JPH0884764A - Leukocyte removing apparatus - Google Patents

Abstract

PURPOSE: To obtain a leukocyte removed platelet preparation simultaneously with blood collecting by connecting the vial needle connected to a bag once storing a plasma component and buffy coat to a pump tube, a leukocyte removing filter and a recovery bag in series. CONSTITUTION: An anticoagulant is introduced into a chamber 10 from a needle tube 110 through a tube 109 and a physiological saline soln. is supplied into an apuncture needle 102 from a needle tube 106 to set a priming state and, in this state, the apuncture needle 102 is thrust in the blood vessel of a donor. The blood collected from the donor is introduced into the separation part 142 of a centrifugal bowl 14 by operating a pump 93 to be separated into a plasma layer, a buffy coat layer and an erythrocyte layer. The separated plasma is recovered in a plasma bag 21 and the platelet floating to the outside of the bowl is recovered in a platelet bag 31. Subsequently, the conc. platelet is passed through a leukocyte removing filter 4 and a leukocyte is removed to be recovered in a recovery bag A.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a leukocyte component-removing filter system for aseptically closing a blood product obtained by removing leukocyte components from blood collected from a blood sampler.

[0002]

2. Description of the Related Art Conventionally, as a method of collecting blood components from a donor (donor) and further obtaining blood products suitable for various uses from the components, the blood components collected from the donor at the time of blood collection are centrifuged to collect red blood cell components and other components. A means for separating a component to convert only a red blood cell component into a donor, collecting other components, and further performing a secondary centrifugation or a separation operation by a filter to obtain a target blood product is widely adopted.

Explaining an example of a method for obtaining a platelet preparation, for example, an anticoagulant is collected from a donor and whole blood components are injected through a pump controlled at a flow rate of about 1/10 of the blood flow in the middle. After addition, it is introduced into the centrifuge bowl via a pump. The whole blood component centrifuged in the centrifuge bowl is separated into a red blood cell component, a buffy coat (white blood cell layer, platelets), and a plasma component. By continuing blood collection, the plasma component is first pushed up and separated and collected.

Next, the once-collected plasma is injected into the bowl at high speed to float the platelets in the buffy coat layer and collect them as concentrated platelets (surge method).

According to this method, a large amount of platelets can be efficiently collected in a short time. However, a large amount of white blood cells are mixed in the platelet preparation obtained by this method, and about n × 10 ⁻⁸ (n is an integer) white blood cells are mixed in 10 units (2 × 10 ¹¹ ) of the platelet preparation. It has been confirmed.

In order to remove the leukocytes, the bag in which the concentrated platelets have been collected is centrifuged (178 g, 3 minutes), and the upper layer thereof is collected in another bag as leukocyte-removed concentrated platelets,
There is also a method of discarding the precipitate together with the centrifuged bag. At this time, although about 90% of the leukocytes contaminated can be removed, 20 to 30% of the platelets are also lost together with the precipitate.

Furthermore, this secondary centrifugation operation is time-consuming because a bag containing platelets is placed in another centrifuge to perform centrifugation, and a considerable amount of time is required until the final preparation is obtained.

As a method that does not use the secondary centrifugation, a bag for collecting platelet components obtained at the time of blood collection is connected to a filter unit, and a collection bag is connected downstream of the filter unit to drop the platelet components by dropping. There is a method of obtaining a concentrated platelet preparation in which a red blood cell component and a white blood cell component are removed by introducing it into a filter unit. The concentrated platelet preparation obtained by this method can obtain a stable preparation with less contamination of other components, but like the secondary centrifugation method, it is practically impossible to perform it simultaneously with blood collection. In reality, it cannot be said that this method is a decisive system even if it takes a considerable time to obtain a proper formulation.

Further, in order to improve the removal efficiency of white blood cell components, it is often the case that the packing density of the filtration material filled in the filter unit is increased. In reality, it cannot be said to be a definitive system because the packing density is limited because it cannot be exceeded.

[0010]

In view of the above situation, the present invention secures a platelet preparation having excellent leukocyte component removal efficiency and simplifies the operation by obtaining blood platelets from a donor and simultaneously removing leukocyte components. The purpose was to provide a system aiming at realization and reduction of time.

[0011]

In order to achieve the above object, the present invention provides a blood component storage bag having a blood component inlet and an outlet for a leukocyte component removal filter, the blood component inlet having one end at the blood component inlet. A blood component carrying tube having a bottle needle for connecting with and having a pump tube at the other end is connected, and a branch for arranging a plurality of blood component storing bags at the end portion of the blood component outlet port. A leukocyte component removal filter to which a blood component transport tube having a tube disposed in the middle is connected, wherein the filtration material filled in the leukocyte removal filter has a packing density of 0.1 g / cm ³ or more, and A bag system with a leukocyte component removal filter, characterized in that the bottle needle to the plurality of blood component storage bags are closed.

Further, the present invention uses the above-mentioned bag system with leukocyte removal filter to forcibly press the concentrated platelet component obtained by the first centrifugation at the time of blood collection into the leukocyte removal filter into a blood component reservoir bag. It is a method for producing a leukocyte-depleted platelet plasma preparation which is closed until the collection.

The bag system with leukocyte removal filter of the present invention will be described in detail below.

The bottle needle used in the bag system with leukocyte removal filter in the present invention is usually polypropylene,
It is integrally molded by injection molding with a thermoplastic material such as polycarbonate or ABS.

Normally, this bottle needle is used to connect to a collection bag for the concentrated platelet component that is being obtained for blood collection to continuously obtain leukocyte-depleted platelets. The connection method is described in JP-B-61-30582. It is also possible to directly join tubes without using a bottle needle by an aseptic connecting device as represented.

The pump tube varies depending on the type of pump used or the flow rate of pressure feeding, but even if air is mixed in the tube, the fluid in the tube can flow and pressure feeding is possible, so a roller pump is used. It is preferable to use a roller tube having an inner diameter of 4.1 to 4.5 mm and an outer diameter of 6.1 to 6.5 mm in order to adapt to this roller pump. It is made of vinyl chloride or polyolefin such as polypropylene. Tubes are preferred.

The leukocyte component removal filter is appropriately selected from natural materials such as Egyptian cotton or porous materials made of plastics such as polyurethane and polyethylene in a cylindrical housing having a bottom having an outlet, and is filled as described later. It is filled according to the ratio and sealed with a lid having an inlet. Alternatively, it is also possible to use a flat membrane-shaped or hollow fiber-shaped separation membrane, in which case it is necessary to appropriately use a housing suitable for the membrane shape.

In the leukocyte-removing filter, it is a conventional means to increase the filling amount of the filter material in order to improve the leukocyte-removing efficiency, but in the case of the conventional drop method, if the filling ratio is increased, the flow rate resistance causes the flow to stop. Alternatively, it takes time and is inefficient as described above. However, in the case of the system incorporating the pump tube as in the present invention, it is possible to pump into the filter by the pump, so A leukocyte-removing filter with higher filling than that used in the method is adopted.

Specifically, in the case of a natural material, it is preferable to use one having a filter material filling amount of at least 0.15 g / cm ³ or more, but from the viewpoint of leukocyte removal rate and blood passage performance, it is 0.15 to 5. 0.25 g / cm ³ is preferred,
The range of 0.15 to 0.20 g / cm ³ is more preferable. Similarly, when a plastic porous body is preferably 0.15~0.30g / cm ³ loading of filter medium is be of at least 0.10 g / cm ³ or more, more preferably 0.15 to A range of 0.20 g / cm ³ is preferred.

The bag A for collecting the concentrated platelets, which is a component flowing out to the downstream side through this filter, is transparent so that the state of the content liquid can be observed, strength that can withstand various operations, hygiene, It is required to be safe and satisfy these requirements. Soft vinyl chloride or polypropylene,
It is preferable to use a polyolefin material such as polyethylene or the like, and a bottle-shaped material satisfies the above requirements, but in order to satisfy the operability, a film composed of the above material is appropriately cut, welded, etc. A so-called soft bag created by going through the process of (1) is more preferable.

The soft vinyl chloride and the polyolefin may be blended with a plasticizer, a stabilizer and the like as appropriate.

In the collection bag A, for example, physiological saline solution,
A platelet preservative such as GAC, PAS, PSM-1 may be pre-loaded.

In the bag system with leukocyte removal filter of the present invention, a priming operation is carried out using physiological saline or heparinized physiological saline before use, but a waste liquid for collecting the priming liquid at this time. It is also useful to provide a cleaning bag downstream of the leukocyte removal filter and upstream of the recovery bag A.

[0024]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The leukocyte removal filter bag system of the present invention will be described below in more detail with reference to the preferred embodiments shown in the accompanying drawings, but the present invention is not limited thereto.

FIG. 1 shows the bag system with leukocyte removal filter of the present invention connected to a blood component separation circuit. As shown in the figure, the bag system with leukocyte removal filter of the present invention is a blood component separation circuit, a bottle needle and a pump tube connected to a bag for temporarily storing plasma and concentrated platelets obtained in the blood component separation circuit, The leukocyte removal filter and the collection bag A are connected in series, and the priming line and the waste bag have branch pipes between the bottle needle and the pump tube and between the leukocyte removal filter and the collection bag, respectively. . These will be sequentially described below.

The bottle needle provided at the most upstream portion is connected so as to communicate with a bag that temporarily stores the concentrated platelets obtained by the blood component separation circuit provided at the end of the blood component separation circuit. However, other than using a bottle needle as this connecting means, it is also possible to connect the downstream side of the bottle needle and the tube extending from the bag side using aseptic joining means.

