JPH0545262A - Decompressive blood collecting tube and its manufacture - Google Patents

Abstract

PURPOSE:To prevent blood sputtering and provide possibility of taking blood dividedly by means of decantation, by furnishing a tab for exfoliation of a sealing member, and allowing part of the exfoliated sealing member to remain at the part with opening. CONSTITUTION:A sealing member 3 for the part with opening of a bottom- equipped tube 2 made of resin has a tab 9 for exfoliation of the sealing member. After sampling blood, the sealing member 3 is exfoliated from the tab 9 side, and the residual part 6a will remain at the portion with opening, and non- residual portion 6a is torn off from the tube 2 together with the sealing member 3. This residual portion 6a prevents sputter of the contained blood resulting from a rise of the internal pressure to be caused by temp. change after sampling of blood in the initial period the tube is opened. It is also prevented that the blood attached to the inner surface of the sealing member 3 sputters in the initial period the tube is opened. Because the tube 2 is open at the non-residual portion 6b, the blood can be taken dividedly by decantation to serve for blood inspection.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a reduced pressure blood collection tube for collecting a blood sample used for blood test and a method for producing the same.

[0002]

2. Description of the Related Art Conventionally, various blood collecting instruments have been used in clinical tests such as biochemical tests and serum tests.
For example, a blood collection instrument including a blood collection tube whose interior is decompressed and a blood collection tube holder capable of accommodating the blood collection tube and having a puncture needle at its tip is often used. As a general reduced-pressure blood collection tube, a tube having a bottomed tube made of glass or plastic and a rubber stopper for sealing the opening of the bottomed tube is used. However, in recent years, an automatic inspection system has been developed in which blood is automatically collected and inspected after collecting blood using a vacuum blood collection tube. Therefore, as a sealing member that seals the opening of the blood collection tube, it is not always required to be able to reseal after opening, like a rubber stopper. Therefore, it is proposed to seal the opening of the plastic bottomed tube with an airtight film, and further provide a sealing member on the airtight film to seal with the needle tip provided at the rear end of the blood sampling needle. Has been done.

In such a reduced pressure blood collection tube, when the airtight film is peeled off, the blood adhered to the inner surface of the film, and further, when the inside becomes slightly positive due to temperature change after blood collection, Blood was scattered and there was a risk of contamination. Therefore, the applicant of the present application has disclosed that
The sample tube shown in Japanese Patent No. 9 is provided. This sampling tube
A bottomed tubular body having an opening and a sealing member for sealing the opening are provided, and the sealing member remains in the opening when the sample is collected and penetrates the sample collecting device. It is composed of a possible film-shaped residual member and a peeling member located outside the residual member and capable of peeling from the residual member.

[0004]

When the sealing member is peeled off, the inside of the liquid sampling tube is slightly positive pressured due to the blood adhering to the inner surface of the sealing member and further the temperature change after blood sampling. In that case, in terms of preventing the scattering of blood inside,
It has a sufficient effect. However, with this sampling tube, the residual member can penetrate the sampling device, so it is possible to sample with a pipette, a nozzle of an automatic tester, etc. , Blood could not be collected by decantation.

[0005]

SUMMARY OF THE INVENTION Therefore, an object of the present invention is to make the inside of the sealing member slightly positive pressure state due to the blood adhered to the inner surface of the sealing member when the sealing member is peeled off and further the temperature change after blood collection. In this case, it is an object of the present invention to provide a reduced pressure blood collection tube which can prevent blood from scattering inside and can easily separate blood by decantation for a blood test, and a method for producing the same.

What achieves the above-mentioned object is to seal a resin-made bottomed tube having one end opened and the other end closed and an opening of the bottomed tube and a piercing needle of a blood collecting instrument for sealing. And a sealing member capable of resealing the piercing part after removing the puncture needle that has been pierced. And a resin thin film provided on a fixing surface of the resin bottomed tube, and a tab for peeling the sealing member from the bottomed tube, and the resin thin film further comprises the tab side from the tab side. The decompression blood collection tube is composed of a residual portion that remains in the opening portion of the bottomed tube on the tab side when the sealing member is peeled off, and a non-residual portion that is peeled off from the bottomed tube together with the sealing member.

In addition, what achieves the above object is to seal a resin-made bottomed tube having one end opened and the other end closed and an opening of the bottomed tube and to pierce with a puncture needle of a blood collecting instrument. A decompressed blood collection tube having a decompressible inside, wherein the sealing member is capable of resealing the airtightness maintaining member and the piercing part after removing the punctured needle that has been pierced. A sealing member, a resin thin film provided on a fixing surface of the resin bottomed tube, and a tab for peeling the sealing member from the bottomed tube, and the resin thin film is the tab. It is a reduced pressure blood collection tube having a slit that divides the side from the side opposite to the tab side. When the sealing member is peeled off from the tab side by the slit, the resin thin film is peeled from the bottomed pipe together with the residual portion remaining in the opening portion of the bottomed pipe on the tab side. Preferably, it is separated from the non-residual portion to be treated.

