JP2007167123A - Vacuum blood collection tube - Google Patents

Abstract

To provide a vacuum blood collection tube capable of rapidly collecting a small amount of blood without causing hemolysis.
A blood flow comprising a tubular body 1 open at both ends and a plug body 3 closing an opening at one end, and isolating one end and the other end of the tubular body in a watertight and airtight manner inside the tubular body. has a part 2, the outer diameter D ₂ of the flow join the club is D ₁ ≧ D ₂ relative to the inner diameter D ₁ of the tubular body, and the length of the flow join the club L ₂ is of the tubular body length L ₁ In contrast, a vacuum blood collection tube with L ₁ > L ₂ .
[Selection] Figure 1

Description

  The present invention relates to a vacuum blood collection tube.

  Conventionally, a method for diagnosing a human disease using blood, urine, or the like as a specimen has long been performed as a method that can be easily diagnosed without damaging the human body.

  In particular, blood can be diagnosed for many test items, and it is a common practice to collect blood and analyze its components in health examinations, disease diagnoses, and the like.

  In recent years, the amount of blood required for a single test is decreasing due to the progress of test apparatuses. In general-purpose biochemical component analyzers, measurement is performed with about 20 to 200 μL / item. However, a device capable of measuring even a small amount of sample has been developed, and about 5 to 10 μL / item can be measured. The required amount of is decreasing. Furthermore, in a blood glucose level self-monitoring device monitored by a diabetic patient, there is also a device capable of measuring the glucose concentration with 1 μL or less.

  In blood tests, a blood collection needle is usually punctured into a vein when blood is collected from a so-called subject such as a patient or a subject for a health checkup. In a normal blood test, blood is collected using a 21G (gauge) (outside diameter 0.81 mm, inside diameter 0.49 mm to 0.61 mm) needle defined in ISO 9626: 1991.

  As a blood collection method, there are a method using a syringe (syringe) and a method using a vacuum blood collection tube (also referred to as a reduced pressure blood collection tube). In the method performed by the first syringe, a blood collection needle is attached to the syringe, puncture is performed, and then the blood sampler pulls the inner cylinder of the syringe by his / her own power. For this reason, there is a problem that it takes time for blood collection or is easy to hemolyze. On the other hand, in the method using the second vacuum blood collection tube, a blood collection needle is attached to the vacuum blood collection tube holder, puncture is performed, and then the vacuum blood collection tube is inserted into the holder, thereby reducing the negative pressure of the blood collection tube. This is a method of collecting blood. In this case, it is common to currently collect blood using a vacuum blood collection tube because the amount of blood collection can be adjusted by adjusting the degree of decompression of the blood collection tube, and the blood collection speed is faster compared to the syringe blood collection. is there.

  As described above, since the required amount of the sample is reduced, if a small amount of blood can be collected in accordance with the inspection apparatus, the burden on the subject such as the patient or the subject of the health check can be reduced. If the amount of blood collected can be reduced, blood can be collected even if a needle that is thinner than the normally used 21G-22G needle and has a small flow rate of blood passing through the inside of the needle is used. Can also be reduced.

  However, the vacuum blood collection tube currently used is generally a vacuum blood collection tube with a capacity of 4.5 mL or more, which is adjusted to a blood collection amount of 4.0 mL to 5.0 mL. In order to collect a small amount of about 1.0 mL with such a vacuum blood collection tube, the vacuum blood collection tube must be pulled out of the holder while the blood is being sucked. However, since the blood collection tube is still in a decompressed state at this time, the blood is hemolyzed and it is difficult to obtain an accurate test value (hemolysis will be described later). In addition, the holders of blood collection tubes that are currently on the market are only suitable for vacuum blood collection tubes with a capacity of 4.5 mL or more. If a blood collection tube with a small volume is created, the length and diameter do not match, and dedicated The need to create a holder for it will come out.

In addition, in order to collect a small amount of blood in a vacuum blood collection tube having a capacity of 6.0 mL or more, there is a commercially available product whose blood collection amount becomes 2.0 mL by adjusting the degree of decompression. However, since the degree of decompression must be lowered, the difference from the atmospheric pressure becomes small, the blood collection speed is remarkably slow, the blood collection volume varies, and the end point is difficult to confirm and judge. Will occur.

