WO2014019255A1

WO2014019255A1 - Vacuum blood collection pipe capable of directly separating serum and method thereof

Info

Publication number: WO2014019255A1
Application number: PCT/CN2012/079965
Authority: WO
Inventors: 朱德新
Original assignee: 上海科华检验医学产品有限公司
Priority date: 2012-07-31
Filing date: 2012-08-10
Publication date: 2014-02-06
Also published as: WO2014019254A1

Abstract

A vacuum blood collection pipe capable of directly separating serum 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 serum outlet (10) is disposed in the middle of the bottom of the blood collection inner pipe (6), and a lower portion of the serum outlet (10) is a serum collection chamber (2). A filtering film (3) is disposed at the upper portion of the serum 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 procoagulant (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 serum composite of blood, the serum can be rapidly separated, having the features of simpleness and convenience, safety and rapidness.

Description

Vacuum blood collection tube capable of directly separating serum and method thereof

[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 serum and a method thereof.

[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 instruments used in different detection indicators, venous blood specimens are classified into serum, plasma and whole blood according to their uses. The acquisition of serum specimens has traditionally been mainly carried out by means of centrifugation. After the blood is passed through a process of natural coagulation or coagulant catalyzed coagulation, the serum 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 serum. If separation of serum is required, it must be completed by a centrifuge after blood collection. Therefore, it takes a certain period of time after blood collection to allow the blood to completely coagulate before the serum can be separated by centrifugation. However, this technique has many shortcomings. If the centrifuge conditions are improperly controlled, hemolysis may occur, or the collection container may be damaged during centrifugation. Causes the specimen to leak or completely damage; In addition, during and after centrifugation, the serum and blood clot are mixed together, and under the action of centrifugal force or during storage, the substance in the red blood cells is released into the serum, thereby Final detection knot If it has an impact, it is not safe and reliable. 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 the serum, and provides a vacuum blood collection tube and a method thereof, which can directly separate serum by a novel structure, safety and reliability. To achieve the above object, a vacuum blood collection tube and a method thereof for directly separating serum are provided, including 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 The structure of the rubber plug 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 respectively connected with the blood collection tube connected with the blood collection tube body and the blood collection tube body, and blood is collected. A serum outflow port is arranged in the middle of the bottom of the tube, a serum collection chamber is arranged in the lower part of the serum outlet, a filter membrane is arranged on the upper part of the serum outlet of the blood collection tube, and a filter element is arranged on the upper part of the filter membrane, and the filter element is further provided There is a buffer sheet, thereby forming a blood collection chamber between the upper part of the filter element and the top of the inner tube of the blood collection tube in the inner tube of the blood collection tube, and a layer of coagulant is disposed on the inner wall of the inner tube of the blood collection tube, and the coagulant comprises thrombin and snake venom extract. , brain pity, ellagic acid, aminocaproic acid, neocoagulant, coagulant, rabbit brain powder, silica, kaolin, silicate, aluminate, or from the above materials Into derivatives composite. 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 manufacturing material of the filter element comprises ultrafine plant fiber, synthetic fiber, polyester sintered product, filter paper, preferably polypropylene synthetic fiber, polyethylene synthetic fiber, polyethylene terephthalate synthetic fiber, Carboxymethylcellulose, 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 cushioning material of the buffer sheet comprises a freeze-dried coagulant tablet, a white clay tablet, a coagulating ball, a nylon film, a filter paper, a synthetic cellulose film, and a buffer sheet. Layer coated coagulant. 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 serum vacuum blood collection tubes, characterized in that the method uses a different physical form of serum 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 serum collection chamber, through the coagulant and the filter element built in the inner tube, the blood flowing into the blood collection chamber is rapidly coagulated, and the blood clot after solidification is blocked by the filter element in the upper part thereof, that is, the blood collection chamber, and the serum component can pass smoothly. The filter element flows into the lower part of the blood collection tube, that is, the serum collection chamber, so that the serum and the blood clot are separated, and the blood collection gel plug connected to the upper end of the inner tube is discarded, and the whole inner tube can be discarded, and the serum sample of the serum collection chamber can be used for each In the inner tube, the filter membrane, the filter element and the filter paper buffer sheet sprayed with the anti-coagulant are sequentially loaded, the inner tube wall is sprayed with a coagulant, and the prepared inner tube is loaded into the blood collection tube body, and the rubber plug 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 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, and the buffer sheet is made of a freeze-drying accelerator. The punching piece, the inner tube wall is sprayed with a thrombin-containing coagulant. The invention has the advantages of utilizing the physical form difference of the blood forming component and the serum component, and rapidly separating the serum by the principle of the simple filtering method, and has the characteristics of simple, safe and rapid, and can be directly separated and qualified without using the conventional centrifugal machine. Serum 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.

