JPH0710274B2 - Blood bag for blood component separation - Google Patents

Description

Description: TECHNICAL FIELD The present invention relates to an improvement of a blood bag used when collecting a blood component and separating each component of blood.

[Prior Art] As shown in FIG. 8, a blood bag 51 currently in use is composed of a parent bag 52 and one or more child bags 58. A blood collection tube 54 to which a blood collection needle 53 for introducing blood into the blood vessel is connected, and a connection tube 60 having a protector 56 capped with a blood transfusion port 55 and a communication piece 57 are mounted therein. Further, the parent bag 52 and the child bag 58 are connected via a connecting tube 59 connected to a connecting tube 60 and a Y-shaped tube 61. The child bag 58 is obtained by centrifuging the blood contained in the parent bag 52 to obtain a buffy coat containing red blood cells, plasma, white blood cells, and platelets, a cryoprecipitate (8th embodiment).
It is called a factor, and is used for the treatment of hemophilia when it is separated into necessary components such as a formulation), and 1 to 3 are appropriately attached depending on the number of required components.

The parent bag 52 usually contains CPD, ACD, ACD-A, ACD-
A blood preservation solution such as solution B is enclosed.

[Problems of Prior Art] However, the parent bag 52 constituting these blood bags 51 is subjected to centrifugal separation processing because the space of the upper end portion 62 is formed wide and the outlet 63 of the blood component is sharply narrowed. When the subsequent blood component is extruded from the parent bag 52, a minute component in the collected blood component (particularly when separating the buffy coat layer) has an interface with the red blood cell layer at the upper end portion 62 of the parent bag 51.
However, there is a problem that the boundary layer between the red blood cell layer and the buffy coat layer is widened laterally as it moves to.

As a result, it was extremely difficult to completely separate only the buffy coat layer because the red blood cell layer was mixed in the child bag that separated and contained the buffy coat layer (recovery rate 60-
70%). In the buffy coat layer, there are lymphocytes containing ATL pathogenic virus, which is a factor of adult T-cell leukemia. Therefore, by removing them, side effects due to blood transfusion can be prevented. Therefore, it is desirable to separate as much buffy coat layer as possible.

Since platelets and cryoprecipitate, which are minute components in blood, are used after being formulated, it is desired to collect as much amount as possible in a pure form.

The present invention has been proposed as a result of intensive studies to solve the above problems, and an object of the present invention is to provide a blood bag capable of efficiently separating and recovering minute components in blood. .

[Means for Solving Problems] The means adopted by the present invention for the above-mentioned purpose are a parent bag for collecting blood from a donor and an upper layer (plasma separated by centrifugation in the parent bag). A first child bag for collecting a layer), a second child bag for collecting an intermediate layer (buffy coat layer) separated by centrifugation in the parent bag, the parent bag and the first child bag And a connecting tube for connecting the second child bag, wherein the upper side of the parent bag and / or the second child bag has a slanted portion continuously inclined toward the top. Is formed into a funnel shape, and the connecting tube is connected to the top of the funnel-shaped upper end portion, and a blood transfusion port is attached to the hypotenuse portion of the funnel-shaped upper end portion.

[Operation] By forming the upper end of the parent bag into a funnel shape, the blood contained in the parent bag is subjected to centrifugal separation to form an upper layer (plasma layer), an intermediate layer (buffy coat layer), and a lower layer (red blood cell layer).
When the plasma layer and the buffy coat layer are transferred to another child bag after separation, the boundary layer between the plasma layer and the buffy coat layer is tapered from bottom to top along the narrowed space to the funnel-shaped tip. Since it can be transferred without being disturbed, the plasma layer and the buffy coat layer can be efficiently separated. In addition, the intermediate layer (buffy coat layer)
By forming the upper end portion of the child bag in which the sample is collected into a funnel shape, the concentrated platelets and the buffy coat layer can be efficiently separated. Furthermore, since the blood transfusion port is attached to the hypotenuse of the funnel-shaped upper end of the parent bag and / or the second child bag, when transfusing blood with the funnel-shaped upper end facing downward, the inside of the bag The blood components of (1) smoothly move along the hypotenuse toward the blood transfusion port, and the amount of the remaining blood components decreases.

