JPH0482555A - Blood sampling bag, sampling liquid introduction device and blood sampler - Google Patents

Abstract

PURPOSE:To enable the sampling of blood or components many times as desired with exellent handling property by combining a sampling section which can trap a part of a liquid introduced into a tube set in the course of the tube connected to a bag body with a sampling liquid introduction device having a needle tube mounted on an opening of a liquid housing section through a hub. CONSTITUTION:When blood introduced into a tube 7 passes over a sampling section 8, the pressing of a blood sampling bag 1 is stopped and the side of a tip from the sampling section 8 of the tube 7 is closed with a clemme or the like. A cap 36 is removed from a sampling liquid introduction device 30 and a needle tube 35 is inserted into a branch tube 10 to further stick into a plug body 12. At this point, when a hub 33 is inserted deep into the branch tube 10 to an extent, a recess 34 of the hub 33 is fitted into a protrusion 14 of the branch tube 10 and a position of the sampling liquid introduction device 30 is fixed with respect to the branch tube 10.

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Application Field> The present invention relates to a blood collection bag, a sampling liquid introduction device, and a blood collection tool.

<Prior Art> When blood collected by a blood collector is transfused to a patient, a cross-matching test is performed.

Conventionally, sampling of blood for transfusion for performing this cross-matching test has been carried out as follows.

After collecting blood in a blood collection bag, the collected blood is introduced into a flexible polyvinyl chloride tube connected to the blood collection bag, and the tubes are closed by heat-sealing at regular intervals (approximately 70 mm). A plurality of blood sample bags called segments were formed, the required number of segments were cut and separated from the tube, the segments were opened, and the blood samples inside were subjected to a cross-matching test.

However, with this method, the tube is squeezed when introducing blood from the blood collection bag to the tube.
This creates a physical load on the sampled blood, which may lead to inaccurate results in cross-matching tests, etc.

In addition, blood sampling, or segment formation, is performed immediately after blood collection, and cross-matching is performed immediately before blood transfusion, so if the time between blood collection and transfusion is long, the blood sample will be stored within the segment. The period of time in which This leads to deterioration of the blood sample and
This may lead to inaccurate results in cross-matching tests, etc.

Furthermore, each blood component is separated and stored in each bag.
When collecting samples for cross-matching tests from bags containing red blood cells that have undergone long-term storage for blood transfusions,
There is also the problem that if a segment is already missing, it cannot be separately collected from a location other than the segment tube.

Further, there are cases where a considerably large number of segments is required (for example, about 13 to 19), which causes the problem that the length of the tube becomes long and the blood collection bag is difficult to handle.

Moreover, the number of segments formed in the tube varies depending on the case (for example, it differs from hospital to hospital), so blood collection bags with various tube lengths must be prepared accordingly. There are also problems.

<Problems to be Solved by the Invention> The present invention has been made in view of the above-mentioned drawbacks of the prior art.The purpose of the present invention is to eliminate the need for forming segments on the tube, provide excellent handling properties, and improve blood flow in the blood collection bag. Another object of the present invention is to provide a blood collection bag, a sampling liquid introduction device, and a blood collection tool that allow sampling of its components any number of times.

Means for Solving the Problems> Such objects are achieved by the following inventions (1) to (4).

(1) It has a bag main body, a tube connected to the bag main body, and a sampling section installed in the middle of the tube and capable of collecting a part of the liquid introduced into the tube, the sampling section comprises a branch tube branching from the tube, a stopper made of an elastic material that is installed so as to shield the inner lumen of the branch tube and capable of being penetrated by a needle tube, and an unsealable seal that encloses the distal end of the branch tube. A blood collection bag comprising: a bag body;

(2) A sampling liquid introduction device having a liquid storage section having an opening and a needle tube attached to the opening of the liquid storage section via a hub, the liquid storage section being pressurable and closed by a pressure-closing device. 1. A sampling liquid introduction device characterized by having elasticity to the extent that it substantially restores to its original shape when pressure is released.

(3) The sampling liquid introducing device according to (2) above, wherein the liquid storage section is constituted by a tube-shaped member having a closed rear end and an opening at the distal end.