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; Fig. 2 is a partial enlarged view of a portion of Fig. 1 of the present invention; as shown in the figure, Fig. 1: 1. Blood collection tube body 2. Serum Collection chamber 3. Filter membrane 4. Filter element 5. Buffer sheet 6. Blood collection tube 7. Coagulant 8. Blood collection chamber 9. Rubber stopper 10. Serum outlet; Designated Fig. 1 is a summary drawing of the present invention. [detailed description]

The invention will now be further described with reference to the drawings, the structure and principle of which is well understood by those skilled in the art. It is understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

The invention provides a vacuum blood collection tube capable of directly separating serum and a method thereof, without using the same The blood chamber and the serum collection chamber rapidly coagulate the blood flowing into the blood collection chamber through the coagulant and the filter element built in the inner tube of the blood collection tube, and the blood clot after solidification is blocked by the filter element in the upper part thereof, that is, the blood collection chamber, and the serum component can be Smoothly through the filter element into the lower part of the blood collection tube, that is, the serum collection chamber, so that the serum and the blood clot are separated, and the rubber plug attached to the blood collection tube attached to the upper end of the blood collection tube can be used to discard the entire blood collection tube to use the serum collection chamber. Serum samples are used for various tests.

As shown in FIG. 1 and FIG. 2, the invention mainly comprises a blood vessel tube body, a blood collection tube inner tube, a filter element and a rubber plug. The inside of the blood collection tube is divided into upper and lower parts by the inner tube, and the upper part is a blood collection chamber. The lower part is the serum collection room.

The blood vessel tube body is made of glass, plastic or other polymer material, and is a round bottom or a pointed bottom, flat bottom tubular structure, one end is closed, and the other end is 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 a hollow T-shaped structure, and the lower part is provided with a serum outflow port; 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 serum can be filtered, and other blood components and coagulant components cannot be passed. The inner wall of the inner tube is coated with a coagulant. After the blood enters the inner tube, it can be rapidly coagulated under the action of the coagulant. The coagulant can also be used. The spray is placed on the upper part of the filter element on the other material; the buffer material is placed on the upper part of the filter element as a coagulant carrier, the filter is 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 serum. The rubber plug of the blood collection tube 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 of the blood collection tube bulges or the safety head cover is placed outside, and is easily pulled out after use, and a circular groove is opened in the middle of the tube cover to facilitate puncture of the blood collection needle during blood collection; the rubber stopper is in contact with the tube body The part has two levels. The outer diameter of the previous layer is matched with 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, which can ensure the filtration in the serum. The rubber plug is then withdrawn from the blood collection tube body along with the entire inner tube.

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. The material for manufacturing the inner tube body includes a high-density polyethylene, a low-density polyethylene, a polypropylene, a polystyrene, a polycarbonate, a polyethylene terephthalate or the like, preferably a 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 is easily removed from the blood collection tube after the serum is filtered on the other hand.

