、 聚萘二甲酸乙二醇脂或聚乙烯对苯二甲酸酯 与聚萘二甲酸乙二醇脂复合材料。 因为上述材料不仅制成后为透明管体而且可 以有效保证真空采血管的负压, 材料易于取得, 造价相对低廉。  The material for manufacturing the blood vessel tube body includes silicate glass, borate glass, soda lime glass, polyester plastic material, polymer material, preferably borate glass, polyethylene terephthalate, polyethylene glycol. Modified polyethylene terephthalate, polycarbonate, polyethylene naphthalate or polyethylene terephthalate and polyethylene naphthalate composite. Because the above materials are not only made into a transparent tube body but also can effectively ensure the vacuum pressure of the vacuum blood collection tube, the material is easy to obtain and the cost is relatively low.
制造内管管体的材料包括高密度聚乙烯、 低密度聚乙烯、 聚丙烯、 聚苯乙 烯、 聚碳酸酯、 聚乙烯对苯二甲酸酯或其他高分子材料, 优选高密度聚乙烯, 其制成的内管相对较为透明且柔软, 一方面可以与采血管内壁贴合, 另一方面 在血浆滤除以后较为容易从采血管内取出。  Materials for manufacturing the inner tube body include high density polyethylene, low density polyethylene, polypropylene, polystyrene, polycarbonate, polyethylene terephthalate or other high molecular materials, preferably high density polyethylene, The inner tube is relatively transparent and soft, and can be attached to the inner wall of the blood collection tube on the one hand, and easily removed from the blood collection tube after plasma filtration on the other hand.
内管内壁喷涂的抗凝剂包括肝素钠、 肝素锂、 柠檬酸钠、 乙二胺四乙酸二 钾、 乙二胺四乙酸三钾、 乙二胺四乙酸二钠、 草酸钾、 草酸钠、 水蛭素等, 为 适应不同的检测项目, 如血糖检测, 还可以添加氟化钠、 碘乙酸钠等目标检测 物的稳定剂, 只要不会对获得血浆的后续检测指标造成影响即可。  Anticoagulant sprayed on the inner wall of the inner tube includes sodium heparin, lithium heparin, sodium citrate, dipotassium edetate, tripotassium edetate, disodium edetate, potassium oxalate, sodium oxalate, leeches In order to adapt to different testing items, such as blood glucose testing, stabilizers such as sodium fluoride and sodium iodide may be added as long as they do not affect the subsequent detection of plasma.
制造滤芯的材料包括超细植物纤维、 人工合成纤维、 聚酯烧结产物、 滤纸, 优选聚丙烯合成纤维、 聚乙烯合成纤维、 聚乙烯对苯二甲酸酯合成纤维、 羧甲 基纤维素、 微晶纤维素、 经加工的植物纤维, 如脱脂棉花, 超细纤维的孔径优 选微米级产品, 优选聚乙烯对苯二甲酸酯合成纤维, 这种纤维不会形成溶血, 不会结合血液中的目标检测组分。  The material for manufacturing the filter element includes ultrafine plant fiber, synthetic fiber, polyester sintered product, filter paper, preferably polypropylene synthetic fiber, polyethylene synthetic fiber, polyethylene terephthalate synthetic fiber, carboxymethyl cellulose, micro Crystalline cellulose, processed plant fibers, such as defatted cotton, the pore size of the ultrafine fibers is preferably a micron-sized product, preferably a polyethylene terephthalate synthetic fiber, which does not form hemolysis and does not bind to blood. Target detection component.
制造采血管胶塞的材料包括天然橡胶、 卤化丁基橡胶、 合成橡胶、 热塑性 弹性体, 优选卤化丁基橡胶, 不仅易于成型, 而且具备足够弹性可以有效保证 采血管预置的真空度, 在使用后也易于拔出。 Materials for manufacturing vascular rubber plugs include natural rubber, halogenated butyl rubber, synthetic rubber, thermoplastic elastomer, preferably halogenated butyl rubber, which is not only easy to mold, but also has sufficient elasticity to ensure effective The preset vacuum of the blood collection tube is also easy to pull out after use.
