WO2019107509A1

WO2019107509A1 - Blood test container

Info

Publication number: WO2019107509A1
Application number: PCT/JP2018/044070
Authority: WO
Inventors: 康雄喜島; 和彦有岡
Original assignee: ジャパン・メディカル・リーフ株式会社
Priority date: 2017-12-01
Filing date: 2018-11-29
Publication date: 2019-06-06
Also published as: JP6480551B1; JP2019100858A

Abstract

[Problem] To perform, with the same accuracy as current tests and using blood collected once from one blood collection tube, a test based on a blood plasma component and a test based on a blood cell component, and to enable tests to be easily performed with good accuracy even when using self-collected blood. [Solution] A blood collection bottle 1 is formed from a bottomed cylindrical container with an open distal end 3, and a separating agent 15 is applied to the inner circumferential wall thereof. A separation float 7 is movably accommodated within the blood collection bottle 1, and a cup 9 obtained by spherically notching a surface that receives blood 21 is formed on the separation float 7. The center portion of the separation float 7 is provided with a communication hole 11, and the cup 9 and a bottom surface 5a of the blood collection bottle 1 are in communication with one another via the communication hole 11. A bottom-side opening surface 13 of the blood collection bottle 1 is formed by enlarging the communication hole 11. To separate the blood 21, the separating agent 15 adheres to the bottom surface of the separation float 7 and the surface of the enlarged hole 13, and the upper portion and lower portion within the blood collection bottle 1 are thus completely hermetically sealed with the separation float 7 as a boundary therebetween. Thus, two blood components can be collected and measured with high accuracy.

Description

Blood test container

The present invention relates to a blood separation container used for blood tests.

Conventionally, when performing a blood test, a needle is usually inserted into a vein, a 5 cc blood is collected, the collected blood is centrifuged, the serum or plasma component is removed, and the target test item is examined. It was

Medical examination blood tests use serum and plasma components for most examination items, but only HbA1c uses blood cell components. For example, in a blood glucose level test for a diabetes test, it is necessary to test not only the blood glucose level of the plasma component but also the blood cell component HbA1c (hemoglobin A1c) reflecting the past average blood glucose level.
In such a case, two blood samples were taken, one for collecting the plasma component and the other for collecting the blood cell component.

Blood collection is performed by inserting a needle into a vein. If there is nerve damage or amputation during blood collection, sequelae may remain for several months or the fingers may become inaccessible.
As described above, blood collection is a risky medical procedure, and even in the case of blood collection conducted by a medical institution, it is said that there are about 100,000 medical accidents associated with blood collection annually.

On the other hand, self-blood sampling is now legal due to the revision of the Doctors Act.

By the way, when blood is collected by a blood collection tube containing an anticoagulant and left or centrifuged, blood cell components are precipitated, so that plasma components are generated in the supernatant.

Conventionally, the separation of blood with a gel-like separating agent is very difficult because the gel-like separating agent adheres to the analysis nozzle, so that the blood cell component in the lower layer is very difficult to collect.

In addition, the conventional blood test apparatus of this type is complicated in structure and not easy to handle.

The current status of blood tests is that, of the approximately 5 cc of blood collected, the blood components used for the actual test are, for example, only a few percent, and most of the blood components are discarded. In addition, since the discarded blood is a medical waste, there is a problem that the disposal requires a lot of management and cost.

Such a background and a huge increase in medical costs are inevitable, and blood tests that are simple, easy to handle, and maintain accuracy are required not only by medical institutions but also by self-collecting blood.

JP 2008-279195 A

JP 2008-232876 A

From the above background, the object of the present invention is to provide a blood separation container capable of performing a test based on a plasma component and a test based on a blood cell component with the same accuracy as in a conventional blood collection with one blood collection tube. I assume.

Another object of the present invention is to provide an easy-to-handle container for separating blood, which enables blood tests to be performed with the same accuracy as in the prior art not only by medical institutions but also by self-collecting blood.

The present invention further provides a blood separation container capable of reliably performing a test based on a plasma component and a test based on a blood cell component even in a necessary and sufficient amount for a blood test, that is, a small amount of blood. With the goal.

Although it is extremely difficult to simultaneously achieve the above-mentioned problems, the present invention further aims to simultaneously achieve these.

