JPH0315913B2 - - Google Patents

Description

[Detailed description of the invention]

(Industrial Application Field) The present invention relates to a blood storage container. Specifically, the present invention relates to a blood storage container in which substantially no air remains in fractionated components when blood is stored in fractions. (Prior Art) In recent years, with the spread of blood storage containers made of soft vinyl chloride resin and other soft synthetic resins, whole blood obtained from a single blood donor can be aseptically separated into various components, such as concentrated red blood cells. Component transfusion, in which only the necessary components are fractionated into blood plasma (CRC), platelet concentrate plasma (PC), and plasma (fresh frozen plasma: FFP), has become commonplace. The blood storage container used to fractionate and store the collected whole blood has, for example, a structure as shown in FIG. 2. That is, in this blood storage container, a blood collection bag 53 made of soft synthetic resin and equipped with a plurality of peel-tab-equipped discharge ports 51 and a connecting discharge port 52 has a blood collection tube 56 with a blood collection needle 57 attached to its tip. is connected to communicate with the internal space 55 of the blood collection bag 53. In addition, the connection outlet 52 of the blood collection bag 53 has a
A connecting tube 66 is connected by a connecting needle 65 at the tip, and this connecting tube 66 is connected to a connecting tube 62 that communicates with an internal space 61 of a first child bag 63 having an outlet 59 with a peel tab, and a connecting tube 62 which also has a peel tab. They are each connected via a branch pipe 64 to a connecting tube 71 that communicates with an internal space 69 of a second child bag 72 having a discharge port 67 . To carry out a blood component fractionation operation using such a blood storage container, first whole blood from a blood donor is collected into a blood collection bag 53 through a blood collection needle 57 and a blood collection tube 56. The blood in the blood collection bag 53 is separated into a red blood cell layer and a platelet-rich plasma layer by centrifugation. Next, the upper platelet-rich plasma layer is transferred from the blood collection bag 53 to the connecting tube 66 by pressurizing operation.
and the first child bag 63 through the connecting tube 62.
separated into Next, the first child bag 63 is separated from the blood collection bag 53 in the middle of the connecting tube 66, and then further centrifuged together with the second child bag 72, separated into platelet pellets and platelet-poor plasma. The platelet-poor plasma is transferred from the first child bag 63 to the second child bag 72 through the connecting tube 62 and the connecting tube 71 by pressurizing operation. However, when the above fractionation operation is performed, the air present in the first child bag 63 and the connecting tubes 62 and 71 inevitably flows into the second child bag 62 during platelet-poor plasma transfer. If the first child bag 63 and the second child bag 72 are fractionated in this state, platelet-poor plasma containing a large amount of air will be obtained. Also,
Depending on the place where blood products are produced, an operation may be performed to return plasma from the second child bag 72 to the first child bag 63 in order to adjust the liquid volume in the first child bag 63. , air is returned to the first child bag 63, and aerated platelet concentrate plasma is obtained. In this blood storage container made of soft synthetic resin, air exists inside the container and the connecting tube, and when blood is collected into this container and blood components are fractionated, either Air will enter the fraction of For example, if air gets into concentrated red blood cell fluid, it is said that hemolysis will occur, and if air gets into platelet-rich plasma, it will have an adverse effect on the preservation state of the platelets, and furthermore, air will get into the plasma. In some cases, denaturation of plasma proteins and deterioration of the product image as plasma became a problem. (Problems to be Solved by the Invention) Therefore, it is an object of the present invention to provide an improved blood storage container. Another object of the present invention is to provide a blood storage container in which blood is collected, separated into components, and stored, in which fractionated components can be well preserved. A further object of the present invention is to provide a blood storage container in which substantially no air remains in fractionated components when blood is stored in fractions. (Means for Solving the Problems) The above objectives are to provide a container main body having a blood storage portion, a container main body that is connected to the container main body so as to be able to communicate with the container main body, and air that remains in the container main body when blood is stored. This is achieved by a blood storage container characterized in that it is equipped with an inflatable air-trapping bag made of soft synthetic resin so that the amount can be adjusted. (Function) The blood storage container of the present invention is connected to a container main body provided with a blood storage portion so as to be able to communicate with the container main body, and adjusts the amount of air remaining in the container main body when blood is stored. Since it is characterized by having a means for making it possible, when blood is collected and its components are separated, there is no possibility that each fraction will inevitably enter one of the container bodies containing the fractionated components. Since the air that would otherwise accumulate can be removed from the container body by means of the air volume control means, all fractionated components can be stored in a substantially air-free state, maintaining good storage conditions. It is something that can be done. Hereinafter, the present invention will be explained in more detail based on embodiments. FIG. 1 is a drawing showing one embodiment of the blood storage container of the present invention. That is, the drawing shows a blood bag, in which a blood collection bag 3 made of soft synthetic resin and equipped with a plurality of peel-tab-equipped discharge ports 1 and a connecting discharge port 2 has its peripheral portion 4 subjected to high-frequency heating or other heating. A blood sampling tube 6 made of soft synthetic resin is connected to the blood sampling tube 6, which is heat-sealed by a means and communicated with the internal space 5 of the blood sampling bag 3. The internal space 5 of this blood collection bag 3 normally stores ACD-A solution, CPD solution, etc. as an anticoagulant, and a blood collection needle 7 is attached to the tip of the blood collection tube 6. This blood collection needle 7
