JP2007159657A - Puncturing needle for blood sampling - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a puncturing needle hardly damaging the whole sampled blood without giving pain or injury to a subject, and having sufficient strength and flow rate. <P>SOLUTION: This puncturing needle for the blood sampling is characterized in that the outside diameter J<SB>1</SB>of the distal end of the needle is ≥0.26 mm to ≤0.34 mm, the inside diameter J<SB>2</SB>is ≥0.17 mm, the outside diameter and inside diameter of the distal end are smaller than the inside diameter and outside diameter of a proximal end, and the length from the distal end to the proximal end of the needle is ≥9 mm. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a puncture needle. More specifically, the present invention relates to a blood collection puncture needle, a test kit including the same, and a blood collection kit.

  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 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, 21G (gauge) (outer diameter 0.81 mm, inner diameter 0.49 mm to 0.61 mm) defined in ISO 9626: 1991 etc. is used, and is painful when punctured into a vein This is normal, and efforts to eliminate pain at the time of blood collection are required in the medical field.

  As means for solving this problem at the time of puncturing, Patent Document 1 and Patent Document 2 disclose a needle having a step structure having a puncturing part to be inserted into a living body and a large diameter part larger than the outer diameter of the puncturing part. Yes.

Patent Document 3 and Patent Document 4 include a taper structure including a puncture portion having a needle tip that can be punctured in a living body, a proximal end portion having a larger outer diameter and inner diameter than the puncture portion, and a taper portion connecting the base end portion. The needle is disclosed.
JP 2002-291844 A JP 2005-21672 A JP 2003-200218 A JP 2003-320430 A

  In the techniques of Patent Literature 1 and Patent Literature 2, pain is reduced by a small-diameter puncture portion, and a sufficient chemical flow rate is ensured by a large-diameter portion on the proximal end side. However, since it is manufactured assuming a puncture needle for injecting a drug solution, the puncture portion is too thin to be used for blood collection. For this reason, when used for blood collection, hemolysis occurs in some cases, and there is a problem that accurate inspection cannot be performed depending on the inspection item.

  In the techniques of Patent Literature 3 and Patent Literature 4, pain is reduced by narrowing the puncture portion, and a sufficient drug solution flow rate is secured at the tapered portion. However, this is a technique for manufacturing a tapered structure, and there is no description of a puncture needle for blood collection.

  An object of the present invention is to provide a puncture needle that does not give pain or a wound to a subject, has little damage to whole blood collected, and has a sufficient flow rate.

The above-described problems of the present invention can be achieved by the following configurations.
1. The outer diameter of the tip of the needle is 0.26 mm or more and 0.34 mm or less, the inner diameter is 0.17 mm or more, the outer diameter and inner diameter of the tip are smaller than the inner diameter and outer diameter of the proximal end, and from the distal end of the needle to the proximal end A puncture needle for blood collection characterized by having a length of 9 mm or more.
2. A puncture needle having a small-diameter portion to be inserted into a living body and a large-diameter portion whose outer diameter is larger than the small-diameter portion, and the outer diameter of the small-diameter portion is 0.26 mm or more and 0.34 mm or less, and the inner diameter is 0.17 mm. The puncture needle for blood collection according to the above item 1, wherein the length from the distal end to the proximal end of the needle is 9 mm or more.
3. A puncture needle having a small-diameter portion inserted into a living body and a tapered portion formed continuously from the small-diameter portion and having an outer diameter continuously larger in the long axis direction than the small-diameter portion, 2. The blood sampling puncture according to item 1, wherein the diameter is 0.26 mm or more and 0.34 mm or less, the inner diameter is 0.17 mm or more, and the length from the distal end to the proximal end of the needle is 9 mm or more. needle. 4). The inner diameter of the tip of the needle inserted into the living body is smaller than the inner diameter of the proximal end, the outer diameter of the distal end is smaller than the outer diameter of the proximal end, and the inner diameter and the outer diameter are tapered in the major axis direction from the distal end to the proximal end. The outer diameter of the distal end is 0.26 mm or more and 0.34 mm or less, the inner diameter is 0.17 mm or more, and the length from the distal end to the proximal end of the needle is 9 mm or more. The blood collection puncture needle according to Item.
5. 5. The blood sampling puncture needle according to any one of 1 to 4 above, wherein the needle base has a mark indicating the direction of the blade.
6). 6. An inspection kit comprising the puncture needle according to any one of 1 to 5 and an inspection chip.
7). 6. A blood collection kit comprising the puncture needle according to any one of items 1 to 5 and a vacuum blood collection tube.
8). 8. The blood collection kit according to item 7, wherein the vacuum blood collection tube has an internal volume of 1.5 mL or less.

