JP2002159475A - Stopper for blood collection tube - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a stopper for a vacuum blood collection tube which has resistance between a blood collection tube holder and a stopper controlled within a reasonable range, can reduce thrusting resistance, can maintain a state of reduced resistance for a long period, of time and is less prone to have a kickback phenomenon caused by a rubber case. SOLUTION: A hard, catching layer 3 with degree of hardness of the surface measured as 55 to 115 by JIS K7202 is placed on a peripheral surface of a main part 1 made of a rubber-like, elastic material. A stopper 1 for blood collection tube is made in such a manner that the hard, catching layer 3 makes contact with a catching part of the blood collection tube found on the inner surface of a blood collection tube holder.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a plug for a blood collection tube, and more particularly to a plug used for a vacuum blood collection method using a blood collection tube holder. The present invention relates to a blood collection tube plug that can be reduced.

[0002]

2. Description of the Related Art Conventionally, a vacuum blood collection method using a blood collection tube holder has been widely used. The vacuum blood collection tube has a bottomed blood collection tube body made of glass or synthetic resin, and a plug for closing an upper opening of the blood collection tube body. In order to maintain the vacuum inside the vacuum blood collection tube, as well as to prevent internal contamination,
The stopper is usually made of a rubber-like elastic body.

At the time of vacuum blood collection, first, a blood collection tube holder equipped with blood collection needles having needle tips at both ends is prepared, and the blood collection needle is pierced into a blood vessel. Thereafter, the vacuum blood collection tube is inserted into the blood collection tube holder, and the tip of the blood collection needle opposite to the side pierced by the blood vessel is pierced through the plug of the vacuum blood collection tube. In this way, blood is sucked into the vacuum blood collection tube using the reduced pressure of the vacuum blood collection tube.

[0004] Since it is used as described above,
The blood collection tube holder is constituted by a cylindrical member having a needle fixing portion at one end. In the needle fixing part at one end of the cylindrical member,
The vacuum blood collection needle is fixed. Also, the other end of the cylindrical body is
It is released for inserting a vacuum blood collection tube, and the cylindrical main body constitutes a blood collection tube locking portion.

[0005] The blood collection tube holder is mainly formed by injection molding of a thermoplastic resin such as polypropylene or polyethylene. When a vacuum blood collection tube is inserted into the cylindrical main body of the blood collection tube holder, the outer peripheral surface of the plug of the vacuum blood collection tube comes into contact with the inner peripheral surface of the blood collection tube holder.

On the other hand, conventionally, a plug of a vacuum blood collection tube is generally made of a rubber-like elastic material as described above. Examples of such a rubber-like elastic body include natural rubber, isoprene rubber, butadiene rubber, and halogenated rubber, and a thermoplastic elastomer having excellent restoring force is also used as the rubber-like elastic body.

[0007]

However, when a vacuum blood collection tube sealed with a rubber-like elastic material as described above is inserted through the opening of the blood collection tube holder, the maximum diameter portion of the plug made of the rubber-like elastic material is used. Then, the inner peripheral surface of the blood collection tube holder comes into contact with the blood collection tube holder, and the insertion resistance of the vacuum blood collection tube is increased. That is, the plug generally has a small-diameter portion having a relatively small diameter that enters into the blood collection tube main body, and a large-diameter portion having a relatively large diameter connected to insertion, and the diameter of the large-diameter portion is
Usually, it is configured to be larger than the diameter of the blood collection tube main body. Therefore, when the vacuum blood collection tube is inserted into the blood collection tube holder, there is a problem that the large diameter portion of the stopper comes into contact with the inner peripheral surface of the blood collection tube holder and the insertion resistance increases.

If the insertion resistance is high, the blood collection tube holder is not stable, and there is a risk that blood vessels of the blood collection subject may be damaged. Further, the insertion resistance between the plug and the inner peripheral surface of the blood collection tube holder also adds to the puncture resistance during blood collection. Therefore, it is desirable that the insertion resistance is small.
Generally, a puncture resistance applied to a blood-collected person at the time of blood collection is 1.0.
It is considered that the weight is preferably equal to or less than kgf.