  On the other hand, in Patent Document 1, there is a vacuum blood collection tube in which two chambers are formed by providing a partition in the middle portion of a blood collection tube main body that is open at both ends, and a plug is attached to one end or both ends of the main body. It is disclosed.

  Patent Document 2 discloses a vacuum blood collection tube having an arc-shaped or conical bottom portion in the middle of the blood collection tube main body.

  Patent Document 3 discloses a vacuum blood collection tube holder for a small amount of blood collection tubes.

  Further, Patent Document 4 discloses a technique in which an incidental part obtained by extending a part of a blood collection tube, such as a cross, is integrally formed on the bottom of a blood collection tube having a small capacity for collecting a small amount of blood collection tubes.

Patent Documents 5 and 6 disclose a technique in which an ordinary holder can be used even with a blood collection tube having a small inner diameter by inserting an adapter between the blood collection tube and the holder.
JP-A-56-143143 Japanese Patent Laid-Open No. 11-151228 JP 57-57530 A JP 2001-95788 A JP-A-6-38944 JP-A-6-38945

  In the technique of Patent Document 1, a normal holder can be used with a long outer shape, and a small amount of blood can be collected by reducing the internal volume. However, when collecting a very small amount of blood of 1 mL or less, the method of providing a flat partition in the middle part of the patent shortens the length from the partition part to the opening part, and blood is easily scattered when opened. This causes problems such as poor separation performance and difficulty in sampling plasma. In this patent, there is no description of the shape of the partition, etc., and in the embodiment, only a flat partition in which the joint portion between the pipe body and the partition is rounded is considered.

  Even in the technique of Patent Document 2, it is possible to collect a small amount of blood by reducing the internal volume by using an ordinary holder having a long outer shape. The blood inflow portion of the patent can be devised to have an arc shape, a conical shape, etc. However, even in the technique of the patent, when collecting a very small amount of blood of 1 mL or less, the length from the partition portion to the opening portion is There are cases where problems such as being short, blood being easily scattered at the time of opening, poor separation ability of centrifugation, and difficulty in sampling plasma.

  Further, the technique of Patent Document 3 has a problem that it is difficult to use because it is necessary to fit into a holder every time blood is collected.

  In the technique of Patent Document 4, since the outer shape is not circular, there is a problem that it is difficult for a blood sampler to hold and there is a risk of burrs due to protrusions.

  In the techniques of Patent Document 5 and Patent Document 6, the outer shape of the blood collection tube is thinner than that of a normal blood collection tube, so that it cannot be used as it is for an analyzer or the like, and has low versatility.

  The object of the present invention is to allow a small amount of blood (for example, 1.0 mL or less) to be collected quickly, and to collect blood without damaging the whole blood, such as hemolysis, and using a normal holder. An object of the present invention is to provide a vacuum blood collection tube that can be used as it is in an analyzer or the like, is easy to hold, has little risk of scattering of contents when opened, and is easy to sample.

The above-described problems of the present invention can be achieved by the following configurations.
1. It has a tubular body having both ends opened and a plug body that closes the opening at one end, and has a blood inflow portion that isolates one end of the tubular body from the other end in a watertight and airtight manner inside the tubular body, The outer diameter D ₂ of the inflow portion is D ₁ ≧ D ₂ with respect to the inner diameter D _{1 of the} tubular body, and the length L _{2 of the} inflow portion is L ₁ > L ₂ with respect to the length L _{1 of the} tubular body. A vacuum blood collection tube.
2. _2. The vacuum blood collection tube according to 1 above, wherein L ₂ > D ₂ .
3. _3. The vacuum according to item 1 or 2, wherein a length L ₃ from one end on the side where the plug is attached to the junction of the blood inflow portion is 30% or less of the length L ₁ of the tubular body. Blood collection tube.
4). 4. The vacuum blood collection tube according to any one of 1 to 3 above, which is used for a puncture needle having an outer diameter of 0.42 mm or less.
5. 5. The vacuum blood collection tube according to any one of 1 to 4 above, wherein the volume of the blood inflow portion is 0.1 mL or more and 1.5 mL or less.
6). The vacuum blood collection tube according to any one of 1 to 5 above, wherein a chemical is attached to the inner wall surface of the inflow portion on the side having the plug.
7). 7. The vacuum blood collection tube according to any one of 1 to 6 above, wherein the degree of reduced pressure on the side of the vacuum blood collection tube having a plug is −400 mmHg or less.
8). 8. A test kit comprising the vacuum blood collection tube according to any one of 1 to 7 and a test chip.