In order to achieve the above object, the blood test container according to the present invention is a blood test instrument comprising a blood collection bottle and a separation float, and the blood collection bottle comprises a bottomed cylindrical container with an open tip end, A separating agent is applied to the peripheral wall, the separation float is movably accommodated in the blood collection bottle, and the separation float is formed with a cup portion in which a surface for receiving blood is notched in a spherical shape, and A communication hole is provided in the portion, and the cup portion communicates with the bottom surface of the blood collection bottle through the communication hole, and the communication hole is formed by enlarging the bottom side opening surface of the blood collection bottle, and the bottom portion of the separation float is It is characterized in that it is formed in the same shape as the bottom of the blood collection bottle.
In the blood test instrument according to claim 1, the cup portion is formed in a hemispherical shape.
Further, in the blood test instrument according to claim 2, the cup portion has a semicircular cross section.
In the blood test instrument according to claim 2, the cup portion is semi-elliptical in cross section, and the major axis is formed in the longitudinal direction of the blood collection bottle.
In the blood test instrument according to any one of claims 1 to 4, the peripheral wall of the enlarged hole of the communication hole is formed in a concave arc shape.
In the blood test instrument according to any one of claims 1 to 4, the peripheral wall of the enlarged hole of the communication hole is formed in an arc shape.
In the blood test instrument according to any one of claims 1 to 4, the peripheral wall of the enlarged hole of the communication hole is formed in a flat shape.
In the blood test instrument according to any one of claims 1 to 7, the separating agent is applied in a band shape to an intermediate portion of the inner peripheral wall of the blood collection bottle.
In the blood test instrument according to claim 1, an anticoagulant is applied to the inner peripheral wall of the upper portion of the blood collection bottle.
In the blood test instrument according to claim 1, the separation float is initially positioned in a semi-fixed state in the middle of the blood collection bottle.
In the blood test instrument according to claim 1, a blood collection nozzle is detachably fitted to the front end of the blood collection bottle, the blood collection nozzle is open at both ends, and is tapered toward the front end. A pressure control groove for pressure control is formed at a proximal end portion detachably fitted to the blood collection bottle.

(1) Effect of once-taken two-component collection When blood is centrifuged, the components of the blood are separated into upper and lower layers, and as shown in FIG. 5 (B), the plasma component 21a is separated at the top of the separation float. The blood cell component 21b is accumulated at the bottom of the blood collection bottle, that is, at the bottom of the blood collection bottle.
At this time, that is, when the blood 21 is separated into the plasma component 21a and the blood cell component 21b, the upper and lower portions in the blood collection bottle are completely sealed by the separating

agents

16a and 16b with the separation float as a boundary.

Due to this sealing effect, the blood plasma component 21a is separated and generated in the upper layer in the blood collection bottle, and the blood cell component 21b is separated and generated in the lower layer. Then, after collecting the plasma component 21a of the centrifuged supernatant, as shown in FIG. 5C, the blood cell component 21b is pushed up above the cup portion of the separation float through the communicating hole by depressing the separation float next. By collecting this blood cell component layer with the analysis nozzle, collection and measurement of the two components of blood become possible.

(2) Equivalence of separation accuracy At the time of suction of the separated plasma component 21a, the plasma component 21a and the blood cell component 21b are completely separated, and there is no possibility that the blood cell component 21b is mixed in the plasma component 21a. Therefore, the accuracy of the blood test can maintain the same accuracy as the conventional test.
Since the upper surface of the separation float is cut like a hemispherical surface when drawing up the plasma component 21a, there is no possibility of colliding with the upper surface of the cup portion even if the analysis nozzle is inserted anywhere in the cup portion, and the plasma component 21a Collection can be stable and reliable.

In addition, since the blood plasma component 21a and the blood cell component 21b are reliably separated, it is possible to conduct a blood test with the same accuracy as in the conventional test, even with a small amount of blood.

(3) Self blood collection possibility, ease of handling, blood collection traceability Since the upper surface of the separation float is cut into a hemispherical shape, the communicating hole can be relatively shortened and collection of the blood cell component 21 b is easy. There is an effect that
In addition, blood is collected into a blood collection bottle by puncturing a finger with a puncture tool (not shown). However, blood collection involves collecting a small amount of blood flowing out from capillaries, so there is no risk of nerve damage or breakage, and self blood collection is also a risk. It can be done without.