Below the bottle needle, a valve such as a roller clamp is arranged as a flow path opening / closing means for blocking / releasing the internal flow path of the tube in the middle of the downstream side tube, and then a pump tube is connected. . A branch pipe is provided between the valve and the pump tube, and a bottle needle is connected to an end of the branch pipe to form a priming line.

A leukocyte removal filter is installed on the downstream side of the pump tube. The leukocyte removal filter is composed of a casing having an inflow port and an outflow port at both ends and a filter material filled in the casing.

A branch pipe is provided on the downstream side of the leukocyte removal filter, and a waste bag is provided on one side, and a collection bag A is provided on the other side in the middle of the connecting tube so as to cut off and release the internal flow path of the tube. A valve composed of, for example, a roller clamp is arranged and connected as an opening / closing means.

The line 10 is mainly a tube 101.
And a puncture needle 102 connected to the tip of the tube 101
And a chamber 103 for removing bubbles disposed in the middle of the tube 101. Tubes 105 and 109 are connected between the puncture needle 102 of the tube 101 and the chamber 103 via tee-shaped branch connectors 104 and 108, respectively. A needle tube 106 with a cap is installed at the tip of the tube 105,
In the middle of the tube 109, for example, a pump 92 for feeding liquid, which is a roller pump, and a chamber 1 for removing bubbles.
11 and 11 are installed.

The base end of the tube 101 is connected to one ends of the tubes 13 and 20 via a T-shaped branch connector 12. A valve 83 that opens and closes the inside of the tube 101 is installed between the branch connector 12 of the tube 20 and the chamber 103.

The other end of the tube 13 is connected to the inflow port 143 of the centrifuge bowl 14, and in the middle of the tube 13, a pump 93 for feeding a liquid, such as a roller pump, is installed.

The centrifuge bowl 14 has a vertically extending tubular body 141 having an inflow port 143 formed at its upper end, and a separating section 142.
It consists of and. A flow path for blood is formed along the bottom of the separation section 142 and the inner surface of the peripheral wall, and an outlet 144 is formed so as to communicate with the upper part of the flow path.

One end of the tube 15 is connected to the outlet 144 of the centrifuge bowl 14, and the other end of the tube 15 is connected to the tubes 17 and 18 via a T-shaped branch connector 16.
Is connected to one end of.

The other end of the tube 17 is connected to the platelet bag 31.
A valve 85 for opening and closing the flow path in the tube 17 is installed in the middle of the tube 17. Further, the other end of the tube 18 is connected to a bubble removing chamber 19, and a valve 86 for opening and closing a flow path in the tube is installed in the middle of the tube 18.

The other end of the tube 20 is connected to the bubble-removing chamber 19, and a valve 84 for opening and closing the flow path in the tube 20 is installed in the middle of the tube 20.

The plasma bag 21 and the air storage bag 22 are connected by a tube 23 so that the insides thereof are communicated with each other after a series of processes.

Further, one end of a tube 24 is connected to the plasma bag 21, and the other end of the tube 24 is connected to the extending chamber 19 for removing bubbles.

The method for producing a platelet preparation and a plasma preparation according to the present invention will be described below with reference to FIG.

(A-0) With the valves 83 and 85 open and the other valves closed, the pumps 92 and 93 are operated (normal rotation) to remove the anticoagulant from the needle tube 110 and the chamber 11.
Branch connector 10 via 1 and tube 109
8, introduced into the tube 101 and the chamber 103, and physiological saline is supplied to the branch connector 104 and the puncture needle 102 through the needle tube 106 chamber 107 and the tube 105 for priming.

(A-1) The pump 92.93 is temporarily stopped, the tube 105 is closed with a clamp, etc., the blood vessel of the donor is punctured with the puncture needle 102, and the pump 93 is operated (normal rotation).
Then, the blood collected from the donor is transferred through the puncture needle 102, the tube 101, the chamber 103, and the tube 13, and is introduced into the separation section 142 from the inflow port 143 of the centrifuge bowl 14 via the tube body 141.

At the same time as this blood collection, the pump 92 is operated to operate the needle tube 101, the chamber 111 and the tube 1.
Deliver anticoagulant via 09.

(A-2) The blood introduced into the centrifuge bowl 14 is separated from the inner layer into the plasma layer, the buffy coat layer and the red blood cell layer in the flow path of the separating section 142 by the rotation of the separating section 142.

