JPS6113936A - Membrane concentration type concentrated blood platelet-containing serum sampling system - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION <Industrial Application Field> The present invention relates to a membrane-concentrated platelet-containing plasma collection system that continuously collects concentrated platelet-containing plasma from extracorporeally circulating blood communicating with a blood vessel of a donor.

<Prior art> Transfusion of platelet-containing plasma is used to treat thrombocytopenia, thrombocytopenic purpura, congenital thrombosthenia, and leukemia.

Used to treat aplastic anemia, infectious diseases, etc.

The transfusion of platelet-containing plasma has increased significantly in recent years, and the demand has increased from 970,000 units in 1980 to
According to the 7th year statistics, the number has increased to 1.62 million units.

Conventionally, a system using a centrifugal separator has been employed to separate this platelet-containing plasma. However, this centrifugal separation system is not only uneconomical because it requires expensive equipment such as a centrifuge, but also because the amount of extracorporeal circulation of donor blood that must be centrifuged is large, which places a burden on the donor. , the lack of blood in the body tends to cause side effects such as nausea and trembling, and low blood pressure; the long time it takes to separate platelets; and the contamination of unnecessary large amounts of blood cell components into the resulting platelet-containing plasma. However, there are drawbacks such as the production of anti-platelet antibodies caused by foreign protein contamination in patients receiving platelet transfusion, resulting in a decrease in the effectiveness of the transfusion.

In order to solve these drawbacks, the present inventors invented a membrane-separated platelet-containing plasma collection system and have already filed a patent application. The system of this invention collects the components that pass through a separation membrane with a maximum pore size of 10 to 70 microns as platelet-containing plasma, which solves the drawbacks of conventional centrifugation systems, but does not reduce the amount of blood contained in plasma. The problem remains that the platelet concentration is slightly low.

<Problems to be Solved by the Invention> The system of the present invention has the disadvantages of the uneconomical nature of the centrifugal separation system described above, the heavy burden and side effects on the donor due to the excessive amount of extracorporeal circulation of donor blood, and the long platelet collection time. The purpose of this invention is to solve problems such as a decrease in the transfusion effect due to impurities in the platelet-containing plasma, and an insufficient concentration of platelets in the platelet-containing plasma in the membrane separation method.

<Means for Solving the Problems> The present invention has been made to solve the above-mentioned drawbacks and problems. The extracorporeal blood circulation circuit interposed with a plasma separator includes means for pumping the platelet-containing plasma that has passed through the separation membrane to a membrane-type platelet concentrator, and the membrane-type platelet concentrator has a concentration of 0.1 to 1.0. Equipped with a concentration membrane with a maximum pore size of microns.

<Operation> In the above means, the donor's blood circulates in an extracorporeal blood circulation circuit that communicates with the donor's blood vessels.

This circulating blood is separated by a membrane-type platelet-containing plasma separator interposed in the extracorporeal blood circulation circuit.

This separation is carried out by a separation membrane with a maximum pore size of 10 to 70 microns, which is installed in the membrane-type platelet-containing plasma separator. The platelet-containing plasma that has passed through this separation membrane is pumped to a membrane platelet concentrator. The red blood cell concentrate from which the platelet-containing plasma has been removed from the circulating blood that has not passed through the separation membrane is returned to the donor via the extracorporeal circulation circuit. The platelet-containing plasma pumped to the membrane platelet concentrator is concentrated by the membrane platelet concentrator. This concentration is performed by a concentrating membrane with a maximum pore size of 0, 1 to 1.0 microns, which is provided in this membrane platelet concentrator. Plasma that has passed through this concentrating membrane is stored in a plasma container, and concentrated platelet-containing plasma that has not passed through this concentrating membrane is stored in a platelet-concentrated plasma container.

<Example> Embodiments of the present invention will be described below based on the drawings.

The drawing is a flow path system diagram of this example. Code 1 in the drawing
is a membrane-concentrated platelet-containing plasma collection system. This system 1 consists of a platelet-containing plasma separating section 2 and a platelet-containing plasma concentrating section 3, each shown surrounded by a dashed line.