According to the present invention, there is provided a puncture needle that does not give pain or a wound to a subject, and does not give a feeling of fear or anxiety caused by pain, and that damages the collected whole blood is small. can do.
Further, according to the present invention, the strength of the needle and the puncture device at the time of puncture is sufficient and puncture can be performed safely. In addition, since the inflow or outflow amount is sufficient, the time required for puncture can be shortened.

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

<Puncture needle>
The puncture needle of the present invention is suitably used for collecting blood of humans and other animals. The collected blood is usually used for blood tests.

{Needle shape}
In order to collect blood and analyze components in the blood, there are needles for collecting blood from arms, elbows, fingertips, etc., and hollow needles inside and hollow needles.
For example, a puncture needle having a hollow is generally used to puncture a vein and collect blood in the vein at a medical institution or in a medical examination, and usually analyze the components in the blood. It is done. For example, components for diagnosing diabetes such as blood glucose level, hemoglobin A1c (HbA1c), components for diagnosing liver function such as glutamate pyruvate transaminase (GPT), glutamate oxaloacetate transaminase (GOT), creatinine (CRE) It is used to analyze components for diagnosing renal function such as urea nitrogen (BUN).
On the other hand, a non-hollow puncture needle called a lancet is generally used by a subject to puncture his / her fingertip and collect blood in an apparatus for self-measuring blood glucose level.
The present invention relates to a puncture needle whose inside is hollow.

  The blood collection puncture needle of the present invention has an outer diameter of the tip of 0.26 mm or more and 0.34 mm or less, an inner diameter of 0.17 mm or more, and the outer diameter and inner diameter of the tip are smaller than the inner diameter and outer diameter of the proximal end, The length from the distal end of the needle to the proximal end is 9 mm or more. As specific forms, the following first form, second form, and third form are suitable. Hereinafter, although it demonstrates in detail, the form of a needle | hook is not this limitation.

  A first form of a puncture needle suitable for the present invention is a puncture needle having a small diameter portion inserted into a living body and a large diameter portion whose outer diameter is larger than the small diameter portion, and the outer diameter of the small diameter portion is 0. .26 mm or more and 0.34 mm or less, the inner diameter is 0.17 mm or more, and the length from the distal end to the proximal end of the needle is 9 mm or more. FIG. 1 shows a first configuration.

  In FIG. 1, the needle H has a small-diameter portion A that is inserted into the living body and a large-diameter portion B that has a larger outer diameter than the small-diameter portion A. C represents the needle base, and L represents the length from the distal end J to the proximal end K of the needle. Each part will be described below.

  The small diameter part A is a part inserted into the living body. You may design so that all the small diameter parts may be inserted, and you may design so that a part of small diameter part may be inserted.

  If the outer diameter is less than or equal to the upper limit value, there will be no pain during venipuncture. Furthermore, the feeling of fear or anxiety caused by pain can be reduced. If the outer diameter is equal to or greater than the lower limit value, the strength against bending at the time of puncturing is weakened, and in some cases, puncturing cannot be prevented.

  If the inner diameter is within the above range, the influence of resistance when blood passes through the needle is small. In addition, if the liquid resistance in the tube is defined by the inner diameter, a great effect can be obtained for securing the blood flow rate. Thereby, the time for collecting the blood volume necessary for the blood test can be shortened. Furthermore, since the resistance of the needle in the tube is small and blood can be collected in a short time, damage to the whole blood during blood collection is small, and so-called hemolysis is less likely. The hemolysis will be described later.

As described above, the outer diameter of the small-diameter portion A is 0.26 mm or more and 0.34 mm or less, and preferably 0.26 mm or more and 0.31 mm or less.
The inner diameter is 0.17 mm or more as described above, but must be smaller than the outer diameter.

  The smaller difference between the outer diameter and the inner diameter of the small diameter portion is preferable in that the inner diameter can be increased and damage to whole blood is small. However, a larger difference is preferable in order to maintain the mechanical strength of the needle. Therefore, the difference between the outer diameter and the inner diameter of the puncture needle is preferably 0.04 mm or more and 0.17 mm or less, more preferably 0.05 mm or more and 0.14 mm or less, and most preferably 0.06 mm or more and 0.12 mm or less. .

