JPH02937B2 - - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION BACKGROUND OF THE INVENTION [Field of the Invention] The present invention relates to a blood collection device such as a vacuum blood collection tube that maintains a reduced pressure state so that a required amount of blood sample can be collected, and in particular to a tube using the vacuum blood collection tube. It concerns the structure between the body and the blood collection aid.

[Prior art and its problems]

A vacuum blood collection tube is used to collect blood for blood tests. As shown in FIG. 1, the vacuum blood collection tube 1 is made up of a tube body 2 made of glass or air-impermeable plastic with a stopper 3, which is also air-impermeable, glued to one open end of the tube body 2, and the inside of the tube body 2 is made of glass or air-impermeable plastic. The space 5 is kept under reduced pressure so that the required amount of blood can be collected. The plug body 3 is generally composed of a rubber stopper 4. The rubber stopper 4 is required to have properties such as gas barrier properties to reduce the increase in internal pressure of the vacuum blood collection tube and resealability to seal the hole after puncture. Therefore, as a constituent material of the rubber stopper 4, vulcanized butyl rubber is generally used. Vulcanized butyl rubber has excellent sealing properties due to its rubber elasticity, but since it contains sulfur, vulcanization accelerators, vulcanization accelerators, etc.
There was a problem that these substances could be eluted into the collected blood and affect the test values of the blood sample, and that the manufacturing cost would be high. If a polymeric composite material with a large compression set is used instead of vulcanized butyl rubber, the rubber stopper can be made cheaper, but the gap between the rubber stopper and the vacuum blood collection tube holder (blood collection aid) used during blood collection can be reduced. In reality, rubber stoppers made of polymeric composite materials could not be used because of the problems described below.

The reduced pressure blood collection tube 1 shown in FIG. 1 is used for blood collection as shown in FIGS. 2 and 3. The reduced pressure blood collection tube 1 is inserted into the reduced pressure blood collection tube holder 6 from the rubber stopper 4 at its tip as shown in FIG. The vacuum blood collection tube holder 6 has a cylindrical holder body 9 with an open rear end, and a puncture needle 8 is attached to the tip of the holder body 9 by a threaded portion 7 between the hub and the holder body. The distal end 8a of the puncture needle 8 has a pointed end for puncturing a human body, etc., and the rear end 8b is covered with a sheath-like elastic body, that is, a rubber tip 10, and has a pointed end capable of puncturing the rubber tip 10. Note that the rubber tip 10 is not limited to the one shown in the drawings; for example, if the puncture needle has an opening only on the side surface, it may be an elastic valve body that exists only on the side surface and exposes the opening when compressed.

When collecting blood, the vacuum blood collection tube 1 is pushed into the holder main body 9 from the state shown in FIG. 2 to the state shown in FIG. At this time, the rear end 8b of the puncture needle 8 is attached to the rubber tip 1.
0, then the rubber stopper 4 of the reduced pressure blood collection tube 1 is pierced, and blood is naturally introduced into the internal space 5 of the reduced pressure blood collection tube 1 through the puncture needle 8 due to its reduced pressure state.

At this time, the rubber tip 10 is folded into a bellows shape between the holder main body 9 and the rubber stopper 4 of the vacuum blood collection tube 1. Even if the rubber tip 10 is folded many times due to multiple blood collections, when the blood collection is completed, it rebounds to its original state as shown in FIG. 2 to prevent blood from leaking from the rear end 8b of the puncture needle 8 and spilling into the holder. In order to do this, it must have strong elasticity. The rubber stopper 4 of the vacuum blood collection tube 1 must be able to maintain the pushed-in state shown in FIG. 3 against the strong elasticity of the rubber tip.

In the case of the rubber stopper made of vulcanized butyl rubber mentioned above, the compression set is approximately 27% (70℃, 22 hours), and although there is some backlash, the rubber stopper 4
grips the rear end of the puncture needle, and can resist the repulsive force of the rubber tip by the frictional force between them or by the frictional force between the rubber stopper and the inner peripheral surface of the holder. When using a rubber stopper,
The compression set of the material is 40% or more (70°C, 22 hours), and the frictional force between the rubber stopper and the rear end of the puncture needle, or the frictional force between the rubber stopper and the inner peripheral surface of the holder. Because the pressure is small, the repulsive force of the rubber tip causes the vacuum blood collection tube to jerk or move backwards, causing the puncture needle to retreat into the rubber stopper or outside the rubber stopper, making it impossible to collect blood, or causing blood to collect inside the holder body. may leak out. It should be noted that all of the above measurements of compression set were performed in accordance with JIS K 6301.