Further, in order to enhance the plugging property of the blood collection tube main body, the plug body surface is often treated with a lubricant such as silicone oil. In this case, the resistance between the inner peripheral surface of the blood collection tube holder and the plug body surface is reduced. Therefore, the above-described adjustment of the piercing resistance can be adjusted by the type and the amount of the silicone oil or the like as the lubricant. However,
As time elapses, the silicon oil on the surface may peel off or impregnate the plug body. Therefore, the surface condition of the plug deteriorates with time, and the resistance between the inner peripheral surface of the blood collection tube holder and the outer surface of the plug tends to increase.

However, it is not preferable that the resistance between the blood collection tube holder and the vacuum blood collection tube is too small. That is, in a vacuum blood collection needle having needle tips at both ends, a sheath rubber is often provided so as to cover the needle tip at the end opposite to the side penetrated by the blood vessel. In such a case, during the blood collection, the urging force in the direction in which the vacuum blood collection tube falls off the blood collection tube holder acts on the stopper due to the sheath rubber covering the tip of the vacuum blood collection needle on the vacuum blood collection side. Blood vessels may fall off the blood collection needle and blood may not be collected completely. This phenomenon is called “kickback phenomenon” by the sheath rubber.

The kickback phenomenon can be prevented by setting the contact resistance between the stopper and the inner peripheral surface of the blood collection tube holder to a certain level. That is, some resistance is required between the plug of the blood collection tube, the blood collection tube holder, and the inner peripheral surface.

SUMMARY OF THE INVENTION An object of the present invention is to solve the above-mentioned problem of the conventional plug for a vacuum blood collection tube, and the resistance between the inner wall of the blood collection tube holder and the plug made of rubber-like elastic material reduces the penetration resistance. A plug for a vacuum blood collection tube, which can maintain a state in which the resistance is reduced for a long period of time, and can realize a moderate resistance in which the kickback phenomenon described above is unlikely to occur. To provide.

[0013]

A plug for a blood collection tube according to the present invention is a plug for a blood collection tube used for a vacuum blood collection method using a blood collection tube holder. When the blood vessel is inserted into the holder, the blood vessel is provided on the outer peripheral surface of the main body so as to come into contact with the blood collection tube locking portion provided on the inner wall surface of the blood collection tube holder, and JIS K
A hard locking layer having a surface hardness of 55 to 115 measured by 7202.

In a specific aspect of the present invention, at least one concave portion is formed in an outer peripheral surface portion of the main body made of the rubber-like elastic body to which the hard locking layer is attached, and the hard locking layer is It is configured to have a protruding portion that enters the recess.

[0015] In another specific aspect of the present invention, the hard locking layer is formed of a heat-shrinkable film. In a further specific aspect of the present invention, the hard locking layer is formed of a partially cut-out resin ring, and the diameter of the resin ring is a diameter of a portion of the rubber-like elastic body where the hard locking layer is provided. The resin ring is extrapolated to the main body by expanding the diameter of the resin ring, and the resin ring is attached to the main body by an elastic reducing action of the resin ring.

[0016]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be clarified by describing specific embodiments of the plug for blood collection tube according to the present invention with reference to the drawings.

FIGS. 1 and 2 are a longitudinal sectional view and a partially cutaway perspective view of a plug for blood collection tube according to a first embodiment of the present invention. The blood collection tube plug 1 is attached to close an opening of a blood collection tube main body used for a vacuum blood collection method using a blood collection tube holder. The blood collection tube main body to be combined is not particularly limited, and an ordinary test tube-shaped blood collection tube main body having a cylindrical shape with a bottom and an opening at an upper end can be used as appropriate.

The plug 1 has a main body 2 made of a rubber-like elastic body and a hard locking layer 3 fixed to the main body 2. The main body 2 made of the rubber-like elastic body protrudes downward from a substantially cylindrical large-diameter portion 2a having a relatively large diameter and a lower surface of the large-diameter portion 2a. And a substantially cylindrical small diameter portion 2b having a small diameter. The concave portion 2 is provided on the upper surface of the large diameter portion 2a.
c is formed. Also, a concave portion 2d is formed on the lower surface of the small diameter portion 2b. The concave portions 2c and 2d are formed at positions where they are overlapped in the height direction, whereby the portion where the concave portions 2c and 2d are provided is thinned. This thinned portion is configured to reduce the penetration resistance of the blood collection needle. That is, the blood collection needle is pierced through the thinned portion.

In the present embodiment, the outer peripheral surface of the large diameter portion 2a is formed as an inclined surface such that the diameter decreases as it goes upward. However, the outer peripheral surface of the large diameter portion 2a does not have to be such an inclined surface.

