JPH0644919B2 - Bag connection - Google Patents

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial field of application> The present invention relates to a bag connecting body having a plurality of bags.

<Conventional technology> When a blood transfusion is performed, the blood obtained from the donor is separated into each component by centrifugal separation, etc. for the purpose of effective use of the blood and reduction of the burden on the blood transfuser. Only a blood transfusion system is in place. The introduction of this component transfusion has enabled effective use of blood compared to the conventional whole blood transfusion.

In such component blood transfusion, a bag collection body (multiple bags) composed of a blood collection bag and one or more other bags is used.

Among the multiple bags, for example, a triple bag is a blood collection bag, a platelet storage bag (hereinafter referred to as a PC bag), and a plasma holding bag (hereinafter referred to as a plasma bag) that are connected by a tube. The blood collected in the bag is centrifuged twice to separate it into three components, red blood cells, concentrated platelets and platelet poor plasma,
These are stored and stored in a blood collection bag, a PC bag and a plasma bag, respectively.

In such a multiple bag system, JP-A-55-60464 discloses that a blood collection bag made of soft polyvinyl chloride containing di (ethylhexyl) phthalate (DEHP) as a plasticizer is used.

In this case, the plasticizer in the blood sampling bag material is eluted into the blood sampling blood, but DEHP has an action of suppressing hemolysis that occurs when the red blood cells are stored for a long period of time, and therefore has good results for the red blood cells stored in the blood sampling bag. give.

On the other hand, plasticizers such as DEHP adversely affect platelets. That is, it is known that plasticizers cause biochemical and physiological changes in platelets and reduce activity and viability after transfusion. (Reference: TRANSFUSION 1986; 26:
351-357).

Therefore, it is said that a material such as a polyolefin-based copolymer is used for the PC bag.

An anticoagulant such as ACD solution, CPD solution, and heparin sodium solution has been put in the blood collection bag in advance. Since DEHP is eluted and mixed in this solution, the blood and the anticoagulant are collected at the time of blood collection. When DE is mixed, DEHP is mixed in the blood.

Blood is once stored in a blood collection bag and then centrifuged to separate it into red blood cells and plasma.The plasticizer contained in soft polyvinyl chloride has the property of being easily extracted by blood plasma. And until this separation operation is completed,
The plasticizer in the blood collection bag will elute over time while being left at room temperature, so that DEHP also transfers to the concentrated platelets separated from the plasma.

As a result, the amount of DEHP eluted in the concentrated platelets was lower than the amount of DEHP eluted in the concentrated red blood cells stored in the blood collection bag, but a decrease in platelet activity and viability occurred, In particular, if a large number of frequent infusions are performed, the patient will be adversely affected.

In addition, even in platelet poor plasma, almost the same amount of DEHP will be eluted and mixed in during transportation or storage, and if this is infused as fresh frozen plasma or plasma preparation in large quantities and frequently, it will have an adverse effect on patients. Exert.

<Problem to be Solved by the Invention> It is an object of the present invention to provide a bag connected body in which the plasticizer is not substantially mixed with plasma, particularly concentrated platelets.

<Means for Solving the Problems> Such an object is achieved by the present invention of the following (1) to (4).

(1) A bag connecting body in which a blood collecting bag for collecting blood and a red blood cell bag for storing red blood cells are connected by a tube, wherein the blood collecting bag is made of a resin that does not substantially elute the plasticizer into the contents. A bag connecting body, which is configured and has a hemolytic inhibitor in a constituent material of the red blood cell bag or in the red blood cell bag.

(2) The bag connected body according to (1), wherein the red blood cell bag is composed of polyvinyl chloride containing di (ethylhexyl) phthalate as a plasticizer.

(3) The blood collection bag has a polyolefin, polyvinyl chloride containing no plasticizer, or di- (n-
The bag linkage according to (1) or (2) above, which is composed of polyvinyl chloride containing decyl) phthalate.

(4) The bag connection body according to any one of (1) to (3) above, wherein the tube is made of polyvinyl chloride.