In addition, when using a rubber stopper made of a polymeric composite material, the sealing performance of the through hole may not be sufficient after being punctured with a puncture needle, and the collected blood may leak through the through hole, causing contamination. There is a risk of

Furthermore, when a rubber stopper made of a polymeric composite material is used, leakage occurs between the rubber stopper and the tube during low-temperature storage, making it impossible to maintain a reduced pressure state.

Purpose of the Invention The present invention was made in view of the above-mentioned circumstances, and its purpose is to use vulcanized rubber with a large compression set or an inexpensive polymer composite that does not require vulcanization as a rubber plug material. Even when using a material that has a small frictional force with the inner peripheral surface of the holder, it is possible to resist the repulsive force of the rubber tip on the vacuum blood collection tube holder side described above during blood collection.
The object of the present invention is to provide an inexpensive blood sampling device that has good resealability at the punctured part and is configured to ensure reliable blood sampling.

DETAILED DESCRIPTION OF THE INVENTION The present invention provides a blood sampling device having a male portion that can be detachably inserted into the female portion of a blood sampling aid having a female portion, the blood sampling device having a male opening. It consists of a blood collection container in the part, a stopper provided in an opening having a piercing part that can be penetrated by a hollow needle protruding into the female part of the blood collection aid, and a depressurized space in the container. , when the piercing portion of the plug body is inserted into the hollow needle and compresses the elastic sheath body, which opens and closes the fluid passage of the hollow needle, in the axial direction of the hollow needle, To provide a blood sampling device characterized by being provided with a protruding locking part that engages with the inner surface of the female part with a frictional force that prevents the plug that is pierced by a repulsive force from retreating. be.

It is preferable that the material of the plug body has a compression set of at least 40%, especially in a portion other than the piercing portion.

Further, it is preferable that a groove is formed in the stopper, and the neck of the blood collection container is pushed into the groove.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The blood sampling device of the present invention will be described in detail below with reference to preferred embodiments shown in the accompanying drawings.

As shown in FIG. 7, the blood sampling device used in the present invention has a gas barrier rubber stopper 30 attached to one open end of a tube body 2 made of glass or gas barrier plastic, and its internal space 5 is A vacuum is maintained so that the required amount of blood can be collected.

The blood sampling device of the present invention has a compression set of 40
In order to compensate for the above-mentioned drawbacks when using a rubber stopper made of a material of It is characterized by having a protruding engaging part that provides a frictional force between it and the inner surface of the female mold part to resist the repulsive force of the rubber chip, and an example of its construction is shown in FIGS. 4 and 5.

As explained with reference to FIGS. 2 and 3, the protruding locking portion provided on the outer periphery of the tube can be used to recover the rebound of the rubber tip of the blood collection aid that is forcibly folded into a bellows shape with a rubber stopper during blood collection. It is necessary to generate a frictional force between the tube body and the holder to prevent the rubber stopper from retreating undesirably due to force.
For example, vertical ribs, horizontal ribs, diagonal ribs, discontinuous protrusions, etc. formed on the outer periphery of the tubular body are applied.

The repulsive abdominal force due to the rubber chip mentioned above is approximately 300
Since the maximum static friction force between the hollow needle and the elastic stopper of the blood collection aid is approximately 150 to 400 g, the locking portion between the tube body and the holder of the present invention is By generating a frictional force with the inner surface of the holder that is at least greater than the value obtained by subtracting the maximum static frictional force from the repulsive restoring force, it is possible to prevent the elastic stopper from retreating.

