JPH0466576B2 - - Google Patents

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. A blood sampling device consisting of a blood sampling tube holder equipped with a puncture needle at the tip is often used.

A typical vacuum blood collection tube is one that consists of a bottomed tube made of glass or plastic and a rubber stopper that seals the opening of the bottomed tube. 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, the opening of the plastic bottomed pipe was
It has been proposed to seal with an airtight film and further provide a sealing member on the airtight film to seal the needle tip provided at the rear end of the blood collection needle (Japanese Utility Model Publication No. 160908/1983). ).

[Problems to be Solved by the Invention] What is shown in Japanese Utility Model Application Publication No. 62-160908 consists of a bottomed tube made of polyethylene terephthalate and a sealing member attached to the opening of this bottomed tube. The sealing member is composed of a highly airtight gas barrier member disposed below and a sealing member disposed above, which are bonded together in a layered manner, and an adhesive film is further disposed below the gas barrier member. are doing. 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. The above method has sufficient effects, but the bonding temperature is high when adhering the sealing member to the bottomed tube, deforming the vicinity of the opening of the bottomed tube, and making it difficult to remove the sealing member. There was a problem. Also,
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 when the temperature exceeds 40°C, the pressure inside the bottomed tube is reduced. The problem was that the adhesive part would peel off due to atmospheric pressure.

[Means for Solving the Problems] Therefore, it is an object of the present invention to prevent the sealing member fixed to the opening of the bottomed tube from peeling even at high temperatures of 40°C or higher, and to prevent the sealing member from peeling off even at high temperatures of 40°C or higher. An object of the present invention is to provide a reduced pressure blood collection tube that 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 and a sealing member capable of resealing the punctured portion after the puncture needle is removed, and the airtightness maintaining member has a softening point lower than that of 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 thin polyester resin.

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. It is a vacuum blood collection tube with a reduced pressure inside, and the sealing member 3
is fixed to the opening of the bottomed tube 2 and seals the opening, and is provided on the airtight maintenance member 4 to seal the punctured part again after the puncture needle is removed. The airtight maintenance member 4 is fixed to the opening of the bottomed tube 2 through a polyester resin having a lower softening point than the polyester resin constituting the bottomed tube 2.

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 vacuum 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 thereof 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 the portion excluding the closed end is approximately cylindrical. Furthermore, in the one shown in FIG. 1, an annular flange 8 is provided at the opening of the bottomed tube 2, extending perpendicularly to the axial direction of the bottomed tube 2 and protruding outward. This flange 8 forms a fixed portion with an airtightness maintaining member of the sealing portion 3, which will be described later.

The material of 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. As a hydrophilic treatment, the inner surface of the bottomed tube 2 is coated with a hydrophilic substance (for example, water-soluble silicone, PVA,
This can be done by coating with PVP, etc.).

In addition, the bottomed tube contains heparin powder, EDTA
A blood cell anticoagulant such as -2K may be attached or housed on the inner surface of 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. As a coagulation accelerator, for example, size
In addition to silica sand of 0.4 to 20 microns, 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 Company, trade name
Min-U-Sil), diatomaceous earth, fine glass powder, kaolin, bentonite, protamine sulfate, and hytropine.

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

The sealing member 3 is formed of 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 the 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. moreover,
A modified polyester resin film 6 forming an adhesive film is provided on the lower surface of this gas barrier film for adhesion 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 resin has excellent adhesive strength to polyethylene terephthalate, and
It has an appropriate softening point and glass transition point. 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 uses aromatic dicarboxylic acids such as terephthalic acid and isophthalic acid as the dicarboxylic acid, and ethylene glycol, 1,4-butanediol, diethylene glycol, neopentyl glycol, etc. as the diol component. Softening point 80~170℃ (JIS
K2531 ring and ball method), glass transition temperature -30℃~80℃
(DSC Law). 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.

The sealing member 3 having a multilayer structure as described above is
As shown in FIG. 2, in advance, a gas barrier film 7 is formed as an upper layer, a resin film 10 is formed as an intermediate layer,
It is formed by covering the lower layer with a modified polyester resin film 6. Furthermore, as shown in FIG. 2, a printed layer 11 for displaying 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 is treated to prevent blood clots from adhering to the inner surface. It is preferable to do so. The treatment can be carried out by coating the inner surface of the sealing member 3 with a hydrophilic substance (for example, water-soluble silicone, 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, isoprene rubber, chloroprene rubber, and silicone rubber, or resins such as thermoplastic elastomers such as styrene-butadiene-styrene (SBS) block copolymer 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. A concave blood accommodating portion 6 is provided approximately at the center of the upper portion of the sealing member 5 .

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. Sealing member 5
The shape is not limited to a circular shape, but may be a substantially circular shape including an ellipse, a polygon such as a square, a pentagon, or a shape that covers the entire upper surface of the airtight maintenance member 4. It's okay. Although the sealing member is preferably provided on the upper surface of the contact member 4, it may be provided on the lower surface of the gas barrier member 4. Furthermore, the sealing member may cover the entire surface of the gas barrier member 4.