<Operation> In the bag connected body having such a configuration, the blood plasma collected in the blood collection bag is centrifuged, the plasma is transferred to the PC bag or the plasma bag, and the red blood cells are transferred to a dedicated red blood cell bag for storage.

At this time, since the blood collection bag is made of, for example, a resin containing no plasticizer, there is no mixing of the plasticizer into the blood when the blood is collected, and the PC bag and the plasma bag do not contain the plasticizer. Since it is composed of, there is no mixing of plasticizer into platelet concentrate or plasma.

On the other hand, the red blood cell bag is, for example, DE, which is a hemolytic inhibitor.
Since it is composed of polyvinyl chloride containing HP as a plasticizer, this DEHP elutes and mixes into the red blood cell bag, and exerts a hemolysis suppressing effect on the red blood cells stored in the bag.

<Example> Hereinafter, a bag connecting body of the present invention will be described in detail based on a preferred example shown in the accompanying drawings.

In addition, in this specification, "blood" means whole blood containing all components. The term "plasma" refers to a substance containing components other than erythrocytes, and is, for example, a generic term for platelet-rich plasma, concentrated platelets, platelet-poor plasma, and platelet-poor plasma from which cryoprecipitate has been removed.

FIG. 1 shows a structural example of a bag connecting body of the present invention. This bag connecting body is formed by connecting a blood collecting bag, a PC bag, a plasma bag, and a red blood cell bag with a tube.

In the blood collection bag 1 located at the second position from the right in FIG. 1, resin sheet materials are stacked, and at the peripheral seal portion 2,
It is made into a bag shape by being fused by high frequency heating or other heating methods.

A blood storage portion 3 for storing the collected blood is formed in an inner portion surrounded by the seal portion 2.

Two outlets 4 and 4 having peel tabs are formed in the upper portion of the blood collection bag 1, and outlets 5a and 5b for connecting to another bag described later are formed between them. .

The tube 14 is connected to the discharge port 5a via the connecting member 15a.
Is connected to one end of the tube 14 and the other end of the tube 14 is provided with a branch connector 24 described later.

In addition, the connecting member 15a and the connecting member 15b described later.
It is preferable to use a member in which the flow path is closed before the breakage, but the flow path is opened when the breakage occurs. For example, a click chip manufactured by Terumo Corp. can be used.

Further, one end of a flexible tube 6 is connected to the upper part of the blood collection bag 1 so as to communicate with the blood component storage unit 3, and a blood collection needle 8 is connected to the other end of the tube 6 via a hub 7. It is installed. Further, a cap 9 that encloses the blood collection needle 8 is attached to the hub 7.

The blood storage unit 3 of the blood collection bag 1 may be provided with A
An anticoagulant such as CD solution, CPD solution, CPDA-1 solution, or heparin sodium solution is contained.

In FIG. 1, a PC bag 3 located on the left side of the blood collection bag 1
0 is a stack of resin sheet materials, the sealing portion 31 of the periphery
In the above, the bag is formed by fusion bonding by high frequency heating or another heating method.

A platelet storage portion 32 for storing plasma (platelet-rich plasma) separated from blood in the blood collection bag 1 is formed in an inner portion surrounded by the seal portion 31.

Two discharge ports 33, 33 having peel tabs are formed on the upper portion of the PC bag 30.

Further, one end of a flexible tube 22 communicating with the platelet storage section 32 is connected to a side portion of the outlet 33 on the upper part of the bag, and the other end of the tube 22 is connected to one branch end of the branch connector 21. It is connected to the. As a result, the blood storage unit 3 of the blood collection bag 1 and the platelet storage unit 32 of the PC bag 30 communicate with each other via the tubes 22 and 14 and the branch connector 21.

The plasma bag 10 located on the left side in FIG. 1 is formed by stacking resin sheet materials and fusing them at the peripheral seal portion 11 by high-frequency heating or another heating method to form a bag shape.

A plasma storage portion 12 for storing plasma (platelet-poor plasma) separated from the platelet-rich plasma in the PC bag 30 is formed in an inner portion surrounded by the seal portion 11.