[Example] FIG. 1 shows a schematic view of a blood bag of the present invention. The blood bag 1 includes a parent bag 20 for collecting blood from a donor, a first child bag 21 for collecting an upper layer (plasma layer) separated by centrifugation in the parent bag 20, and an intermediate layer (buffy coat). Second child bag 22 for collecting layers), a third child bag 23 enclosing a chemical solution described later, and connecting tubes 17, 18, 19 connecting these parent bag 20 and child bags 21, 22, 23 Has been done.

The upper end portion 9 of the main body of the parent bag 20 is formed into a so-called funnel shape by the oblique side portion which is inclined toward the top.
As shown in FIG. 2, a blood collection tube 3 to which a blood collection needle is connected and a blood transfusion port 5 capped by a protector 4 are attached to the hypotenuse of the funnel-shaped upper end 9, and the top of the funnel-shaped upper end 9 is attached. The connection tube 17 is connected to the connection tube 7 via a connection tube 7 in which the communication piece 6 is loaded.

Around the outlet 10 of the funnel-shaped upper end portion 9 is formed narrow, and an outlet 11 for blood and an outlet 12 for blood components are provided at a position lower than the outlet 10 with the outlet 10 as a top. The parent bag 20 having a capacity of 200 ml, 400 ml, or 450 ml is used, and a preservative solution of blood such as CPD, ACD, ACD-A, ACD-B solution is sealed inside.

The first child bag 21 having a capacity of 100 ml to 300 ml is used. The second child bag 22 having a capacity of 50 ml to 300 ml is used, and the upper end portion of the main body is formed like a funnel like the parent bag 20. The third child bag 23 has a capacity of 100 ml to 300 ml.
If necessary, a mixture of physiological saline, adenine, glucose, phosphate and maltose (SAGPM solution), a mixture of physiological saline, glucose and maltose (SG-maltose solution) ), Physiological saline, glucose, a mixed solution of mannitol (SG-mannitol solution) and the like are enclosed.

The funnel shapes at the upper ends of the main body of the parent bag 20 and the second child bag 22 are, as shown in FIG. 2, a bottom side A and the other two sides (oblique side).
The angle θ formed by B and C is preferably 10 ° to 80 °. That is, when the angle θ is 10 ° or less,
When the separation and recovery efficiency of each minute component in whole blood is not sufficient and the angle θ is 80 ° or more, the gradient becomes too steep, and there is a problem of difficulty in mold making and moldability. .

A protector 4 capped with a blood transfusion port 5 is formed on the upper ends of the main bodies of the first to third child bags 21, 22 and 23 as in the case of the parent bag 20. In the case of the second child bag 22, the blood transfusion port 5 is attached to the hypotenuse of the funnel-shaped upper end. Also, as shown in FIG. 3, the area around the outlet 10a in the upper part of the main body of the second child bag 22 is narrow. An outlet 12a for the blood component is provided at a position lower than the outlet, with the outlet 10a as the top.

The parent bag 20 and the second child bag 22 are manufactured by the method shown in FIG. 4 (here, the parent bag 20 will be described as an example). That is, the two sheets 13 that make up the parent bag 20
Connection tube 7 with a communication piece stored inside
The jig 25 fitted with the connecting tube 15 and the export port 5 is not shown is sandwiched. After that, these are sandwiched from above and below by molds 14 and 14 formed in a funnel shape having a groove portion 16 and molded by high frequency welding.

Next, an example of a method of using the blood bag 1 of the present invention will be described with reference to FIG.

Blood is collected from the blood collection needle 2 through the blood collection tube 3 to the parent bag 20
It is introduced inside and is centrifuged at 3500 rpm.

After centrifugation, the upper layer is separated into a plasma layer, the lower layer into a red blood cell layer, and the intermediate layer into a buffy coat layer.

Each of these layers is transferred to each child bag as follows. First, most of the upper plasma layer (about 100 to 200 ml) is collected in the first child bag 21 via the connecting tube 17. The remaining small amount of plasma layer (about 30 to 70 ml) and the buffy coat layer are transferred to the second child bag 22 via the connecting tubes 17 and 18. Third
Connect the SAGPM stock solution in the child bag 23 of the connection tube 19, 18, 1
Store in the parent bag 20 via 7 and store the red blood cells.

Next, the second child bag 22 is subjected to centrifugal separation at 800 rpm (weak centrifugation), and all the platelet-rich concentrated platelet plasma layers are transferred to the third child bag 23 to obtain non-pellet concentrated platelets.