On the other hand, a plurality of annular grooves 2e, 2f extending in the circumferential direction are formed on the outer peripheral surface of the large diameter 2a, and the grooves 2e, 2f constitute a concave portion in the present invention. In this embodiment, the grooves 2e and 2f are formed at different height positions in the large diameter portion 2a. However, the number of the grooves 2e and 2f as the concave portions is not limited, and only one groove may be formed, or three or more grooves may be formed.

In the present invention, the concave portion is not limited to an annular groove, but may be an appropriate groove or a bottomed hole which is engaged with a protruding portion provided on the hard locking portion 3. The rubber-like elastic body constituting the main body is not particularly limited, and an appropriate material having rubber elasticity can be used, and is not particularly limited. That is, any natural rubber, synthetic rubber or elastomer can be used, and examples of the synthetic rubber include halogenated butyl rubber such as chlorinated butyl rubber, isoprene rubber and butadiene rubber. Further, a thermoplastic elastomer having excellent resilience can be used as the material having the rubber elasticity.

In order to reliably and hermetically seal the blood collection tube main body, the hardness of the rubber-like elastic body constituting the main body is determined by JI.
The hardness of the cured rubber of SK6301 is preferably in the range of 40 to 60.

On the outer peripheral surface of the large diameter portion 2a of the main body 2, a hard locking layer 3 is provided.
The ring 3a has a substantially cylindrical ring 3a in close contact with the outer peripheral surface thereof, and annular ribs 3b and 3c protruding inward from the inner surface of the ring 3a. The annular ribs 3b and 3c as protrusions are
e, 2f. Due to the engagement between the annular ribs 3b, 3c and the grooves 2e, 2f, when an external force is applied to the hard locking layer 3a in the axial direction of the main body 2,
The hard locking layer 3 is hard to fall off from the main body 2.

The hard locking layer 3 is made of JIS K7202
Is configured to have a surface hardness of 55 to 115. In this case, the entirety of the hard locking layer 3 may be made of a material having the above-mentioned surface hardness, or the outer surface of the hard locking layer 3 may have the above-mentioned outer surface when mounted on the main body 2 as shown in FIGS. As long as the surface hardness range can be realized, the hard locking layer 3 may be configured by combining a plurality of materials.

Examples of the material having a surface hardness in the above specific range include thermoplastic hard synthetic resins such as polypropylene, polyethylene, polyacetal and polycarbonate.

In this embodiment, after preparing the main body 2 made of the rubber-like elastic body, the main body 2 is placed in a mold, and the hard locking layer 3 is formed by insert molding.
It is fixed to.

In the plug 1, as described above, the hard locking layer 3 is provided on the outer peripheral surface of the large diameter portion 2a including the maximum diameter portion of the main body 2. Therefore, when the vacuum blood collection tube provided with the plug 1 is inserted into the blood collection tube holder during vacuum blood collection, the inner surface of the tubular blood collection tube locking portion of the blood collection tube holder and the outer surface of the plug 1 are formed. The resistance between the hard locking layer 3 is appropriately reduced. Therefore, the insertion resistance of the vacuum blood collection tube to the blood collection tube holder is reduced, and undesired movement of the blood collection tube holder can be suppressed, and there is no possibility of causing damage to blood vessels of the blood collection subject. In addition, the puncture resistance applied to the blood-collected person is reduced, and the burden on the blood-collected person is reduced.

Further, since the surface hardness measured according to JIS K7202 is 55 or more, the resistance between the blood collection tube holder and the plug 1 is not too small. The phenomenon can also be effectively suppressed.

Next, a specific experimental example using the plug 1 will be described. The main body 2 was manufactured using chlorinated butyl rubber, the main body 2 was housed in a mold, and the hard locking layer 3 was formed by injection molding of polypropylene to obtain the plug 1. The maximum diameter of the obtained plug was 17.3 mm. The thus obtained plug 1 was vacuum-plugged into a blood collection tube main body made of polyethylene terephthalate to obtain a vacuum blood collection tube. Insert the above vacuum blood collection tube into a blood collection tube holder (Sekisui Chemical Co., Ltd. blood collection holder N) equipped with a blood collection needle (trade name: Venoject II blood collection needle S21G × 11/2, manufactured by Terumo Corporation), and collect the plug and the blood collection tube. When the contact resistance with the blood vessel holder was measured, the average was 0.94 kgf (standard deviation 0.10).
Met.