  According to the present invention, it is possible to provide a vacuum blood collection tube capable of collecting blood quickly and without damaging whole blood even in a small amount (1.0 mL or less) of blood collection. Moreover, since the conventional holder can be used as it is and can also be used as it is for an analyzer, it is highly versatile. Furthermore, the vacuum blood collection tube has a specific blood inflow part inside the tubular body, so that the contents can be prevented from being scattered at the time of opening, the sampling is easy, the safety is high, and the operability is good. Can be provided.

  Hereinafter, the present invention will be described in more detail.

<Vacuum blood collection tube (decompression blood collection tube)>
The vacuum blood collection tube of the present invention comprises a tubular body having both ends opened and a plug that closes the opening at one end, and one end and the other end of the tubular body are isolated in a watertight and airtight manner inside the tubular body. A blood inflow portion, the outer diameter D _{2 of the} inflow portion is D ₁ ≧ D ₂ with respect to the inner diameter D _{1 of the} tubular body, and the length L _{1 of the} inflow portion is the length L of the tubular body. ₂ , L ₁ > L ₂ . The form of the blood collection tube of the present invention will be described with reference to the example shown in FIG.

  In the vacuum blood collection tube, the tubular body 1 is integrally formed with the blood inflow portion 2. As the molding method, any conventionally known method in this field can be used. The poor workability of removal with a holding tool, which has been studied in the past, is eliminated, and since it is integrally molded, it can be manufactured at a molding cost that is not much different from that of a conventional vacuum blood collection tube.

The tubular body 1 is not particularly limited as long as it is cylindrical, and is preferably substantially cylindrical.
The opening of the tubular body 1 will be described. FIG. 2 is an illustration of a preferred embodiment of the tubular body 1 and the blood inflow portion 2 in the vacuum blood collection tube of the present invention. Of the two openings of the tubular body 1, the end on the 7 side is closed with a plug 3 (not shown in FIG. 2). The opening may be the same as shown in FIG. 2B or thick as shown in FIG. 2A with respect to the average thickness of the cylinder. Further, the opening may be turned outward as shown in FIG. Moreover, the shape in the opening part 7 and the opening part of the other side may be the same, or may differ.

Preferably the length L ₁ of the tubular body 1 is at least 55.0 mm, more preferably at least 60.0 mm, and most preferably at least 65.0 mm. If L ₁ is in the above range, it is suitable for use of a conventionally used holder.
It is preferable that the inner diameter D ₁ of the tubular body 1 is at least 9.0 mm, more preferably at least 9.5 mm, and most preferably at least 10.0 mm.

  The outer diameter of the tubular body 1 is preferably 10.0 mm or more, more preferably 11.0 mm or more, and most preferably 12.0 mm or more. If it exists in said range, it is suitable for use of the holder currently used conventionally.

  The amount of blood collected from the vacuum blood collection tube is determined by the degree of decompression of the tube and the volume of the tube. When collecting a small amount of blood, the degree of decompression is increased or the volume of the tube is decreased. Although details of the degree of decompression will be described later, raising the degree of decompression (closer to atmospheric pressure) not only significantly slows the blood collection rate, but also causes variations in the amount of collected blood and difficulty in determining the end point. To do. Therefore, in the present invention, the volume of the tube is reduced and a small amount of blood is collected. When the volume of the tube is reduced, the volume of blood collected becomes small and free of blood (free space) due to the small volume of the tube when the degree of decompression of the tube is the same as that of a normal vacuum blood collection tube. ) Becomes smaller.

  Blood flows into the blood inlet 2. In the case of a small amount of blood collection, if the tube volume is reduced as described above, the space (free space) into which blood does not enter becomes smaller, so the length of the blood inflow section is shortened. If the diameter is large, the plug is opened. Problems such as increased risk of content scattering when plugged, and difficulty in sampling after centrifugation. In order to solve this problem, the vacuum blood collection tube of the present invention has a blood inflow portion 2 that satisfies the above-mentioned specific inner diameter and length relationship with the tubular body 1 in the tubular body 1, thereby centrifuging. Separation is improved and sampling after centrifugation is facilitated.