The platelet-containing plasma separation section 2 includes an extracorporeal blood circulation circuit 4 communicating with veins in both arms of the donor D. This extracorporeal blood circulation circuit 4 includes a membrane-type platelet-containing plasma separator 5 equipped with a separation membrane having a maximum pore size of 10 to 70 microns, and a blood pump 6 for circulating donor D's blood within this extracorporeal blood circulation circuit 4. , an anticoagulant connected from an anticoagulant container 7 to the upstream side of the extracorporeal blood circulation circuit 4 in order to add an anticoagulant to the extracorporeal blood circulation circuit 4 in order to anticoagulate the circulating blood. A liquid line 8 is provided.

This anticoagulant line 8 comprises an anticoagulant pump 9 for pumping anticoagulant from the anticoagulant container 7 into the circulating blood, but this anticoagulant pump 9 may be omitted. , a conventional drip method may be adopted in which the anticoagulant is added to the circulating blood by gravity flow. In the drawings, reference numerals 10 and 11 indicate air traps inserted in the extracorporeal blood circulation circuit 4 upstream and downstream of the membrane-type platelet-containing plasma separator 5, respectively. The air traps 10, 11 each include a pressure gauge PI, P2 that captures the air within the relevant circuit and indicates the pressure within the relevant circuit. P3
is a pressure gauge that indicates the separation pressure of the membrane type platelet-containing plasma separator 5.

The platelet-containing plasma concentration section 3 includes a concentration circuit 13 interposed with a membrane-type platelet concentrator 12 for concentrating the platelet-containing plasma that has passed through the separation membrane of the membrane-type platelet-containing plasma separator 5.
Equipped with The membrane type platelet concentrator 12 has a thickness of 0.1 to 1.
- Equipped with a concentrator membrane with a maximum pore size of 0 microns. The concentration circuit 13 includes an introduction line 13a for transporting the platelet-containing plasma separated by the model platelet-containing blood separator 5 to the membrane-type platelet concentrator 12, and a concentrating membrane of the membrane-type platelet concentrator 12. A plasma line 13 transporting plasma to a plasma container 15, preferably in the form of a blood bag.
b, and a concentrated platelet-containing plasma container 16, preferably in the form of a blood bag, for storing the concentrated platelet-containing plasma that does not pass through the concentration membrane.
The concentrated platelet-containing plasma line 13C is connected to the extracorporeal blood circulation circuit 4 on the inflow side of the membrane-type platelet-containing plasma separator 5 of the platelet-containing plasma separation section 2 from the plasma container 15 as necessary. It is also possible to provide a return line 14, indicated by a continuous chain line. The introduction line 13a and the return line 14 are provided with an introduction pump 17 and a return pump 18 for pumping the platelet-containing plasma and plasma, respectively.
will be deployed. In the drawing, 19 is an air trap installed in the introduction line 13a, and the air trap 19 is installed in the introduction line 13a.
A pressure gauge P4 is provided to capture the air in the line 13a and to indicate the pressure in the line 13a. P5 is the above model
1 Indicates the concentration pressure of the platelet concentrator 12.

The system 1 of the present invention is configured as described above, and in the platelet-containing plasma separation section 2, blood is circulated through the extracorporeal blood circulation circuit 4 communicating with the veins of both arms of the donor D. This blood circulation is performed by operating the blood pump 6.

The blood transported by the blood pump 6 is anticoagulated by adding a prescribed ratio of anticoagulant from the anticoagulant container 7. This addition may be carried out by operating the anticoagulant pump 9 or by gravity flow in a dripping method in which the pump 9 is omitted.