滤芯上方可以附加一个缓冲材料, 材料上涂布有抗凝剂或添加物, 这样首 先流入采血管的血液可以迅速与抗凝剂混合, 不会凝固。 缓冲材料包括冻干抗 凝剂的压片、 尼龙膜、 滤纸、 合成纤维素膜等, 优选喷涂有抗凝剂的滤纸片, 缓冲材料的作用是防止血液一开始流入采血室时没有接触到喷涂在管壁上的抗 凝剂而直接流入过滤芯形成凝固, 形成微小凝块, 造成分离的血浆不合格。  A cushioning material may be attached to the filter element, and the material is coated with an anticoagulant or an additive, so that the blood flowing into the blood collection tube first can be quickly mixed with the anticoagulant and does not solidify. The cushioning material comprises a tablet of a freeze-dried anticoagulant, a nylon membrane, a filter paper, a synthetic cellulose membrane, etc., preferably a filter paper sheet coated with an anticoagulant, and the buffer material prevents the blood from being in contact with the spray when initially flowing into the blood collection chamber. The anticoagulant on the tube wall directly flows into the filter to form a solid, forming a tiny clot, which causes the separated plasma to fail.
滤芯下方可以附加一层过滤膜, 过滤膜为圆形片状, 其外径与内管内径相 等, 由微孔惰性疏水材料制成, 孔径小于血液细胞组分, 可以有效阻隔血液的 有形成分, 本身不会与血液中的任何成分反应, 也不会吸附血液中的任何组分。 这种材料包括醋酸纤维素、 硝酸纤维素、 混合纤维素酯、 尼龙 6、 尼龙 66、 聚 偏氟乙烯、 聚四氟乙烯、 聚醚砜、 聚丙烯等材料制成的微孔滤膜。 优选不对称 聚砜膜, 膜材的不对称结构可以捕获血液中的细胞组分且不发生裂解, 不会形 成溶血, 也不会吸附关键性的生物标记物。 滤芯上部与胶塞下端之间应留有足 够的空间, 否则难以采到足够量的血液。 滤芯下部与采血管管底之间也应留有 足够空间, 否则过滤的血浆无法容纳。  A filter membrane can be added under the filter element. The filter membrane has a circular sheet shape, and the outer diameter is equal to the inner diameter of the inner tube. It is made of microporous inert hydrophobic material, and the pore diameter is smaller than the blood cell component, which can effectively block the formation of blood. Does not itself react with any components of the blood, nor does it adsorb any components of the blood. Such materials include microporous membranes made of materials such as cellulose acetate, nitrocellulose, mixed cellulose ester, nylon 6, nylon 66, polyvinylidene fluoride, polytetrafluoroethylene, polyethersulfone, polypropylene, and the like. An asymmetric polysulfone membrane is preferred, and the asymmetric structure of the membrane captures cellular components in the blood without cleavage, does not form hemolysis, and does not adsorb critical biomarkers. There should be sufficient space between the upper part of the filter element and the lower end of the rubber plug, otherwise it is difficult to obtain a sufficient amount of blood. There should also be sufficient space between the lower part of the filter element and the bottom of the blood collection tube, otherwise the filtered plasma cannot be accommodated.
本发明通过以上设计可以实现采血后不借助离心机而直接分离出合格的血 浆。  The invention can realize the direct separation of qualified blood plasma without using a centrifuge after blood collection by the above design.
实施例 1  Example 1
以硼酸盐玻璃制作采血管管体, 氯化丁基橡胶制作采血管胶塞, 高密度聚 乙烯制作采血管内管, 内管依次装填不对称聚砜过滤膜、 聚乙烯对苯二甲酸酯 纤维滤芯和喷有乙二胺四乙酸二钾抗凝剂的滤纸缓冲片, 内管管壁喷涂乙二胺 四乙酸二钾抗凝剂, 将上述制作好的内管装入采血管管体, 将胶塞置于采血管 管体上方, 放入真空机内预置真空后压塞。 实施例 2 The blood vessel tube is made of borate glass, the vascular rubber plug is made by chlorinated butyl rubber, the blood collection tube is made of high density polyethylene, and the inner tube is sequentially filled with asymmetric polysulfone filter membrane and polyethylene terephthalate. a fiber filter core and a filter paper buffer sheet sprayed with an anticoagulant of ethylenediaminetetraacetic acid dipotassium, and an anti-coagulant of ethylenediaminetetraacetate is sprayed on the inner tube wall, and the prepared inner tube is loaded into the blood collection tube body. Place the rubber stopper on top of the blood collection tube body, put it into the vacuum machine and preset the vacuum and then press it. Example 2
以聚乙烯对苯二甲酸酯制作采血管管体, 氯化丁基橡胶制作采血管胶塞, 高密度聚乙烯制作采血管内管, 内管依次装填不对称聚砜过滤膜、 聚乙烯对苯 二甲酸酯纤维滤芯和喷涂有肝素钠的滤纸缓冲片, 内管管壁喷涂肝素钠抗凝剂, 将上述制作好的内管装入采血管管体, 将胶塞置于采血管管体上方, 放入真空 机内预置真空后压塞。  The vascular tube body is made of polyethylene terephthalate, the vascular rubber plug is made of chlorinated butyl rubber, the blood collection tube is made of high density polyethylene, and the inner tube is loaded with asymmetric polysulfone filter membrane and polyethylene benzene. a diester fiber filter element and a filter paper buffer sheet coated with heparin sodium, a heparin sodium anticoagulant sprayed on the inner tube wall, the inner tube prepared above is loaded into the blood collection tube body, and the rubber stopper is placed on the blood collection tube body Above, put it into the vacuum machine and preset the vacuum and then press it.