  The blood inflow portion 2 may have any shape as long as it satisfies the above relationship with the tubular body 1. Preferably, it has a recess into which blood flows. For example, as shown in FIG. 1, blood can be introduced by having a recess on the opposite side of the plug 3. The shape of the recess may be a hemispherical shape as shown in FIG. 2A, a substantially cylindrical shape as shown in FIG. 2B, and a shape closed on the opposite side to the opening 7, or It may be conical as shown in FIG. The recess in FIG. 2 (a) includes a substantially test tubular shape.

Preferably the length L ₂ of the blood inflow portion 2 is not less than 10.0 mm, more preferably at least 12.0 mm, and most preferably at least 14.0 mm.
Preferably the outer diameter D ₂ of the blood inflow portion 2 is less than 9.0 mm, more preferably at most 8.5 mm, and most preferably less 8.0 mm. The outer diameter D ₂ is the outer diameter of the concave portion of the blood inflow portion 2. In the case of a conical shape as shown in FIG. 2C, D ₁ = D ₂ .

  The wall thickness of the tubular body 1 and the blood inflow portion 2 is preferably 0.3 mm to 2.0 mm, more preferably 0.4 mm to 1.8 mm, and 0.5 mm to 1.5 mm. Is most preferred. The wall thickness of the tubular body 1 and the wall thickness of the blood inflow portion 2 may be the same or different.

More preferably greater than blood length L ₂ of the inlet portion 2 is the outer diameter D _2, and more preferably the length L ₂ is at least 1.5 times the outer diameter D _2. Increasing the ratio of L _{2 to} D _{2 in} blood inflow part 2 reduces the risk of scattering, increases the centrifuge capability, and facilitates plasma sampling.

The volume of the blood inflow part 2 is preferably 0.1 or more and 1.5 mL or less, more preferably 0.2 or more and 1.4 mL or less, and most preferably 0.3 or more and 1.3 mL or less. preferable. It is preferable to match the target blood collection volume.
Further, the total volume of the tubular body 1 is preferably 0.5 mL or more and 2.5 mL or less, more preferably 0.7 mL or more and 2.3 mL or less, and 0.9 mL or more and 2.0 mL or less. Is most preferred.

The length L ₃ from one end on the side where the plug is attached to the junction of the blood inflow portion is preferably 30% or less, more preferably 25% or less of the length L ₁ of the tubular body, % Is most preferred. When the length of L ₃ is shortened, the volume other than the blood inflow portion is reduced (that is, the free space is reduced), and a vacuum blood collection tube with a low degree of decompression can be created, which is preferable. However, in the case of using a plug body that is partly inserted into a tubular body and closed, such as a rubber plug, L ₃ is preferably 10 mm or more in consideration of the portion into which the rubber plug is inserted. Further, when the plug is in the form of a film, L ₃ is preferably 3 mm or more.

  The tubular body 1 may be formed of glass, plastic or any other material. In view of safety, it is preferable that the PET is a high gas barrier PET generally used for vacuum blood collection tubes. The material is preferably transparent. Moreover, as a material of the blood inflow part 2, the thing similar to the tubular body 1 is mentioned.

  The plug body 3 may be of any specification as long as it has a structure and material for closing the tubular body 1. For example, a stopper generally used for a blood collection tube can be mentioned, and a stopper made of a film having a rubber stopper or a rubber portion is particularly preferable. If the plug body 3 is a rubber plug, for example, the opening can be closed as shown in FIG. An example of a film stopper having a rubber portion is shown in FIGS. Here, the plug 3 is shown as a film plug 13 having a rubber part. FIG. 4 is a view of the plug body 13 as viewed from the direction of the opening 7. The film 4 is sealed in the opening of the tubular body 21. It is preferable that the film plug 13 has a protrusion 6 for removal from the tubular body 21. The protrusion 6 is preferably made of the same material as the film. The film stopper 13 has a rubber part 5. The rubber part 5 is preferably made of the same material as that of a rubber stopper usually used for blood collection tubes.