Further, what achieves the above-mentioned object is a step of forming a resin bottomed tube having one end opened and the other end closed, and the opening of the bottomed tube is sealed and a puncture needle of a blood collecting device is provided. A method of manufacturing a reduced pressure blood collection tube, comprising: a step of forming a pierceable sealing member by; and a sealing member fixing step of fixing the sealing member to an opening of the resin bottomed tube,
In the step of forming the sealing member, a step of forming a slit in the resin thin film after forming a laminated film for a sealing member having at least a gas barrier film and a resin thin film for fixing the bottomed tube, And a step of cutting the laminated film into a predetermined shape.

In the step of forming the sealing member, after forming a sealing member laminated film having at least a gas barrier film and a resin thin film for fixing to a bottomed tube, slits are formed in the resin thin film. After forming, the laminated film has a predetermined shape and has a tab for peeling the sealing member from the bottomed tube, the resin thin film by the slit, the tab side and the opposite side of the tab side. It is preferable to have a step of cutting the laminated film so as to be divided into. Further, in the step of forming the sealing member, after forming a laminated film for a sealing member having at least a gas barrier film and a resin thin film for fixing the bottomed tube, the laminated film is formed into a predetermined shape. And cutting the sealing member into a shape having a tab for peeling from the bottomed tube, and then forming a slit in the resin thin film of the cut laminated film to separate the tab side and the opposite side of the tab side. It is preferable to have a step. Further, the step of forming the slit in the resin thin film is preferably performed by irradiating a laser from the resin thin film side of the laminated film for a sealing member.

The reduced pressure blood collection tube of the present invention will be described with reference to the embodiment shown in FIG. The reduced pressure blood collection tube 1 of the present invention seals a resin bottomed tube 2 having one end opened and the other end closed, and an opening of the bottomed tube 2 and a sealing member which can be pierced by a puncture needle of a blood collecting instrument. 3, which is a decompressed blood collection tube whose inside is decompressed, wherein the sealing member 3 is a sealing member capable of sealing the airtightness maintaining member 4 and the piercing part again after removing the punctured needle that has been pierced. 5, a resin thin film 6 provided on the fixing surface of the resin bottomed tube 3, and a tab 9 for peeling the sealing member 3 from the bottomed tube 2. Further, the resin thin film 6 includes the tab 9 When the sealing member 3 is peeled from the bottom side, the residual portion 6a remaining in the opening portion of the bottomed tube 2 on the tab 9 side and the sealing member 3 (in other words, the airtightness maintaining member 4) are peeled from the bottomed tube 2. And a non-residual portion 6b.

Therefore, according to this blood collection tube, when the sealing member is peeled off from the tab side after blood collection, the residual portion of the resin thin film remains in the opening portion of the bottomed tube on the tab side and the non-remaining portion is sealed. It is separated from the bottomed tube together with the member. Therefore, scattering of internal blood due to internal pressure rise due to temperature change after blood collection at the beginning of opening can be prevented by the above-mentioned residual portion of the resin thin film, and due to the residual portion of this resin thin film, sealing at the beginning of opening is performed. It is possible to prevent the blood attached to the inner surface of the member from scattering. Further, since the bottomed tube is opened in the non-residual portion of the resin thin film, blood can be fractionated by decantation for blood test.

In other words, the reduced pressure blood collection tube of the present invention has a resin bottomed tube 2 with one end open and the other end closed.
And a sealing member 3 that seals the opening of the bottomed tube 2 and that can be pierced by a puncture needle of a blood collecting device, and is a depressurized blood collection tube whose inside is depressurized, and the sealing member 3 is airtight and maintainable. The member 4, the sealing member 5 that can reseal the piercing portion after the punctured needle that has been pierced is removed, the resin thin film 6 provided on the fixing surface of the resin bottomed tube 3, and the sealing member 3 With a tab 9 for peeling the resin thin film 6 from the bottomed tube 2.
Has a slit 13 that separates the tab 9 side and the side opposite to the tab 9 side. Due to the slits 13, the resin thin film 6 is provided with the tab 9 when the sealing member 3 is peeled off from the tab 9 side.
It is divided into a residual portion 6a remaining in the opening portion of the bottomed tube 2 on the side and a non-residual portion 6b separated from the bottomed tube 2 together with the sealing member 3 (in other words, the airtightness maintaining member 4).