The fixation between the sealing member 3 and the bottomed tube 2 is achieved by attaching the sealing member 3 bonded with a modified polyester resin film to the periphery of the opening of the bottomed tube 2, or, in the case of the one shown in FIG. 1, to the surface of the flange 8. The modified polyester resin film is attached by airtightly adhering the modified polyester resin film using heat, ultrasonic waves, high frequency waves, or the like.

In addition, the inside of the bottomed pipe 2 is brought into a reduced pressure state by:
By fixing the sealing member 3 to the opening of the bottomed tube 2 under a reduced pressure atmosphere, the inside thereof can be brought into a reduced pressure state.

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

Example 1 The bottomed tube had the shape shown in Fig. 1, and the opening of the blood collection tube had an inner diameter of 13.4 mm, a wall thickness of 1.0 mm,
Taper 15/1000, outer diameter 17.3mm, wall thickness at opening
One with a 2.0 mm flange was made by injection molding polyethylene terephthalate.

As the airtight maintaining member forming the sealing member,
The top layer is a cellulose-based coating layer that covers the printed surface, then the printed surface that distinguishes the product type, then a 30μ aluminum foil layer that provides gas barrier properties, then a 16μ stretched polyethylene terephthalate layer that gives the film strength, and then Modified polyester layer (5μ
ELITEL UE3220 manufactured by Unitika Co., Ltd., softening point 120℃,
A composite film having a glass transition point of 5° C.) was punched out to form a tab in a portion thereof.

2.5 mg of the anticoagulant EDTA-2K was placed inside a bottomed tube, and the film was heat-sealed (sealing temperature: 130°C) under reduced pressure (580 torr) to prepare a sample with a blood collection volume of approximately 5 cc. The sealing member was made of natural rubber and had a diameter of 7.0 mm, a thickness of 2.0 mm, and a concave blood accommodating portion of 3.0 mm in diameter and 0.3 mm in depth in the center. The sealing member was adhered to the upper surface of the above-mentioned airtightness maintaining portion using an instant adhesive.

After blood collection, the sealing member could be opened using an easy-peel tab provided on the film. After easy peeling, the modified polyester resin remained on the flange of the bottomed tube and was stretched.
Peeled off with PET film. Also,
The prepared blood collection tube of the present invention was heated at 50°C for 10
Although the tubes were allowed to stand for several days, the sealing members did not peel off in all of the blood collection tubes.

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

As the airtight maintaining member forming the sealing member,
The top layer is a cellulose-based coating layer that covers the printed surface, then the printed surface that distinguishes the product type, then a 30μ aluminum foil layer that provides gas barrier properties, then a 16μ stretched polyethylene terephthalate layer that gives the film strength, and then A composite film consisting of a modified polyester layer (5μ ELITEL UE3220 manufactured by Unitika Co., Ltd.) was punched out so that a tab was formed in a portion of the film.

Water-soluble silicone was sprayed on the inner surface of the bottomed tube and the inner surface of the sealing member, and the inside of the bottomed tube was further made with glass powder (glass powder average particle size 2 μm) and polyvinylpyrrolidone to promote blood coagulation. 2 mg of agent (weight ratio of glass powder to polyvinylpyrrolidone, 5:1) 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 prepare a blood sample with a volume of approximately 5 cc.

The sealing material is made of natural rubber, with a diameter of 7.0 mm and a thickness of 2.0 mm at the center of the upper part.
A concave blood storage section with a diameter of 0.3 mm and a depth of 0.3 mm was created. The sealing member was adhered to the upper surface of the airtightness maintaining member using an instant adhesive.

After blood collection, the sealing member could be opened using an easy-peel tab provided on the film. After easy peeling, the modified polyester resin remained on the flange of the bottomed tube and was stretched.
Peeled off with PET film. Also,
The prepared blood collection tube of the present invention was heated at 50°C for 10
Although the tubes were allowed to stand for several days, the sealing members did not peel off in all 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 collection needle (not shown) attached to a blood collection 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 collection device, an amount of blood flows into the reduced pressure blood collection tube 1 according to the amount of reduced pressure. After blood collection is completed, insert blood collection tube 1 from the blood collection device.
Remove. After the blood collection has been completed, the reduced pressure blood collection tube 1 is transported to an automatic testing device or the like and undergoes necessary testing.

[Effects of the Invention] The reduced pressure blood collection tube of the present invention includes a bottomed tube made of polyester resin with one end open and the other end closed, and the opening of the bottomed tube is sealed and can be punctured with a puncture needle of a blood sampling device. The vacuum blood collection tube is made of a passable sealing material and has a reduced pressure inside, the sealing member comprising:
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 is capable of resealing the punctured portion after the puncture needle is removed. The air-tightness maintaining member is fixed to the opening of the bottomed tube through a polyester resin having a lower softening point than the polyester resin constituting the bottomed tube, so that the temperature at 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 drawings]

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. DESCRIPTION OF SYMBOLS 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.

Claims (1)

[Claims] 1 Consists 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, and the inside is depressurized. The sealing member includes an airtightness maintaining member fixed to the opening of the bottomed tube and sealing the opening, and an airtightness maintaining member provided on the airtightness maintaining member and pierced by the airtightness maintaining member. 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.