(4) A blood collection tool comprising a combination of the blood collection bag described in (1) above and at least one sampling liquid introduction device described in (2) or (3) above.

<Function> In the present invention, after blood is collected into a blood collection bag, the collected blood or blood cell components obtained by centrifugation are introduced into a tube connected to the blood collection bag, and sampled from a sampling part installed in the middle of the tube. Sample using a liquid introduction device.

In this case, in the sampling section, a stopper is installed in a branch pipe branched from the tube, and the needle provided in the sampling liquid introduction device is passed through the stopper to sample the blood or its components in the blood collection bag. It is a closed system and can be sampled any number of times.

<Example> Hereinafter, a blood collection bag, a sampling liquid introduction device, and a blood collection tool of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

FIG. 1 is a front view showing a configuration example of a blood sampling tool of the present invention. The blood collection tool shown in the figure includes a blood collection bag 1 and a sampling liquid introduction device 30.

The blood collection bag 1 is made by stacking resin sheet materials such as soft polyvinyl chloride, and sealing parts 2 on the periphery thereof.
It is fused into a bag shape by high frequency heating or other heating methods.

A blood storage space 3 in which collected blood is stored is formed in the inner portion surrounded by the seal portion 2.

Two outlets 4.4 with beer tabs are formed in the upper part of the blood collection bag 1, and an outlet 5 is formed between them for connection to, for example, another bag.

One end of a tube 7 is connected to the discharge port 5 via a connecting member 6.

Further, a sampling section 8, which will be described later, is formed in the middle of the tube 7.

It is preferable to use a member for the connecting member 6 whose flow path is closed before it is broken, but which opens the flow path when it is broken. For example, a click chip manufactured by Terumo ■ can be used.

Further, the tube 7 may be directly connected to the seal portion 2 at the top of the blood collection bag.

Further, one end of a flexible tube 17 is connected to the upper part of the blood collection bag 1 so as to communicate with the blood storage space 3, and a blood collection needle 19 is attached to the other end of the tube 17 via a hub 18. has been done. Further, a cap 20 that encloses the blood collection needle 19 is attached to the hub 7 .

In addition, the blood storage part 3 of the blood collection bag 1 may be filled with A if necessary.
Anticoagulants such as CD solution, CPD solution, CPDA-1 solution, and heparin sodium solution are contained.

The sampling part 8 formed in the middle of the tube 7 is a part that collects a part of the liquid (particularly blood or its components) inside the tube 7, and as shown enlarged in FIG.
It consists of a connector 9 connected to a tube 7.

This connector 9 has a branch pipe 10 that branches at a predetermined angle with respect to the tube 7.

In this case, the inclination angle α of the branch pipe 10 is not particularly limited, but it is preferably about 20 to 16 degrees, particularly 30 degrees.
It is preferable to set the angle to about 15° or about 15°.

A stopper 12 made of an elastic material is fixedly installed in the middle of the branch pipe 10 so as to shield the inner cavity 11 thereof. This plug 12 can be pierced with a needle tube 35 of a sampling liquid introduction device 3o, which will be described later, and when the needle tube 35 that has been pierced is removed, the punctured portion self-closes to maintain airtightness.

Examples of the constituent material of the stopper 12 include various rubbers such as natural rubber, inbrene rubber, chloroprene rubber, nitrile rubber, butyl rubber, fluororubber, butadiene rubber, styrene butadiene rubber, ethylene propylene rubber, urethane rubber, silicone rubber, and polyurethane. , polyamide elastomer, polybutadiene, silicone resin, soft resin such as soft polyvinyl chloride, polyethylene, polypropylene, or a combination of two or more of these.

Furthermore, it is preferable that the plug body 12 has a penetration resistance that does not put a burden on the needle tip when the needle tube 35 is penetrated, and that the needle tube 35 that has been penetrated therein does not come out very easily. .

Further, the effective surface area of the stopper 12 exposed on the side of the branch pipe tip 13 is 0.2c+++" or more, particularly 0.3 to 2.0c
It is preferable to set it to about m''.

A protrusion 14 serving as a positioning means is formed on the inner circumferential surface of the branch pipe 10 near the tip 13. This convex portion 14 fits into a recess 34 formed in the hub 33 when the sampling liquid introduction device 30 is mounted, and is used to position the sampling liquid introduction device 30.

Note that the connector 9 including the branch pipe 10 is made of, for example, polyvinyl chloride, polyethylene, polypropylene, or the like.

Further, the distal end portion 13 of the branch pipe 10 is covered with a bag body 15. As shown in FIG. 1, the bag 15 has a beer tab 16 formed therein, and the bag 15 can be opened by pinching the tip of the beer tab 16 and peeling it off. There is.

Examples of the constituent material of the bag 15 include soft polyvinyl chloride, polyester, polyethylene, polypropylene, ethylene-vinyl acetate copolymer, and the like.

Providing such a bag 15 prevents contamination of the tip 13 of the branch tube 10 and prevents bacteria from entering the tube 7 and the blood collection bag 1.

Note that instead of the bag body 15, a member such as a removable cover or a cap may be installed on the tip end 13 of the branch pipe 10.

In the illustrated example, one branch pipe 10 is formed in the connector 9, but in the present invention, a plurality of branch pipes may be formed in one connector 10.

Further, the sampling portion 8 may be formed at a plurality of locations on the tube 7.

Furthermore, the sampling section 8 may be formed in the middle of the tube 17.

In the present invention, the configuration of the sampling section 8 is not limited to that shown in the drawings, and may be, for example, a three-way stopcock, a rubber tube that can self-close after puncturing the needle tube, or the like.

Next, the sampling liquid introducing device 30 will be explained with reference to FIG. 3.

The sampling liquid introducing device 30 has a tube-shaped liquid storage section 31. The tip of this liquid storage section 31 is
It is open (opening 32), and the rear end is closed by fusing or adhesive bonding.

The liquid storage section 31 can be compressed and closed, and has enough elasticity to substantially restore its original shape when the compression is released. Therefore, the constituent material of the liquid storage portion 31 may be soft polyvinyl chloride, polyethylene, polypropylene, polyurethane, polybutadiene, natural rubber, isoprene rubber, chloroprene rubber, silicone rubber, or a combination of two or more of these. can be mentioned.

Note that the liquid storage section 31 is not limited to the tube-shaped one shown in the figure, but may be any container as long as it has a closed space inside.

Further, an opening (not shown) may be provided in a predetermined portion of the liquid storage portion 31, and a valve, filter, or the like for venting air may be attached to this opening.

A rear end of a hub 33 made of a relatively hard material such as hard polyvinyl chloride, polyethylene, or polypropylene is fitted into the opening 32 at the tip of the liquid storage section 31 . In this case, the joint between the liquid storage section 31 and the hub 33 is preferably fused or bonded with an adhesive.

Note that the hub 33 may be detachably fitted into the liquid storage section 31.

Further, a needle tube 35 is fixed to the tip of the hub 33 so that its lumen and the lumen of the hub 33 communicate with each other.

A recess 34 serving as positioning means is formed on the outer peripheral surface of the hub 33. When the hub 33 is inserted into the branch pipe 10, the recess 34 fits into the convex part 14 formed on the inner peripheral surface of the branch pipe 10. As a result, the sampling liquid introduction device 30 is positioned, is securely attached to the branch pipe 30, and is prevented from wobbling or accidentally coming off.

Note that such recesses 34 and protrusions 14 are used as positioning means (
This is an example of a wobbling prevention means or a wobbling prevention means),
It is not limited to this. For example, the hub 33 and the branch pipe 10
The formation of the concave portion and the convex portion may be reversed, and
Other configuration examples include a configuration in which the distal end portion 13 of the branch pipe 10 and the hub 33 are screwed together, or a configuration in which an arbitrary locking mechanism is provided.

When the sampling liquid introduction device 30 is not in use, a cap 36 that encloses the needle tube 35 is attached to the hub 33 in order to prevent contamination of the needle tube 35 and to ensure safety.