(A) is a front view showing an embodiment of a blood separation container according to the present invention, (B) is a plan view of (A), (C) is a cross-sectional view taken along the line CC of (A), (D) is It is the D section enlarged view of C). (A) is a front view of the inspection bottle of FIG. 1, (B) is a plan view of (A), (C) is a cross-sectional view taken along the line CC of (A), and (D) is a cross-section taken along line DD of (B) FIG. (A) is a front view of the separation float of FIG. 1, (B) is a plan view of (A), (C) is a bottom view of (A), (D) is a DD sectional view of (A), E) is a perspective view of (A), (F) is an enlarged view of an F part of (D). (A) Front view of the blood collection nozzle of FIG. 1, (B) is a bottom view of (A), (C) is a plan view of (A), (D) is a cross-sectional view taken along DD of (A), (E ) Is an EE sectional view of (B). (A) is a schematic cross-sectional view of a first step showing a method of using the blood separating container according to the present invention, (B) is a schematic cross-sectional view of the second step, (C) is a schematic cross-sectional view of the third step. is there. (A) is a schematic sectional drawing which shows the example of suction of the plasma component by the container for blood separation by this invention, (B) is a schematic sectional drawing which shows the example of suction of the plasma component by a comparative example. It is a graph which shows correlation with finger blood and venous blood of TP. It is a graph which shows correlation with finger blood and venous blood of ALB. It is a graph which shows correlation with finger blood and venous blood of AST. It is a graph which shows correlation with finger blood and venous blood of ALT. It is a graph which shows correlation with finger-head blood and venous blood of (gamma) -GTP. It is a graph which shows correlation with finger blood and venous blood of BUN. It is a graph which shows correlation with finger blood and venous blood of CREA. It is a graph which shows correlation with finger blood and venous blood of UA. It is a graph which shows correlation with finger blood and venous blood of T-CHO. It is a graph which shows correlation with finger blood and venous blood of HDL-C. It is a graph which shows correlation with finger blood and venous blood of LDL-C. It is a graph which shows correlation with finger blood and venous blood of TG. It is a graph which shows correlation with finger blood and venous blood of CRP. It is a graph which shows correlation with finger blood and venous blood of HbA1c.

Next, the blood test instrument according to the present invention will be described in more detail based on the drawings showing the embodiment. For the sake of convenience, the same reference numerals are given to parts that perform the same function, and the descriptions thereof will be omitted. FIG. 1 shows a blood test device according to the present invention in which a blood collection nozzle for blood collection is incorporated.

Reference numeral 1 denotes a blood collection bottle, which comprises a bottomed cylindrical container in which the tip 3 is opened. FIG. 2 shows the details of the

blood collection bottle

1, 5 being the bottom of the blood collection bottle 1 having a concave arc shaped bottom 5a and having its proximal end extended outwardly to form a leg 5b. The tip 3 is provided with a removable lid 4. A separation float 7 is movably accommodated in the blood collection bottle 1.

FIG. 3 shows the details of the separating float 7. That is, the separation float 7 is formed on the upper surface thereof with a cup portion 9 cut in a hemispherical shape (in the illustrated embodiment, a semicircular cross section in the illustrated embodiment), and the blood 21 collected by this cup portion 9 (shown in FIG. ). Further, a communication hole 11 is provided at the central portion of the separation float 7, and the cup portion 9 and the bottom surface 5 a of the blood collection bottle 1 are communicated with each other through the communication hole 11.
In the communication hole 11, the opening surface on the bottom side of the blood collection bottle 1 is enlarged, and the enlarged hole 13 is formed here. The peripheral wall 13a of the enlarged hole 13 of the communication hole 11 is formed in a concave arc shape as shown in FIG. 3 (F).

In the vicinity of the middle portion of the inner peripheral wall 1b of the blood collection bottle 1, a gel-like separating agent 16a having a specific gravity slightly larger than that of the float 7 is initially formed in a band shape as shown in FIG. It is applied.

Reference numeral 17 denotes a blood collection nozzle, which is detachably fitted to the front end portion 3 of the blood collection bottle 1. As shown in FIG. 4, the blood collection nozzle 17 is open at both ends, is formed in a tapered shape toward the tip end portion 17 a, and pressure adjustment is performed on the proximal end portion 17 b detachably fitted to the blood collection bottle 1. The pressure control groove 18 for the is formed.