A variety of anticoagulants can be used, or the ACD fluid at a blood flow rate of 4 is usually added. This anticoagulated blood is separated by the membrane-type platelet-containing plasma separator 5 into platelet-containing plasma that passes through the separation membrane and red blood cell concentrate that does not pass through the separation membrane. The red blood cell concentrate from which platelet-containing plasma has been separated from the anticoagulated blood is returned to the donor D's vein via the extracorporeal blood circulation circuit 4. The platelet-containing plasma separated by the membrane-type platelet-containing plasma separator 5 is transferred to the inlet line 13 of the platelet-containing plasma concentrator 3.
a to the platelet-containing plasma concentrator 12 by operation of the introduction pump 17. This pumped platelet-containing plasma is transferred to the platelet-containing plasma concentrator 1.
The plasma passes through the concentrating membrane installed in the platelet 2, and the concentrated C that does not pass through the concentrating membrane, and is then stored in the platelet concentrate-containing plasma container 16. The plasma that has passed through the concentration membrane is stored in the plasma container 15 via the plasma line 13b.

If the maximum pore size of the concentrating membrane is 1.0 microns or more, part of the platelets will pass through the concentrating membrane, resulting in a decrease in the yield of concentrated platelet-containing plasma and an excessive decrease in platelet concentration, and if the maximum pore size is 0. - If it is 1 micron or less, the flow rate of plasma passing through the concentration membrane will be restricted and the yield of concentrated platelet-containing plasma will increase, but the degree of platelet concentration will decrease. Therefore, the maximum pore size of the concentration membrane is 0.1 i
It must be 1.0 micron. Materials for this retina include cellulose diacetate, cellulose triacetate, polyvinyl alcohol, polymethyl methacrylate, polyacrylonitrile, polysulfone, polycarbonate, polyethylene, polypropylene, and the like. A membrane platelet concentrator equipped with the concentration membrane includes:
Any type such as a hollow fiber type, flat plate type, or chew type may be used, but the hollow fiber type is preferable in terms of filling amount, compactness, etc.

In the above embodiment, a hollow fiber type deformed platelet-containing plasma separator 5 with a membrane area of 0.3 - and a hollow fiber type membrane platelet concentrator 12 with a membrane area of 0.25 doors are used, At a blood flow rate of c5me/min and an ACD liquid flow rate of 5+I+1'/min, anticoagulated blood is pumped at 50% by operation of the blood pump 6.
me Circulate in the extracorporeal blood circulation circuit 4 at a flow rate of 7 minutes, and set the flow rate of the introduction pump 17 to 20 rM/min'
plasma, 5' me 7 at a flow rate of 15-7 minutes.
Concentrated platelet-containing plasma can be obtained with a flow rate of 10 minutes, the collection time of the concentrated platelet-containing plasma is 25 minutes, the donor's restraint time from venipuncture to needle removal is approximately 40 minutes, and the amount of extracorporeal blood circulation is small. It was about 150, l. Note that, prior to collecting the concentrated platelet-containing plasma, the necessary parts of the system were filled with physiological saline.

In the above embodiment, when a return line 14 is provided that communicates from the plasma container 15 to the extracorporeal blood circulation circuit 4 on the inflow side of the deformed platelet-containing plasma separator 5, the return line 14 connected to the return line 14 is If the pump 18 is operated to return the plasma that has passed through the concentration membrane to the extracorporeal blood circulation circuit 4 on the inflow side of the deformed platelet-containing plasma separator 5,
This plasma flow is added to the anticoagulated blood flow in the membrane type platelet-containing plasma separator 3, and the flow rate along the separation membrane equipped in this model surface platelet-containing plasma separator 5 is increased. By increasing the flow rate, it is possible to eliminate the decrease in the separation performance of the separation membrane caused by protein deposition from the blood flow on the separation membrane,
Upon completion of collection of concentrated platelet-containing plasma, all the plasma in the return line 14 is stored in the plasma container 15.

It is also possible to apply the single needle method to the system of the present invention, which requires only venipuncture of one arm of the donor.The single needle method reduces the burden on the donor.

This single-needle method uses an extracorporeal blood circulation circuit that branches from a vein in one arm of the donor, and a first tube that alternately opens and closes and is placed close to this branch point on the blood sending side and the blood returning side of the branch. A second clamp and a second container are provided in communication with the extracorporeal blood circulation circuit upstream and downstream of the deformed platelet-containing plasma separator, respectively. When the first clamp opens and the second clamp closes, part of the anticoagulated blood is stored in the first container, and the rest is transported to the deformed platelet-containing plasma separator, where it is separated into platelet-containing plasma. It is separated into red blood cell concentrate. This platelet-containing plasma is pumped to a membrane platelet concentrator and concentrated in the same manner as in the previous example. The entire amount of the red blood cell concentrate is stored in the second container.