Coagulants sprayed on the inner wall of the inner tube include thrombin, snake venom extract, brain pity, ellagic acid, aminocaproic acid, neocoagulant, coagulant, rabbit brain powder, silica, kaolin, silicate, Aluminate, or a derivative or complex synthesized by the above materials, preferably thrombin, because it not only has a fast coagulation rate, but also does not affect the subsequent detection index of the obtained serum.

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. The material for manufacturing the rubber plug of the blood collection tube includes natural rubber, halogenated butyl rubber, synthetic rubber, thermoplastic elastomer, preferably halogenated butyl rubber, which is not only easy to shape, but also has sufficient elasticity to effectively ensure the preset vacuum degree of the blood collection tube. It is also easy to pull out after use.

A buffer material may be attached to the filter element, and the material is coated with a coagulant, so that the blood flowing into the blood collection tube first can be quickly mixed with the coagulant, which is beneficial to rapid blood coagulation. Cushioning material including lyophilization Coagulant tablet, kaolin tablet, condensed pellet, nylon membrane, filter paper, synthetic cellulose membrane, preferably prepared by lyophilization of thrombin-containing coagulant, by brain pity and white A condensing sphere or a coagulating sheet made of a clay mixture. The buffering material prevents the blood from flowing directly into the filter core without contacting the coagulant sprayed on the tube wall when it initially flows into the blood collection chamber, making it difficult for the blood to coagulate rapidly. Causes serum to be unable to separate quickly. 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 enough space between the lower part of the filter element and the bottom of the blood collection tube, otherwise the filtered serum cannot be accommodated.

The invention can realize the direct separation of qualified blood serum without using a centrifuge after blood collection by the above design.

Example 1

The blood vessel tube is made of borate glass, the rubber plug of the blood collection tube is made of chlorobutyl rubber, the inner tube of the blood collection tube is made of high density polyethylene, and the inner tube is sequentially filled with asymmetric polysulfone filter membrane and polyethylene terephthalic acid. An ester fiber filter element and a buffer sheet made of a lyophilized coagulant, a thrombin-containing coagulant is sprayed on the inner tube wall, and the prepared inner tube is loaded into the blood collection tube body, and the rubber stopper is placed on the blood collection tube Above the pipe body, put it into the vacuum machine and preset the vacuum and then press it.

Example 2

The blood vessel tube is made of polyethylene terephthalate, and the rubber plug of the blood collection tube is made of chlorobutyl rubber. High-density polyethylene is used to make the inner tube of the blood collection tube. The inner tube is sequentially filled with an asymmetric polysulfone filter membrane, a polyethylene terephthalate fiber filter element, and a buffer sheet made of a freeze-dried accelerator. The inner tube wall is sprayed with coagulation. Enzyme coagulant, the above prepared 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 embossed.

Example 3

Polyethylene glycol modified polyethylene terephthalate is used to make blood vessel tube, chlorinated butyl rubber is used to make blood vessel plug, high density polyethylene is used to make blood collection tube, and inner tube is loaded with asymmetric polysulfone. a filter membrane, a polyethylene terephthalate fiber filter and a buffer sheet made of a freeze-dried accelerator, a thrombin-containing coagulant sprayed on the inner tube wall, and the prepared inner tube is loaded into the blood collection tube The tube body is placed on the upper part of the blood collection tube body, and placed in a vacuum machine to preset a vacuum and then tamped.

Example 4

The valve tube is made of polyethylene terephthalate, the rubber plug of the blood collection tube 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 terephthalate. a formate fiber filter element and a buffer sheet made of brain pity and white clay, and a thrombin-containing coagulant is sprayed on the inner tube wall, and the prepared inner tube is loaded into the blood collection tube body, and the rubber stopper is placed. Above the blood collection tube body, put it into the vacuum machine and preset the vacuum and then press it.