The blood collection bottle 1, the separation float 7, and the blood collection nozzle 17 are all made of plastic.

The separation float 7 is positioned in a semi-fixed state at a longitudinally intermediate portion of the inner peripheral wall 1 b of the blood collection bottle 1 before use. This is because of the tackiness of the gel-like separating agent 16a that is initially applied.

When blood collection nozzle 17 shown in FIG. 4 is used at the time of blood collection, blood collection nozzle 17 is detachably fitted to tip portion 3 of blood collection bottle 1 as shown in FIG. In this case, an anticoagulant (not shown) is sprayed on the inner peripheral wall 17c of the blood collection nozzle 17 and the upper inner peripheral wall 1a of the blood collection bottle 1, and is in a dry state at the time of use.

Next, blood collection will be described. A user (general person or medical staff) collects a small amount of blood from the finger of the hand with a puncture device not shown. When the blood 21 collected is flowed into the blood collection bottle 1 from the blood collection nozzle 17, an anticoagulant is applied to the inside of the blood collection nozzle 17 and the inner surface of the blood collection bottle 1, as shown in FIG. It is transported to the blood analysis center without doing anything.

When blood 21 is centrifuged at the blood analysis center, the blood components are separated into upper and lower layers, and as shown in FIG. 5 (B), plasma component 21a at the top of separation float 7 and below separation float 7 That is, the blood cell component 21b is accumulated in the bottom 5 of the blood collection bottle 1.

Here, the time when the blood 21 is separated into the plasma component 21a and the blood cell component 21b will be described in detail. The gel-like separation agent 16a applied in a band shape to the inner peripheral wall 1b of the blood collection bottle 1 is inserted into the blood collection bottle 1 while rotating the separation float 7, whereby the outer peripheral wall 7a of the separation float 7 and the blood collection bottle 1 First, the space between the outer peripheral wall 7a of the separation float 7 and the inner peripheral wall 1b of the blood collection bottle 1 is sealed. When the blood 21 is centrifuged in this state, the blood cell component 21 b having a large specific gravity drops from the communication hole 11 to the bottom 5. At this time, due to the specific gravity difference of each part, as shown in FIG. 5 (B), the blood plasma component 21a, the separation float 7, the separating agent 16b, and the blood cell component 21b are layered sequentially from the top. The separation agent 16a entering between the outer peripheral wall 7a of the separation float 7 and the inner peripheral wall 1b of the blood collection bottle 1 by the insertion of the separation float 7 gradually falls when the end of the centrifugal separation is reached. The adhesive force gathers in the central direction and finally continues to form a layered separating agent 16 b at the bottom 7 b of the separating float 7. The enlarged hole 13 and the communicating hole 11 of the separation float 7 are closed by the separating agent 16 b.
Due to this sealing effect, the blood plasma component 21a shown by hatching is separated and generated in the upper layer in the blood collection bottle 1, and the blood cell component 21b shown in cross hatching is separated and generated in the lower layer.

Therefore, after collecting the plasma component 21a of the centrifuged supernatant, the separation float 7 is then pushed from the position of A (shown in FIG. 5 (B)) to the position of B (shown in FIG. 5 (C)). Since the separating agent 16b is removed into the cup portion 9 by the pressing pressure, the blood cell component 21b is pushed up above the cup portion 9 of the separation float 7 through the communication hole 11, and this blood cell component layer is subjected to the analysis nozzle 19 Collecting and measuring the two components of blood becomes possible.

Next, the separated plasma component 21a is sucked by the analysis nozzle 19 and subjected to a predetermined test by an automatic analyzer (not shown). Since the blood plasma component 21a and the blood cell component 21b are completely separated at the time of this suction and there is no possibility that the blood cell component 21b is mixed in the blood plasma component 21a, the accuracy of the blood test is equivalent to that of the conventional test. Can be maintained.

In this regard, if the inner peripheral surface 9a of the cup portion 9 'is conical as shown in FIG. 6B, the analysis nozzle 19 of the automatic analyzer collides with the inner peripheral surface 9a of the cup portion 9'. In such a case, the blood cell component 21b is mixed, so that accurate analysis can not be performed. When the analysis nozzle 19 collides with the inner peripheral surface of the cup portion, the separation float 7 is pushed down, and the blood cell component 21b of the lower layer is pushed up, so that blood cells are mixed.