On the upper part of the plasma bag 10, two outlets 13 having a peel tab are formed.

Further, one end of a flexible tube 24 communicating with the plasma storage unit 12 is connected to a side portion of the outlet 13 at the upper part of the bag, and the other end thereof is connected to the other branch end of the branch connector 21. ing. Thereby, the plasma bag 10
Of the blood plasma storage section 12 and the blood storage sections 3 and the platelet storage sections 32 of the other bags 2 and 30 are tubes 24, 14, and 2.
2 and the branch connector 21.

The branch connector 21 is formed of a molded product made of resin such as polyvinyl chloride or polycarbonate.

The red blood cell bag 40 located on the right side in FIG. 1 is a dedicated bag for storing and storing red blood cells, which is formed by stacking resin sheet materials and melting them at a peripheral edge seal portion 41 by high frequency heating or another heating method. It was worn and made into a bag.

An erythrocyte storage portion 42 for storing erythrocytes separated from the blood in the blood collection bag 1 is formed in an inner portion surrounded by the seal portion 41.

In the upper part of the red blood cell bag 40, two outlets 43, 43 having peel tabs are formed.

Further, one end of a flexible tube 25 that communicates with the red blood cell storage unit 42 is connected to the side portion of the outlet port 43 at the top of the bag, and the other end of this tube 25 is connected to the connecting member 15.
It is connected to the discharge port 5b of the blood collection bag 1 via b.

As a result, the blood storage unit 3 of the blood collection bag 1 and the red blood cell storage unit 42 of the red blood cell bag 40 communicate with each other via the tube 25.

The erythrocyte storage unit 42 of the erythrocyte bag 40 contains a erythrocyte preservation solution, if necessary. Examples of this red blood cell preservation solution include S. A. G. M. Liquid (0.87
7% sodium chloride, 0.0169% adenine, 0.8
18% glucose, an aqueous solution containing 0.525% D-mannitol) and the like.

Next, constituent materials, sizes, and the like of each bag and tube in the illustrated bag connecting body will be described.

The blood collection bag 1 is made of a resin material that does not substantially elute the plasticizer into the contents (blood, anticoagulant). Specifically, the following are mentioned.

Polyolefin As the polyolefin, a polymer obtained by polymerizing or copolymerizing olefins or diolefins such as ethylene, propylene, butadiene and isoprene is used.
Examples thereof include polyethylene, polypropylene, linear low density polyethylene, linear belly low density polyethylene, ethylene-vinyl acetate copolymer (EVA), and polymer blends of EVA and various thermoplastic elastomers. Among them, EVA is particularly preferable because it is excellent in transparency, flexibility, workability, strength (toughness) at low temperature and the like.

Polyvinyl chloride containing no plasticizer Examples of polyvinyl chloride containing no plasticizer (non-plasticized vinyl chloride) include NP-resin manufactured by Toagosei Co., Ltd. and Smedica manufactured by Sekisui Co., Ltd. .

Di- (n-decyl) phthalate (DnD) as a plasticizer
Polyvinyl chloride containing P) When this DnDP plasticized polyvinyl chloride is used, the elution amount of the plasticizer is extremely small.

That is, the elution amount is about 1/70 to 1/100 or less as compared with DEHP plasticized polyvinyl chloride.

Moreover, DnDP itself has low toxicity and is not mutagenic (see JP-A-61-33661).

Therefore, adverse effects on platelets do not occur.

The content of such plasticizer DnDP is 30 to 70 parts by weight, particularly 40 to 6 parts by weight based on 100 parts by weight of polyvinyl chloride.
It is preferably 0 part by weight.

The reason is that if it is less than 30 parts by weight, the flexibility of the bag becomes poor, and if it exceeds 70 parts by weight, the amount of the plasticizer eluted in the bag increases and the strength also decreases. is there.