It is preferable to put chemicals on the side of the tubular body 1 or the inflow part 2 having the plug 3 as required. Examples of chemicals include anticoagulants, coagulation promoters, antiglycolytic agents, etc., and serum or plasma separators commonly used in blood collection tubes, anticoagulants, coagulation promoters, antiglycolytic agents, etc. Can be appropriately used depending on the component to be analyzed.
Any conventionally used serum or plasma separating agent can be used. For example, synthetic resin having fluidity at room temperature (for example, dicyclopentadiene oligomer), thixotropic agent (for example, condensate of sorbitol and aromatic aldehyde, polyoxyethylene polyoxypropylene block copolymer, etc.) ), A specific gravity adjusting agent (for example, silica) and a viscosity adjusting agent (for example, a phthalate ester) are added and kneaded to obtain a thixotropic gel.
Examples of the blood anticoagulant include sodium ethylenediaminetetraacetate dipotassium salt, ethylenediaminetetraacetate sodium tripotassium salt, ethylenediaminetetraacetate sodium disodium salt, heparin sodium, heparin lithium, sodium fluoride, and citric acid.
As the blood coagulation promoter, any of those conventionally used as blood coagulation promoters can be used, and examples thereof include fine powder silica.
These chemicals may be put in any form such as powder, sheet or tablet. Moreover, when putting in the inflow part 2, it is preferable to make it adhere to the inner wall face of a pipe | tube so that it may be easy to mix with a chemical | medical agent.

  When collecting blood from a vein, it is common to puncture the vein with a blood collection needle and then attach the vacuum blood collection tube to the non-punctured side of the blood collection needle and collect the blood by decompression. Is. The degree of decompression of the vacuum blood collection tube is determined by the volume of the blood collection tube and the amount of blood to be collected, and is calculated by 760 × (blood collection amount / volume of tube). For example, if 5 mL blood collection is required for a 6 mL blood collection tube, it may be designed with 760 × (5/6) = 633 and a reduced pressure of −633 mmHg. Similarly, in order to collect 2 mL of blood into a 6 mL blood collection tube, it may be designed to be −253 mmHg with 760 × (2/6) = 253. As can be seen from this, in general, when the amount of collected blood is reduced compared to the capacity of the tube, the degree of decompression must be set low, and the blood suction speed becomes slow. Therefore, it is usually preferable to collect blood with a blood collection tube having a size corresponding to the necessary blood collection amount. When 0.5 mL of blood is collected into a 0.6 mL blood collection tube, 760 × (0.5 / 0.6) = 633, and the degree of decompression is the same as that when 5 mL of blood is collected into a 6 mL blood collection tube. In this case, the time until the suction is completed as compared with the previous 5 mL blood collection can be reduced to 1/10. In addition, the vacuum degree described here defines atmospheric pressure as 0 mmHg and vacuum as -760 mmHg. The vacuum blood collection tube of the present invention can obtain the same effect as that of collecting blood with a blood collection tube having a size corresponding to the required blood collection amount by providing the blood inflow portion 2.

  The degree of reduced pressure on the side of the vacuum blood collection tube of the present invention having a plug is preferably −400 mmHg or less (higher vacuum than −400 mmHg), more preferably −450 mmHg or less, and −500 mmHg or less. Most preferred.

  The vacuum blood collection tube of the present invention is used together with a blood collection needle (puncture needle). The needle for blood collection to be used may be any commercially available needle. As the shape of the needle, vacuum blood collection may be performed using a double-ended blood collection needle usually used for a vacuum blood collection tube, or a luer adapter may be attached to an injection needle for vacuum blood collection. Usually, a 21G or 22G needle is used for blood collection. The time required to collect blood depends on the condition of the subject (generally a patient) and the proficiency of the examiner (typically a doctor, nurse, or clinical laboratory technician), but it can range from a few seconds to a few tens of seconds. It is normal to complete with. On the other hand, when the blood collection tube of the present invention is used, as described above, the time until the suction is completed is shortened, so that the permeation speed inside the needle is slow (that is, the blood flow rate is low), which is generally used. Blood can be collected with a finer puncture needle. By using a fine needle, it is possible to relieve the pain and pain of the subject. The outer diameter of the needle is preferably 0.82 mm or less, more preferably 0.50 mm or less, and most preferably 0.42 mm or less as the outer diameter of the tip for puncturing the human body. The needle to be used may be a tapered needle or a step needle.