FIG. 1 is a sectional view of an embodiment of the reduced pressure blood collection tube of the present invention, FIG. 2 is a partially enlarged sectional view of the reduced pressure blood collection tube shown in FIG. 1, and FIGS. FIG. 5 is a plan view of the sealing member, and FIG. 5 is an explanatory diagram for explaining the action of the reduced pressure blood collection tube of the present invention. Therefore, the reduced pressure blood collection tube of the present invention will be specifically described with reference to the drawings. The reduced pressure blood collection tube 1 of the present invention comprises a bottomed tube 2 and a sealing member 3 that seals the opening of the bottomed tube 2, and the inside is decompressed by a predetermined blood collection amount. The bottomed tube 2 is a tubular body having one end opened and the other end closed, and the portion excluding the closed end is substantially cylindrical. Further, in the structure shown in FIG. 1, an annular flange 8 is provided at the opening of the bottomed tube 2 so as to extend orthogonally to the axial direction of the bottomed tube 2 and project outward. This flange 8
Form a fixed portion of the hermetically sealed portion 3 to be described later with the airtightness maintaining member.

As a material for the bottomed tube 2, a material having a high gas barrier property is preferable in order to maintain a depressurized state inside, for example, an acrylonitrile resin, polyvinyl chloride, polyethylene terephthalate, PMMA (polymethylmetha). It is preferable to use an acrylate), a polyelter resin, or the like. As the polyester resin, polyethylene terephthalate, a mixture of polyethylene terephthalate and polyethylene isophthalate resin, and the like are preferable. Further, when the bottomed tube 2 is formed of a material having a low gas barrier property (for example, polypropylene, polyethylene, polystyrene, etc.), polyvinyl alcohol, ethylene-vinyl alcohol co-weighed on the surface of the bottomed tube 2 (for example, outer surface). It can be used by coating a film having a gas barrier property such as coalescence, and by devising the packaging form in order to maintain the reduced pressure inside the bottomed tube. Further, when the bottomed tube 2 is formed of polyvinyl chloride, in order to prevent the stabilizer contained in the vinyl chloride from eluting into the collected blood,
It is preferable to coat the inner surface of the bottomed tube 2 with an elution inhibitor.

Further, when the bottomed tube 2 is formed by using a hydrophobic synthetic resin, it is preferable that the inner surface is hydrophilized to prevent blood cells from adhering to the inner surface of the bottomed tube. The hydrophilic treatment can be performed by coating the inner surface of the bottomed tube 2 with a hydrophilic substance (eg, water-soluble silicone, PVA, PVP, etc.). Furthermore, in the bottomed tube,
A blood anticoagulant such as heparin powder or EDTA-2K may be attached or stored on the inner surface of the bottomed tube. On the contrary,
The blood coagulation promoter may be attached or stored on the inner surface, and further, a filter paper, a non-woven fabric, or the like having the blood coagulation promoter attached or impregnated may be enclosed in the bottomed tube 2. As the coagulation accelerator, for example, a size of 0.4 to 20
In addition to micron silica sand, crystalline silica with a size of 5 microns or less and an average particle size of 1.1 microns (eg, Pennsylvania.
Glass Sand Co., trade name Min-U-Sil), diatomaceous earth, glass fine powder, kaolin, bentonite, protamine sulfate and thrombin. Further, a serum separating agent may be housed inside the bottomed tube 2. The serum separating agent is a gel substance having a thixotropic property having an intermediate specific gravity between serum and blood cell components, for example, α-olefin / maleic acid diester copolymer as a main component, to which a viscosity and specific gravity adjusting agent are added. Those that are suitable can be used.

The sealing member 3 is an airtightness maintaining member 4
And a sealing member 5 provided thereon, and a resin thin film 6 forming an adhesive member provided on the lower surface of the airtightness maintaining member.
It is formed by and. The airtightness maintaining member 4 has a function of sealing the opening of the bottomed tube 2 and maintaining a depressurized state inside the bottomed tube 2, and is a gas barrier formed of a substance having a high gas barrier property. Film, for example, metal foil such as aluminum foil, ethylene-vinyl alcohol copolymer, resin film material such as polyvinylidene chloride, or the like. Furthermore, because of the fixation to the opening of the bottomed tube 2 on the lower surface of this gas barrier film,
A resin thin film 6 forming an adhesive film is provided. In the embodiment shown in FIG. 1, the resin thin film 6 is the resin thin film base film 10 provided on the lower surface of the gas barrier film, and the resin thin film adhesive film provided on the lower surface of the resin thin film base film 10. 12 and. The resin thin film base film 10 has a function of maintaining the strength of the sealing member. A stretched PET film is preferably used as the resin thin film base film. Further, as the resin thin film adhesive film 12, a modified polyester resin can be preferably used. This resin thin film adhesive film 12
Has a heat fusion property with the resin forming the bottomed tube 2, and also has an easy peel property.

As the modified polyester resin, an aromatic dicarboxylic acid such as terephthalic acid or isophthalic acid is used as the dicarboxylic acid, and ethylene glycol, 1.4-butanediol, diethylene glycol or neopentyl glycol is used as the diol component. And
Softening point 80-170 ° C (JIS K2531 ring and ball method),
A glass transition point in the range of −30 ° C. to 80 ° C. (DSC method) is suitable.