In addition, when polyvinyl chloride as described above is used as a constituent material of the blood collection bag 1, flexibility which endures a centrifugation operation or storage under shaking and heat resistance to sterilization are obtained, and wrinkles during centrifugation are not generated. There is an advantage that the occurrence (affecting the dispersibility of platelets) is small.

In addition, a stabilizer or the like can be added to the sheet material of the blood collection bag 1. Examples of the stabilizer include an epoxy compound and a Ca-Zn stabilizer.

The thickness of the sheet material of blood collection bag 1 is preferably 0.25.
.About.0.45 mm, more preferably 0.35 to 0.45 mm. This is because if the thickness of the sheet material is less than 0.25 mm, sufficient strength cannot be obtained, and if it exceeds 0.45 mm, the flexibility deteriorates, which affects the operability of blood collection and the discharge ability during transfusion.

The PC bag 30 is also made of the same material as the blood collection bag 1, and among them, it is particularly preferable to use DnDP plasticized polyvinyl chloride.

The use of DnDP plasticized polyvinyl chloride has the following advantages in addition to the above characteristics.

That is, since DnDP plasticized polyvinyl chloride has high gas permeability (O ₂ gas permeability and CO ₂ gas permeability), the bag capacity (surface area) required to store the same number of platelets is DEHP plasticized. Compared with the case where polyvinyl chloride is used, the amount can be reduced.

This makes the formulation workable. In particular,
Centrifuge cup volume, size of separation stand, volume and size of shaker used for platelet storage, or various transportation
It can be said that a compact bag size has a great advantage in terms of storage container space.

Further, as a merit in manufacturing, it is possible to save the material.

The content of such a plasticizer DnDP is the same as described above. In addition, the same stabilizer and the like as described above can be added to the sheet material of the PC bag 30.

The inner surface area (hereinafter referred to as “effective inner surface area”) of the portion of the platelet storage portion 32 that may be involved in gas permeability is preferably 100 to 450 cm ² , and more preferably 200 to 350 c.
m ² and more preferably 260 to 340 cm ² .

If the effective inner surface area is less than 100 cm ² , the desired gas permeability cannot be obtained, and if it exceeds 450 cm ² , the size of the bag becomes large and the operability deteriorates.

Further, the amount of CO ₂ gas permeation in the platelet storage unit 32 is
Preferably 3.1 ml (CO ₂ ) / day · atm · ml
(PC) (30 ° C) or higher, more preferably 3.6 ml (C
O ₂ ) / day · atm · ml (PC) (30 ° C) or more,
More preferably 4.0 ml (CO ₂ ) / day · atm
・ It is recommended to use at least ml (PC) (30 ° C).

CO ₂ gas permeation rate is 3.1 ml (CO ₂ ) / day · at
When it is less than m · ml (PC) (30 ° C), it is about 0.92
This is because it is difficult to store 3.4 × 10 ⁶ / μl platelets for a long period of time.

With the above-described configuration, a PC bag is provided that can store one unit or more of platelets, particularly platelets having a number of platelets exceeding 2 × 10 ¹⁰ for an effective period of 72 hours or more.

The plasma bag 10 is also made of the same material as that of the blood collection bag 1. Further, the thickness of the sheet material of the plasma bag 30 is the same as that of the blood collection bag 1.

The red blood cell bag 40 is preferably made of polyvinyl chloride containing di (ethylhexyl) phthalate (DEHP), which is a hemolysis-suppressing substance, as a plasticizer.

By using this DEHP as a plasticizer, DEHP eluted in the red blood cell bag 40 has a protective effect on the red blood cell membrane, suppresses hemolysis, and contributes to long-term storage of red blood cells.

The content of such plasticizer DEHP is 30 to 70 parts by weight, particularly 40 to 6 parts by weight based on 100 parts by weight of polyvinyl chloride.
It is preferably 0 part by weight.

The reason is that if it is less than 30 parts by weight, the flexibility of the bag becomes poor, and if it exceeds 70 parts by weight, the amount of the plasticizer eluted into the bag increases and the strength decreases. .

In addition, a stabilizer or the like can be added to the sheet material of the red blood cell bag 40. Examples of the stabilizer include an epoxy compound and a Ca-Zn stabilizer.