In the present invention, when blood is collected using the puncture needle and vacuum blood collection tube of the present invention, the passage speed of whole blood inside the needle is preferably 0.01 mL / second or more.
If 100 μL, which is the minimum amount necessary for blood tests, can be secured, it is considered useful as a vacuum blood collection tube for micro blood tests. In the present invention, as a vacuum blood collection tube capable of collecting 100 μL of blood necessary for 10 seconds, 1 It is preferable that 10 μL of blood can be collected per second.

[Hemolysis]
The collected blood is generally analyzed and diagnosed using plasma / serum collected by centrifuging at about 3000 rpm for about 10 minutes to precipitate blood cell components and then collecting the supernatant. However, when a strong force such as pressure is applied to the collected whole blood, the red blood cells are destroyed and the hemoglobin in the red blood cells is eluted, and the plasma / serum may be reddish. This is called hemolysis.
When specimens such as hemolyzed plasma and serum are used for analysis and diagnosis, the analysis results may be affected. In the case of components that are present in erythrocytes at a higher concentration than in plasma, this appears prominently, resulting in an error in the analysis results. Such components are, for example, potassium ion, lactate dehydrogenase (LDH), adenylate kinase (AK), catalase and the like.

<Inspection chip>
The vacuum blood collection tube of the present invention can constitute a test kit together with a test chip. Compared to blood tests using automatic analyzers that have been performed in medical institutions and testing institutions in the past, testing with a test chip makes it possible to test multiple items with a small amount. Assuming that the time required for blood collection is constant, the smaller the amount of blood required for the examination, the smaller the inner diameter of the puncture needle of the present invention, thereby making it possible to reduce the outer diameter. Therefore, the puncture needle of the present invention is preferably used together with a test chip that can be tested with a small amount of blood.
A test chip is a sample after flowing a sample such as blood through a flow path having a fine cross-sectional area using capillary action or electrophoresis in order to measure various components contained in blood and reacting with a reagent. A small chip-like device for blood analysis that separates each component in blood and performs transmission spectroscopic analysis, or performs luminescence reaction with a reagent to perform spectroscopic analysis of the emitted light. .

  Since the vacuum blood collection tube of the present invention can collect a small amount of blood, it should be used for blood collection for monitoring health in a pharmacy, a health care shop, etc. You can also. In particular, it is highly useful for applications such as health checks for healthy people, especially those who are healthy at first glance but are concerned about illness. Measurements for healthy persons include general biochemical items and blood counts, blood fluidity (smoothness), and stress marker measurements. Blood fluidity (smoothness) can be measured by MC-FAN (manufactured by MC Laboratory) or the like.

  The present invention will be described below with reference to examples, but the present invention is not limited thereto.

{Manufacture of vacuum blood collection tubes}
In Example 1 and Example 2, a glass vacuum blood collection tube was used, and the shape shown in FIG. 1 was used. In Comparative Example 3, a glass vacuum blood collection tube f was used, and the shape shown in FIG. 5 was used.
The blood collection tube of Example capacity of inlet 2 to adjust the length L ₂ so that the capacitance of Table 1, to prepare a vacuum blood collection tube b and c. Tubular body 1 as can be commonly used in the holder to be used, the length L ₁ 75 mm, an outer diameter of 13 mm, to prepare a glass tube with an inner diameter D ₁ 10.5 mm. The blood collection tube f has the same structure of the tubular body 1 as in the embodiment, except that there is no blood inflow portion 2 and a partition is provided in the middle portion of the tubular body 1. After attaching a rubber stopper for the vacuum blood collection tube to the glass tube, connect a vacuum pump to the tube, attach a 27G needle to the tip of the tube, puncture the rubber stopper with the needle, and then suction until the pressure shown in Table 2 is reached. The pressure was reduced. When the degree of decompression shown in Table 2 was reached, the needle was removed from the rubber stopper, and the vacuum blood collection tubes of Example 1 and Example 2 were produced. The dimensions are shown in Table 1.
In addition, since the vacuum blood collection tube created in the Example does not puncture the human body directly, sterilization was not performed. However, when using it for a human body, a sterilization process is put in and a vacuum blood collection tube is produced. In Table 2, the volume of the inflow portion is the volume of the blood inflow portion 2, the blood collection volume is the blood collection volume calculated from the degree of decompression, the outer diameter and length are the shape outer diameter and length L ₁ of the tubular body 1, and the degree of decompression is The value obtained by reducing the pressure with a vacuum pump is shown.