Further, in the structure shown in FIG. 1, the sealing member 3
A tab 9 is provided for separating from the bottomed tube 2. As shown in FIG. 2, the sealing member 3 having the above multi-layered structure is prepared by applying a gas barrier film 7 as an upper layer, a resin thin film base film 10 as an intermediate layer, and a resin thin film adhesive film 12 as a lower layer in advance. It is formed. further,
As shown in FIG. 2, on the upper surface of the gas barrier film,
It is also possible to provide a print layer 11 that displays the type and the like, and an overcoat (for example, a cellulose-based coating layer) that protects the print layer.

The resin thin film 6 of the sealing member 3 is provided with a slit 13 as shown in FIG. As shown in FIG. 3, the slit 13 has a tab 9 side and a tab 9 side.
The resin thin film 6 is separated from the opposite side of the bottomed tube 2, and when the sealing member is peeled off from the bottomed tube 2, the resin thin film 6 remains at the opening portion of the bottomed tube 2 on the tab 9 side and the sealing member 3 ( In other words, it is divided into the non-residual portion 6b separated from the bottomed tube 2 together with the airtightness maintaining member 4). Slit 1
3 may be provided on the entire resin thin film 6 in the thickness direction,
As shown in FIG. 2, it is preferable that the slit 13 is provided in the resin thin film adhesive film 12 portion of the resin thin film 6 and not provided in the resin thin film base film 10. By not providing the slit in the resin thin film base film 10, it is possible to prevent the strength of the resin thin film base film from being lowered.

Since the slit 13 is provided, the sealing member 3 is inserted from the tab 9 side as shown in FIG.
When peeled from the bottomed tube 2, a residual portion 6a remains in the opening portion of the bottomed tube 2 on the tab 9 side, and the non-residual portion 6b is the bottomed tube together with the sealing member 3 (in other words, the airtightness maintaining member 4). 2 is peeled off. The width of the slit is 10-5
It is preferably about 00 μm. In addition, the depth of the slit is the entire thickness of the resin thin film adhesive film 12 to 1 / thickness.
It may reach the resin thin film base film 10 by about 5 or even slightly. Also, as the position of the slit,
When viewed from the opening surface of the bottomed tube, the ratio of the area of the residual portion 6a and the area of the non-residual portion 6b is 5:95 to 4
It is preferably provided at a position of about 0:60.

Further, in the case of a blood collection tube requiring coagulation, since the inner surface (adhesive film surface) of the sealing member 3 is a hydrophobic surface, at least a portion which comes into contact with blood is treated to form a blood clot on the inner surface. It is preferable to prevent adhesion. The treatment can be performed by coating the inner surface of the sealing member 3 with a hydrophilic substance (eg, water-soluble silicone, PVA, PVP, etc.).

The sealable member 5 has a puncture hole formed in the sealing member 3 after the puncture needle provided in the blood collecting device is pierced by the sealing member 3 of the blood collection tube 1 and removed. It has a function of sealing and maintaining a liquid-tight state. Examples of the sealing member include rubber materials such as natural rubber, isoprene rubber, chloroprene rubber, and silicone rubber, or styrene-butadiene-styrene (SB
S) Resins such as thermoplastic elastomers such as block copolymers can be used. The sealable member 5 has a shape as shown in FIG. 1, and the bottom surface of the sealable member 5 is a flat surface portion that forms a bonding surface with the airtightness maintaining member 4. A concave blood containing portion 6 is provided substantially at the center of the upper portion of the elastic member 5. The concave blood storage portion 6 has a function of storing and isolating blood attached to the sealing member 5 when the puncture needle of the blood collecting device is removed from the sealing member. The sealable member 5 is provided substantially 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 elliptical shape, a polygonal shape such as a quadrangle, a pentagonal shape, and the entire upper surface of the airtightness maintaining member 4 is covered. It may be one that does. The sealing member is preferably provided on the upper surface of the sealing member 4, but may be provided on the lower surface of the gas barrier member 4. Further, the sealing member may cover the entire surface of the gas barrier member 4.

Then, the sealing member 3 and the bottomed tube 2 are fixed to each other by fixing the resin thin film adhesive film 12 of the sealing member 3 to the peripheral edge of the opening of the bottomed tube 2, that is, the surface of the flange 8 in FIG. Then, the modified polyester resin film is attached airtightly by fusion using heat, ultrasonic waves, high frequency, or the like. Then, the slit in the contact portion between the bottomed tube 2 and the resin thin film adhesive film 12 disappears due to fusion bonding, and the sealing member and the bottomed tube are airtightly fixed over the entire circumference. The inside of the bottomed tube 2 is depressurized by fixing the sealing member 3 to the opening of the bottomed tube 2 in a depressurized atmosphere to bring the inside into a depressurized state. be able to.