A cap 8 is attached to the. Furthermore, the blood collection bag 3 has a connecting tube 12 made of soft synthetic resin, which is equipped with a discharge port 9 with a peel tab, and whose peripheral edge 10 is heat-sealed by high frequency, and which communicates with the internal space 11. The first child bag 13 equipped with the branch pipe 1
4, a connecting tube 1 connected to the connecting outlet 2 of the blood collection bag 3 by a connecting needle 15 at its tip.
It is connected by being connected to 6. Further, the second child bag 22 is equipped with a connecting tube 21 made of soft synthetic resin, which is equipped with a discharge port 17 with a peel tab, whose peripheral edge 18 is sealed, and which communicates with the internal space 19. It is connected to the blood collection bag 3 and the first child bag 13 by being connected to the connection tubes 12 and 16 via. Therefore, in this embodiment, the air-trapping bag 23 further connects the connecting tube 25 communicating with the internal space 24 with the connecting tubes 12, 16, and 21 via the branch pipe 14.
It is connected to the blood collection bag 3, the first child bag 13, and the second child bag 22. Further, it is desirable that the air-trapping bag 23 be sealed with a clip or a cleanser to prevent blood from entering the bag before actual use. In addition, blood collection bag 3, first child bag 13, second child bag
The materials constituting the child bag 22, blood collection tube 6, and connection tubes 12, 16, and 21 are as follows:
Soft synthetic resins with good processability, flexibility, transparency, low water vapor permeability, high gas permeability, heat resistance, etc. are preferred, such as soft vinyl chloride resin, ethylene-
Vinyl acetate copolymer, soft vinyl chloride resin blended with polyurethane resin, ethylene-carbon monoxide-
Examples include vinyl acetate copolymer and ethylene vinyl alcohol-vinyl chloride copolymer. Also,
The air trapping bag 23 and the connecting tube 25 may also be constructed of the same materials as described above. The capacity of the air-trapping bag 23 may be any capacity that is sufficient to trap the amount of air present in the blood storage container and the connecting tube that cannot be removed. In order to perform a blood component separation operation using such a blood storage container, first, the blood collection needle 7 is inserted into the blood donor's vein, and the blood collection bag 3 is held below the position of the blood collection needle 7. Blood collection bag 3 is set according to the amount of blood collected only by pressure and blood head pressure.
is deformed and blood is collected into the internal space 5 of the blood collection bag 3. The blood in the blood collection bag 3 is separated into a red blood cell layer and a platelet-rich plasma layer by centrifugation. Next, the upper platelet-rich plasma layer is placed on a separation stand (not shown) and passed from the blood collection bag 3 through the connecting tube 16 and the connecting tube 12 by pressurizing operation without disturbing the separated boundary.
It is separated into child bags 13. Next, the first child Bug 1
3 is separated from the blood collection bag 3 midway through the connecting tube 16, and then further centrifuged together with the second child bag 72 to separate platelet pellets and platelet-poor plasma, and the platelet-poor plasma in the upper layer is transferred to a separation stand. (not shown) and transferred from the first child bag through connecting tube 12 and connecting tube 21 to second child bag 22 by a pressurizing operation without disturbing the separated boundaries. In this state, the first child bag 13 and the connecting tube 1
2 and 21 necessarily collects in the second child bag 22. Therefore, next
After separating the child bag 12 from the second child bag 22 in the middle of the connecting tube 12, the air-trapping bag 2
After releasing the click tip or clamp etc. in step 3, the second child bag 22 is gently pressurized to expel the residual air present in the internal space 19 from the second child bag 22, and the air trapping tube 21 and the connection tube 25 are used to trap air. Transfer residual air into bag 23. In this way, the second child Bug 2
The second child bag 22 is cut off in the middle of the connecting tube 21 with no air present in the internal space 19 of the second child bag 21. By the above operations, platelet-poor plasma, platelet-rich plasma, and concentrated red blood cell fluid can be fractionated substantially without air inclusion. In this embodiment, a bag is used as an example of the air volume adjustment means, but the present invention is not limited to this form, and the present invention is not limited to this form. The air amount adjusting means may be of any type as long as it is capable of discharging the air present in the main body, and for example, a syringe or the like may also be used.
Further, although the above description has been made using a three-barrel blood bag as an example, a two-barrel blood bag, a quadruple-barrel blood bag, or other blood storage containers may be similarly equipped with an air volume adjusting means. . (Examples) Hereinafter, the present invention will be explained in more detail with reference to Examples. Example 1 Using a blood bag as shown in FIG. 1, blood was collected and fractionated to prepare platelet plasma concentrate containing no air. 22 hours of this platelet plasma concentrate
The platelets were stored with rotational shaking at ℃ for 5 days, and changes over time in platelet count and platelet particle size distribution before and after storage were examined. The platelet count was calculated using an automatic blood count device (ELT-8, manufactured by Orso), and the platelet particle size distribution was calculated using a Coulter Counter Mode analyzer (Coulter Counter Mode).
ZB1, manufactured by Coulter Counter and
Channalyzer C-1000 (manufactured by Coulter Counter). The results are shown in Tables 1-2 and 3-
Shown in Figure 4. Comparative Example 1 Blood was collected and fractionated using a conventional blood bag as shown in FIG. 2 to obtain concentrated platelet plasma containing residual air. This platelet plasma concentrate was stored under rotary shaking at 22° C. for 5 days in the same manner as in Example 1, and changes in platelet count over time and platelet particle size distribution before and after storage were examined. The results are shown in Tables 1-2 and 3-
Shown in Figure 4.

【table】

【table】

[Table] As is clear from Table 1 and Figure 3, in Example 1, which was stored in an air-free condition, the platelet concentration in the platelet concentrate plasma was higher than in Comparative Example 1, which was stored in an air condition. As is clear from Table 2 and FIG. 4, in the particle size distribution of platelets, in Example 1, there was little expression of microparticles that are said to be produced by platelet disintegration. That is, Example 1, in which the blood bags were stored without air, had better shelf life of platelets. (Effects of the Invention) As described above, the present invention provides a container main body having a blood storage portion, a container main body that is connected to the container main body so as to be able to communicate with the container main body, and air that remains in the container main body when blood is stored. This blood storage container is characterized by being equipped with an air-trapping bag made of flexible synthetic resin that is expandable so that the amount can be adjusted, so when storing blood or blood components, the blood storage container The air remaining in the blood can be removed by the regulating means, and the blood or blood components can be stored in a substantially air-free state, resulting in extremely excellent storage stability. Particularly when collecting blood, separating its components, and storing each fraction, for example, if an air-trapping bag made of soft synthetic resin is provided as a means of adjusting the amount of residual air, it is possible to keep the container intact without disrupting the closed system. This eliminates air contamination within each blood component fraction. Therefore, problems caused by the presence of air, such as occurrence of hemolysis in concentrated red blood cell fluid, disintegration of platelets in concentrated platelet plasma, denaturation of plasma proteins in platelet-poor plasma, and deterioration of the product image, can be suitably solved. .

[Brief explanation of the drawing]

FIG. 1 is a front view showing an embodiment of the blood storage container of the present invention, FIG. 2 is a front view showing an embodiment of a conventional blood storage container, and FIG. 3 is a front view showing the platelet count over time. FIG. 4 is a graph showing changes in platelet particle size distribution. 3...Blood collection bag, 6...Blood collection tube, 1
2, 16, 21, 25...Connection tube, 13,
22...Child bag, 23...Air trapping bag.

Claims (1)

[Claims] 1. A container body provided with a blood storage portion, and an expandable soft synthetic resin that is communicatively connected to the container body and is capable of adjusting the amount of air remaining in the container body when blood is stored. 1. A blood storage container characterized by comprising a manufactured air trapping bag.