Examples of the hemolysis-suppressing substances include plasticizers such as dioctyl malate (DOM), 2-ethylhexanoic acid triglyceride (TGO), and various citric acid esters, in addition to the DEHP.

Further, instead of the red blood cell bag 40 made of the DEHP plasticized polyvinyl chloride, the red blood cell bag 40 may be made of the same material as that of the blood collection bag 1 described above. However, in this case, the hemolysis-suppressing substance is placed in the red blood cell storage portion 42 of the red blood cell bag 40. As the method, for example, a DEHP plasticized polyvinyl chloride piece is used for the red blood cell storage unit 4.
You can put it in 2.

With such a configuration, when concentrated red blood cells are stored in the red blood cell bag 40, the concentration of the plasticizer eluted during the storage is 3
It is preferably about 0 to 500 ppm, especially about 50 to 80 ppm.

The thickness of the seawood of the red blood cell bag 40 is preferably 0.2.
5 to 0.45 mm, more preferably 0.35 to 0.45 mm
And If the thickness of the sheet material is less than 0.25 mm, sufficient strength cannot be obtained, and if it exceeds 0.45 mm, the flexibility decreases.
This is because the operability and the discharge capacity during infusion are reduced.

The size of the red blood cell bag 40 is not particularly limited, but the inner volume is about 100 to 500 ml, particularly 200 to 5 ml.
About 100 ml is preferable.

The material of construction of the tubes 6, 14, 22, 24 and 25 is preferably polyvinyl chloride. Tube 6,
If 14, 22, 24, and 25 are made of polyvinyl chloride, sufficient flexibility and flexibility can be obtained, so that they are easy to handle and suitable for clogging by clench etc., and also with each bag and branch connector 21. This is because the bondability becomes good.

The type and content of the plasticizer in the tubes 6, 14, 22, 24 and 25 are not particularly limited, but it is preferable to use DnDP as the plasticizer particularly in the tubes 6, 14, 24 and 22.

The inner diameter of the tubes 6, 14, 22, 24 and 25 is preferably about 2.0 to 4.0 mm.

Further, each of the tubes 6, 14, 22, 24 and 25 is not limited to a single tube, but a plurality of tubes may be connected by a tube connecting member such as a connector. As a result, the bags 1, 10, 30, 40, etc. can be separated by attaching and detaching the tube connecting member during centrifugal separation of blood components and other preparation operations.

Next, a method of using the illustrated bag connecting body will be described.

1) The blood collection bag 1 is placed at a low place, and in a state where the tubes 14 and 25 are closed (before the connecting members 15a and 15b are broken by the click tip), the blood collection needle 8 is punctured into the blood vessel of the blood sampler to collect blood. To do. As a result, the blood sampled is introduced into the blood container 3 of the blood collection bag 1 via the tube 6.

Since the blood collection bag 1 is made of a resin that does not substantially elute the plasticizer as described above, the plasticizer does not elute into the introduced blood or the anticoagulant that has been put in advance.

2) Closing the tube 6 with a clamp etc., and collecting the blood bag 1
Is subjected to centrifugation to separate into red blood cells and plasma containing other components.

3) While closing the tube 24 with a clamp or the like,
The blockage of the tube 14 is released (breakage of the connecting member 14a by the click tip), the blood collection bag 1 is pressed, and the separated supernatant plasma is introduced into the platelet storage portion 32 of the PC bag 30 via the tubes 14 and 22. To do.

4) When the interface between plasma and red blood cells reaches the upper end of the blood storage unit 3, the pressing of the blood collection bag 1 is stopped and the tube 2
Block 2 with a clamp.

5) The blockage of the tube 25 is released (the connecting member 15b is broken by the click tip), the blood collection bag 1 is further pressed, and the red blood cells remaining in the blood collection bag 1 are stored in the red blood cell bag 40 via the tube 25. It is introduced into the part 42.

When the introduction of red blood cells is completed, the tube 25 is closed with a clamp or the like, and cut and separated by a tube sealing device or the like.