Example 5

The blood vessel tube is made of borate glass, the rubber plug of the blood collection tube is made of bromobutyl rubber, the inner tube of blood collection tube is made of high transparent polypropylene, and the inner tube is sequentially filled with asymmetric polysulfone filter membrane and polyethylene terephthalic acid. The ester fiber filter element and the filter paper coated with the coagulant, the inner tube wall is sprayed with a thrombin-containing coagulant, and the prepared inner tube is loaded into the blood collection tube body, and the rubber plug is placed above the blood collection tube body. , put in the vacuum machine to preset the vacuum and then press the plug.

Example 6 Polyethylene terephthalate modified polyethylene terephthalate is used to make blood vessel tube, halogenated butyl rubber is used to make blood vessel plug, low density polyethylene is used to make blood collection tube, and inner tube is loaded with asymmetric polysulfone. a filter film, a polyethylene terephthalate fiber filter and a buffer film made of a polyester film coated with a coagulant, and a thrombin-containing coagulant is sprayed on the inner tube wall to load the prepared inner tube The blood vessel tube is placed, and the rubber stopper is placed above the blood collection tube body, and placed in a vacuum machine to preset a vacuum and then embossed.

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. The serum collected in the blood collection tube was observed to be pale yellow, clear and transparent.

Claims

A vacuum blood collection tube capable of directly separating serum, 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) The inner tube of the blood collection tube (6), the middle of the bottom of the blood collection tube (6) is provided with a serum outlet (10), the lower part of the serum outlet is a serum collection chamber (2), and the inner tube of the blood collection tube (6) a filter membrane (3) is disposed on an upper portion of the outlet, a filter cartridge (4) is disposed on an upper portion of the filter membrane (3), and a buffer sheet (5) is further disposed on the filter cartridge (4), thereby adopting a blood vessel inner 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 a layer of coagulant (7) is further disposed on the inner wall of the inner tube (6) of the blood collection tube. Coagulants include thrombin, snake venom extract, brain pity, ellagic acid, aminocaproic acid, neocoagulant, coagulant, rabbit brain powder, silica, kaolin, silicate, aluminate , or a derivative or complex synthesized from the above materials.

2. A vacuum blood collection tube capable of directly separating serum 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. A vacuum blood collection tube capable of directly separating serum 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. A vacuum blood collection tube capable of directly separating serum 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. A vacuum blood collection tube capable of directly separating serum according to claim 1, wherein said rubber stopper (9) is made of natural rubber, halogenated butyl rubber, synthetic rubber, thermoplastic elastomer. .

6. A vacuum blood collection tube capable of directly separating serum 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 The coagulant tablet, the kaolin tablet, the coagulating ball, the nylon membrane, the filter paper, the synthetic cellulose film, and the buffer sheet are further provided with a layer of coated coagulant.

7. A vacuum blood collection tube capable of directly separating serum 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. A method for directly separating serum from a blood collection tube, characterized in that the method utilizes a physical form in which serum and blood are formed, and an inner tube equipped with a filter element is installed inside the blood collection tube to separate the blood collection tube inside. In the blood collection chamber and the serum collection chamber, the blood flowing into the blood collection chamber is rapidly coagulated by the coagulant and the filter element built in the inner tube, and the coagulated blood clot is blocked by the filter element in the upper part thereof, that is, the blood collection chamber, and the serum component can be Smoothly through the filter element into the lower part of the blood collection tube, that is, the serum collection chamber, so that the serum and the blood clot are separated, and the blood collection tube attached to the upper end of the inner tube is removed, and the whole inner tube can be discarded to use the serum sample of the serum collection chamber. In various tests; in the inner tube, the filter membrane, the filter element and the filter paper buffer sheet sprayed with the anti-coagulant are sequentially loaded, the inner tube wall is sprayed with a coagulant, and the prepared inner tube is loaded into the blood collection 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.

9. A method for directly separating serum from a blood collection tube according to claim 8, wherein said 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, and the buffer sheet is promoted by freeze-drying. A buffer sheet made of a coagulant, and the inner tube wall is sprayed with a thrombin-containing coagulant.