  As described above, the small-diameter portion A is in the above-described range from the viewpoints of pain, needle mechanical strength, blood collection time, hemolysis, and the like. On the other hand, by increasing the thickness of the needle except for the portion that is punctured in the living body, the strength of the needle can be increased, and a safe puncture needle can be provided. Further, when puncturing into a living body, particularly when puncturing a vein, puncturing is performed while looking for a vein at an angle, and therefore it is preferable that the length is longer than the length that is punctured in the living body. This extra length is usually about 5 mm or more.

  The large diameter part B is larger than the outer diameter of the small diameter part A, preferably 0.35 mm or more, and more preferably 0.40 mm or more. In addition, the inner diameter of the large diameter portion B is preferably larger than the inner diameter of the small diameter portion A.

The length L from the distal end J to the proximal end K of the needle is 9 mm or more, preferably 9 mm to 38 mm, more preferably 9 mm to 25 mm, and most preferably 9 mm to 20 mm. The length L is the total length of the large-diameter portion B and the small-diameter portion A. If the length L is too short, as described above, when puncturing a vein, puncture while looking for the vein at an angle. Therefore, puncturing becomes difficult. On the other hand, if the length is too long, stable puncture cannot be performed. In the present invention, by setting the outer diameter and the length within the above ranges, a puncture needle having optimum strength as a puncture needle for blood collection can be obtained.
The length of the small diameter portion A is preferably 7 mm or more, and the length of the large diameter portion B is preferably 2 mm or more.

  Further, the small diameter portion and the large diameter portion may be directly connected as shown in FIG. 1, and the portion connecting the small diameter portion A and the large diameter portion B as shown in FIG. Or you may have a part (taper D) from which an internal diameter changes continuously. From the viewpoint of manufacturing, a structure having a tapered portion D between the small diameter portion A and the large diameter portion B is more preferable. The length of the taper portion D is preferably 30% or less of L, and more preferably 20% or less.

  The second form of the puncture needle of the present invention includes a small-diameter portion that is inserted into a living body, and a tapered portion that is formed continuously from the small-diameter portion and has an outer diameter that is continuously larger in the major axis direction than the small-diameter portion. A puncture needle having an outer diameter of 0.26 mm or more and 0.34 mm or less, an inner diameter of 0.17 mm or more, and a length from the distal end to the proximal end of the needle of 9 mm or more. Features. FIG. 2 shows a second configuration.

  In FIG. 2, the needle H has a small-diameter portion A that is inserted into the living body, and a tapered portion E that is formed continuously from the small-diameter portion A and whose outer diameter is continuously larger in the long axis direction than the small-diameter portion A. . C represents the needle base, and L represents the length from the distal end J to the proximal end K of the needle. Each part will be described below.

  The second form of the puncture needle suitable for the present invention is the same as the first form except that the large-diameter part B in the first form is the tapered part E described above. is there. The taper portion E can maintain the flow rate and increase the strength of the needle.

  The small-diameter portion A of the second form has the same form as the small-diameter part A of the first form, has the same features and functions, and the preferred range and the like are also the same.

  The tapered portion E has an outer diameter that is continuously larger in the long axis direction than the small diameter portion. The outer diameter of the base end K in the tapered portion E is preferably 0.35 mm or more, and more preferably 0.40 mm or more.

The length L from the distal end J to the proximal end K of the needle is 9 mm or more, preferably 9 mm to 38 mm, more preferably 9 mm to 25 mm, and most preferably 9 mm to 20 mm. The length L is the combined length of the tapered portion E and the small diameter portion A. If the length L is too short, as described above, when puncturing a vein, puncture while looking for the vein at an angle. This is difficult to puncture. On the other hand, if the length is too long, stable puncture cannot be performed. In the present invention, by setting the outer diameter and the length within the above ranges, a puncture needle having optimum strength as a puncture needle for blood collection can be obtained.
The length of the small diameter portion A is preferably 7 mm or more, and the length of the tapered portion E is preferably 2 mm or more.

The taper angle is determined by the length of the tapered portion E, the outer diameter of the small diameter portion A, and the outer diameter of the proximal end K. The angle of the outer diameter of the tapered portion E is preferably 0.3 degrees or more and more preferably 0.5 degrees or more with respect to a line parallel to the central axis of the needle.
Further, the inner diameter of the tapered portion is also a tapered structure. That is, the inner diameter of the tapered portion E is larger than the inner diameter of the distal end J and smaller than the inner diameter of the proximal end K. The taper angle of the inner diameter may be the same as or different from the taper angle of the outer diameter.