Next, a method for manufacturing the reduced pressure blood collection tube of the present invention will be described. The manufacturing method of the present invention comprises a step of forming a resin bottomed tube having one end opened and the other end closed, and sealing the opening of the bottomed tube and piercing with a puncture needle of a blood collecting instrument. A method of manufacturing a reduced pressure blood collection tube comprising a step of forming a member and a step of fixing a sealing member to the opening of the resin bottomed tube, wherein the step of forming the sealing member is a gas barrier. Forming a laminated film for a sealing member having at least a flexible film and a resin thin film for fixing the bottomed tube, forming a slit in the resin thin film, and cutting the laminated film into a predetermined shape. And a step of performing.

Therefore, each step will be described. The step of forming a resin bottomed tube having one end open and the other end closed is performed, for example, by using an acrylonitrile resin, polyvinyl chloride, polyethylene terephthalate, PMMA (polymethylmethacrylate), polyelter resin, or the like. It can be performed by molding.

The step of forming the sealing member is performed by forming a laminated film for a sealing member, which has at least a gas barrier film and a resin thin film for fixing the bottomed tube. Specifically, a gas barrier film formed of a substance having a high gas barrier property, for example, a metal foil such as an aluminum foil, an ethylene-vinyl alcohol copolymer, a resin film material such as polyvinylidene chloride as a substrate, The resin thin film 6 is formed on either surface of the gas barrier film. Specifically, a resin forming the resin thin film base film 10, for example, a stretched PET film is prepared, and a resin thin film forming a resin thin film adhesive film 12 on the upper surface of the resin thin film base film, for example, modified The resin thin film 6 is formed by sticking together the polyester resin thin films. Then, if necessary, a printed layer 11 and an overcoat (for example, a cellulose-based coating layer) for protecting the printed layer are provided on the other surface of the gas barrier film to form a laminated film for a sealing member. It

Then, a step of forming a slit in the resin thin film 6 is performed. To form the slits, for example, the slits are formed at regular intervals on the laminated film for a sealing member. The slits are preferably formed by irradiating a laser from the resin thin film side of the laminated film for a sealing member. To form slits with a laser, the resin thin film adhesive film of the cut laminated film for the sealing member is focused and irradiated with laser light, and the slit forming part of the resin thin film adhesive film absorbs light and is heated, melted or evaporated. It is conceivable to use a laser heating process. Since the formation of slits using such a laser is a non-contact process, it can be performed without deforming the laminated film for sealing members, and the resin thin film bonding can be performed with a spot diameter of several times the emission wavelength. Since it is a local heating that can be focused on the film, it is possible to locally limit the thermal influence on the surroundings. For such slit processing, a general laser processing machine, for example, a CO ₂ laser processing machine having an output of about 5 to 100 W can be used. Further, the slit may be formed in the resin thin film adhesive film 12 portion of the resin thin film 6 by using a cutter.

The shape of the slit is preferably linear as shown in FIG. 3, but may be curved as shown in FIG. Then, as shown in FIG. 3, the sealing member laminated film having the slits formed in this way is formed so that the resin thin film 6 is divided into the tab side 6a and the tab-side opposite side 6b by the slits, It is cut into a predetermined shape to form a sealing member. The cutting is performed by punching with a punching machine, for example. In addition, the formation of the slit of the sealing member is preferably performed before cutting the sealing member, as described above, because it is easy in terms of work and is preferable. After cutting into a shape that has a tab for peeling the sealing member from the bottomed tube, a slit is formed in the resin thin film of the cut laminated film to separate the tab side and the side opposite to the tab side. You may. Also in this case, the method described above can be used as the method for forming the slit.

[0029]

The operation of the vacuum blood collection tube of the present invention will be described. When performing blood collection using the reduced pressure blood collection tube of the present invention, a blood collection needle (not shown) attached to a blood collection device (not shown)
Puncture the blood vessel. Next, the reduced pressure blood collection tube 1 is pierced by the tip of a puncture needle (not shown) formed at the rear end of the blood collection needle until it penetrates the sealing member 3 of the reduced pressure blood collection tube 1 and reaches the inside of the reduced pressure blood collection tube 1. When it is inserted into the blood collecting instrument, the reduced-pressure blood collection tube 1 is filled with an amount of blood according to the reduced pressure. After the blood collection is completed, the blood collection tube 1 is removed from the blood collection device.