Although it does not preclude sampling using a syringe for the blood collection bag 1 of the present invention, with a syringe, compared to holding the syringe outer cylinder with one hand and pulling the plunger with the other hand, Sampling liquid introduction device 30
Now, you can introduce the sampling liquid with one hand.
Excellent operability.

The volume of the sampling liquid introducing device 30 may be any volume as long as it can secure the amount of liquid necessary for sampling (0.3~2.
0IIl! In particular, it is preferably about 0.5 to 7 ml.

In the cross-matching test, it is necessary to specify that the sampling liquid introduced into the sampling liquid introduction device 30 is the same as that in the blood collection bag 1. Part 3
1 A display identifying the blood collection bag 1 on the surface (not shown)
For example, it is preferable that the manufacturing lot number of the blood collection bag 1 is attached.

Furthermore, a scale (not shown) may be provided on the surface of the liquid display section 31 to indicate the amount of the sampling liquid.

In addition to being used for sampling for cross-matching tests, the sampling liquid introducing device 3° of the present invention can also be used alone for other purposes, such as sampling culture fluid.

The blood collection tool of the present invention is a combination of the blood collection bag 1 described above and one or more sampling liquid introduction devices 30, but when not in use, these are put together and packaged as a set. It is preferable to enclose it inside.

In this case, it is preferable that the blood collection bag 1 and the sampling liquid introduction device 30, which are the contents of the packaging material, are subjected to sterilization treatment such as autoclave sterilization, EOG sterilization, and gamma ray sterilization.

Next, a method of using the blood collection tool, blood collection bag, and sampling liquid introducing device of the present invention will be explained.

1) Place the blood collection bag l in a low place and the tube 7 is occluded (before the connecting member 6 is broken by the click tip)
Then, the blood sampling needle 19 is punctured into the blood vessel of the person collecting blood to collect blood. Thereby, the collected blood is introduced into the blood storage space 3 of the blood collection bag 1 through the tube 17.

The introduced collected blood is mixed with an anticoagulant that has been placed in the blood storage space 3 in advance.

2) Block the tube 17 with a cleanser, etc.
Breaking of the connecting member 6 by the click tip to unblock the tube 7) The blood collection bag 1 is pressed to introduce the blood in the blood storage space 3 into the tube 7.

3) When the blood introduced into the tube 7 exceeds the sampling section 8, the pressure on the blood collection bag 1 is stopped, and the distal end of the tube 7 from the sampling section 8 is closed with a clamp or the like.

4) Pinch the tip of the beer tab 16 with your fingers and peel it off to open the bag 15 and expose the tip 13 of the branch pipe 10.

5) Remove the cap 36 from the sampling liquid introduction device 30, insert the needle tube 35 into the branch tube 10, and then pierce the stopper 12 with the needle tube 35. At this time, when the hub 33 is inserted to a certain depth inside the branch pipe 10, the hub 33
The concave portion 34 of No. 3 and the convex portion 14 of the branch pipe 10 fit together, and the position of the sampling liquid introducing device 30 with respect to the branch pipe 10 is fixed (see Fig. 3).

6) In the state shown in FIG. 3, press and close the body of the liquid storage section 31 with your fingers, then release the press and close it to restore it to its original shape. As a result, the blood 40 in the connector 9 passes through the needle tube 35 and the lumen of the hub 33 to the liquid storage section 31.
It is sucked in and introduced into the body.

Note that this operation can be performed more easily than with a syringe.

7) Pull out the needle tube 35 from the stopper 12 and remove the sampling liquid introducing device 30 from the branch tube 10. At this time, the plug body 12 closes itself due to its elasticity and maintains airtightness, so that outside air does not enter and blood 40 does not leak out.

The sampling liquid introducing device 30 containing the blood sample in this manner can be used as is for a cross-matching test. To take out the blood sample in the sampling liquid introducing device 30, the needle tip is directed downward and the body of the liquid storage section 31 is pressed to cause blood to flow out from the needle tip.

This operation is also easier than using a syringe.

8) Such sampling can be performed any number of times by repeating the operations 5) to 7) above.

9) After removing the sampling liquid introducing device 30 from the branch pipe 10, cover the tip 13 of the branch pipe 10 with the bag body 15. This protects the tip 13 of the branch pipe 10 and prevents contamination due to inadvertent contact.