An example of the configuration of the blood sampling device of the present invention that satisfies such conditions will be described below. In these examples, longitudinal ribs are formed on the outer surface of the tube,
As mentioned above, the tube body of the present invention is not limited to these. The male end of the tube of the vacuum blood collection tube only needs to have a shape that fits into the female part of the holder (blood collection aid), and the tubes are not of approximately the same diameter, but have a small diameter. It may have a male section and a rear section with a larger diameter.

The rubber stopper of the vacuum blood collection tube is as shown in Figure 6.
The top part has a recess 21 for storing a rubber tip that is forcibly folded during blood collection, and the bottom part has a recess 22 for easily exposing the puncture needle to the internal space of the vacuum blood collection tube.

In the tube body of a vacuum blood collection tube to which such a rubber stopper is attached, the example shown in FIG.
are formed symmetrically on the outer periphery of the tube body 2, and these ribs 31 are in contact with the wall of the vacuum blood collection tube holder,
A frictional force is generated that resists the repulsive restoring force of the rubber chip and prevents the rubber stopper 30 from retreating.

The example shown in FIG. 5 is an example in which two longitudinal ribs 31 are provided symmetrically. The vertical ribs 31 may be provided at any position as long as the holder and the tube overlap when the tube is inserted into the holder.

As the rubber stopper material used in the present invention, a material having a large compression set such as a polymer composite material can be used. Polymer-based composite materials include butyl-based materials such as polyisobutylene and partially cross-linked butyl rubber, thermoplastic resins such as polyethylene to impart fluidity during molding, and mica (mica) to improve gas barrier properties. ) etc. can be used. However, with rubber stoppers made of materials with large compression set such as polymeric composite materials, the sealing properties of the through holes may not be sufficient after being punctured with a puncture needle, and blood can be collected through these through holes. blood leaks out,
There is a risk of contamination. Therefore, in this type of rubber stopper, a resealing portion made of a resealable material can be formed in at least a portion of the area where the puncture needle is expected to penetrate, so as to enclose the puncture needle.

In FIG. 6, this resealing portion 32 is
An example is shown in which it is provided from the top recess 21 to the bottom recess 22. However, the resealing part 32
0 does not have to penetrate from the bottom recess 22 to the top recess 21, and can be provided only near the bottom recess 22 of the rubber stopper 30 or only near the top recess 21 of the rubber stopper 30.

The constituent materials of the resealing part formed in the rubber stopper include styrene-butadiene block copolymer such as CALIFLEX TR-2104 (manufactured by Ciel Chemical Co., Ltd.), hydrogenated styrene-butadiene block copolymer such as AR-804 (Aron (manufactured by Kasei Co., Ltd.) or mica-containing Lavalon (manufactured by Mitsubishi Yuka Co., Ltd.).

The groove 33 shown in FIG. 6b is for inserting the neck of a tube such as a glass tube of a vacuum blood collection tube.
The rubber stopper is brought into close contact with the inner and outer surfaces of the tube, thereby preventing an increase in pressure within the tube due to leakage that may occur due to the difference in thermal contraction between the rubber stopper and the tube at low temperatures. The depth of the groove is preferably 0.2 mm or more, preferably about 0.7 to 1.5 mm.

The slit 34 formed facing the bottom recess 22 shown in FIG. 6b is designed to facilitate attachment and detachment of the rubber stopper to a tube body such as a glass tube, and to effectively prevent detachment when the stopper is attached. It is something.

Next, an example of a method for manufacturing a rubber stopper used in the vacuum blood collection tube of the present invention will be briefly described.

First, 75 weight ratios of partially crosslinked butyl rubber, 25 weight ratios of polyethylene, 40 weight ratios of mica, and 2 weight ratios of liquid paraffin are kneaded at 150° C. using a Banbury mixer, then formed into a sheet and then pelletized. Using a pelletized gas barrier composite material, it is molded into the shape of a rubber stopper using an injection molding machine.
A resealing portion 32 shown in the figure is further embedded by injection molding.

This series of molding can be performed more efficiently by using a two-color injection molding machine.

Specific Effects of the Invention Next, the effects of the blood sampling method using the blood sampling device of the present invention will be explained using FIGS. 7, 8, and 9, according to the circumstances during blood sampling.