{Commercial vacuum blood collection tube}
In Comparative Example 1 and Comparative Example 2, a commercially available vacuum blood collection tube was used as it was. In Table 2, the volume measures the volume of the entire blood collection tube, and the blood collection volume indicates a set value. The outer diameter and length are values obtained by measuring a blood collection tube. The degree of decompression is calculated from the volume and the amount of blood collected, and the degree of decompression is shown in parentheses.

{Blood transit time}
Using the vacuum blood collection tubes of Example 1 to Example 2 and Comparative Example 1 to Comparative Example 3, the blood collection rate was measured. Remove the piston (inner cylinder) of a 10 mL Terumo syringe commercially available from Terumo Corporation, and insert a puncture needle (outer diameter 0.31 mm, inner diameter 0.22 mm, length 15 mm) at the tip of the injection cylinder (outer cylinder). After that, 5 mL of whole blood collected from two healthy men was gently injected into the syringe. Since the blood passage speed is affected by the hematocrit value, the hematocrit value is also shown. The hematocrit values of this whole blood were 40.6% and 55.1%. For blood collection, a vacuum blood collection tube “Benoject II” manufactured by Terumo Corporation using lithium heparin as an anticoagulant was used, and 20 mL was collected and pooled in a 50 mL capacity Sumilon tube marketed by Sumitomo Bakelite. Was used as whole blood for evaluation.
A needle attached to the tip and whole blood injected into the tube is gently punctured into the rubber part of the vacuum blood collection tube of Comparative Examples 1 to 3 of Example 1 to Example 2. For the vacuum blood collection tubes of Examples 1 to 3 where the suction was completed at 1 mL or less, the time until the suction stopped was measured. Further, in Comparative Examples 1 and 2 in which the suction did not stop at 1 mL, when the vacuum was sucked up to 1 mL, the blood collection tube was taken out from the holder, and the time taken up to that time was measured. The blood collection time was A for less than 20 seconds, B for 20 seconds to less than 50 seconds, C for 50 seconds to less than 100 seconds, and D for more than 100 seconds. The results are shown in Table 3. The blood collection tubes of Examples 1 to 2 and Comparative Examples 1 and 3 were able to collect blood in less than 100 seconds. In particular, when the capacity of the blood collection tube was small, blood collection was completed in 20 seconds or less. On the other hand, in the blood collection tube of Comparative Example 2 having a tube capacity of 6.4 mL and a blood collection volume of 2 mL, the decompression degree is set to be low, so that it takes a long time to perform 1.0 mL blood collection. I understood.
The puncture needle used in this experiment is thinner than 21G (outer diameter 0.81 mm, inner diameter 0.81 mm) that is normally used for blood collection, and this puncture needle is used as the puncture needle in the blood collection kit of the present invention. Thus, it is possible to reduce the pain of the subject.

(Hematocrit value)
Generally speaking, whole blood contains components as cells such as red blood cells, white blood cells, and platelets, and components as aqueous solutions such as plasma or serum. In the whole blood, there are 4 to 5 million red blood cells / μL, and the red blood cells occupy most of the solid components in the whole blood. The volume ratio of the red blood cells in the whole blood is called the hematocrit value. Usually, whole blood is put into a glass tube called a hematocrit tube, and the volume of solid content remaining after centrifugation is determined as a hematocrit value. It is said that the hematocrit value of healthy men is 40 to 55%, and the hematocrit value of women is around 30 to 45%.

{Evaluation of hemolysis}
Supernatant obtained by centrifuging whole blood collected in a vacuum blood collection tube at {Blood passage time} at room temperature and 3000 rpm for 10 minutes is collected, an absorption spectrum is measured with UV-2550 (manufactured by Shimadzu), and hemoglobin is obtained. Hemolysis was assessed by the increase in absorbance at 415 nm resulting from the absorption of. For comparison, the absorbance of plasma obtained by centrifuging whole blood that was pooled in a Sumilon tube and not passed through a hollow needle under the same conditions was measured, and the increase in OD relative to this was evaluated. Table 3 shows the results.
Shown in The increase in OD was defined as the degree of hemolysis, and if there was an increase of OD = 0.1 or more, it was judged as hemolysis. In the case of no hemolysis, the evaluation was made by ◯, when OD = 0.1 to 0.3, x, and when OD = 0.3 or more, XX. Hemolysis was not observed in the blood collection tubes of Examples 1 and 2 and Comparative Example 3. On the other hand, the blood collection tubes of Comparative Examples 1 and 2 that ended blood collection during aspiration were hemolyzed because they remained in a reduced pressure state. In particular, in the vacuum blood collection tube of Comparative Example 1 having a high degree of reduced pressure, hemolysis was intensely performed.