实施例 3  Example 3
以聚乙二醇改性聚乙烯对苯二甲酸酯制作采血管管体, 氯化丁基橡胶制作 采血管胶塞, 高密度聚乙烯制作采血管内管, 内管依次装填不对称聚砜过滤膜、 聚乙烯对苯二甲酸酯纤维滤芯和喷涂有肝素锂的滤纸缓冲片, 内管管壁喷涂肝 素锂抗凝剂, 将上述制作好的内管装入采血管管体, 将胶塞置于采血管管体上 方, 放入真空机内预置真空后压塞。  The vascular tube body is made of polyethylene glycol modified polyethylene terephthalate, the vascular rubber plug is made by chlorinated butyl rubber, the blood collection tube is made of high density polyethylene, and the inner tube is sequentially filled with asymmetric polysulfone filtration. Membrane, polyethylene terephthalate fiber filter and filter paper buffer coated with lithium heparin, sprayed with heparin lithium anticoagulant on the inner tube wall, the inner tube prepared above is loaded into the blood collection tube body, and the rubber stopper is inserted Place it on top of the blood collection tube body, put it into the vacuum machine and preset the vacuum and then press it.
实施例 4  Example 4
以聚乙烯对苯二甲酸酯制作采血管管体, 溴化丁基橡胶制作采血管胶塞, 聚丙烯制作采血管内管, 内管依次装填不对称聚砜过滤膜、 聚乙烯对苯二甲酸 酯纤维滤芯和喷涂有乙二胺四乙酸三钾的滤纸缓冲纸片, 内管管壁喷涂乙二胺 四乙酸三钾抗凝剂, 将上述制作好的内管装入采血管管体, 将胶塞置于采血管 管体上方, 放入真空机内预置真空后压塞。  The vascular tube body is made of polyethylene terephthalate, the vascular rubber plug is made of bromobutyl rubber, the inner tube of the blood collection tube is made of polypropylene, and the inner tube is sequentially filled with asymmetric polysulfone filter membrane and polyethylene terephthalic acid. The acid ester fiber filter element and the filter paper buffer paper coated with the tripotassium EDTA, the inner tube wall is sprayed with the anti-coagulant of ethylenediaminetetraacetic acid, and the prepared inner tube is loaded into the blood collection tube body. Place the rubber stopper on top of the blood collection tube body, put it into the vacuum machine and preset the vacuum and then press it.
实施例 5  Example 5
以硼酸盐玻璃制作采血管管体, 溴化丁基橡胶制作采血管胶塞, 高透明聚 丙烯制作采血管内管, 内管依次装填不对称聚砜过滤膜、 聚乙烯对苯二甲酸酯 纤维滤芯和喷涂有柠檬酸钠抗凝剂的滤纸片, 内管管壁喷涂柠檬酸钠抗凝剂, 将上述制作好的内管装入采血管管体, 将胶塞置于采血管管体上方, 放入真空 机内预置真空后压塞。 The blood vessel tube is made of borate glass, the vascular rubber plug is made of bromobutyl rubber, the blood collection tube is made of high transparent polypropylene, and the inner tube is sequentially filled with asymmetric polysulfone filter membrane and polyethylene terephthalate. a fiber filter and a filter paper coated with sodium citrate anticoagulant, spraying a sodium citrate anticoagulant on the inner tube wall, loading the prepared inner tube into the blood collection tube body, and placing the rubber plug on the blood collection tube body Above, put vacuum After the vacuum is preset in the machine, the plug is pressed.
