Body fluid collection device and body fluid collection device kit

Abstract

A body fluid collecting device comprises a containing part with an opening end and a cover body covering the opening end, and the containing part is configured to contain a body fluid sample. The body fluid collecting device is a vacuum tube, the cover body is a puncturable cover body, the puncturable cover body seals the open end, and the containing part is selectively communicated with the outside of the body fluid collecting device through the puncturable cover body. The containing part comprises an inner bottom face opposite to the open end and an inner side face connected with the inner bottom face, the inner side face comprises a first area and a second area which are connected, the first area and the second area are annular, and the first area is closer to the open end than the second area. The body fluid collecting device further comprises a functional layer, the functional layer at least covers the first area and / or the inner bottom face, and the functional layer is configured to make contact with the body fluid sample and react with the body fluid sample. The utility model further provides a body fluid collecting device kit.

Description

Technical Field

[0001] The present application relates to the field of biochemical detection, and in particular to a body fluid collection device and a body fluid collection device kit. Background Art

[0002] Sampling (such as blood sampling) is the first step in testing human health indicators. A safe, convenient and effective sampling method can not only protect the subject from infection and harm during the sampling process, but also improve the accuracy of the test after sampling. However, when taking blood samples, it is necessary to pierce the human skin with a puncture piece, squeeze the blood out of the skin and then scrape it into the blood collector. If the time from the blood being squeezed out of the skin to being collected in the blood collector is long, blood coagulation is likely to occur, reducing the quality of blood collection. Utility Model Content

[0003] In order to solve the above deficiencies, it is necessary to provide a body fluid collection device and a body fluid collection device kit that can improve the quality of body fluid samples.

[0004] The present application provides a body fluid collection device, comprising a receiving portion having an open end and a cover body covering the open end, wherein the receiving portion is configured to receive a body fluid sample. The body fluid collection device is a vacuum tube, and the cover body is a puncturable cover body, wherein the puncturable cover body seals the open end, and the receiving portion is selectively connected to the outside of the body fluid collection device through the puncturable cover body. The receiving portion comprises an inner bottom surface opposite to the open end and an inner side surface connected to the inner bottom surface, wherein the inner side surface comprises a first area and a second area connected to each other, wherein the first area and the second area are both annular, and the first area is closer to the open end than the second area. The body fluid collection device also comprises a functional layer, wherein the functional layer at least covers the first area and / or the inner bottom surface, and the functional layer is configured to contact and react with the body fluid sample.

[0005] In some possible implementations, the second area and the inner bottom surface are both exposed from the functional layer.

[0006] In some possible implementations, the functional layer also covers the second area.

[0007] In some possible implementations, the cover body includes a first cover portion and a second cover portion connected to each other, the first cover portion extends into the accommodating portion and blocks the opening end, and the second cover portion is disposed outside the accommodating portion and abuts against the opening end. At least part of the functional layer is exposed from the first cover portion.

[0008] In some possible implementations, a recess is provided on a surface of the second cover portion facing away from the first cover portion.

[0009] In some possible implementations, the cover has a predetermined color, and the predetermined color is configured to indicate the type of the body fluid collection device.

[0010] In some possible implementations, the body fluid collection device is a vacuum tube, and the cover is a puncturable cover.

[0011] In some possible implementations, the body fluid collection device is a serum separation tube, and the functional layer is a coagulant layer.

[0012] In some possible implementations, the body fluid collection device is an emergency biochemical tube, and the functional layer is a lithium heparin layer or a sodium heparin layer.

[0013] In some possible implementations, the body fluid collection device is a routine blood test tube, and the functional layer is a tripotassium salt layer of ethylenediaminetetraacetic acid, a dipotassium salt layer of ethylenediaminetetraacetic acid, or a disodium salt layer of ethylenediaminetetraacetic acid.

[0014] In some possible implementations, the body fluid collection device is a nucleic acid detection tube, and the functional layer is a dipotassium salt layer of ethylenediaminetetraacetic acid.

[0015] In some possible implementations, the body fluid collection device is a coagulation function detection tube, and the functional layer is a sodium citrate layer.

[0016] In some possible implementations, the body fluid collection device is an erythrocyte sedimentation tube, and the functional layer is a sodium citrate layer.

[0017] In some possible implementations, the body fluid collection device is a trace element tube, and the functional layer is a lithium heparin layer.

[0018] The present application also provides a body fluid collection device kit, comprising at least two body fluid collection devices as described above. Different body fluid collection devices have different functional layers, and different body fluid collection devices have different cover colors.

