JP2007167124A - Vacuum blood collection tube - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a vacuum blood collection tube which enables a quick collection of blood less than 1.0 mL without the destruction of red blood cells and reduces pains during the blood collection. <P>SOLUTION: The vacuum blood collection tube comprises a tubular body having one open end and the other closed end and a plug body closing the opening, has a volume equal to or less than 1.5 mL, and is used for a puncture needle with an outer diameter equal to or less than 0.42 mm. <P>COPYRIGHT: (C)2007,JPO&INPIT

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 to collect blood or it 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. Moreover, 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, and pain at the time of blood collection 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, 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 has to 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 check and determine. Will occur.

  On the other hand, use of a small amount of blood collection tube has been studied. In Patent Document 1 and Patent Document 2, it is proposed to attach a holder so that a conventional blood collection tube holder can be used even for a vacuum blood collection tube of a size smaller than that normally used.

  Patent Documents 3 and 4 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.

Patent Document 5 discloses a technique for reducing pain in a hollow needle for blood collection by reducing the outer diameter.
JP 57-57530 A JP 2001-95788 A JP-A-6-38944 JP-A-6-38945 JP 2003-83958 A

  In the techniques of Patent Document 1 to Patent Document 4, since conventional holders such as adapters, holders, and extension tools are used, auxiliary tools must be used, and manufacturing costs and labor during blood collection are actually increased. There were many inconveniences when commercializing.

  In addition, the hollow needle of 100 μm or less proposed in Patent Document 5 has a low needle strength in the first place, and has a high risk of bending the needle at the time of puncture.

  It is an object of the present invention to collect a small amount (1.0 mL or less) of blood quickly and with less pain, and can collect blood without damaging the whole blood, such as hemolysis, and is easy to manufacture. To provide a blood collection tube.

The above-described problems of the present invention can be achieved by the following configurations.
1. A vacuum blood collection tube comprising a tubular body having one end opened and the other end closed, and a plug body closing the opening, wherein the vacuum blood collection tube has a capacity of 1.5 mL or less and an outer diameter of 0.42 mm or less. A vacuum blood collection tube characterized by being a vacuum blood collection tube for use in a puncture needle.
2. 2. The vacuum blood collection tube according to 1 above, wherein an outer diameter of the tubular body is 10.0 mm or less.
3. 3. The vacuum blood collection tube according to 1 or 2 above, wherein a chemical is attached to the inner wall surface of the tubular body.
4). 4. The vacuum blood collection tube according to any one of items 1 to 3, wherein the degree of decompression is −400 mmHg or less.
5. 5. A test kit comprising the vacuum blood collection tube according to any one of items 1 to 4 and a test chip.
6). 5. A blood collection kit comprising the vacuum blood collection tube according to any one of items 1 to 4 and a puncture needle having an outer diameter of 0.42 mm or less.

  According to the present invention, it is possible to provide a vacuum blood collection tube that can collect blood quickly and with little pain, even with a small amount (1.0 mL or less) of blood collection.

  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 is a vacuum blood collection tube comprising a tubular body having one end opened and the other end closed, and a plug body closing the opening, and the volume of the vacuum blood collection tube is 1.5 mL or less. And a vacuum blood collection tube for use in a puncture needle having an outer diameter of 0.42 mm or less. A capacity | capacitance refers to the remaining volume except the part which mounts a stopper.

  The capacity is preferably from 0.1 mL to 1.5 mL, more preferably from 0.2 mL to 1.4 mL, and most preferably from 0.3 mL to 1.3 mL. Since the volume of the vacuum blood collection tube corresponds to the volume of the portion into which blood flows under reduced pressure, if this volume is too large compared to the intended blood collection volume, the degree of decompression cannot be increased and the speed of blood collection is slow. appear. On the other hand, if the target blood collection volume is small compared to the target blood collection volume, the target blood collection volume cannot be ensured, or if a drug such as an anticoagulant is previously placed in the vacuum blood collection tube, the drug and the collected whole blood will not The problem of not being able to do enough occurs.