实施例 6  Example 6
以聚乙二醇改性的聚乙烯对苯二甲酸酯制作采血管管体, 卤化丁基橡胶制 作采血管胶塞, 低密度聚乙烯制作采血管内管, 内管依次装填不对称聚砜过滤 膜、 聚乙烯对苯二甲酸酯纤维滤芯和喷涂有水蛭素抗凝剂的涤纶膜制成的缓冲 片, 内管管壁喷涂水蛭素抗凝剂, 将上述制作好的内管装入采血管管体, 将胶 塞置于采血管管体上方, 放入真空机内预置真空后压塞。  Polyethylene terephthalate modified polyethylene terephthalate is used to make blood vessel tube, halogenated butyl rubber is used to make blood vessel rubber plug, low density polyethylene is used to make blood collection tube, and inner tube is loaded with asymmetric polysulfone filtration. a buffer sheet made of a film, a polyethylene terephthalate fiber filter and a polyester film coated with a hirudin anticoagulant, and a hydroquinone anticoagulant is sprayed on the inner tube wall, and the prepared inner tube is loaded into the tube. In the vascular tube body, the rubber stopper is placed above the blood collection tube body, and placed in a vacuum machine to preset a vacuum and then tamped.
实施例 7  Example 7
以聚乙烯对苯二甲酸酯制作采血管管体, 卤化丁基橡胶制作采血管胶塞, 高密度聚乙烯制作采血管内管, 内管依次装填不对称聚砜过滤膜、 聚乙烯对苯 二甲酸酯纤维滤芯和喷涂有草酸钾抗凝剂和氟化钠稳定剂的涤纶膜制成的缓冲 片, 内管管壁喷涂草酸钾抗凝剂和氟化钠稳定剂, 将上述制作好的内管装入采 血管管体, 将胶塞置于采血管管体上方, 放入真空机内预置真空后压塞。  The valve tube is made of polyethylene terephthalate, the vascular rubber plug is made of halogenated butyl rubber, the inner tube of blood collection tube is made of high density polyethylene, and the inner tube is loaded with asymmetric polysulfone filter membrane and polyethylene terephthalate. a buffer sheet made of a polyesterate fiber filter and a polyester film coated with potassium oxalate anticoagulant and sodium fluoride stabilizer, sprayed with potassium oxalate anticoagulant and sodium fluoride stabilizer on the inner tube wall, which is prepared as described above. The inner tube is loaded into the blood collection tube body, and the rubber stopper is placed above the blood collection tube body, and placed in a vacuum machine to preset a vacuum and then pressed.
分别按上述实施例制作好真空采血管, 使用静脉穿刺针穿刺静脉, 分别足 量采血, 采血后直立放置 15分钟, 拨出采血管胶塞与内管一并弃去。 观察采血 管管体内收集到的血浆为淡黄色、 透明或半透明液体。  According to the above examples, the vacuum blood collection tube was prepared, and the vein was punctured with a venous puncture needle, and blood was collected separately. After the blood collection, the blood was placed upright for 15 minutes, and the blood collection rubber plug and the inner tube were discarded. Observe that the blood collected in the blood collection tube is a pale yellow, transparent or translucent liquid.