  In the third form of the puncture needle suitable for the present invention, the inner diameter of the distal end of the needle inserted into the living body is smaller than the inner diameter of the proximal end, and the outer diameter of the distal end is smaller than the outer diameter of the proximal end. An inner diameter and an outer diameter are tapered in the major axis direction, the outer diameter of the distal end is 0.26 mm or more and 0.34 mm or less, the inner diameter is 0.17 mm or more, and from the distal end of the needle to the proximal end The length is 9 mm or more. FIG. 3 shows a third embodiment.

  In FIG. 3, the needle H forms a taper shape from the distal end J inserted into the living body to the proximal end K. C represents the needle base, and L represents the length from the tip J to the base K of the needle. Each part will be described below.

  The third form of the puncture needle of the present invention has a structure in which the tapered part E in the second form is continuously connected to the puncture part at the tip, and by making the entire needle H into a tapered structure, The pain reduction function can be maintained on the distal end J side of the needle H, and the strength and flow rate can be maintained on the proximal end K side.

  The tip J of the third form is a portion inserted into the living body.

  If the outer diameter is less than or equal to the upper limit value, there will be no pain during venipuncture. Furthermore, the feeling of fear or anxiety caused by pain can be reduced. If the outer diameter is equal to or greater than the lower limit value, the strength against bending at the time of puncturing is weakened, and in some cases, puncturing cannot be prevented.

  If the inner diameter is within the above range, the influence of resistance when blood passes through the needle is small. In addition, if the liquid resistance in the tube is defined by the inner diameter, a great effect can be obtained for securing the blood flow rate. Thereby, the time for collecting the blood volume necessary for the blood test can be shortened. Furthermore, since the resistance of the needle in the tube is small and blood can be collected in a short time, damage to the whole blood during blood collection is small, and so-called hemolysis is less likely.

As described above, the outer diameter of the tip J is 0.26 mm or more and 0.34 mm or less, and preferably 0.26 mm or more and 0.31 mm or less.
The inner diameter is 0.17 mm or more as described above, but must be smaller than the outer diameter.

  Further, the smaller the difference between the outer diameter and the inner diameter of the tip J is preferable in that the inner diameter can be increased and damage to the whole blood is small. However, a larger one is preferable in order to maintain the mechanical strength of the needle. Therefore, the difference between the outer diameter and the inner diameter of the puncture needle is preferably 0.04 mm or more and 0.17 mm or less, more preferably 0.05 mm or more and 0.14 mm or less, and most preferably 0.06 mm or more and 0.12 mm or less. .

  The tip J is in the above-mentioned range from the viewpoints of pain, strength, blood collection time, hemolysis and the like as described above. On the other hand, by gradually increasing the thickness of the needle toward the proximal end K except for the part that is punctured into the living body, the strength of the needle can be further increased and a safe puncture needle can be provided.

  The proximal end K is larger than the outer diameter of the distal end J, preferably 0.35 mm or more, more preferably 0.40 mm or more, and most preferably 0.45 mm or more. Further, the inner diameter of the proximal end K is larger than the inner diameter of the distal end J due to the tapered structure.

  The length L from the distal end J to the proximal end K of the needle is 9 mm or more, preferably 9 mm to 38 mm, more preferably 9 mm to 25 mm, and most preferably 9 mm to 20 mm. If the length L is too short, puncturing into a vein is difficult because puncturing is performed while looking for a vein at an angle. On the other hand, if the length is too long, stable puncture cannot be performed. In the present invention, by setting the outer diameter and the length within the above ranges, a puncture needle having optimum strength as a puncture needle for blood collection can be obtained.

  The taper angle is determined by the length L of the needle H, the outer diameter of the distal end J, and the outer diameter of the proximal end K. The angle of the outer diameter of the needle H is preferably 0.3 degrees or more, and more preferably 0.5 degrees or more with respect to a line parallel to the central axis of the needle.

  In the following, further preferred embodiments common to the first, second and third modes will be described.

  The shape of cutting the needle tip for puncturing may be any of three-sided cut, one-sided cut, straight line cut, or curved line cut. The cutting angle of the needle tip in the case of a one-side cut is preferably an angle of 8 degrees to 30 degrees in the blade edge angle θ defined by Japanese Industrial Standard T3101-1979. In the case of a three-surface cut, the cutting angle of the needle tip is preferably 7 to 20 degrees for the first grinding angle a and 10 to 30 degrees for the second grinding angle b. FIG. 3 shows a preferable three-surface cut needle tip. The first grinding angle a is shown in FIG. 3A, and the second grinding angle b is shown in FIG. 3B (see ISO 7864).