6) Centrifuge the PC bag 30 to separate it into concentrated platelets and platelet poor plasma.

7) The blockage of the tube 22 and the blockage of the tube 24 are released, respectively, and the tube 14 is blocked with a clamp or the like, and the supernatant platelet poor plasma separated by pressing the PC bag is separated into the tube 22 and the branch connector 21.
Then, it is introduced into the plasma storage portion 12 of the plasma bag 10 via the tube 24.

By performing the above operation, the PC bag 30,
The plasma bag 10 and the red blood cell bag 40 respectively contain concentrated platelets, platelet poor plasma and red blood cells (concentrated red blood cells).
Is stored.

In this case, the blood collection bag 1, the PC bag 30, the plasma bag 10, which is the portion through which the plasma has passed or which is stored.
Since the tubes 6, 14, 22, and 24 are made of a resin that does not substantially elute the plasticizer, the plasticizer does not elute or mix into the plasma at these portions.

Further, in the red blood cell bag 40 in which red blood cells are stored, DEHP, which is a hemolysis-suppressing substance, is eluted and mixed, so that hemolysis is suppressed, which is preferable for storage of red blood cells.

It is possible that the plasticizer DEHP of the red blood cell bag 40 may migrate into the blood collection bag 1 by autoclave sterilization of the connected bag, but this amount is 10 pp
Since it is less than m, it has little effect on platelets.

Although the bag connecting body of the present invention having the four bags shown in the drawings has been described above, the present invention is not limited to this.

For example, one or both of the PC bag 30 and the plasma bag 10 are omitted in the illustrated configuration, or one such as a bag for collecting cryoprecipitate (AHF) or a bag for removing leukocytes, or 1 Two or more other bags, or a bag to which a filter or the like is added may be used.

Also, the tube connection pattern is not limited to that shown in the figure. For example, one of the tubes 14 and 25 may have its blood collection bag side connection end connected to the middle of the other tube via a branch connector.

<Effects of the Invention> As described above, according to the bag connecting body of the present invention, since a dedicated red blood cell bag for storing red blood cells is separately provided, the mixing of the plasticizer into plasma, particularly concentrated platelet plasma, is substantially caused. Does not occur, thus increasing safety to the human body.

Further, in the storage of red blood cells, hemolysis is suppressed, and storage for a longer period of time becomes possible.

[Brief description of drawings]

FIG. 1 is a plan view showing a configuration example of a bag connecting body of the present invention. Explanation of code 1 …… Blood collection bag 2 …… Seal section 3 …… Blood storage section 4, 5a, 5b …… Discharge port 6 …… Tube 7 …… Hub 8 …… Blood collection needle, 9 …… Cap 10 …… Plasma Bag 11 …… Seal part 12 …… Plasma storage part 13 …… Ejection port 14 …… Tube 15a, 15b …… Connecting member 21 …… Branch connector 22, 24,25 …… Tube 30 …… PC bag 31 …… Seal Part 32 …… Platelet storage part 33 …… Ejection port 40 …… Red blood cell bag 41 …… Sealing part 42 …… Red blood cell storage part 43 …… Ejection port

Claims (4)

[Claims] 1. A bag connecting body in which a blood collecting bag for collecting blood and a red blood cell bag for storing red blood cells are connected by a tube, wherein the blood collecting bag does not substantially elute the plasticizer into the contents. A bag connecting body which is made of resin and has a hemolytic inhibitor in a constituent material of the red blood cell bag or in the red blood cell bag. 2. The bag assembly according to claim 1, wherein the red blood cell bag is made of polyvinyl chloride containing di (ethylhexyl) phthalate as a plasticizer. 3. The blood collection bag comprises polyolefin, polyvinyl chloride containing no plasticizer, or di-plasticizer.
The bag connection body according to claim 1 or 2, which is composed of polyvinyl chloride containing (n-decyl) phthalate. 4. The bag connecting body according to claim 1, wherein the tube is made of polyvinyl chloride.