  The outer diameter of the tubular body is preferably 10.0 mm or less, more preferably 9.0 mm or less, and most preferably 8.0 mm or less. Since the vacuum blood collection tube of the present invention has a volume of 1.5 mL or less and is smaller than usual, it is thinner or longer than the diameter of a commonly used blood collection tube (usually about 13 mm in outer diameter and about 75 mm in length). Short, thin and short. Among these, it is preferable to reduce the volume by reducing the diameter, and it is preferable to secure a length for holding the blood collection tube.

  The tubular body 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 from the viewpoint of use. The tubular body may be produced using any known method as long as it has the above capacity.

  The plug body that closes the opening may have any specifications as long as the structure and material seal the tubular body. 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.

It is preferable to put chemicals in the vacuum blood collection tube of the present invention as necessary. Examples of chemicals include serum or plasma separation agents, anticoagulants, coagulation promoters, antiglycolytic agents, etc. Anticoagulants, coagulation promoters, antiglycolytic agents, etc. that are generally used in blood collection tubes Can be appropriately used according to the analysis target component.
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 puncture the blood collection needle on 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 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 outer diameter of the needle used is 0.42 mm or less, preferably 0.38 mm or less, and most preferably 0.34 mm or less as the outer diameter of the tip for puncturing the human body. By using the needle in the above range as the puncture needle and the volume of the vacuum blood collection tube being 1.5 mL or less, it is possible to relieve the pain and pain of the subject. Further, from the viewpoint of needle strength and blood flow rate, the outer diameter of the blood collection needle (puncture needle) to be used is preferably 0.20 mm or more, more preferably 0.23 mm or more as the outer diameter of the tip for puncturing the human body. Is more preferable, and 0.26 mm or more is most preferable.
As the shape of the needle to be used, a double-ended blood collecting needle usually used for a vacuum blood collection tube may be used, or a luer adapter may be attached to an injection needle for blood collection. Further, a tapered needle or a step needle may be used.
The time required to collect blood depends on the condition of the subject (generally a patient) and the proficiency level of the examiner (generally a doctor, nurse, or clinical laboratory technician), but is usually used In the blood collection tube, it is usually completed in several seconds to several tens of seconds. By using the vacuum blood collection tube of the present invention together with the puncture needle having the above specific outer diameter, blood collection can be completed quickly. The blood collection kit of the present invention includes the vacuum blood collection tube and the puncture 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.

  Since the vacuum blood collection tube of the present invention has a smaller capacity than usual, the outer diameter and the length are different as described above, and it is difficult to use a generally used vacuum blood collection tube holder as it is. Therefore, it is preferable to manufacture a dedicated holder for a small amount of blood collection tube according to the shape of the blood collection tube. In order to facilitate puncturing, the length is preferably 30 mm or more, more preferably 35 mm or more, and most preferably 40 mm or more.

[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}
The vacuum blood collection tubes used in Examples 1 and 2 and Comparative Example 3 were produced using commercially available polypropylene tubes (PP tubes) so as to have the sizes shown in Table 1. The tube sizes are shown in Table 1. After attaching a rubber stopper to the PP tube (a rubber stopper used in commercially available vacuum blood collection tubes), connect a vacuum pump to the tube, attach a 27G needle to the tip of the tube, and puncture the rubber stopper with the needle. The pressure was reduced to the pressure shown in Table 1 and reduced. When the degree of decompression shown in Table 1 was reached, the needle was removed from the rubber stopper, and the vacuum blood collection tube a of Example 1, the vacuum blood collection tube b of Example 2, and the vacuum blood collection tube e of Comparative Example 3 were produced.
In addition, since the vacuum blood collection tube produced in the Example does not puncture a human body directly, it did not sterilize, but when using it for a human body, a sterilization process is put in and a vacuum blood collection tube is produced. In Table 1, the volume represents the volume of the tubular body, the blood collection volume represents the blood collection volume calculated from the degree of decompression, the outer diameter and the length represent the shape of the tubular body, and the degree of decompression represents the value reduced by the vacuum pump.