When the sealing member of the vacuum blood collection tube 1 for which blood collection was completed was opened with the peel tab 9, the resin thin film 6 (the resin thin film base film 10 and the resin thin film adhesive film 12) on the tab side of the slit was Remained in the opening of the bottomed tube on the side. It is considered that this is because the adhesive force between the resin thin film 6 and the bottomed tube is higher than the adhesive force between the resin thin film 6 and the gas barrier film 7. The sticking force is due to the strength of the bond and the size of the bond area. When opened from the tab side, the sealing member 3 is the flange 8 of the bottomed tube 2.
At the moment of starting peeling from the surface of the resin, in other words, regarding peeling at the portion fixed to the flange 8, the fixing area between the resin thin film 6 and the bottomed tube, the resin thin film 6 and the gas barrier film 7 The fixing area is the same, and in this portion, both the gas barrier film and the flange of the bottomed tube are bonded to the resin thin film 6. If the adhesive force between the resin thin film 6 and the bottomed tube is higher than the adhesive force between the resin thin film 6 and the gas barrier film 7, the gap between the resin thin film 6 and the gas barrier film 7 (specifically, Between the resin thin film base film 10 and the gas barrier film 7), the sealing member 3 is delaminated. Once delamination is performed, delamination is likely to continue, and if the force necessary for delamination is lower than the strength of the remaining resin thin film 6, the resin thin film 6 is fixed to the flange 8 of the bottomed tube 2. And remains so as to cover the opening of the bottomed tube. Therefore, scattering of internal blood due to internal pressure rise due to temperature change after blood collection at the beginning of opening can be prevented by the residual portion of the resin thin film, and due to the residual portion of the resin thin film at the beginning of opening. It is also possible to prevent the blood attached to the inner surface of the sealing member from scattering.

Then, the peeling work proceeds, and the peeling position reaches the slit 13 portion. The entire resin thin film adhesive film 12 is fixed to the resin thin film base film 10 until the slit 13 is reached, and the resin thin film base film 10 remains on the bottomed tube side of the resin thin film adhesive film 12. Thus, it cooperates with the delamination between the resin thin film base film 10 and the gas barrier film 7. However, since the resin thin film adhesive film 12 does not exist in the portion where the slits 13 are provided, the above-described action of the resin thin film base film 10 working to remain on the bottomed tube side is lost. In the slit 13 portion, the fixing portion of the resin thin film 6 of the sealing member and the flange 8 of the bottomed tube 2 is
It is only the width of the flange 8 on both sides, and the resin thin film 6 (resin thin film base film 10) and the gas barrier film 7
Far less contact area with. For this reason, the delamination between the resin thin film 6 and the gas barrier film 7 is completed, and conversely, the resin thin film 6 of the portion fixed to the flange 8 of the bottomed tube 2 and the resin of the non-fixed portion The resin thin film 6 (both the resin thin film base film 10 and the resin thin film adhesive film 12) is cut at the boundary portion with the thin film 6 and fixed to the flange 8 of the bottomed tube 2 at the portion.
Only the resin thin film 6 remains on the flange 8 and is not fixed to the flange 8, and is peeled off together with the gas barrier film 7. For this reason, the blood collection tube 1 is opened from the slit 13 at the portion opposite to the tab.

[0032]

EXAMPLES Next, examples of the blood collection tube of the present invention will be described. (Example 1) The bottomed tube has a shape as shown in Fig. 1, an inner diameter of the opening of the blood collection tube of 13.4 mm, and a wall thickness of 1.0.
mm, taper 15/1000, outer diameter 17.
A product having a flange of 3 mm and a wall thickness of 2.0 mm was prepared by injection molding polyethylene terephthalate. As the airtightness maintaining member forming the sealing member, a printing surface for distinguishing the product type on the upper surface, then an aluminum foil layer (40μ) for providing a gas barrier property, a stretched polyethylene terephthalate layer (12μ for a resin thin film base film). ), And then, a laminated film for a sealing member, which is composed of a modified polyester layer (5 μ, Elitel UE3220 manufactured by Unitika Ltd., softening point 120 ° C., glass transition point 5 ° C.) which is an adhesive film of a resin thin film, was prepared. Then, from the modified polyester layer side of the laminated film for a sealing member, a laser was irradiated with a CO ₂ laser processing machine (manufactured by Seidensha Electronics Co., Ltd., wavelength 10.6 μm, rated output 50 W) to form slits. The width of the formed slit is 200 μm,
The depth was 5 μm.

Then, the laminated film for a sealing member, in which the slits were formed as described above, was punched out so that a tab was formed on a part of the laminated film, to prepare a sealing member. The shape of the sealing member is as shown in FIG. 3, the diameter of the portion that seals the opening of the bottomed tube is 18 mm, and the tab is 9 m long.
m, width 8 mm, and a slit was formed at a position 13 mm from the end of the portion that seals the opening of the bottomed tube facing the end of the tab, as shown in FIG. Put 2.5 mg of anticoagulant EDTA-2K inside the bottomed tube,
The sealing member was heat-sealed (sealing temperature 130 ° C.) under reduced pressure (580 Torr) to prepare a blood sampling amount of about 5 cc. As the sealable member, a natural rubber member having a diameter of 7.0 mm, a thickness of 2.0 mm, and a concave blood accommodating portion having a diameter of 3.0 mm and a depth of 0.3 mm is formed in the upper central portion. did. The sealable member was adhered to the upper surface of the airtightness maintaining member using an instant adhesive.