{Needle material}
The material of the needle is a material capable of forming a hollow needle, such as stainless steel such as SUS304, metal such as nickel-free stainless steel, resin such as polycarbonate and acrylate polymer, inorganic material such as quartz glass and borosilicate glass. If there is no particular limitation. Among them, it is preferable to use a metal such as stainless steel because it is easy to maintain the mechanical strength at the outer diameter. Further, the outer surface or inner surface of the needle may be coated with a material other than the needle material. In particular, it is preferable to coat with another material (such as silicon) for the purpose of lowering puncture resistance and facilitating puncture.

{Needle form}
The puncture needle of the present invention is a puncture needle for blood collection. The form of the needle may be any form as long as it can be used for blood collection, such as an injection needle, a blood collection needle, and a winged needle. The general shape of the injection needle is shown in FIG. It consists of a needle base (hub) 1 and a needle tube (canula) 2 and is usually marketed with a protective cap (protector) 3 for protecting the blade. There are a method of collecting blood by bonding to a syringe and a method of collecting blood by using a luer adapter. A general form is defined in JIS T-3209. A general shape of the blood collection needle is shown in FIG. It is composed of a needle tube (canula) 2 and a needle base (hub) 1 having blade tips at both ends penetrating in the front-rear direction. For continuous blood collection, one having a hemostatic rubber cover 4 at the rear of the needle base 1 is generally used. Usually, it is marketed in the form of covering a protective cap (protector) 3 for protecting the blade. It is attached to a vacuum blood collection holder and used for vacuum blood collection. A general form is defined in JIS T-3220.

When the puncture needle of the present invention takes the form of a blood collection needle, the needle has two ends, but the tip of the needle is the end that punctures the human body, and corresponds to L1 in FIG. The proximal end of the needle is the proximal end on the side that punctures the human body and corresponds to L2 in FIG. Further, when the puncture needle of the present invention takes the form of a blood collection needle, the outer diameter of the distal end on the plug puncture side (rubber cover side) is larger than the outer diameter of the distal end on the human body puncture side, and punctures the human body. Since the needle is thin on the side, there is little pain, and the side that punctures the vacuum blood collection tube can be punctured smoothly into the rubber stopper because the needle can be thickened.

  Since the puncture needle of the present invention has a thin outer diameter, the direction of the needle blade may be difficult to see compared to the 21G needle normally used for blood collection. For this reason, it is preferable to mark the needle base to indicate the direction of the blade. This mark may be any mark such as Δ, ○, and ●. The mark may be attached by any method such as printing, sticking a sticker, or applying unevenness.

  The needle of the present invention may be further devised in consideration of safety, workability and the like. For example, it is preferable to install a safety cover that is locked with a cover so as not to touch the needle after blood collection. In the case of a blood collection needle, it is also preferable to connect two needle tubes or make the needle base transparent or translucent so that a so-called flashback can be visually confirmed, which indicates that the vein has been punctured.

  When the puncture needle of the present invention takes the form of an injection needle, the injection needle may be attached to a syringe to form an integrated blood collection syringe. Alternatively, a luer adapter may be attached to the injection needle, and a vacuum blood collection tube holder may be attached to form an integral needle holder. When the puncture needle of the present invention takes the form of a blood collection needle, the blood collection needle may be attached to a vacuum blood collection holder to form an integrated needle holder. In this way, by providing an integrated blood collection device in a usage form in advance, it is possible to save the trouble of attaching a needle at the time of blood collection and removing and attaching the needle after blood collection, and further, a needle stick accident is less likely to occur. Therefore, it is preferable in hospitals and the like where there are a large number of blood samples, because this leads to shortening of the blood collection time.

{Manufacture of needles}
The puncture needle of the present invention is not particularly limited, and can be manufactured according to a conventional method in this field.

[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.