FIG. 7 is a partial sectional view of a vacuum blood collection tube 100 in which a rubber stopper 30 is attached to a tube body 2 according to the present invention.
The neck of the tube body 2 is pushed into the groove 33 of the rubber stopper 30,
The inner and outer surfaces of the tube body 2 are pressed against the rubber stopper. The internal space 5 is maintained in a reduced pressure state by a rubber stopper 30 made of a material with large compression set such as a gas barrier polymeric composite material, and the slit 3 of the rubber stopper 30
4 facilitates attachment and detachment of the rubber stopper 30 to and from the tube body 2. Further, ribs 31 formed on the outer surface of the tube body 2 and projecting from the tube surface act as a locking portion in cooperation with the vacuum blood collection tube holder 6 described below.

When blood is collected using the blood collection device of the present invention, the vacuum blood collection tube 100 having a ribbed tube body is pushed into the main body 9 of the holder 6 from the rear end opening, as shown in FIG. At this time, the rib 31 of the tubular body 2 is pushed into the holder body 9 while being in close contact with the inner peripheral surface.
At this time, the reduced pressure blood collection tube 100 is inserted without compressing the air within the holder body. Vacuum blood collection tube 1
FIG. 9 shows the state in which 00 is completely inserted into the main body 9 of the holder 6. In this state, as described at the beginning of the specification, the rear end 8b of the puncture needle 8 pierces the rubber tip 10, further penetrates the rubber stopper 30 of the vacuum blood collection tube 100, and reaches the internal space 5 of the vacuum blood collection tube 100. , blood under positive pressure is naturally introduced into the internal space 5 under reduced pressure through the puncture needle 8 due to the pressure gradient.

The reduced pressure blood collection tube 100 receives the repulsive force of the rubber tip 10 which is forcibly folded into the recess 21 of the rubber stopper 30 when the reduced pressure blood collection tube is pushed into the tube. However, tube body 2
The ribs 31 formed on the outer surface of the holder body 9 are in close contact with the inner peripheral surface of the holder body 9, and a large frictional force is generated between them. Since the sum of this frictional force and the frictional force between the rubber stopper 30 and the rear end 8b of the puncture needle 8 is set to be larger than the repulsive force of the folded rubber tip 10, the vacuum blood collection tube 100 is held in a holder. During blood collection, the position where the blood sample is completely inserted into the tube 6 to ensure blood collection, that is, the state shown in FIG. 9, is maintained at all times.

When the required amount of blood is collected, the internal space 5 is pressurized and the blood collection is completed. When blood collection is completed, the vacuum blood collection tube 100 is forcibly pulled out from the holder 6.
At this time, the rubber tip 10 is restored to its original state as shown in FIG. 8 to prevent leakage of blood, contamination of the holder, and contamination of the puncture needle. Thereby, preparations for blood collection using the next new vacuum blood collection tube are completed, and blood collection can be performed one after another as described above. As described above, blood sampling using the blood sampling device of the present invention enables safe and sanitary blood sampling.

In addition, in the blood sampling device of the present invention assembled as shown in FIG. 7, the tube body 2 is pushed into the groove 33 of the rubber stopper 30 and is sealed from the inner and outer surfaces of the tube body by the rubber stopper. Even in low-temperature conditions, no leakage occurs due to the difference in heat shrinkage rate between the tube and the rubber stopper.

Specific Effects of the Invention As is clear from the above description and the examples below, the blood sampling device of the present invention provides many advantages as described below.

(1) In the blood sampling device of the present invention, since the locking portion is provided on the outer surface of the vacuum blood collection tube, a frictional force between the tube and the blood sampling aid is greater than the repulsive force of the rubber tip folded by the tube. , it is possible to prevent the blood collection tube from retreating due to the repulsive force of the rubber tip.

(2) The rubber stopper of the blood sampling device of the present invention preferably does not use vulcanized butyl rubber, which has a small compression set as in the past, but uses a material with a large compression set, such as a polymeric composite material. Since no vulcanization is performed, there is no need for a vulcanization process in manufacturing, and there is no problem of elution of sulfur, vulcanization accelerators, vulcanization accelerators, etc. into the collected blood during use, and there is also an increase in manufacturing costs. It uses inexpensive materials and requires fewer manufacturing steps, making it possible to significantly reduce costs. In addition, when using vulcanized rubber, it has become possible to use one with a large compression set.