{Commercial vacuum blood collection tube}
In Comparative Example 1 and Comparative Example 2, the commercially available vacuum blood collection tube used was used as it was. In Table 1, the volume measures the volume of the entire vacuum blood collection tube, and the blood collection volume indicates a set value. The outer diameter and length are values obtained by measuring a vacuum 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 and Comparative Examples 1 and 2, 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 Examples 1, 2 and Comparative Examples 1-3. For the vacuum blood collection tubes of Examples 1 and 2 and Comparative Example 3 where the suction ends at 1.5 mL or less, the time until the suction stops was measured. Further, in Comparative Example 1 and Comparative Example 2 in which the suction did not stop at 1.5 mL, when the suction was performed up to 1.5 mL, the needle was pulled out, 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 2. The blood collection tubes of Example 1 and Example 2 were able to collect blood in 50 seconds or less even with blood having a high hematocrit value. On the other hand, in the blood of Comparative Examples 1 to 3, blood sampling may take 50 seconds or more. In particular, in the blood collection tube of Comparative Example 2 having a tube capacity of 6.4 mL and a blood collection amount of 2 mL, it was found that a long time was required for blood collection because the degree of decompression was set low.
The puncture needle used in this experiment is thinner than 21G (outside diameter 0.81 mm, inside diameter 0.81 mm) that is normally used for blood collection, and by using this puncture needle together with the vacuum blood collection tube of the present invention, 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 whole blood, there are 4 to 5 million red blood cells / μL, and red blood cells occupy most of 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 evaluated by the increase in absorbance at 415 nm derived 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. The results are shown in Table 2. 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. Evaluation was made as ○ when no hemolysis was performed, × when OD = 0.1 to 0.3 was increased, and XX when OD = 0.3 or higher was observed. No hemolysis was observed in the blood collection tube of Example 1. 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.

  From Table 2, when the vacuum blood collection tube of Example 1 to Example 2 is used, 1 mL or less of blood can be collected without hemolysis. On the other hand, when a conventionally used blood collection tube having a capacity of 6.4 mL is used, hemolysis occurs and accurate examination is impossible. It was also found that blood collection tube e having a volume exceeding 1.5 mL took too much time for blood collection.

  Actually, two blood samples (one male and one female) collect blood with the vacuum blood collection tube of Example 1 using a puncture needle (outer diameter 0.31 mm, inner diameter 0.22 mm, length 15 mm). Went. Since the size of the vacuum blood collection tube is small, the conventional holder cannot be used, and blood was collected by producing a dedicated holder. Both were able to collect blood with less pain compared to normal blood collection. The blood collection time was 20 seconds for men and 15 seconds for women. The amount of blood collected was about 0.7 mL.

Claims (6)

  A vacuum blood collection tube comprising a tubular body having one end opened and the other end closed, and a plug body closing the opening, wherein the vacuum blood collection tube has a capacity of 1.5 mL or less and an outer diameter of 0.42 mm or less. A vacuum blood collection tube characterized by being a vacuum blood collection tube for use in a puncture needle.   The vacuum blood collection tube according to claim 1, wherein an outer diameter of the tubular body is 10.0 mm or less.   The vacuum blood collection tube according to claim 1 or 2, wherein a chemical is attached to an inner wall surface of the tubular body.   The vacuum blood collection tube according to any one of claims 1 to 3, wherein the degree of decompression is -400 mmHg or less.   A test kit comprising the vacuum blood collection tube according to claim 1 and a test chip.   A blood collection kit comprising the vacuum blood collection tube according to any one of claims 1 to 4 and a puncture needle having an outer diameter of 0.42 mm or less.