The puncture needle of the present invention can be used for syringe blood collection or vacuum blood collection. In view of blood collection time and ease of blood collection, vacuum blood collection is more preferable.
<Vacuum blood collection tube>
The puncture needle of the present invention can constitute a blood collection kit together with a vacuum blood collection tube. When the puncture needle of the present invention is an injection needle, combining the injection needle and a luer adapter, and mounting it on a vacuum blood collection tube holder, connecting the vacuum blood collection tube, blood collection starts with the negative pressure of the blood collection tube Is done. When the puncture needle of the present invention is a blood collection needle, blood collection is started by the negative pressure of the blood collection tube by attaching the blood collection needle to a vacuum blood collection tube holder and connecting the vacuum blood collection tube.
The vacuum blood collection tube used when collecting blood with the puncture needle of the present invention may be any commercially available vacuum blood collection tube.
The vacuum blood collection tube is usually pre-sealed with anticoagulant, antiglycolytic agent, etc., and is used properly depending on the component to be analyzed. Also, depending on the purpose of analyzing the amount of blood collected by the blood collection tube, vacuum blood collection tubes with different capacities are properly used, but blood collection tubes with collection amounts of 2 mL, 5 mL, and 10 mL are generally used. The time required to collect blood depends on the condition of the subject (generally a patient) and the proficiency of the examiner (generally a doctor, nurse, or clinical laboratory technician), but it can range from several seconds to several tens of seconds. It is normal to complete with.
The degree of vacuum of the commercially available vacuum blood collection tube is about -200 mmHg to -650 mmHg, and any commercially available vacuum blood collection tube can be used in the blood collection kit of the present invention. In view of the blood collection speed and the like, a vacuum blood collection tube having a degree of reduced pressure of −400 mmHg or more is preferable, a vacuum blood collection tube of −450 mmHg or more is more preferable, and a vacuum blood collection tube of −500 mmHg or more is most preferable. . In addition, the degree of decompression described here defines atmospheric pressure as 0 mmHg and vacuum as -760 mmHg.

  In the present invention, if a small-capacity blood collection tube is used in addition to a commercially available vacuum blood collection tube, it is possible to collect only the amount necessary for the examination, which reduces the burden on the subject. it can. It is preferable to use a blood collection tube with a volume of 7 mL or less, more preferably a blood collection tube with a volume of 4 mL or less, and most preferably a blood collection tube with a volume of 1.5 mL or less.

<Inspection chip>
The puncture needle of the present invention can constitute an inspection kit together with an inspection 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. .

<Blood collection volume>
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 in the needle is preferably 0.01 mL / second or more.
In the method of collecting blood by inserting a needle that is normally used at the tip of a disposable syringe such as a Terumo syringe and then puncturing the vein into a vein and pulling the piston of the syringe, the blood is collected depending on the amount of blood required. It is common to use a syringe of 1 mL to 25 mL and in some cases 50 mL. One of the advantages of blood collection using a syringe is that, for example, when a small amount of blood is taken from a newborn, a child, an elderly person, etc., and only a limited amount of blood is analyzed, only the necessary amount can be collected. For example, blood of 100 μL to several 100 μL may be collected. Even when such a small amount of blood is collected, the time required is usually several seconds to several tens of seconds. From these facts, if 100 μL, which is the minimum amount necessary for blood tests, can be secured, it is considered useful as a blood collection needle for micro blood tests, and in the present invention as a needle that can collect blood with a required blood volume of 100 μL in 10 seconds. A puncture needle that can collect 10 μL of blood per second is desirable.

<Other aspects>
The puncture needle of the present invention can be used in addition to puncturing a human vein to obtain blood. It is particularly useful when collecting blood from small animals with thin blood vessels, can also be used when collecting blood from animals such as dogs and cats at animal hospitals, and in physics and chemistry experiments such as chemistry, biochemistry, and biology, It can also be used when collecting blood from small animals such as mice and rabbits.

  Furthermore, blood collection for humans can be used for blood collection for monitoring health in pharmacies, health care shops, etc., as well as in hospitals, health examinations, and medical checkups where blood is usually collected. Since the pain can be reduced as compared with a normal blood collection needle, it is highly useful for applications such as a health check for healthy people, particularly 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. In addition, since the puncture needle of the present invention has less pain at the time of blood collection, it is useful for measuring a substance that may be affected by stimulation at the time of blood collection such as a stress marker.

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

{Manufacturing of a stepped puncture needle having a small diameter part and a large diameter part}
The puncture needles a to c having the small diameter part A and the large diameter part B shown in FIG. 4 were manufactured as follows. The dimensions of the puncture needles a to c are shown in Table 1.

  For the production of the puncture needle, a stepped pipe having the above dimensions was prepared by drawing with a die. Next, the first grinding angle of the needle tip is processed into a sharp shape by cutting 3 faces at an angle of 9 to 13 degrees, the resin needle base member and the needle are joined with an adhesive, and sterilized with gamma rays Thus, the puncture needle a of Example 1 and the puncture needles b and c of Comparative Examples 1 and 2 were produced.

