JPH01310640A - Reduced pressure blood collecting tube - Google Patents

Abstract

PURPOSE:To obviate the exfoliation of a sealing member even at a high temp. of >=40 deg.C and to allow easy stripping of the sealing member by fixing an airtightness maintaining type member to the aperture of a blind tube via a polyester resin having the softening point lower than the softening point of the polyester resin of the blind tube. CONSTITUTION:The airtightness maintaining type member 4 has the function to hermetically seal the aperture of the blind tube 2 and to maintain the reduced pressure state in the blind tube 2. Said member is formed of a material having a high gas barrier property, for example, film and is provided with a modified polyester resin film 6 forming an adhesive film to the rear surface thereof in order to fix said surface to the aperture of the blind tube 2. The modified polyester resin film 6 has thermal weldability with the polyester resin forming the blind tube 2, has also an easy peeling property and has the softening point lower than the softening point of the polyester resin constituting the blind tube 2. The hermetic member 3 is mounted to the periphery 8 of the aperture of the blind tube 2 by hermetically depositing the modified polyester resin film 6 thereto by welding using heat.

Description

DETAILED DESCRIPTION OF THE INVENTION [Industrial Field of Application] The present invention relates to a reduced pressure blood collection tube for collecting blood samples for use in blood tests.

[Prior Art] Conventionally, various blood sampling instruments have been used in clinical tests, such as biochemical tests and serum tests. There are many blood sampling devices in use that consist of a blood sampling tube holder with a puncture needle at the tip.

As an in-shell vacuum blood collection tube, one consisting of a bottomed tube made of glass or plastic and a rubber stopper that seals the opening of the bottomed tube is used. However, in recent years, automatic testing systems have been developed that automatically collect and test the blood inside the blood collection tube after blood is collected using a vacuum blood collection tube. For this reason, the sealing member for sealing the opening of the blood collection tube is no longer necessarily required to be able to be resealed after being opened, like a rubber stopper.

Therefore, it has been proposed that the opening of the plastic tube with a bottom is sealed with an airtight film, and a sealing member is further provided on the airtight film to seal the needle tip provided at the rear end of the blood collection needle. (160.9/1986)
Publication No. 08).

[Problems to be Solved by the Invention] What is shown in Japanese Utility Model Application Publication No. 62-160.908 is a bottomed tube made of polyethylene terephthalate and a sealing member attached to the opening of the bottomed tube. The sealing member is composed of a highly airtight gas barrier member disposed below and a sealing member disposed above and bonded together in a layered manner, and further an adhesive film is disposed below the gas barrier member. It is set up. The sealing member is fixed to the periphery of the opening of the bottomed tube by heat-sealing an adhesive film. A polyethylene terephthalate film is used as the adhesive film. Although the above methods have sufficient effects, the adhesive temperature is high when bonding the sealing member to the bottomed tube (the area near the opening of the bottomed tube may be deformed, and the sealing member may be peeled off). In addition, it was considered to use an EvA (ethylene vinyl acetate)-based hot melt adhesive as the adhesive film, but hot melt adhesives have poor heat resistance and cannot be used at temperatures above 40°C. In this case, since the inside of the bottomed tube is under reduced pressure, there is a problem in that the adhesive part peels off due to atmospheric pressure.

[Means for Solving the Problems] Therefore, an object of the present invention is to prevent the sealing member fixed to the opening of the bottomed tube from peeling off even at high temperatures of 40'C or more, and further, An object of the present invention is to provide a reduced pressure blood collection tube whose sealing member can be easily peeled off.

What achieves the above purpose is a bottomed tube made of polyester resin with one end open and the other end closed, and a sealing member that seals the opening of the bottomed tube and can be pierced by a puncture needle of a blood sampling device. A vacuum blood collection tube with a reduced pressure inside, the sealing member being fixed to the opening of the bottomed tube and sealing the opening; and the airtightness maintaining member. a sealing member provided on the member and capable of resealing the punctured portion after the puncture needle is removed, and the airtightness maintaining member is softer than the polyester resin constituting the bottomed tube. This is a vacuum blood collection tube that is fixed to the opening of the bottomed tube through a polyester resin with a low point.

The reduced pressure blood collection tube of the present invention will be explained using an example shown in FIG.

The vacuum blood collection tube 1 of the present invention includes a bottomed tube 2 made of polyester resin with one end open and the other end closed, and the opening of the bottomed tube 2 sealed and capable of being pierced by a puncture needle of a blood sampling device. The sealing member 3 is a vacuum blood collection tube whose interior is depressurized, and the sealing member 3 is fixed to the opening of the bottomed tube 2, and the airtightness maintaining member 4 seals the opening, and the airtightness maintaining member 4. 4
The airtightness maintaining member 4 has a softening point lower than that of the polyester resin constituting the bottomed tube 2. It is fixed to the opening of the bottomed tube 2 through a polyester resin having a low temperature.