For comparison, a plug made of chlorinated butyl rubber was provided without the hard locking layer 3, but with the same overall dimensions as the plug 1, ie, the maximum diameter was 17.3 mm. The body was made. Using this stopper, a vacuum blood collection tube was prepared in the same manner as in the above experimental example, and the contact resistance with the blood collection tube holder was measured. The average was 1.41 kgf.
(Standard deviation 0.15).

In each of the examples and the comparative examples, the number of samples n whose resistance was measured was five. FIG.
FIG. 4 is an exploded perspective view and a longitudinal sectional view for explaining a plug according to a second embodiment of the present invention.

In the second embodiment, the main body 12 is
2a and a small diameter portion 12b. The main body 12 is formed in the same manner as the main body 2 of the first embodiment, except that the grooves 2e and 2f as the concave portions are not formed.

In this embodiment, the large diameter portion 12 of the main body 12 is used.
A heat-shrinkable tube 13 shown separately in the upper part of FIG. 3 is extrapolated to the outer surface of FIG. Heat shrink tube 13
, Which constitutes the hard locking layer of the present invention, has a surface hardness of 55 to 115 as measured by JIS K7202 after shrinkage. Therefore, the first
Similarly to the plug 1 of the first embodiment, the contact resistance with the blood collection tube holder can be controlled to an appropriate value, and the burden on the blood-collecting person can be reduced, similarly to the plug 1 of the first embodiment. It is possible,
The kickback phenomenon due to the sheath rubber can be suppressed.

The material of the heat-shrinkable tube 13 is not particularly limited as long as the surface hardness can be realized, but a tube made of a polyvinyl chloride-based, polyolefin-based or polyethylene terephthalate-based heat-shrinkable resin is used. Can be

FIGS. 5 and 6 are an exploded perspective view and an external perspective view for explaining a plug according to a third embodiment of the present invention. In the plug 21 of the third embodiment, a resin ring 23 for forming a hard locking layer is fixed to a main body 22 made of a rubber-like elastic body.

The main body 22 has a large-diameter portion 22a and a small-diameter portion 22b, similarly to the main body 2 of the first embodiment. Body 22
Are different from the main body 2 of the first embodiment in that the grooves 2e, 2
Instead of f, a single groove 22c is formed on the outer peripheral surface of the large diameter portion 22a. The groove 22c is formed in the resin ring 2
3 is provided for fixing, but is not necessarily required. That is, the cross-sectional shape of the groove 22c is configured such that the resin ring 23 fits. In other respects, the main body 22 is configured in the same manner as the main body 2 of the first embodiment. The description of the embodiment will be referred to.

On the other hand, the resin ring 23 has an annular shape with a part cut away. That is, the resin ring 23
In this configuration, the one end 23a and the other end 23a are separated from each other, so that the diameter can be expanded or reduced by applying an external force.

The material constituting the resin ring 23 has a surface hardness of 55 to 55 measured according to JIS K7202.
The material is not particularly limited as long as it is 115, and can be made of the same material as that of the hard locking layer 3 of the first embodiment. However, since the resin ring 23 is combined with the main body 22 as described later, the resin ring 23 does not need to be formed of a thermoplastic resin, but is formed of a thermosetting resin such as a phenol resin or a urea resin. Is also good.

To obtain the plug 21, first, a main body 22 made of a rubber-like elastic body and a resin ring 23 are prepared. Next, an external force is applied so as to keep the ends 23a and 23b of the resin ring 23 apart from each other, the diameter is increased, and the resin ring 23 is inserted into the main body 22.
It is attached to the groove 22c. When removing the external force that was applied,
The inner diameter of the resin ring 23 is reduced by the elastic diameter reducing action, and the resin ring 23 is fixed to the groove 22 c of the main body 22 by the elastic holding action.

Since the resin ring 23 functions as the hard locking layer of the present invention, the maximum diameter portion of the plug 21 is configured to be the maximum diameter portion of the resin ring 23. is necessary. That is, in the state shown in FIG.
The thickness of the resin ring 23 is selected so as to be the maximum diameter portion of the resin ring 23. In other words, the horizontal dimension of the cross section of the resin ring 23 is larger than the dimension from the deepest part of the groove 22c to the maximum diameter part of the main body 22.