(3) When blood is collected using the blood collection device of the present invention, when the vacuum blood collection tube is pushed into the holder, a frictional force greater than the repulsive force of the folded rubber tip is applied to the locking portion provided on the outer surface of the blood collection tube. Because it has a gap between the tube and the holder, even if the stopper is made of a material with a large compression set such as a polymeric composite material, backlash (retraction of the vacuum blood collection tube) will not occur, ensuring reliable and hygienic blood collection. Ru.

EXAMPLES Next, the blood sampling device of the present invention will be specifically described with reference to examples.

Example 1 A blood sampling device as shown in FIG. 10 was prepared.

The tube was made of polyethylene terephthalate by injection molding. The outer diameter of the tube body is 12.8 mm, and two ribs 31 are placed symmetrically on the tube body at a position 10 mm from the tip of the rubber stopper as shown in FIG.
Individually formed.

The rubber stopper was produced by injection molding by kneading partially crosslinked butyl rubber at a weight ratio of 70, low density polyethylene at a weight ratio of 30, mica at a weight ratio of 40, and liquid paraffin at a weight ratio of 2. Compression set of rubber stopper is 75% (70℃, 22 hours)
The outer diameter was 12.8mm.

The holder is made of polypropylene and has an inner diameter of 13.0 mm.
The wall thickness was 0.8mm. The repulsive restoring force of the rubber chip was 350g.

Using the blood sampling device of the present invention having such a configuration and a blood sampling device having a similar configuration without ribs,
After conducting a blood sampling test with 100 tubes of each,
None of the inventive products with ribs buckled, but all the ones without ribs buckled.

[Brief explanation of drawings]

FIG. 1 is a sectional view of a conventional vacuum blood collection tube, FIGS. 2 and 3 are sectional views showing how blood is collected using the vacuum blood collection tube of FIG. 1, and FIGS. FIGS. 4a and 5a are plan views, FIGS. 4b and 5b are partial cross-sectional side views, and FIG. 6 is an example of the configuration of a rubber stopper of a vacuum blood collection tube. So, Figure 6a is the plan view,
Figure b is a partially sectional side view thereof, Figure 7 is a partial sectional view of the blood sampling device of the present invention, and Figures 8 and 9 are 7
FIG. 10 is a sectional view of the blood sampling device of the present invention used in the examples; FIG. 11a is a partial sectional side view of the tube shown in FIG. 10; Figure 11b is a plan view of Figure 11a. Explanation of symbols, 1... Decompression blood collection tube, 2... Tube body,
3...Plug body, 4...Rubber stopper, 5...Inner space, 6
...Reduced pressure blood collection tube holder, 7...Threaded part, 8...
Puncture needle, 8a... tip, 8b... rear end, 9... holder body, 10... rubber tip, 21, 22...
... recess, 30... rubber stopper, 31... rib, 32...
...resealing part, 33...groove, 34...slit,
100...Reduced pressure blood collection tube of the present invention.

Claims (1)

[Scope of Claims] 1. A blood sampling aid having a male part that can be removably inserted into the female part of a blood sampling aid having a female part, the blood collecting apparatus having an opening in the male part. Consisting of a blood collection container, a stopper provided at an opening having a piercing part that can be penetrated by a hollow needle protruding into the female part of the blood collection aid, and a depressurized space within the container,
When the piercing portion of the stopper penetrates the hollow needle into the outer surface of the container and compresses the elastic sheath that opens and closes the fluid passage of the hollow needle in the axial direction of the hollow needle, the sheath repulses. A blood sampling device comprising a protruding locking portion that engages with the inner surface of the female portion with a frictional force that prevents the plug being pierced by force from retreating. 2. The blood sampling device according to claim 1 or 2, wherein the plug has a compression set of at least 40%. 3. The portion of the plug other than the piercing portion has a compression set of at least 40%.
The blood sampling device according to paragraph 2 or paragraph 2. 4. The blood collection device according to any one of claims 1 to 4, wherein a groove is formed in the plug, and the neck of the blood collection container is inserted into the groove.