After collecting the blood, the sealing member was opened with a peeling tab provided on the film. The resin thin film (stretched polyethylene terephthalate layer and modified polyester layer) on the tab side of the slit was formed on the tab side with a bottomed tube. The portion of the resin thin film remaining in the opening portion and the other portion, which was not fixed to the flange of the bottomed tube, was peeled off together with the aluminum foil layer and did not remain. Further, the resin thin film (stretched polyethylene terephthalate layer and modified polyester layer) in the portion fixed to the flange of the bottomed tube remained on the flange of the bottomed tube. The prepared blood collection tubes of the present invention were left in a 50 ° C oven for 10 days, but the sealing member was not peeled off in all the blood collection tubes.

(Example 2) As the bottomed tube and the sealing member, the same ones as in Example 1 were used. Then, spray water-soluble silicone on the inner surface of the bottomed tube and the inner surface of the sealing member,
Further, inside the bottomed tube, 2 mg of a blood coagulation promoter prepared by using glass powder (glass powder average particle size 2 μm) and polyvinylpyrrolidone (weight ratio of glass powder and polyvinylpyrrolidone, 5: 1) is stored. did. Then, in a depressurized state (580 Torr), the sealing member is heat-sealed to the open end of the bottomed tube (seal temperature 130 ° C.) to obtain a blood collection amount of about 5 c.
The thing of c was created.

As the sealing member, a natural rubber member having a diameter of 7.0 mm and a thickness of 2.0 mm and having a concave blood accommodating portion having a diameter of 3.0 mm and a depth of 0.3 mm is provided at the center of the upper portion. Created one. The sealable member was adhered to the upper surface of the airtightness maintaining member using an instant adhesive. Then, after blood collection, the sealing member was opened with a peel tab provided on the film, and the resin thin film (stretched polyethylene terephthalate layer and modified polyester layer) on the tab side of the slit was placed on the opening portion of the bottomed tube on the tab side. The remaining portion of the resin thin film that is not fixed to the flange of the bottomed tube is the resin thin film of the other portion, along with the aluminum foil layer,
It peeled off and did not remain. Further, the resin thin film (stretched polyethylene terephthalate layer and modified polyester layer) in the portion fixed to the flange of the bottomed tube remained on the flange of the bottomed tube. The prepared blood collection tubes of the present invention were left in a 50 ° C oven for 10 days, but the sealing member was not peeled off in all the blood collection tubes. It was also found that the adhesiveness was not deteriorated even when silicone was applied.

[0037]

The vacuum blood collection tube of the present invention has one end open,
A decompressed blood collection tube which has a resin bottomed tube having the other end closed and a sealing member which seals the opening of the bottomed tube and which can be pierced by a puncture needle of a blood sampling instrument, and whose inside is decompressed. The sealing member is provided on the fixing surface between the airtightness maintaining member, the sealing member that can reseal the piercing portion after the punctured needle that has been pierced is removed, and the resin bottomed tube. A resin thin film and a tab for separating the sealing member from the bottomed tube, and the resin thin film has an opening of the bottomed tube on the tab side when the sealing member is separated from the tab side. Since there is a residual portion remaining in the portion and a non-residual portion that is peeled off from the bottomed tube together with the sealing member, when the sealing member is peeled off from the tab side after blood collection, the residual portion of the resin thin film is Remains in the opening of the bottomed tube on the tab side,
The non-residual portion is separated from the bottomed tube together with the sealing member. Therefore, scattering of internal blood due to internal pressure rise due to temperature change after blood collection at the beginning of opening can be prevented by the above-mentioned residual portion of the resin thin film, and due to the residual portion of this resin thin film, sealing at the beginning of opening is performed. It is possible to prevent the blood attached to the inner surface of the member from scattering. Further, since the bottomed tube is opened in the non-residual portion of the resin thin film, blood can be fractionated by decantation for blood test.

The vacuum blood collection tube of the present invention seals the bottomed tube made of resin with one end open and the other end closed and the opening of the bottomed tube, and can be pierced by the puncture needle of the blood collecting instrument. Is a decompression blood collection tube whose inside is decompressed, wherein the sealing member seals the airtightness maintaining member and the piercing part again after the punctured needle that has been pierced is removed. Elastic member, a resin thin film provided on a fixing surface of the resin bottomed tube, and a tab for peeling the sealing member from the bottomed tube, and the resin thin film is on the tab side. Since it has a slit that separates the tab side and the opposite side of the tab side, when the sealing member is peeled off from the tab side after blood collection, the tab side portion from the slit of the resin thin film is the opening portion of the bottomed tube on the tab side. Remains on the tab, and the part opposite the tab from the slit is the sealing member. Both are peeled from the bottomed tube.
Therefore, the scattering of the internal blood due to the internal pressure increase due to the temperature change after blood collection at the beginning of opening can be prevented by the resin thin film remaining in the opening of the bottomed tube after opening, and the resin thin film The remaining portion can prevent the blood attached to the inner surface of the sealing member from being scattered at the beginning of opening.
Further, since the bottomed tube is opened in the non-residual portion of the resin thin film, blood can be fractionated by decantation for blood test.