[0019] In the present application, when the functional layer covers the first area, the body fluid collection device can be placed vertically with the cover facing downwards during use. When the body fluid sample enters the receiving portion through the opening end, it will preferentially contact the first area on the inner side of the receiving portion, so that the functional layer on the first area can quickly contact the body fluid sample and react with the body fluid sample, thereby improving the situation where the body fluid sample has a long time from flowing out of the barrier to entering the body fluid collection device, resulting in a decrease in the quality of the body fluid sample (such as blood coagulation). When the functional layer covers the inner bottom surface, the body fluid collection device can also be placed vertically with the cover facing upwards during use. When the body fluid sample enters the receiving portion through the opening end, it will preferentially contact the inner bottom surface of the receiving portion under the action of gravity, so that the functional layer on the inner bottom surface can quickly contact the body fluid sample and react with the body fluid sample, which can also improve the quality of the body fluid sample. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 This is a schematic diagram of the structure of a body fluid collection device provided in one embodiment of the present application.

[0021] Figure 2 for Figure 1 An exploded view of the body fluid collection device shown.

[0022] Figure 3 for Figure 1 The body fluid collection device shown is a cross-sectional view along the cutting line III-III in some embodiments.

[0023] Figure 4 for Figure 1 The body fluid collection device shown is a cross-sectional view along the cutting line III-III in some other embodiments.

[0024] Main component symbols

[0025] Accommodation portion 10

[0026] Open end 11

[0027] Inner bottom surface 12

[0028] Inside side 13

[0029] Cover 20

[0030] The first cover portion 21

[0031] Second cover portion 22

[0032] Functional layer 30

[0033] First Area 131

[0034] Second area 132

[0035] Body fluid collection device 100

[0036] Recess 220

[0037] Space

[0038] Central axis O

[0039] The following specific implementation methods will further illustrate the present application in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION

[0040] The technical solutions in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all of the embodiments.

[0041] It should be noted that when a component is considered to be "set on" another component, it can be directly set on the other component or there can be a central component at the same time; when a component is considered to be "installed on" another component, it can be directly installed on the other component or there can be a central component at the same time. The term "and / or" used in this article includes all and any combinations of one or more related listed items.

[0042] See also Figures 1 to 3 In one embodiment of the present application, a body fluid collection device 100 is provided, which can be used in conjunction with a body fluid sampling device (not shown). The body fluid sampling device can be used to pierce a barrier (such as human skin) to sample body fluids, and the body fluid sample can be a blood sample or an interstitial fluid sample. The body fluid collection device 100 is used to connect to the body fluid sampling device and collect body fluid samples from the body fluid sampling device.

[0043] The body fluid collection device 100 comprises a receiving portion 10 having an open end 11 and a cover 20 covering the open end 11. The cover 20 can seal the receiving portion 10, wherein the cover 20 can be detachably connected to the open end 11. The receiving portion 10 is configured to receive a body fluid sample.

[0044] The body fluid collection device 100 is a vacuum tube, so that there is a pressure difference between the inside and outside of the body fluid collection device 100, and the cover body 20 is a puncturable cover body. The receiving portion 10 can be selectively connected to the outside of the body fluid collection device 100 (especially to the above-mentioned body fluid sampling device) through the puncturable cover body. Specifically, before the body fluid sample needs to be collected, a puncture member (not shown) can be passed through the cover body 20, and the puncture member is connected to the body fluid sampling device. In this way, after the body fluid sampling device punctures the barrier, the outflowing body fluid sample can enter the receiving portion 10 of the body fluid collection device 100 through the puncture member under the drive of the pressure difference, avoiding the risk of hemolysis caused by scraping the body fluid sample (such as a blood sample) into the receiving portion 10. Among them, the receiving portion 10 can be made of glass or plastic. The cover body 20 can be made of silicone. The receiving portion 10 and the cover body 20 can be molded separately by injection molding, thereby reducing the production cost.

[0045] The accommodating portion 10 includes an inner bottom surface 12 opposite to the opening end 11 and an inner side surface 13 connected to the inner bottom surface 12. The inner bottom surface 12 and the inner side surface 13 together constitute a space S for accommodating a body fluid sample, and one end of the inner side surface 13 away from the inner bottom surface 12 is surrounded to form the opening end 11. The inner side surface 13 includes a first area 131 and a second area 132, defining that the body fluid collection device 100 has a central axis O, and the first area 131 and the second area 132 are connected in the extension direction of the central axis O. The first area 131 and the second area 132 are both annular. The first area 131 is connected to the opening end 11, and the second area 132 is connected to the inner bottom surface 12, so the first area 131 is closer to the opening end 11 and the cover body 20 than the second area 132.