FIG. 1 is a sectional view of one embodiment of the reduced pressure blood collection tube of the present invention, and FIG. 2 is a partially enlarged sectional view of the sealing member of the reduced pressure blood collection tube shown in FIG. 1.

Therefore, the reduced pressure blood collection tube of the present invention will be specifically explained using FIGS. 1 and 2.

The reduced pressure blood collection tube 1 of the present invention consists of a bottomed tube 2 and a sealing member 3 that seals the opening of the bottomed tube 2, and the inside is reduced in pressure by a predetermined amount of blood to be collected.

The bottomed tube 2 is a cylindrical body with one end open and the other end closed, and except for the closed end, the bottomed tube 2 has a substantially cylindrical shape. An annular flange 8 is provided at the opening of the tube 2, extending perpendicularly to the axial direction of the bottomed tube 2 and protruding outward. It forms the solid blue part of.

The material for the bottomed tube 2 is preferably one with high gas barrier properties in order to maintain the internal reduced pressure state, and is made of polyester resin. As the polyester resin, polyethylene terephthalate and the like are preferred.

Preferably, the inner surface of the bottomed tube 2 is subjected to a hydrophilic treatment to prevent blood cells from adhering to the inner surface of the bottomed tube. The hydrophilic treatment can be carried out by coating the inner surface of the bottomed tube 2 with a hydrophilic substance (for example, water-soluble silicone, PVA, PVP, etc.).

Furthermore, a blood anticoagulant such as heparin powder or EDTA-2 may be attached to or contained in the bottomed tube. Conversely, a blood coagulation accelerator may be attached to or housed inside the tube.Furthermore, a blood coagulation accelerator may be attached to or impregnated with filter paper, non-woven fabric, etc. and sealed inside the bottomed tube 2. good. Examples of coagulation accelerators include:
A pond of silica sand with a size of 0.4 to 20 microns, a crystalline silica with a size of 5 microns or less and an average particle size of 1.1 microns (for example, manufactured by Pennsylvania Glass Sand Co., trade name Min)
-U-3il), diatomaceous earth, glass fine powder, kaolin,
These include bentonite, protamine sulfate and thrombin.

Furthermore, a serum separating agent may be stored inside the bottomed tube 2. A serum separating agent is a gel-like substance with chicken-tropic properties that has a specific gravity intermediate between that of serum and blood cell components. For example, the main component is an α-olefin/maleic acid diester copolymer, and a viscosity and specific gravity adjusting agent is added to this. Those added can be suitably used.

The sealing member 3 is formed by an airtightness maintaining member 4, a sealing member 5 provided thereon, and a modified polyester resin film 6 forming an adhesive member provided on the lower surface of the airtightness maintaining member. ing.

The airtight maintenance member 4 has the function of sealing the opening of the bottomed tube 2 and maintaining a reduced pressure state inside the bottomed tube 2, and is a gas barrier formed of a material with high gas barrier properties. It is formed of a plastic film, for example, a metal foil such as aluminum foil, an ethylene-vinyl alcohol copolymer, a resin film material such as polyvinylidene chloride, or the like. Furthermore, a modified polyester resin film 6 forming an adhesive film is provided on the lower surface of this gas barrier film for fixation to the opening of the bottomed tube 2. The modified polyester resin 6 may be coated on the entire lower surface of the airtight maintenance member 4, or may be coated in an annular manner at least on the portion that becomes the fixed portion of the opening of the bottomed tube 2.

The modified polyester resin film has heat fusion properties with the polyester resin forming the bottomed tube 2 and also has easy beer properties. The modified polyester resin has a softening point lower than that of the polyester resin constituting the bottomed tube 2. In particular, modified polyester resins have excellent adhesive strength to polyethylene terephthalate, and also have appropriate softening points and glass transition points. Furthermore, it is preferable to provide a resin film on the lower surface of the gas barrier film. This resin film has functions such as maintaining the strength of the film. As the resin film, a stretched PET film is preferably used.

The modified polyester resin contains dicarboxylic acids such as aromatic dicarboxylic acids such as terephthalic acid and isophthalic acid, and diol components such as ethylene glycol and 1.
It uses 4-butanediol, diethylene glycol, neopentyl glycol, etc., and has a softening point of 80~
170'C (JIS K2531 ring and ball method) and a glass transition point in the range of -30°C to 80°C (DSC method).

Furthermore, in the one shown in FIG. 1, a tab 9 is provided for peeling off the sealing member 3 from the bottomed tube 2.