Claims

1. 一种可直接分离血浆的真空采血管, 包括采血管管体、 内管、 胶塞、 滤 芯, 其特征在于所述的采血管管体 (1 ) 的顶部设有胶塞 (9), 胶塞 (9) 的结 构近似为插头形状, 胶塞结构的上部中央设有半圆形凹槽, 胶塞 (9) 下部左右 两端嵌入连接采血管管体 (1 ) 和采血管管体 (1 ) 中的采血管内管 (6), 采血 管内管 (6) 的底部中间设有血浆流出口 (10), 血浆流出口的下部为血浆收集 室 (2 ), 在采血管内管 (6) 血浆流出口的上部设有过滤膜 (3 ), 过滤膜 (3) 的上部设有滤芯 (4), 所述的滤芯 (4) 上还设有缓冲片 (5), 由此在采血管内 管 (6) 内构成由滤芯 (4) 上部至采血管内管 (6) 顶部之间的采血室 (8), 在 采血管内管 (6) 的内壁上设有一层抗凝剂 (7), 所述的抗凝剂包括肝素钠、 肝 素锂、 柠檬酸钠、 乙二胺四乙酸二钾、 乙二胺四乙酸三钾、 乙二胺四乙酸二钠、 草酸钾、 草酸钠、 水蛭素及目标检测物的稳定剂。 A vacuum blood collection tube capable of directly separating plasma, comprising a blood collection tube body, an inner tube, a rubber stopper, and a filter element, wherein the blood collection tube body (1) is provided with a rubber stopper (9) at the top thereof. The structure of the rubber plug (9) is approximately plug shape, and the upper center of the rubber plug structure is provided with a semi-circular groove, and the left and right ends of the rubber plug (9) are embedded and connected with the blood collection tube body (1) and the blood collection tube body ( 1) in the endovascular tube (6), in the middle of the bottom of the blood collection tube (6) is provided with a plasma outflow port (10), the lower part of the plasma outflow port is a plasma collection chamber (2), in the endovascular tube (6) plasma The upper part of the outflow port is provided with a filter membrane (3), the upper part of the filter membrane (3) is provided with a filter element (4), and the filter element (4) is further provided with a buffer sheet (5), thereby being in the inner tube of the blood collection tube ( 6) The blood collection chamber (8) between the upper part of the filter element (4) and the top of the inner tube (6) of the blood collection tube is provided, and an anticoagulant (7) is arranged on the inner wall of the inner tube (6) of the blood collection tube, Anticoagulants include sodium heparin, lithium heparin, sodium citrate, dipotassium edetate, B Amine tripotassium EDTA, disodium edetate, potassium oxalate, sodium oxalate, hirudin and stabilizer detection target object.
2. 如权利要求书 1所述的一种可直接分离血浆的真空采血管, 其特征在于 所述的采血管管体 (1 ) 由玻璃、 聚酯塑胶、 高分子材料中的一种或一种以上复 合制成。 2. A vacuum blood collection tube capable of directly separating plasma according to claim 1, wherein said blood collection tube body (1) is one or one of glass, polyester plastic, and polymer material. More than one kind of compound.
3. 如权利要求书 1所述的一种可直接分离血浆的真空采血管, 其特征在于 所述的采血管内管 (6) 其管体的制造材料主要为高分子材料, 包括高密度聚乙 烯、 低密度聚乙烯、 聚丙烯、 聚苯乙烯、 聚碳酸酯、 聚乙烯、 对苯二甲酸酯。 3. A vacuum blood collection tube capable of directly separating plasma according to claim 1, wherein said blood collection tube (6) is made of a polymer material, including high density polyethylene. , low density polyethylene, polypropylene, polystyrene, polycarbonate, polyethylene, terephthalate.
4. 如权利要求书 1所述的一种可直接分离血浆的真空采血管, 其特征在于 所述的滤芯(4)的制造材料包括超细植物纤维、人工合成纤维、聚酯烧结产物、 滤纸, 优选聚丙烯合成纤维、 聚乙烯合成纤维、 聚乙烯对苯二甲酸酯合成纤维、 羧甲基纤维素、 微晶纤维素、 经加工的植物纤维。 4. A vacuum blood collection tube capable of directly separating plasma according to claim 1, wherein said filter element (4) is made of ultrafine plant fibers, synthetic fibers, polyester sintered products, filter paper. Preferred are polypropylene synthetic fibers, polyethylene synthetic fibers, polyethylene terephthalate synthetic fibers, carboxymethyl cellulose, microcrystalline cellulose, and processed plant fibers.
5. 如权利要求书 1所述的一种可直接分离血浆的真空采血管, 其特征在于 所述的胶塞 (9 ) 的材料包括天然橡胶、 卤化丁基橡胶、 合成橡胶、 热塑性弹性 体。 A vacuum blood collection tube capable of directly separating plasma according to claim 1, wherein the material of the rubber stopper (9) comprises natural rubber, halogenated butyl rubber, synthetic rubber, and thermoplastic elastomer.
6. 如权利要求书 1所述的一种可直接分离血浆的真空采血管, 其特征在于 所述的滤芯 (4 ) 上方设有一层缓冲片 (5), 缓冲片的缓冲材料包括冻干的抗凝 剂压片、 尼龙膜、 滤纸、 合成纤维素膜, 缓冲片上还设有一层涂布的抗凝剂。 6. A vacuum blood collection tube capable of directly separating plasma according to claim 1, wherein said filter element (4) is provided with a buffer sheet (5), and the buffer material of the buffer sheet comprises lyophilized Anticoagulant tablet, nylon membrane, filter paper, synthetic cellulose membrane, and a coated anticoagulant on the buffer sheet.