Further, according to the present invention, a step of forming a resin bottomed tube having one end opened and the other end closed, and the opening of the bottomed tube are sealed and can be pierced by a puncture needle of a blood collecting instrument. A method of manufacturing a reduced pressure blood collection tube having a step of forming a sealing member, and a sealing member fixing step of fixing the sealing member to the opening of the resin bottomed tube, the step of forming the sealing member comprising: After forming a laminated film for a sealing member having at least a gas barrier film and a resin thin film for fixing to a bottomed tube, forming a slit in the resin thin film, and forming the laminated film into a predetermined shape. Since the method is a method for producing a reduced pressure blood collection tube having a step of cutting into pieces, a reduced pressure blood collection tube having the above-described effects can be manufactured.

[Brief description of drawings]

FIG. 1 is a cross-sectional view of an embodiment of a reduced pressure blood collection tube of the present invention.

FIG. 2 is a partially enlarged cross-sectional view of the reduced pressure blood collection tube shown in FIG.

FIG. 3 is a plan view of the sealing member as seen from the resin thin film side.

FIG. 4 is a plan view of a sealing member of another example as viewed from the resin thin film side.

FIG. 5 is an explanatory view for explaining the action of the reduced pressure blood collection tube of the present invention.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Reduced pressure blood collection tube 2 Resin bottomed tube 3 Sealing member 4 Airtightness maintaining member 5 Sealing member 6 Resin thin film 6a Residual portion 6b Non-residual portion 7 Gas barrier film 9 Tab 10 Resin thin film base film 12 Resin thin film adhesive film 13 slits

Claims (7)

[Claims] 1. A resin bottomed tube having one end open and the other end closed, and a sealing member that seals the opening of the bottomed tube and that can be pierced by a puncture needle of a blood collecting instrument. Is a reduced pressure blood collection tube, wherein the sealing member is an airtightness maintaining member, a sealing member that can reseal the piercing portion after the punctured needle that has been pierced is removed, and the resin-made member A resin thin film provided on a surface fixed to the bottom pipe, and a tab for peeling the sealing member from the bottomed pipe, and the resin thin film is used when the sealing member is peeled from the tab side. A reduced pressure blood collection tube comprising: a residual portion remaining in the opening portion of the bottomed tube on the tab side, and a non-residual portion separated from the bottomed tube together with the sealing member. 2. A resin-made bottomed tube having one end open and the other end closed, and a sealing member for sealing the opening of the bottomed tube and being pierceable by a puncture needle of a blood collecting instrument, Is a reduced pressure blood collection tube, wherein the sealing member is an airtightness maintaining member, a sealing member that can reseal the piercing portion after the punctured needle that has been pierced is removed, and the resin-made member It has a resin thin film provided on a surface fixed to the bottom tube and a tab for separating the sealing member from the bottomed tube, and further, the resin thin film has a tab side and a side opposite to the tab side. A reduced-pressure blood collection tube having a slit that divides the tube. 3. The resin thin film is formed by the slit.
When the sealing member is peeled off from the tab side, a residual portion remaining in the opening portion of the bottomed pipe on the tab side and a non-residual portion peeled off from the bottomed pipe together with the sealing member are separated. The reduced pressure blood collection tube according to claim 2. 4. A step of forming a resin bottomed tube having one end open and the other end closed, and a sealing member for sealing the opening of the bottomed tube and being pierceable by a puncture needle of a blood collecting instrument. A method of manufacturing a reduced pressure blood collection tube comprising a step of forming and a sealing member fixing step of fixing the sealing member to an opening of the resin bottomed tube, wherein the step of forming the sealing member is a gas barrier film. And, after forming a laminated film for a sealing member having at least a resin thin film for fixing with a bottomed tube, a step of forming a slit in the resin thin film,
And a step of cutting the laminated film into a predetermined shape. 5. The step of forming the sealing member comprises forming a laminated film for a sealing member having at least a gas barrier film and a resin thin film for fixing the bottomed tube, and then slitting the resin thin film. After forming, the laminated film has a predetermined shape and has a tab for peeling the sealing member from the bottomed tube, the resin thin film by the slit, the tab side and the opposite side of the tab side. The method for producing a reduced pressure blood collection tube according to claim 4, further comprising the step of cutting the laminated film so as to be divided into. 6. The step of forming the sealing member comprises forming a laminated film for a sealing member having at least a gas barrier film and a resin thin film for fixing to a bottomed tube, and then forming the laminated film into a predetermined film. After cutting into a shape having a tab for peeling the sealing member from the bottomed tube, a slit for separating the tab side and the side facing each other on the resin thin film of the cut laminated film The method for producing a reduced pressure blood collection tube according to claim 3, further comprising the step of forming a. 7. The step of forming a slit in the resin thin film is performed by irradiating a laser from the resin thin film side of the laminated film for a sealing member. A method for producing a vacuum blood collection tube.