As shown in FIG. 2, the sealing member 3 having a multilayer structure as described above is formed in advance by adhering a gas barrier film 7 as an upper layer, a resin film 10° as an intermediate layer, and a modified polyester resin film 6 as a lower layer. Ru. Furthermore, as shown in FIG. 2, a printed layer 11 for indicating the product type, etc., and an overcoat 12 (for example, a cellulose-based coating layer) for protecting the printed layer may be provided on the upper surface of the gas barrier film. good.

In addition, in the case of blood collection tubes that require coagulation, the inner surface (adhesive film surface) of the sealing member 3 is a hydrophobic surface, so at least the part that comes into contact with blood should be treated to prevent blood clots from adhering to the inner surface. It is preferable to do so. As a treatment, the inner surface of the sealing member 3 is coated with a hydrophilic f1 substance (for example, water-soluble silicone,
This can be done by coating with PVA, PVP, etc.).

The sealing member 5 seals the puncture hole formed in the sealing member 3 after the puncture needle provided in the blood sampling device pierces the sealing member 3 of the blood collection tube 1 and is removed. It has the function of maintaining a liquid-tight state. As the sealing member, for example, rubber materials such as natural rubber, inurene rubber, chloroprene rubber, and silicone rubber, and resins such as thermoplastic elastomers such as styrene-butadiene-styrene (SBS) block copolymers can be used.

The sealing member 5 has a shape as shown in FIG. 1, and the bottom surface of the sealing member 5 is a flat surface that forms an adhesive surface with the airtightness maintaining member 4. Approximately at the center of the upper part of the sealing member 5, there is a concave blood storage portion 6.
is provided.

This concave blood storage section 6 has a function of storing and isolating blood adhering to the sealing member 5 when the puncture needle of the blood sampling device is removed from the sealing member. The sealing member 5 is provided approximately at the center of the airtightness maintaining member. The shape of the sealing member 5 is not limited to a circular shape, but may be a substantially circular shape including an ellipse, a square, a polygon such as a pentagon (also, if the entire upper surface of the airtightness maintaining member 4 is It may also be covered.

Although the sealing member is preferably provided on the upper surface of the sealing member 4, it may be provided on the lower surface of the gas barrier column member 4.

Furthermore, the sealing member may cover the entire surface of the gas barrier column member 4.

In order to fix the sealing member 3 and the bottomed tube 2, the sealing member 3 bonded with the modified polyester resin film is fixed to the bottomed tube 2.
In the case of the periphery of the opening shown in FIG. 1, the modified polyester resin film is airtightly attached to the surface of the flange 8 by fusion using heat, ultrasonic waves, high frequency waves, or the like.

Furthermore, the inside of the bottomed tube 2 is brought into a reduced pressure state by fixing the above-mentioned sealing member 3 to the opening of the bottomed pipe 2 under a reduced pressure atmosphere. be able to.

[Example] Next, an example of the blood collection tube of the present invention will be described.

(Example 1) The bottomed tube had a shape as shown in Fig. 1, and the opening of the blood collection tube had an inner diameter of 13.4zx, a wall thickness of 1.0xx, and a taper of 15/1000. A flange having a diameter of 17.3xg and a wall thickness of 2.0xx was made by injection molding polyethylene terephthalate.

The airtightness maintaining member forming the sealing member consists of a cellulose-based coating layer that covers the printed surface as an upper layer, then a printed surface that distinguishes the product type, then an aluminum foil layer (30μ) that provides gas barrier properties, and then A stretched polyethylene terephthalate layer (16μ) that gives strength to the film, followed by a modified polyester layer (5μ Elythyl U manufactured by Unitika Co., Ltd.)
E3220, softening point 120°C, glass transition point 5°C)
A 'f31 composite film consisting of the following was punched out so that a tab was formed in a portion thereof.

Anticoagulant EDT A-2K 2 inside the bottomed tube
．． 5119 and heat-sealed the filter under reduced pressure (sealing temperature: 130° C.) to prepare a blood collection volume of approximately 5 cc. As the sealing member, a natural rubber member is used, and the diameter is 7.0 cm, the thickness is 2.0 cm, and a concave blood storage part with a diameter of 3.011 m and a depth of 0.3 ix is formed in the upper center. created something. The sealing member was adhered to the upper surface of the airtightness maintaining member using an instant adhesive.

After the blood was collected, the sealing member could be opened using the easy beer tab provided on the film. When the resin was easily brewed, the modified polyester resin remained on the flange of the bottomed tube and was peeled off from the stretched PET film. Furthermore, although the prepared blood collection tubes of the present invention were left in a 50°C oven for 10 days, the sealing member did not peel off in any of the blood collection tubes.