[0046] like Figure 3 As shown, the body fluid collection device 100 further includes a functional layer 30, which is disposed on the first region 131 and can cover the first region 131 along the circumferential direction, and the second region 132 and the inner bottom surface 12 are not provided with the functional layer 30, that is, the second region 132 and the inner bottom surface 12 are both exposed to the functional layer 30. Figure 4 As shown, the functional layer 30 can also be provided on the inner bottom surface 12, and the functional layer 30 is not provided on the first area 131 and the second area 132, that is, the first area 131 and the second area 132 are both exposed to the functional layer 30. The functional layer 30 can be formed by spraying an additive solution and curing it. The functional layer 30 is configured to contact and react with a body fluid sample. When in use, how the body fluid collection device 100 is placed can be determined according to the setting of the functional layer 30. For example, when the functional layer 30 is provided on the first area 131, the body fluid collection device 100 can be placed vertically with the cover body 20 facing downward, and the puncture member passes through the cover body 20, so that the body fluid sample passes through the puncture member and enters the receiving portion 10 of the body fluid collection device 100. At this time, the body fluid sample will preferentially contact the first area 131 of the inner side surface 13 of the receiving portion 10, so that the functional layer 30 on the first area 131 can quickly contact the body fluid sample and react with the body fluid sample, thereby improving the situation where the body fluid sample flows out of the barrier and enters the body fluid collection device 100 for a long time, resulting in a decrease in sample quality (such as blood coagulation). For another example, when the functional layer 30 is arranged on the inner bottom surface 12, the body fluid collection device 100 can also be placed vertically with the cover body 20 facing upward, and the puncture member passes through the cover body 20, so that the body fluid sample passes through the puncture member and enters the receiving portion 10 of the body fluid collection device 100. At this time, the body fluid sample will preferentially contact the inner bottom surface 12 of the receiving portion 10 under the action of gravity, so that the functional layer 30 on the inner bottom surface 12 can quickly contact the body fluid sample and react with the body fluid sample, which can also improve the quality of the body fluid sample.

[0047] In some other embodiments, the functional layer 30 may also be disposed on the second region 132 , so that when a large amount of the collected body fluid sample is present, the functional layer 30 may fully contact the body fluid sample and react with the body fluid sample.

[0048] In some embodiments, the cover 20 includes a first cover portion 21 and a second cover portion 22 connected to each other. The first cover portion 21 extends into the receiving portion 10 and blocks the open end 11. The second cover portion 22 is disposed outside the receiving portion 10 and abuts against the open end 11, and the width of the second cover portion 22 is greater than the width of the first cover portion 21. At least part of the functional layer 30 is exposed from the first cover portion 21. That is, when the cover 20 is covered on the receiving portion 10, at least part of the functional layer 30 is exposed from the first cover portion 21 so that it can contact the body fluid sample entering the receiving portion 10. When spraying the additive solution, the additive solution can be sprayed on the entire first area 131, or the additive solution can be sprayed on part of the first area 131 (i.e., the first area 121 exposed to the first cover portion 21 after the cover 20 is covered). Among them, a recess 220 can be provided on the surface of the second cover portion 22 away from the first cover portion 21, thereby reducing the thickness of part of the second cover portion 22 to facilitate the puncture member to pass through the cover 20.

[0049] In some embodiments, the body fluid collection device 100 is a serum separation tube, and the functional layer 30 is a coagulant layer. The functional layer 30 can shorten the blood coagulation time and facilitate the rapid acquisition of serum. The body fluid collection device 100 can also be an emergency biochemical tube. In this case, the functional layer 30 is a heparin lithium layer or a heparin sodium layer. The functional layer 30 can prevent the formation of thrombin, play an anticoagulant role, and inhibit platelet aggregation. The body fluid collection device 100 can also be a blood routine tube. In this case, the functional layer 30 is an ethylenediaminetetraacetic acid tripotassium salt layer, an ethylenediaminetetraacetic acid dipotassium salt layer, or an ethylenediaminetetraacetic acid disodium salt layer. The ethylenediaminetetraacetic acid (EDTA) in the functional layer 30 can chelate with calcium ions in the blood sample to form a soluble calcium chelate, play an anticoagulant role, and inhibit platelet aggregation. The body fluid collection device 100 can also be a nucleic acid detection tube, in which case the functional layer 30 is a dipotassium salt layer of ethylenediaminetetraacetic acid, which can chelate with calcium ions in the blood sample to form a soluble calcium chelate, thereby playing an anticoagulant role. The body fluid collection device 100 can also be a coagulation function detection tube or an erythrocyte sedimentation tube, in which the functional layer 30 is a sodium citrate layer, which can combine with calcium ions in the blood sample to form a soluble calcium chelate, thereby playing an anticoagulant role. The body fluid collection device 100 can also be a blood glucose tube, in which case the functional layer 30 is composed of one of oxalate, ethylenediaminetetraacetic acid and heparin salt and fluoride (such as sodium fluoride), and the fluoride in the functional layer 30 can be used as an inhibitor to ensure the original properties of the blood sample, while blood cell metabolism is stagnant. The body fluid collection device 100 can also be a trace element tube, in which case the functional layer 30 is a lithium heparin layer, which can be used for the detection of trace elements and has no effect on sodium ions. The body fluid collection device 100 can also be an ACD tube. In this case, the functional layer 30 is composed of sodium citrate, citric acid and glucose. The sodium citrate in the functional layer 30 can play an anticoagulant role, and citric acid has a protective effect on the carbonization of glucose during disinfection, while glucose can prolong the storage time of red blood cells and improve hemolysis.