10) Such sampling is preferably performed immediately before the cross-matching test performed when the collected blood is transfused into the blood collection bag 1, but is not limited thereto.

For example, after a blood sample is collected in the sampling liquid introducing device 3o by the above-described operation, the vicinity of the opening 32 of the liquid storage portion 31 is sealed and closed by fusion, etc., and the hub 33 side is closed from this sealing portion. It is also possible to cut and separate it from the hub 33 to form a segment (unit package) containing the blood sample with the liquid storage part 31 closed at both ends, and to store this segment until a cross-matching test is performed.

In this case, the length of the liquid storage portion 31 may be increased to a certain extent (for example, approximately 20 to 100! I1m), and two or more locations may be closed to form a plurality of segments in one liquid storage portion. .

Also, a mark can be placed on the location to be blocked.

11) In the above, the case of sampling whole blood was described, but after the operation in l), the collected blood is centrifuged by performing a centrifugal operation at the blood collection point < lag l, and the separated blood components, especially red blood cells ( Concentrated red blood cell fluid) to be exact in tube 7
The red blood cells can also be sampled.

In this case, the red blood cells are preferably introduced into the tube after components other than the red blood cells (plasma, buffy coat liquid, etc.) are transferred to another bag (not shown) connected to the other end of the tube 7.

In addition, the objects to be sampled by the sampling liquid introducing device 30 are not only red blood cells but also plasma, buffy coat liquid, etc.
It may also be platelet concentrate or the like.

12) Furthermore, even when whole blood is sampled into the sampling liquid introduction device 30, the liquid storage portion 31 can be made into a segment as described above, and the sampled blood can be centrifuged by performing a centrifugal operation on this segment. .

<Effects of the Invention> As described above, according to the present invention, it is possible to sample the blood or its components in the blood collection bag as many times as necessary using the sampling liquid introduction device, so that it is possible to sample the blood or its components in the blood collection bag as many times as necessary using the sampling liquid introducing device. There is no need to form several segments, which improves ease of handling and improves the accuracy of cross-matching tests.

[Brief explanation of the drawing]

FIG. 1 is a front view showing a configuration example of a blood sampling tool of the present invention. FIG. 2 is an enlarged sectional front view showing an example of the configuration of the sampling section in the present invention. FIG. 3 is an enlarged sectional front view showing a state in which the sampling liquid introduction device of the present invention is attached to the sampling section. Explanation of symbols 1... Blood collection bag 2... Seal part 3... Blood storage space 4.5... Outlet port 6... Connecting member 7... Tube 8... Sampling part 9...・Connector 10...Branch pipe 11...Inner lumen 12...Blug body 13...Tip portion 14...Convex portion 15...Bag body 16...Beer tab 17...Tube 18・...Hub 19...Blood collection needle 20...Cap 30...Sampling liquid introducing device 31...Liquid storage section 32...Opening 33...Hub 34...Recess 35...Needle tube 36 ...Cap 40...Blood FIG, 1 Application Person's attorney Person Terumo Corporation

Claims (4)

[Claims] (1) It has a bag main body, a tube connected to the bag main body, and a sampling section installed in the middle of the tube and capable of collecting a part of the liquid introduced into the tube, the sampling section comprises a branch tube branching from the tube, a stopper made of an elastic material that is installed so as to shield the inner lumen of the branch tube and capable of being penetrated by a needle tube, and an unsealable seal that encloses the distal end of the branch tube. A blood collection bag comprising: a bag body; (2) A sampling liquid introduction device having a liquid storage part having an opening and a needle tube attached to the opening of the liquid storage part via a hub, wherein the liquid storage part can be compressed and closed, and 1. A sampling liquid introducing device characterized by having elasticity to the extent that it can substantially return to its original shape when pressure is released. (3) The sampling liquid introducing device according to claim 2, wherein the liquid storage section is constituted by a tube-shaped member having a closed rear end and an opening at the distal end. (4) A blood collection tool comprising a combination of the blood collection bag according to claim 1 and at least one sampling liquid introducing device according to claim 2 or 3.