7. 如权利要求书 1所述的一种可直接分离血浆的真空采血管, 其特征在于 所述的过滤膜 (3 ) 为微孔滤膜, 其制造材料包括醋酸纤维素、 硝酸纤维素、 混 合纤维素酯、 尼龙 6、 尼龙 66、 聚偏氟乙烯、 聚四氟乙烯、 聚醚砜、 聚丙烯材 料。 7. A vacuum blood collection tube capable of directly separating plasma according to claim 1, wherein said filtration membrane (3) is a microporous membrane, and the material for which the preparation comprises cellulose acetate, nitrocellulose, Mixed cellulose ester, nylon 6, nylon 66, polyvinylidene fluoride, polytetrafluoroethylene, polyethersulfone, polypropylene material.
8. 一种可直接分离血浆的真空采血管的方法, 其特征在于该方法利用血浆 与血液有形成分的物理形态不同, 在采血管内部安装一个装有滤芯的内管, 把 采血管内部分隔成采血室和血浆收集室, 通过内置在内管的抗凝剂和滤芯, 使 流入采血室的血液不会凝固, 血液的有形成分被滤芯挡在其上部, 即采血室, 而血浆成分可以顺利通过滤芯流入采血管的下部, 即血浆收集室, 从而使血浆 与血液的有形成分分开, 拔出连接在内管上端的采血管胶塞弃去整个内管即可 使用血浆收集室的血浆标本用于各种检测; 在内管中依次装填过滤膜、 滤芯和 喷有抗凝剂的滤纸缓冲片, 内管管壁喷涂抗凝剂, 将上述制作好的内管装入采 血管管体, 将胶塞置于采血管管体上方, 放入真空机内预置真空后压塞。 8. A method for directly separating plasma vacuum blood collection tubes, characterized in that the method utilizes a different physical form of plasma and blood formation, and an inner tube equipped with a filter element is installed inside the blood collection tube to separate the blood collection tube interior The blood collection chamber and the plasma collection chamber pass through the anticoagulant and the filter element built in the inner tube, so that the blood flowing into the blood collection chamber does not solidify, and the formed part of the blood is blocked by the filter element in the upper part thereof, that is, the blood collection chamber, and the plasma component can be Smoothly through the filter element into the lower part of the blood collection tube, that is, the plasma collection chamber, so that the plasma and blood formation are separated. Pull out the blood collection tube plug connected to the upper end of the inner tube and discard the entire inner tube to use the plasma of the plasma collection chamber. Specimens are used for various tests; the filter membrane, the filter element and the filter paper buffer sheet sprayed with anticoagulant are sequentially loaded into the inner tube, the anti-coagulant is sprayed on the inner tube wall, and the prepared inner tube is loaded into the blood collection tube body. Place the rubber stopper on top of the blood collection tube body, put it into the vacuum machine and preset the vacuum and then press it.
9. 如权利要求 8所述的一种可直接分离血浆的真空采血管的方法, 其特征 在于所述的采血管管体以硼酸盐玻璃制作, 采血管胶塞以氯化丁基橡胶制作, 采血管内管以高密度聚乙烯制作, 所述的过滤膜为不对称聚砜过滤膜, 所述 滤芯为聚乙烯对苯二甲酸酯纤维滤芯, 所述的缓冲片为喷有乙二胺四乙酸二 抗凝剂的滤纸缓冲片, 所述的内管管壁喷涂乙二胺四乙酸二钾抗凝剂。 9. The method of claim 8, wherein the blood collection tube body is made of borate glass, and the blood collection tube is made of chlorinated butyl rubber. , The blood collection tube is made of high-density polyethylene, the filter membrane is an asymmetric polysulfone filter membrane, the filter element is a polyethylene terephthalate fiber filter element, and the buffer sheet is sprayed with ethylene diamine. A filter paper buffer sheet of the acetic acid secondary anticoagulant, and the inner tube wall is sprayed with an anti-coagulant of ethylenediaminetetraacetate.
PCT/CN2012/079961 2012-07-31 2012-08-10 Vacuum blood collection pipe capable of directly separating plasma and method thereof WO2014019254A1 (en)

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