[0050] Among them, the cover 20 may have a predetermined color to indicate the type of the body fluid collection device 100. For example, when the body fluid collection device 100 is a serum separation tube, the cover 20 is red. When the body fluid collection device 100 is an emergency biochemistry tube, the cover 20 is green. When the body fluid collection device 100 is a blood routine test tube or a nucleic acid detection tube, the cover 20 is purple. When the body fluid collection device 100 is a coagulation function test tube, the cover 20 is light blue. When the body fluid collection device 100 is an erythrocyte sedimentation tube, the cover 20 is black. When the body fluid collection device 100 is a blood glucose tube, the cover 20 is gray. When the body fluid collection device 100 is a trace element tube, the cover 20 is dark blue or green. When the body fluid collection device 100 is an ACD tube, the cover 20 is golden yellow.

[0051] Another embodiment of the present application further provides a body fluid collection device kit (not shown), which includes at least two body fluid collection devices 100. Different body fluid collection devices 100 have different functional layers 30, that is, the body fluid collection device kit has different types of body fluid collection devices 100. Moreover, the cover bodies 20 of different body fluid collection devices 100 have different colors, thereby indicating different types of body fluid collection devices 100.

[0052] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present application and are not intended to limit it. Although the present application has been described in detail with reference to the preferred embodiments, a person of ordinary skill in the art should understand that the technical solution of the present application may be modified or replaced by equivalents without departing from the spirit and scope of the technical solution of the present application.

Claims

1. A body fluid collection device, comprising a receiving portion having an open end and a cover body covering the open end, wherein the receiving portion is configured to receive a body fluid sample, characterized in that: The body fluid collection device is a vacuum tube, the cover is a puncturable cover, the puncturable cover seals the open end, and the receiving portion is selectively connected to the outside of the body fluid collection device through the puncturable cover; The accommodating portion includes an inner bottom surface opposite to the opening end and an inner side surface connected to the inner bottom surface, the inner side surface includes a first area and a second area connected to each other, the first area and the second area are both annular, the first area is closer to the opening end than the second area, the body fluid collection device also includes a functional layer, the functional layer at least covers the first area and / or the inner bottom surface, and the functional layer is configured to contact and react with the body fluid sample.

2. The body fluid collection device according to claim 1, characterized in that: The second area and the inner bottom surface are both exposed on the functional layer; or, the functional layer also covers the second area.

3. The body fluid collection device according to claim 1, characterized in that: The cover body includes a first cover portion and a second cover portion connected to each other, the first cover portion extends into the accommodating portion and blocks the opening end, and the second cover portion is arranged outside the accommodating portion and abuts against the opening end; at least part of the functional layer is exposed from the first cover portion.

4. The body fluid collection device according to claim 3, characterized in that: A recess is provided on a surface of the second cover portion facing away from the first cover portion.

5. The body fluid collection device according to claim 1, characterized in that: The cover has a predetermined color configured to indicate a type of the bodily fluid collection device.

6. The body fluid collection device according to any one of claims 1 to 5, characterized in that: The body fluid collection device is a serum separation tube, and the functional layer is a coagulant layer.

7. The body fluid collection device according to any one of claims 1 to 5, characterized in that: The body fluid collection device is an emergency biochemical tube, and the functional layer is a heparin lithium layer or a heparin sodium layer.

8. The body fluid collection device according to any one of claims 1 to 5, characterized in that: The body fluid collection device is a routine blood test tube, and the functional layer is a tripotassium salt layer of ethylenediaminetetraacetic acid, a dipotassium salt layer of ethylenediaminetetraacetic acid, or a disodium salt layer of ethylenediaminetetraacetic acid.

9. The body fluid collection device according to any one of claims 1 to 5, characterized in that: The body fluid collection device is a nucleic acid detection tube, and the functional layer is a dipotassium salt layer of ethylenediaminetetraacetic acid.

10. The body fluid collection device according to any one of claims 1 to 5, characterized in that: The body fluid collection device is a coagulation function detection tube or an erythrocyte sedimentation tube, and the functional layer is a sodium citrate layer.

11. The body fluid collection device according to any one of claims 1 to 5, characterized in that: The body fluid collection device is a trace element tube, and the functional layer is a heparin lithium layer.

12. A body fluid collection device kit, characterized in that: It comprises at least two body fluid collection devices as described in any one of claims 1 to 11, different body fluid collection devices have different functional layers, and the covers of different body fluid collection devices have different colors.

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