(Example 2) The same bottomed tube as in Example 1 was used.

The airtightness maintaining member forming the sealing member consists of a cellulose-based coating layer that covers the printed surface as an upper layer, then a printed surface that distinguishes the product type, then an aluminum foil layer (30μ) that provides gas barrier properties, and then A stretched polyethylene terephthalate layer (16μ) that gives strength to the film, followed by a modified polyester layer (5μ Elythyl U manufactured by Unitika Co., Ltd.)
A composite film consisting of E3220) was punched out so that a tab was formed in a portion of the composite film.

Water-soluble silicone is sprayed on the inner surface of the bottomed tube and the inner surface of the sealing member, and glass powder (
A blood coagulation promoter 2M9 (weight ratio of glass powder to polyvinylpyrrolidone, 5:1) prepared using glass powder (average particle diameter 2 μm) and polyvinylpyrrolidone was stored. Then, under reduced pressure (580 torr), a sealing member was heat-sealed to the open end of the bottomed tube (sealing temperature: 130°C) to create a sealing member with a surface area of approximately 5 cc.

As the sealing member, a natural rubber member is used, and the diameter is 7.
．． 0xm, thickness 2.0mm, diameter 3.0mm at the top center
, one having a concave blood accommodating portion with a depth of 0.3+u+ was prepared. The sealing member was adhered to the upper surface of the airtightness maintaining member using an instant adhesive.

After the blood was collected, the sealing member could be opened using the easy beer tab provided on the film. When the resin was easily brewed, the modified polyester resin remained on the flange of the bottomed tube and was peeled off from the stretched PET film. Further, although the prepared blood collection tubes of the present invention were left in a 50° C. oven for 10 days, the sealing member did not peel off in any of the blood collection tubes.

It was also found that the adhesion did not decrease even if silicone was applied.

[Effect] The operation of the reduced pressure blood collection tube of the present invention will be explained.

When blood is collected using the vacuum blood collection tube of the present invention,
A blood sampling needle (not shown) attached to a blood sampling device (not shown) is punctured into a blood vessel.

Next, the vacuum blood collection tube 1 is inserted until the tip of the puncture needle (not shown) formed at the rear end of the blood collection needle pierces the sealing member 3 of the vacuum blood collection tube 1 and reaches the inside of the vacuum blood collection tube 1. When inserted into the blood sampling device, blood flows into the reduced pressure blood collection tube 1 in an amount corresponding to the amount of reduced pressure. After blood collection is completed, the blood collection tube 1 is removed from the blood collection device. The 4 blood vessels 1 whose blood has been completely collected are transported to an automatic testing device and subjected to necessary tests.

[Effects of the Invention] A tube with a closed bottom made of polyester resin, and a sealing member that seals the opening of the bottom tube and can be pierced by a puncture needle of a blood sampling device, and the inside is reduced in pressure. In the blood collection tube, the sealing member includes an airtight maintenance member that is fixed to the opening of the bottomed tube and seals the opening, and an airtightness maintenance member that is provided on the airtightness maintenance member and that allows the puncture needle to pass therethrough. and a sealing member capable of resealing the punctured portion after removal, and the airtightness maintaining member seals the bottomed tube through a polyester resin whose softening point is lower than that of the polyester resin constituting the bottomed tube. Since it is fixed in the opening, the temperature is 40°C.
Even at high temperatures above, the sealing member fixed to the opening of the bottomed tube does not peel off, and furthermore, the sealing member can be easily peeled off.

[Brief explanation of the drawing]

FIG. 1 is a sectional view showing an embodiment of the reduced pressure blood collection tube of the present invention, and FIG. 2 is a partially enlarged sectional view of the sealing member of the reduced pressure blood collection tube of the present invention. 1...Reduced pressure blood collection tube 2...Bottomed tube 3...Sealing member 4...Airtight maintenance member 5...Sealing member 6...
...Modified polyester resin 8...Flange 9...Tab Figure 1

Claims (1)

[Claims] (1) Consisting of a bottomed tube made of polyester resin with one end open and the other end closed, and a sealing member that seals the opening of the bottomed tube and can be pierced by a puncture needle of a blood collection device;
The vacuum blood collection tube has a reduced pressure inside, and the sealing member includes an airtight maintenance member that is fixed to the opening of the bottomed tube and seals the opening, and an airtightness maintenance member that is provided on the airtightness maintenance member and that is pierced. and a sealing member capable of resealing the punctured portion after the puncture needle is removed, and the airtightness maintaining member is made of a polyester resin having a softening point lower than that of the polyester resin constituting the bottomed tube. A reduced pressure blood collection tube, characterized in that the tube is fixed to the opening of the bottomed tube through the tube.