On the other hand, in the present embodiment, the analysis nozzle 19 is not at the suitable position (near the center) of the cup portion 9 as shown in FIG. 5B, but the cup portion 9 as shown in FIG. Even if it is positioned at the improper position (eccentric position), the cup portion 9 is formed in a hemispherical shape, and the blood cell component 21b in the lower layer is pushed up because it is equidistant at any position of the cup portion 9. In addition, since there is no risk of contamination of the blood cell component 21b, the collection of the plasma component 21a can be made stable and reliable.

Further, in the separation float 7, since the inner peripheral surface 9a of the cup portion 9 is cut in a hemispherical shape, the communication hole 11 can be relatively shortened, and the blood cell component 21b can be easily collected. There is. This is because when the communication hole 11 is elongated, the pressing distance of the separation float 7 becomes longer at the time of collecting the blood cell component 21b, so that the collection of the blood cell component 21b becomes difficult.

In the above, when the cup 9 is semi-elliptical in cross section and the major axis is formed in the longitudinal direction of the blood collection bottle, the risk of contamination of the blood cell component 21b described in FIG. It is desirable because the relative shortening of 11 may be further improved.

Furthermore, according to the blood test instrument according to the present embodiment, the blood collection of the blood collection bottle 1 is performed by puncturing a finger with a puncture tool (not shown). Yes, there is no risk of nerve damage or amputation, and self-collection can be performed without risk.

In addition, since the blood plasma component 21a and the blood cell component 21b are reliably separated, it is possible to conduct a blood test with the same accuracy as the conventional test, even if the blood volume is as small as about 150 μl, for example. In addition, "150 μl" of blood collection is an amount securing the re-inspection.

Here, the high accuracy of the blood test will be described. There is an evaluation by a third party organization about the high accuracy of the blood test. Report by the Clinical Examination Department, Saitama Medical Center, Jichi Medical University (Prof. Kiyoka Omoto, Chief Engineer Fujino Shinji, Deputy Chief Engineer Tatsuro Watano) “Comparison of data between digital blood with multi-functional micro blood collection tube and venous blood with injection needle ". The inspection items of this report, preparation of inspection materials, reagents used and analyzers and results are as follows.

<Inspection item>
14 items including specific test items TP · ALB · AST · ALT · γ-GTP · BUN · CUN · UA · T-CHO · HDL-C · LDL-C · TG · CRP · HbA1 c

<Preparation of inspection material>
1) Blood Collection Method Blood collection was carried out by collecting 3 ml of venous blood for comparison test in a biochemical blood collection tube and 2 ml in an EDTA blood collection tube (for HbA1c), and quickly collected finger head blood according to the present invention according to the manual.
2) Preparation before test The blood samples collected in 1) were centrifuged at 3400 rpm for 7 minutes for biochemical blood collection tubes and at 2050 rpm for 5 minutes for EDTA blood collection tubes, and the obtained blood glucose and plasma were subjected to a test.

<Use reagent and analyzer>
A list of measurement reagents is shown in Table 1. For measurement, items other than HbA1c were measured by an automatic biochemical analyzer (JCA.BM6070, JEOL), and HbA1c was measured by an enzymatic method using an automatic biochemical analyzer (JCA.BM6050, JEOL).

<Result>
Table 2 and FIGS. 7A to 7N show the correlation between the finger blood and the venous blood of each item. The correlation coefficient of TP was the worst among 0.884 and 14 items, but the difference between the mean value of the finger head blood and the measured value of vein was as small as 1.3%. The TP of finger blood was higher than that of venous blood. It is believed that the finger blood is plasma blood and is due to the difference in fiprinogen content. The measured value of each item converged almost on the regression line, showing very effective results, and no case was found to be misjudged.