Further, since the resin ring 23 is mounted on the main body 22 by the above-described action of expanding and reducing the diameter, the inner diameter of the resin ring 23 in the initial state is determined by the portion of the main body 22 to which the resin ring 23 is attached, that is, It is preferable that the diameter of the groove 22c is larger than the diameter of the minimum diameter portion of the groove 22c.

In the stopper 21 of the present embodiment, the blood collection tube holder comes into contact with the resin ring 23 as the hard locking layer at the time of vacuum blood sampling, so that the contact resistance is kept within an appropriate range as in the first embodiment. Thus, the burden on the blood sampler can be reduced, and the kickback phenomenon caused by the rubber sheath can be suppressed.

[0043]

In the plug for blood collection tube according to the present invention, a hard locking layer is provided on the outer peripheral surface of a rubber-like elastic body, and the hard locking layer has a surface hardness measured according to JIS K7202. Is in the range of 55 to 115, so that when inserted into the blood collection tube holder, the contact resistance between the inner wall surface of the holder and the plug is reduced, so that the blood collection operation can be performed easily and the piercing resistance can be improved. Thus, the burden on the blood collection subject can be reduced. In addition, the kickback phenomenon due to the rubber sheath can be suppressed, the falling off of the vacuum blood collection tube can be reliably prevented, and the blood collection operation by the vacuum blood collection method can be performed easily and stably.

At least one concave portion is formed on the outer peripheral surface of the main body made of a rubber-like elastic body to which the hard locking layer is attached, and the hard locking layer has a projecting portion that can enter the concave portion. In the structure in which the locking layer is integrated by insert molding, it is possible to prevent the hard locking layer from falling off the main body made of the rubber-like elastic body by the engagement between the recess and the projection.

When the hard locking layer is made of a heat-shrinkable film, it is shrunk by heating and the hard locking layer is fixed to the main body made of a rubber-like elastic material.
Again, it is possible to prevent the hard locking layer from falling off the main body.

Further, the hard locking layer is formed of a partially cut-out resin ring, and the resin ring is expanded by applying an external force to the resin ring.
When the resin ring is attached to the rubber-like elastic body by the elastic diameter reducing action of the resin ring, the resin ring as the hard locking layer can be prevented from falling off from the main body.

[Brief description of the drawings]

FIG. 1 is a longitudinal sectional view of a blood collection tube plug according to a first embodiment of the present invention.

FIG. 2 is a partially cutaway perspective view of the plug for blood collection tube of the first embodiment.

FIG. 3 is an exploded perspective view of a blood collection tube plug according to a second embodiment of the present invention.

FIG. 4 is a longitudinal sectional view of a plug for blood collection tube according to a second embodiment.

FIG. 5 is an exploded perspective view of a blood collection tube plug according to a third embodiment of the present invention.

FIG. 6 is a perspective view showing the appearance of a blood collection tube main body of a third embodiment.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 ... Plug body 2 ... Main body 2a ... Large diameter part 2b ... Small diameter part 2c, 2d ... Depression 2e, 2f ... Groove (recess) 3 ... Hard locking layer 3b, 3c ... Annular rib (projection part) 11 ... Plug 12 ... Main body 13 ... Heat shrink tube 21 ... Plug body 22 ... Main body 22c ... Groove 23 ... Resin ring

Claims (4)

[Claims] 1. A plug for a blood collection tube used in a vacuum blood collection method using a blood collection tube holder, comprising: a main body made of a rubber-like elastic body; and an inner wall surface of the blood collection tube holder when the blood collection tube is inserted into the holder. Provided on the outer peripheral surface of the main body so as to be in contact with the blood collection tube locking portion provided in the JIS K720
And a hard locking layer having a surface hardness of 55 to 115 measured according to 2. 2. A body comprising the rubber-like elastic body, wherein at least one concave portion is formed on an outer peripheral surface portion to which the hard locking layer is attached, and the hard locking layer projects into the concave portion. The plug for a blood collection tube according to claim 1, wherein the plug is integrated with a main body made of a rubber-like elastic body by insert molding. 3. The blood collection tube plug according to claim 1, wherein the hard locking layer is formed of a heat-shrinkable film. 4. The hard locking layer is formed of a partially cut-out resin ring, and the diameter of the resin ring is smaller than the diameter of a portion of the rubber-like elastic body where the hard locking layer is provided. The resin ring is externally inserted into the main body by expanding the diameter of the resin ring, and the resin ring is attached to the main body by an elastic diameter reducing action of the resin ring.
The plug for a blood collection tube according to the above.