The platelet concentrate thus obtained is not agglutinated and therefore easy to collect and easy to use.

As described above, the upper end portion 9 of the parent bag 20 of the present invention is formed in a funnel shape so that the periphery of the blood component outlet port 10 is narrowed. Therefore, the buffy coat layer described above is used as a second child bag. Effective when moving to 22.

That is, the red blood cell layer, the plasma layer, and the buffy coat layer smoothly move along the funnel-shaped hypotenuses B and C, and the boundary layer thereof is not disturbed, and the parent bag is filled as much as possible.
It moves to a position close to the blood component outlet 10 formed at the upper end 9 of 20. Therefore, when each component is pushed out from the parent bag 20, the red blood cell layer is less likely to be mixed with the buffy coat layer.

Furthermore, as many buffy coat layers as possible are partially mixed in the red blood cell layer, which can be separated at this time, so the separation and recovery rate of the pure buffy coat layer is surprisingly 80-90%.
Improved.

Further, since the upper end portion 24 of the child bag 22 is also formed in a funnel shape like the parent bag 20, the concentrated platelet plasma layer and the buffy coat layer, which are minute components, can be separated from each other without mixing as much as possible, and a pure non-pure The recovery rate of platelets in the pellet was improved.

5 and 6 are schematic views showing another embodiment of the blood bag of the present invention. In the blood bag 1b of FIG. 5, the upper part of the main body of the parent bag 20 is formed into a funnel shape, and Child bag 21
In this example, b, 22b, and 23b have the same bag shape as the conventional one. In the blood bag 1c of FIG. 6, the upper part of the main body of the second child bag 22c for collecting the intermediate layer (buffy coat layer) is formed in a funnel shape, and the parent bag 20c and the other child bags 21c and 23c are conventionally formed. This is an example of the same bag shape as. The blood bag 1b is used for collecting and storing plasma and red blood cells that do not contain a buffy coat layer, and the blood bag 1c is used for collecting pure platelet concentrates. The other detailed shape usage examples of the blood bags 1b and 1c are substantially the same as the blood bag 1 shown in FIG.

FIG. 7 is a schematic view showing another embodiment of the blood bag of the present invention. The blood bag 1d includes a parent bag 30 having a capacity of 400 ml and a first child bag 31 (capacity 300 m) for collecting an upper layer (plasma layer).
l), the second child bag 32 (volume 80 ml) for collecting the intermediate layer (buffy coat layer), and the third child bag (volume 300 m)
l) 33 and the fourth child bag 34 (capacity 300 ml) are connected via connecting tubes 36, 37, 38, 39. The blood bag 1d has substantially the same structure as the blood bag 1 except that the fourth separation bag 34 is connected to the first child bag 31 via the connecting tube 36, and thus the details thereof will be omitted.

Next, an example of how to use the blood bag 1d will be described.
Blood is introduced from the blood collector to the inside of the parent bag 30 by a blood collection needle, and this is centrifuged at 3500 rpm.

By centrifugation, the upper layer is the plasma layer, the lower layer is the red blood cell layer,
The intermediate layer is separated into each layer of the buffy coat layer. Each of these layers is transferred to each child bag by the following method.

The supernatant of the plasma layer is transferred to a child bag 31 (about 200 ml) so that a small amount of the lower layer (lower layer of the plasma layer) remains. Cut the part of a,
The parent bag 30, the child bags 32, 33 and the child bags 31, 34 are separated.

The child bags 31, 34 are used to separate the cryoprecipitate. The child bag 31 is cooled to −30 to 80 ° C., frozen, thawed at 4 ° C., and subjected to centrifugation to agglomerate the cryoprecipitate, and only the plasma component is passed through the connecting tube 36 to the child bag 34. Transfer inside. After that, the cryoprecipitate aggregated at the bottom of the child bag 31 is dissolved in a stabilizer solution and centrifuged, and then the supernatant solution is freeze-dried to formulate the cryoprecipitate.

The small amount of plasma layer and buffy coat layer remaining in the parent bag 30 are transferred to the child bag 32 via the connecting tubes 37 and 38. Cut the portion b and centrifuge at 800 rpm.