Blood delivery from the donor is stopped when the first clamp is closed and the second clamp is opened. When the first container is held at a high position, the anticoagulated blood stored in the first container flows down by gravity to the deformed platelet-containing plasma separator, and the platelet-containing plasma is separated by this separator. It is carried out continuously. The red blood cell concentrate from which the platelet-containing plasma has been separated from the anticoagulated blood is combined with the stored red blood cell concentrate flowing down from the second container held at a high position, and is returned to the donor. This first. Plasma containing platelets is continuously separated by alternately opening and closing the second clamp;
Accordingly, the concentration of this platelet-containing plasma is also carried out continuously.

<Effects of the Invention> In the present invention, platelet-containing plasma separated from extracorporeally circulating blood by a separation membrane having a maximum pore size of 10 to 70 microns is concentrated by a concentrating membrane having a maximum pore size of 0.1 to 1.0 microns. Since this system can obtain concentrated platelet-containing plasma, it is highly economical as it does not require expensive equipment, and when a hollow fiber type is used as a deformed platelet-containing plasma separator, the amount of extracorporeally circulating blood is small. This reduces the burden on donors and reduces side effects, and since this system uses membranes for separation and concentration, processing efficiency is high.As a result, it takes only a short time to collect concentrated platelet-containing medicines, making it more streamlined. Since separation and concentration is performed using a membrane with the maximum pore size, the obtained concentrated platelet-containing plasma contains almost no impurities and has a moderate degree of concentration, so it has excellent transfusion effects.

Furthermore, since the system of the present invention can easily be applied in a completely sealed manner, contamination from the outside can be eliminated, and useful plasma other than concentrated platelet-containing plasma can also be collected at the same time.

[Brief explanation of the drawing]

The drawing is a flow path system diagram of an embodiment of the present invention, in which 4 is an extracorporeal blood circulation circuit, 5 is a membrane-type platelet-containing plasma separator, 6 is a blood pump, 12 is a membrane-type platelet concentrator, 15 is a plasma container, 1
6 is a plasma container containing concentrated platelets. Patent applicant Nitsunyo Co., Ltd. Agent: Patent attorney Kazuhide Okada 'Tatsuichi'-1, Yu Bao 4, Extracorporeal blood circulation circuit 15. plasma container
□１５、Linear blood structure containing blood structure
16. 6 bound platelet-containing plasma collectors, 12 blood vessels and 12 blood vessels, 1 mechanical blood concentrator

Claims (2)

[Claims] (1) In an extracorporeal blood circulation circuit interposed with a membrane-type platelet-containing plasma separator equipped with a separation membrane with a maximum pore size of 10 to 70 microns, the platelet-containing plasma that has passed through the separation membrane is transferred to a membrane-type platelet concentrator. The pumped platelet-containing plasma is separated by the membrane-type platelet concentrator into plasma that passes through the concentrating membrane of this concentrator and concentrated platelet-containing plasma that does not pass through the concentrating membrane. A membrane-concentrated platelet-containing plasma collection system characterized in that the membrane has a maximum pore size of 0.1 to 1.0 microns. (2) Concentration by the concentrating membrane includes an introduction line for introducing platelet-containing plasma from the membrane-type platelet-containing plasma separator into the membrane-type platelet concentrator, and the concentrating membrane equipped on the membrane-type platelet concentrator. a plasma line that transports the passed plasma to the plasma container; a concentrated platelet-containing plasma line that transports the concentrated platelet-containing plasma that does not pass through the concentration membrane to the concentrated platelet-containing plasma container; and a platelet-containing plasma separator from the plasma container. A circuit consisting of a return line communicating with the extracorporeal blood circulation circuit on the introduction side, and an introduction pump for introducing platelet-containing plasma into the introduction line and the return line, and a return pump for returning the plasma, respectively. 2. A membrane-concentrated platelet-containing plasma collection system according to claim 1, characterized in that: