JPH0693907B2 - Platelet storage device - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to an apparatus for preserving platelets, which is capable of preserving platelets in a liquid state for a long period of time.

[0002]

2. Description of the Related Art Infectious diseases,
For patients who receive platelet supplementation due to thrombocytopenia, trauma, radiation damage, etc., platelet concentrate (PC: Platele
Component blood of t Concentrate) is required. The platelet concentrate is plasma containing platelets in a high concentration, and can be obtained by centrifuging blood collected from a donor or by donating blood components. The function of platelets is extremely unstable by either method, and prompt platelet infusion is required.

As a method for preserving the platelet concentrate, it is injected into a bag made of flexible polyvinyl chloride (PVC) or polyolefin (PO) and stored at room temperature (22).
There is a method to store in liquid form by shaking at (° C).

The shelf life of the concentrated platelets is set at 3 days in Japan and 5 days in other countries from the viewpoint of maintaining platelet function. Moreover, the storage period of the platelet concentrate (pheresis PC) obtained by the component blood donation is further limited. On the other hand, HLA (lymphocyte antigen) -compatible platelets are desired to be stored in a liquid state in a better condition for a long period of time due to the time constraints of the donor.

In order to solve these problems, we have proposed an invention relating to "a method for preserving platelets" (Japanese Patent Laid-Open No. 25560/1990).
1) Furthermore, in the "Trial of Long-term Preservation of Platelets by Double Bag System" announced at the 39th Annual Meeting of the Japan Society for Transfusion in 1991, concentrated platelets were maintained for a long period of at least 2 weeks while maintaining a long-term liquid state. Clarified that it is possible to save.

[0006] However, since it becomes possible to store the platelets for a long period of time along with the possibility of storing them for a long period of time, the platelets may leak to the outer bag due to the damage of the inner bag. Then, the physical strength of the device for storing platelets has arisen as a new problem.

Therefore, as a result of intensive studies, we have been able to preserve platelet function for a long period of time,
Further, the inventors have invented a platelet storage device that is more stable in strength than the platelet storage devices created so far.

[0008]

SUMMARY OF THE INVENTION The present invention is a device for storing platelets in a liquid state, which is an outer bag containing a platelet storage solution and a semipermeable container containing the platelets inserted in the outer bag. A platelet storage device composed of an inner bag, the end of the inner bag in which the flange-shaped base of the inner fluid operation port is inserted is adhered to the upper end of the outer bag, and the outer end is attached to the lower end. (EN) A device for preserving platelets, in which a brim-shaped base of a liquid operation port is adhered. In this case, it is desirable that the device for storing platelets is stored while being shaken.

Examples of the material of the semipermeable inner bag include polyolefin resins such as polyethylene and polypropylene, polyolefin copolymer resins such as polyvinyl acetate and polyvinyl alcohol, polyacrylonitrile,
Resins such as polymethylmethacrylate, polysulfone, polycarbonate and polyamide can be used. As the material for the outer bag, use a polyolefin resin such as polyethylene or polypropylene, a polyolefin copolymer resin such as polyvinyl acetate or polyvinyl alcohol, a resin such as polyacrylonitrile, polymethylmethacrylate, polysulfone, polycarbonate or polyamide. You can The materials for the inner bag and the outer bag are not limited to these as long as they can be easily combined. Further, the above materials can be used by being laminated in multiple layers.

[0010]

EXAMPLES Next, examples of the present invention will be specifically described. FIG. 1 shows an example of a platelet storage device 1a used in the present invention, in which 1 is an outer bag, 2 is an inner bag inserted in this outer bag, and between the outer bag 1 and the inner bag 2. Has a space for containing the storage solution.

The outer bag 1 is a laminated sheet composed of a casting polypropylene sheet and a biaxially oriented polypropylene sheet, and has a sheet thickness of 200 μm, and is made by heat-sealing the casting polypropylene sheet into a bag shape in the inside. The capacity is 2 liters, and a plurality of external liquid operation ports 3 having a flange-shaped base portion 3b are provided at the lower end portion. The end 3a of the external liquid operation port 3 is sealed so that it can be peeled off later. In addition, mounting holes 4 for a rotary agitator, which will be described later, are opened at the corners of the outer bag 1.

The inner bag 2 is made by sealing two films made of polypropylene and has a film thickness of 150 μm.
m, molecular weight cutoff 10,000, volume 100 ml,
An inner liquid operation port 5 having a collar-shaped base portion 5b is provided at the upper end thereof. The end 5a of the internal liquid operation port 5 is sealed so that it can be peeled off later. The inner bag 2 is hydrophilized. The device 1a for storing platelets of the present invention has an internal liquid operation port 5 at the opening end of the inner bag 2.
The collar-shaped base portion 5b is fitted and inserted into the inner bag 2 and the outer liquid operation port 3
The base portion 3b of the inner bag 2 and the end portion of the inner bag 2 are bonded to the upper end portion of the outer bag 2 by heat-sealing the base portion 3b between the two sheets forming the outer bag 1. And outer bag 2
The base portion 3b of the external liquid operation port can be bonded to the lower end portion of the.

FIG. 2 shows a platelet storage device 1b used as a comparative example, which is composed of an outer bag 6 and an inner bag 7 accommodated therein. The outer bag 6 is made of a soft polyvinyl chloride sheet and is made by sealing the periphery of the bag with a high frequency, and has a sheet thickness of 0.4 mm and a capacity of 2 liters. An external liquid operation port 8 is provided. Further, mounting holes 9 for the rotary agitator are opened at the corners of the outer bag 6, respectively.

The inner bag 7 is a tubular cellulose film having a thickness of 20 μm and a molecular weight cut-off of 10,000, and is made by sealing the openings at both ends of the cellulose film with sutures, and has a capacity of The volume is 100 ml, and the inner liquid operation port 10 is provided at the upper end thereof. Further, the inner bag is covered and protected by the mesh 11. This internal liquid operation port 1
0 projects to the outer bag 6.

FIG. 3 is a perspective view of the rotary agitator 12a used in the present embodiment, which includes a box 12 having a drive mechanism, a control mechanism and the like built therein, and a rotary plate 13 mounted on the box 12 at a predetermined angle. Equipped with a rotating plate 1
The four corners of 3 are provided with stoppers 14 for fixing the platelet storage device 1a (1b), and the platelet storage device 1a (1b) is attached to the mounting hole 4 (9) of the outer bag 1 (6). ) Is inserted into the stopper 14 and fixed to the rotary plate 13. The stopper 14 is movable along the mounting position adjusting groove 15.

As a strength test, three platelet storage devices 1a of the present invention and three platelet storage devices 1b of the comparative examples were prepared, and tap water was supplied to each of the inner bags 2 (7) for 10 times.
0 ml, 1 liter was packed in the outer bag 1 (6), 1 liter of air was further packed in the outer bag 1 (6), and the respective platelet storage devices 1a and 1b were attached to the rotary agitator 12a. It was carried out by giving a rotary shaking at 50 rpm which is 10 times the rotation number of 5 rpm which is usually considered to be appropriate. This state was continued for one month, and the states of the platelet storage devices 1a and 1b were observed during this period. The results of this experiment will be described below.

No abnormality was found in the three platelet storage devices 1a of the present invention. On the other hand, in the three comparative examples, the seal portion of the inner bag 7 was torn on the 7th, 10th, and 13th days, and the tap water injected into the inner bag 7 leaked to the outer bag side. .

[0018]

According to the present invention described above, by increasing the bonding area of the outer bag and the inner bag, the inner bag and the inner bag operation port, and the outer liquid operation port and the outer bag, the strength of the bonded portion is increased and the length is increased. It becomes possible to withstand shaking for a period, and the risk of leakage of internal liquid due to tearing of the inner bag is solved.

[Brief description of drawings]

FIG. 1 is a device for storing platelets of the present invention

FIG. 2 is a device for storing platelets in a comparative example.

FIG. 3 is a perspective view of a rotary agitator used in the platelet storage device of the present invention and the platelet storage device of the comparative example.

[Explanation of symbols]

 1a Platelet storage device 1 Outer bag 2 Inner bag 3 Outer fluid operation port 4 Mounting hole 5 Inner fluid operation port

 ─────────────────────────────────────────────────── ─── Continuation of front page (56) References JP-A-2-255601 (JP, A) JP-A 59-137064 (JP, A) JP-A 61-203965 (JP, A) JP-A 63- 294858 (JP, A)

Claims (1)

[Claims] 1. A device for storing platelets in a liquid state, which is composed of an outer bag containing a platelet preservation solution and a semipermeable inner bag containing platelets inserted in the outer bag. An instrument, the end of the inner bag in which the flange-shaped base of the inner liquid operation port is fitted is adhered to the upper end of the outer bag, and the flange-shaped base of the outer liquid operation port is attached to the lower end of the outer bag. A device for preserving platelets, characterized in that