{Manufacture of straight structure puncture needle}
The straight structure puncture needle e used in Comparative Example 4 was produced by the following method.
Cold-drawn a commercially available hollow stainless steel tube, processed into a sharp shape by cutting the first tip angle of the needle tip from 9 to 13 degrees into a three-sided surface, and adhesive the resin needle base member and needle And sterilized with gamma rays to produce a puncture needle e of Comparative Example 4. This puncture needle was prepared so that the outer diameter, inner diameter, and length were the dimensions shown in Table 2.

{Commercial puncture needle}
Tapered insulin administration needle d used in Comparative Example 3 The commercially available product “Nanopath 33” is a pen needle, and the needle base structure did not match the Terumo syringe, so the needle was inserted at the tip of the syringe barrel. After that, the experiment was conducted by winding the needle with parafilm and maintaining airtightness and watertightness between the syringe barrel and the needle base.
The commercially available blood collection needle f 21G having a straight structure used in Comparative Example 5 was used as it was.

  Table 2 shows the outer diameter, inner diameter, and length of these puncture needles. The outer diameter and inner diameter were cut from a needle tube, the cross section was photographed using an optical microscope (50 times), and the dimensions were measured from the images. These puncture needles were prepared with sterilization treatment such as gamma irradiation.

{Evaluation of ease of puncture (blood collection)}
Using the puncture needles of Example 1 and Comparative Examples 1 to 5, the ease of puncture (blood collection) was evaluated. Five piercers punctured the elbow flex vein with respect to two healthy persons. The results are shown in Table 3. A needle that can be punctured by all five piercers with confidence is indicated by ◎, a needle that has been punctured but felt anxious, and a needle that may not be punctured is indicated by ×.
The puncture needle a of Example 1, Comparative Examples 1-2 and Comparative Example 5 and the blood collection puncture needles of Comparative Example 5 had a needle length of 10 mm or more and reached the vein sufficiently and could be punctured in any case. Further, since the puncture needles a to c have thick roots, the strength against bending is strong, and the puncture needles a to c can be punctured with peace of mind. The puncture needle f is a straight needle, but has a large thickness and can be punctured with peace of mind. On the other hand, the needle of Comparative Example 3 has a short needle length, and it may be difficult to puncture a vein successfully. The straight needle of Comparative Example 4 had a sufficient length so that it could be punctured smoothly. However, since the strength of the needle was weak, there was a slight anxiety about the puncture.

{Pain assessment}
In the evaluation of ease of puncture (blood collection), a blood sample (10 healthy subjects) determined whether or not pain was felt. The score of 10 people was totaled, with 1 point if you felt pain and 0 point if you did not feel pain. The evaluation results are shown in Table 3, with 9 to 10 points being x, 4 to 8 points being Δ, and 3 points or less being ◯.
The puncture needles of Example 1, Comparative Example 1, Comparative Example 3 to Comparative Example 4 had a tip outer diameter of 0.22 to 0.31, both evaluated as Δ, and some people did not feel pain. On the other hand, the puncture needle of Comparative Example 2 and the puncture needle of Comparative Example 5 had a large outer diameter, and everyone felt pain.

{Evaluation of blood passage speed}
Remove the piston (inner cylinder) of a 10 mL Terumo syringe commercially available from Terumo Co., Ltd., attach each puncture needle to the tip of the syringe cylinder (outer cylinder), and then collect all blood collected from healthy males in the syringe cylinder 5 mL of blood was gently injected. The hematocrit value of this whole blood was 42.5%. 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.
Gently puncture the rubber part of another unused vacuum blood collection tube “Benoject II (blood collection volume: 5 mL)” with a needle attached to the tip and injecting whole blood into the tube. Whole blood in the syringe The speed at which the needle was sucked into the vacuum blood collection tube through the needle was measured. In the measurement, the level of the liquid level when 1.0 mL of liquid enters the blood collection tube is marked in advance, and 1.0 mL of whole blood is collected starting from when the needle is punctured into the vacuum blood collection tube. The time when entering the blood collection tube was measured to determine the blood collection rate per second. The speed was 500 μL / second or more as A, 50 to 500 μL / second as B, 10 to 50 μL / second as C, and 10 μL / second or less as D. The results are shown in Table 3.
Further, since the blood passage speed is affected by the hematocrit value, the value of the hematocrit value is also shown in Table 3.