{Holder mountability}
A Venoject II holder was used as a commonly used blood collection tube holder, and it was confirmed that the vacuum blood collection tubes of Examples 1 and 2 and Comparative Examples 1 and 2 could be attached to the holder. Evaluation was made with a case where it was possible to wear as ◯ and a case where it could not be worn as x. It was found that the vacuum blood collection tubes manufactured in Example 1 to Example 3 can be mounted on a normal holder without any problem.

{Blood dispersibility}
When the collected blood collection tube is opened or when sampling, the collection tube that may have been scattered is evaluated as x, and the collection tube that can be worked without scattering is evaluated as ◯.
The blood collection tubes of Examples 1 and 2 and Comparative Examples 1 and 2 were able to work without problems. On the other hand, since the blood collection tube of Comparative Example 3 has little free space and no blood inflow portion, blood may scatter.

  From Table 3, when the vacuum blood collection tube of Example 1 and Example 2 is used, blood collection of 1 mL or less is possible without hemolysis. In addition, by using the vacuum blood collection tube of the present invention, it is possible to use a holder that is normally used as it is. Furthermore, when compared with Comparative Example 3, it was possible to provide a blood collection tube that is difficult to scatter by providing a blood inflow portion. On the other hand, when 1 mL of blood was collected using a conventionally used blood collection tube with a capacity of 6.4 mL, hemolysis occurred and accurate examination was impossible.

It is sectional drawing which shows one form of the blood collection tube of this invention. It is sectional drawing which shows the form of the blood collection tube of this invention. It is sectional drawing which shows one form of the blood collection tube of this invention. It is the schematic which looked at the stopper made from the film which has the rubber part in the blood collection tube of this invention from the direction of the opening part. It is sectional drawing which shows the form of the blood collection tube of a comparative example.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Tubular body 2 Blood inflow part 3 Stopper (plug body)
7 Opening portion 8 Vacuum blood collection tube L ₁ Length of tubular body 1 D ₁ Inside diameter of tubular body 1 L ₂ Length of blood inflow portion 2 D ₂ Outer diameter of blood inflow portion 2 L ₃ Tubular body 1 plug Length from one end to the junction of the blood inflow portion 11 Tubular body 12 Blood inflow portion 21 Tubular body 22 Blood inflow portion 32 Blood inflow portion 42 Blood inflow portion 13 Plug made of film having rubber portion 4 Film 5 Rubber Part 6 Protruding part 9 Tubular body (comparative example)
10 Vacuum blood collection tube (comparative example)

Claims (8)

A tubular body having both ends opened and a plug body that closes the opening at one end, and has a blood inflow portion that isolates one end of the tubular body from the other end in a watertight and airtight manner inside the tubular body, The outer diameter D ₂ of the inflow portion is D ₁ ≧ D ₂ with respect to the inner diameter D _{1 of the} tubular body, and the length L _{2 of the} inflow portion is L ₁ > L ₂ with respect to the length L _{1 of the} tubular body. A vacuum blood collection tube. The vacuum blood collection tube according to claim 1, wherein L ₂ > D ₂ . Adopted vacuum according to claim 1 or 2, wherein the length L ₃ from one end side to the junction point of the blood inflow portion for mounting the plug body is less than 30% of the length L ₁ of the tubular body Blood vessels.   The vacuum blood collection tube according to any one of claims 1 to 3, which is used for a puncture needle having an outer diameter of 0.42 mm or less.   The vacuum blood collection tube according to any one of claims 1 to 4, wherein a volume of the blood inflow portion is 0.1 mL or more and 1.5 mL or less.   The vacuum blood collection tube according to any one of claims 1 to 5, wherein a chemical is attached to the inner wall surface of the inflow portion on the side having the plug.   The vacuum blood collection tube according to any one of claims 1 to 6, wherein the degree of reduced pressure on the side of the vacuum blood collection tube having a plug is -400 mmHg or less.   A test kit comprising the vacuum blood collection tube according to claim 1 and a test chip.

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