The concentrated platelet plasma layer separates into the upper layer and the buffy coat layer into the lower layer. The concentrated platelet plasma layer is transferred to the child bag 33 via the connecting tube 39. Non-pellet platelets are obtained in the child bag 33.

As described above, since the upper end portion 35 of the child bag 32 is also formed in a funnel shape, the above-mentioned two layers, which are minute components, can be separated from each other without mixing as much as possible, and pure non-pellet platelets can be separated. Recovery rate was improved.

Next, cutting at point c leaves the concentrated red blood cell layer in the parent bag 30.

As described above, the blood bag 1d can separate whole blood into the components of concentrated red blood cells, plasma, cryoprecipitate, concentrated platelets, and buffy coat.

In the present invention, the arrangement of each child bag 21, 22, 23 is not limited to the order shown in the drawings, and can be appropriately changed according to the convenience of the blood component separation operation.

Further, the third child bag 23 enclosing the preservative solution for erythrocytes is not indispensable for the present invention, and is not necessary when only pure plasma or concentrated platelets are desired.

[Effects of the Invention] As described above, the present invention can efficiently collect minute components necessary for blood products and the like and separate minute components unnecessary for the human body. That is, the blood collected in the parent bag is centrifuged to separate it into an upper layer (plasma layer), an intermediate layer (buffy coat layer) and a lower layer (erythrocyte layer), and then an upper layer (plasma layer) and an intermediate layer (buffy coat layer). ) Is transferred to the first child bag and the second child bag, respectively, because the boundary layers of the respective layers move from the bottom to the top in the funnel-shaped upper end portion along the narrowed and tapered space without disturbance. As a result, the proportion of blood components in each layer is reduced, and efficient separation is possible.

Since the upper end portion of the second child bag is formed in a funnel shape, the second child bag obtained by separating the intermediate layer (buffy coat layer) is subjected to a centrifugal separation treatment to separate into concentrated platelets and buffy coat layer, Even when extracting the upper layer of platelets, the boundary layer between the platelets and the buffy coat layer moves to the top of the funnel-shaped upper end without being disturbed, and the proportion of blood components in each layer is reduced.

Since a blood transfusion port is attached to the hypotenuse of the funnel-shaped upper end, when transfusing a bag with the funnel-shaped upper end facing downward, blood components inside the bag are directed along the hypotenuse toward the blood transfusion port. Moves smoothly to less residue.

[Brief description of drawings]

FIG. 1 is a schematic view of a blood bag of the present invention, FIG. 2 is an enlarged view of a parent bag, FIG. 3 is an enlarged view of a child bag, and FIG. 4 is a schematic diagram showing a method for producing the parent bag, and FIG. 7 to 7 are schematic views showing another embodiment of the blood bag of the present invention. FIG. 8 is a schematic view of a conventional blood bag. In the figure, 1, 1b, 1c and 1d are blood bags, 2 are blood collection needles, 3 are blood collection tubes, 4 are protectors, 5 are blood transfusion ports, 6 are communication pieces, 7 are connection tubes, 8 are connection tubes, and 9 are Upper end, 10 and 12 are outlets, 11 is inlet, 13 is seat,
14 is a mold, 15 is a connecting tube, 16 is a groove portion, 17, 18 and 19 are connecting tubes, 20, 20b and 20c are parent bags, 21, 21b and 21c
22, 22b, 22c, 23, 23b, 23c are child bags, 24 is the upper end,
25 is a jig, 30 is a parent bag, 31, 32, 33, 34 are child bags,
Reference numeral 35 denotes an upper end portion, and 36, 37, 38, 39 denote connecting tubes.

Claims (1)

[Claims] 1. A parent bag for collecting blood from a donor, a first child bag adopting an upper layer (plasma layer) separated by centrifugation in the parent bag, and centrifugation in the parent bag as well. For separating blood components, including a second child bag for collecting the intermediate layer (buffy coat layer) separated by the treatment, and a connecting tube for connecting the parent bag, the first child bag and the second child bag In the blood bag, the upper end portion of the parent bag and / or the second child bag is formed in a funnel shape by a hypotenuse portion which is continuously inclined toward the top portion, and the connecting tube is formed on the top portion of the funnel-shaped upper end portion. A blood bag for blood component separation, characterized in that the blood bag is connected and a blood transfusion port is attached to the hypotenuse of the funnel-shaped upper end.