(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}
The supernatant obtained by centrifuging the whole blood collected in the vacuum blood collection tube in the above {evaluation of blood passing speed} at room temperature and 3000 rpm for 10 minutes is collected, and the clinical laboratory automatic analyzer 7170 manufactured by Hitachi, Ltd. is used. The activity of lactate dehydrogenase (LDH) in the supernatant was measured to evaluate hemolysis. As a comparison, the activity of LDH in 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 LDH relative to this was evaluated. The results are shown in Table 3. The increase in LDH was defined as the degree of hemolysis, and if there was an increase of +10 U / L or more, it was judged as hemolysis. The evaluation was ○ when no hemolysis was performed, and × when hemolysis was performed. The results are shown in Table 3.

From Table 3, the needle of Example 1 is easy to collect blood, reduces pain, has a high blood passage speed, and allows rapid blood collection. In addition, no hemolysis was observed in the collected blood, and blood could be collected without damaging the blood.
On the other hand, since the inner diameter of the tip of the puncture needle of Comparative Example 1 was too thin, blood collection speed was slow and hemolysis sometimes occurred. The puncture needles of Comparative Example 2 and Comparative Example 5 felt pain during puncture because the outer diameter of the tip was too large. Since the puncture needle of Comparative Example 3 had an inner diameter at the tip that was too thin, the blood collection rate was slow, hemolysis occurred, and the length was too short, making it difficult to puncture. With the straight needle of Comparative Example 4, there was a concern about strength and blood collection was difficult, and compared with the needle of Example 1, the blood passage speed was slow.

It is the schematic which shows the 1st form of the puncture needle of this invention. It is the schematic which shows the 2nd form of the puncture needle of this invention. It is the schematic which shows the 3rd form of the puncture needle of this invention. It is the schematic which shows one Embodiment of the 1st form of the puncture needle of this invention. It is the schematic which shows one form of the puncture needle for blood collection of this invention. It is the schematic which shows one form of the puncture needle for blood collection of this invention. It is explanatory drawing which shows the cut shape of the needle point in the puncture needle of this invention.

Explanation of symbols

A Small diameter portion B Large diameter portion C Needle base D Tapered portion in the first configuration E Tapered portion in the second configuration H Needle J Tip J ₁ Outer diameter of the small diameter portion J ₂ Inner diameter of the small diameter portion A K ₁ Large diameter portion outer diameter K ₂ inside diameter K proximal L length of the large-diameter portion B of B

1 Needle base (hub)
2 Needle tube (canula)
3 Protection cap (Protector)
4 Hemostatic rubber cover L1 Tip L2 Base end L Length from tip to base a First grinding angle b Second grinding angle

Claims (8)

  The outer diameter of the tip of the needle is 0.26 mm or more and 0.34 mm or less, the inner diameter is 0.17 mm or more, the outer diameter and inner diameter of the tip are smaller than the inner diameter and outer diameter of the proximal end, and from the distal end of the needle to the proximal end A puncture needle for blood collection characterized by having a length of 9 mm or more.   A puncture needle having a small-diameter portion to be inserted into a living body and a large-diameter portion whose outer diameter is larger than the small-diameter portion, and the outer diameter of the small-diameter portion is 0.26 mm or more and 0.34 mm or less, and the inner diameter is 0.17 mm. The puncture needle for blood collection according to claim 1, wherein the length from the distal end to the proximal end of the needle is 9 mm or more.   A puncture needle having a small-diameter portion inserted into a living body and a tapered portion formed continuously from the small-diameter portion and having an outer diameter continuously larger in the long axis direction than the small-diameter portion, The puncture for blood collection according to claim 1, wherein the diameter is 0.26 mm or more and 0.34 mm or less, the inner diameter is 0.17 mm or more, and the length from the distal end to the proximal end of the needle is 9 mm or more. needle.   The inner diameter of the tip of the needle inserted into the living body is smaller than the inner diameter of the proximal end, the outer diameter of the distal end is smaller than the outer diameter of the proximal end, and the inner diameter and the outer diameter are tapered in the major axis direction from the distal end to the proximal end. The outer diameter of the distal end is 0.26 mm or more and 0.34 mm or less, the inner diameter is 0.17 mm or more, and the length from the distal end to the proximal end of the needle is 9 mm or more. The puncture needle for blood collection according to 1.   5. The blood sampling puncture needle according to claim 1, wherein a mark indicating the direction of the blade is provided on the needle base.   An inspection kit comprising the puncture needle according to claim 1 and an inspection chip.   A blood collection kit comprising the puncture needle according to any one of claims 1 to 5 and a vacuum blood collection tube.   The blood collection kit according to claim 7, wherein an internal volume of the vacuum blood collection tube is 1.5 mL or less.

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