According to this, the blood test according to the present invention has less error factors than the conventional method, and the analysis result is evaluated as almost equal to the medical institution data. In addition, blood suction into the nozzle at the time of blood collection is extremely good and blood collection can be smoothly performed, blood collection volume is also sufficient at 150 to 200 μl, and blood plasma and blood cells can be measured from one blood collection tube. , We have received a great deal of evaluation, such as contributing to the prevention of errors due to misclassification and labor saving. Therefore, the medical institution also contributes to the burden reduction at the time of blood collection, blood collection work for medical examinations and examination work, and the contribution to the industry and the national economy is extremely large by reducing medical waste.

As described above, according to the blood test instrument according to the present embodiment, the structure is simple and easy to handle, and a reliable sealing effect can be obtained in blood separation.

The blood test instrument according to the present invention is not limited to the above embodiment. For example, the enlarged hole 13 of the communication hole 11 can have a circumferential wall shaped like an arc or flat.
The application of the separating agent may be applied in the form of dots at an intermediate position of the inner peripheral wall 1 b of the blood collection bottle 1. Further, the initial position of the separation float 7 is also allowed to be changed depending on the amount of the blood plasma component 21a and the blood cell component 21b to be collected. The shape of the inner peripheral wall 17c of the blood collection nozzle 17 is arbitrary, and a step (not shown) may be provided halfway. Furthermore, if the shape of the bottom surface 7b of the separation float 7 is the same as the shape of the bottom 5 of the blood collection bottle 1, it is more advantageous for the collection of the blood cell component 21b.
The user can be easily used and handled by medical personnel as well as general persons.
In addition, the examination item of the report after paragraph 0043 is for demonstrating the high precision of a blood test, and does not limit the examination item of the instrument for a blood test by this invention.

The instrument for a blood test according to the present invention can be used for a blood test.

DESCRIPTION OF SYMBOLS 1 blood collection bottle 1a upper inner peripheral wall 1b inner peripheral wall 3 tip 4 lid 5 bottom 5a bottom 5b leg 7 separation float 7a outer peripheral wall 7b bottom 9 cup part 9 'cup part 9a inner peripheral face 11 communication hole 13 enlarged hole 13a peripheral wall

16a separation agent

16b separation agent 17 blood collection nozzle 17a tip 17b proximal end 17c inner peripheral wall 18 pressure adjustment groove 19 analysis nozzle 21 blood 21a plasma component 21b blood component

Claims

A blood test instrument comprising a blood collection bottle and a separation float, wherein
The blood collection bottle consists of a bottomed cylindrical container whose tip is open, and a separating agent is applied to the inner peripheral wall,
The separation float is movably accommodated in the blood collection bottle,
The separation float is formed with a cup portion in which a surface for receiving blood is notched in a spherical shape, and a communication hole is provided in the central portion,
The cup portion and the bottom surface of the blood collection bottle are communicated with each other through the communication hole,
The communication hole is formed by enlarging the bottom side opening surface of the blood collection bottle,
The bottom of the separation float is formed in the same shape as the bottom of the blood collection bottle.
The blood test apparatus according to claim 1, wherein the cup portion is formed in a hemispherical shape.
The blood test apparatus according to claim 2, wherein the cup portion has a semicircular cross section.
The blood test apparatus according to claim 2, wherein the cup portion is semi-elliptical in cross section, and the major axis is formed in the longitudinal direction of the blood collection bottle.
The blood test device according to any one of claims 1 to 4, wherein a peripheral wall of the enlarged hole of the communication hole is formed in a concave arc shape.
The blood test apparatus according to any one of claims 1 to 4, wherein the peripheral wall of the enlarged hole of the communication hole is formed in an arc shape.
The blood test apparatus according to any one of claims 1 to 4, wherein the peripheral wall of the enlarged hole of the communication hole is formed flat.
The blood test apparatus according to any one of claims 1 to 7, wherein the separating agent is applied in a band shape to an intermediate portion of an inner peripheral wall of the blood collection bottle.
The blood test apparatus according to claim 1, wherein an anticoagulant is applied to the inner peripheral wall of the upper portion of the blood collection bottle.
The blood test apparatus according to claim 1, wherein the separation float is initially positioned in a semi-fixed state in the middle of the blood collection bottle.
The blood test apparatus according to claim 1, wherein a blood collection nozzle is detachably fitted to the front end of the blood collection bottle, the blood collection nozzle is open at both ends, and is tapered toward the front end, the blood collection bottle A blood test instrument characterized in that a pressure control groove for pressure control is formed at a proximal end portion detachably fitted to the