(A-3) The valve 85 is closed and the valve 86 is
The plasma in the separation part 142 is caused to flow out through the outlet 144, and the tubes 15, 18, the chamber 19, and the tube 2 are opened.
(A-4) When the opening of the bowl 14 is continued, the buffy coat layer formed in the separating portion 142 of the bowl 14 rises up to near the shoulder of the bowl. come. When the optical sensor in the centrifuge detects this buffy coat layer, the pump 93 stops and the inflow of whole blood ends. Then valve 8
4, 85 are opened, the other valves are closed, and the pump 93 is rotated at high speed in the forward direction so that the plasma in the plasma bag 21 flows into the separation part 142 from the inlet 143 of the centrifuge bowl 14 via the tube 141 at high speed. Let

Platelets float on the flow of plasma and float out of the bowl, and flow out to the platelet bag 31, and the concentrated platelets are collected in this bag.

(A-5) When the collection of the concentrated platelets in the platelet bag 31 is completed, the pump 93 and the bowl 14 are stopped, the valves 83 and 85 are opened, the other valves are closed, and the pump 93 is rotated in the reverse direction. , The red blood cells remaining in the centrifuge bowl 14, the tube body 141, the tube 13, the chamber 1
Blood is returned to the donor via 03, the tube 101, and the puncture needle 102.

(A-6) Before and after the step (A-5), the valve 71 is opened and the pump 91 is rotated to rotate the needle tube 7.
4, the pump tube 91 and the leukocyte removal filter 4 are primed, the valve 53 is opened, and the priming solution (physiological saline) is put into the waste solution bag 54.
After priming is completed, the pump 91 is stopped and the valve 71 is closed.

(A-7) The valves 71 and 53 are closed and the valve 51 is opened to allow the concentrated platelets from the platelet bag 31 to pass through the leukocyte removal filter 4 to collect the leukocyte-removed concentrated platelets in the recovery bag A.

(A-8) After the concentrated platelets have been completely drained from the bag 31, the rotation of the pump 91 is stopped and the valve 5
1 is closed (A-9) The tube is aseptically cut and sealed on the downstream side of the valve 51.

In the following, as a working example of the present invention described above, a white blood cell removal filter using a polyurethane porous body as a filter material, and as a comparative example 1, a platelet preparation obtained by component blood sampling, a filter having the same specifications as the working example is used. Platelet recovery rate, leukocyte removal rate and operation time were measured for those that were subjected to aseptic fusion bonding and leukocyte removal, and those that were subjected to leukocyte removal by centrifugation (178 g, 3 minutes, using CR7B3 manufactured by Hitachi Koki) as Comparative Example 2. The results obtained are shown in Table 1. Although the circuit of the present invention is a closed system, in the present measurement, a platelet sample was taken from the middle of the circuit and the number of each platelet was measured by Sysmex K-2000.
(Manufactured by Toa Medical Electronics), the white blood cell count was measured by Sysmex K-2000 for the order of 10 ⁷ or more, and by the Nageotte chamber method for the 10 ⁴ order.

[0051]

[Table 1]

[0052]

As described in detail above, since the leukocyte-removing filter-equipped bag system of the present invention can obtain a leukocyte-removing platelet preparation at the same time as blood sampling, it is expected that the operation is simple and the workability is improved. . In addition, since the leukocyte removal filter can be highly filled with a filter material to press fit the buffy coat into the leukocyte removal filter via a pump, it is possible to obtain a stable platelet preparation with excellent leukocyte removal efficiency. Is expected to make a significant contribution to

[Brief description of drawings]

FIG. 1 is a plan view showing a configuration example when a bag system with leukocyte removal filter of the present invention is applied to a bag connecting body for separating blood components.

[Explanation of symbols]

 1A Bag system with leukocyte removal filter 2 Blood component separation circuit 31 Buffy coat bag 4 Leukocyte removal filter A Recovery bag 51, 53, 71, 81 Valve 52, 72 Branch pipe 54 Waste solution bag

Claims (2)

[Claims] 1. A leukocyte component removal filter having a blood component inlet port and an outlet port, wherein the blood component inlet port has a bottle needle for connecting to a blood component storage bag at one end and a pump for the other end portion. A blood component carrying tube having a tube is connected, and a blood component carrying tube having a branch pipe for arranging a plurality of blood component storing bags at the end is connected to the blood component outlet port. A leukocyte component removal filter, wherein the filtration material filled in the leukocyte removal filter has a packing density of 0.1 g / cm ³ or more, and is closed from the bottle needle to the plurality of blood component storage bags. A bag system with a white blood cell component removal filter characterized by 2. A leukocyte component removal filter having a blood component inlet and an outlet, wherein the blood component inlet has a bottle needle for connecting to a blood component storage bag at one end and a pump for the other end. A blood component carrying tube having a tube is connected, and a blood component carrying tube having a branch pipe for arranging a plurality of blood component storing bags at the end is connected to the blood component outlet port. A leukocyte-removing platelet, which is a leukocyte-removing platelet that is closed until the concentrated platelet component connected to the bottle needle is forcibly pumped into the leukocyte-removing filter by the pump means and collected in the blood-component storage bag. Method for producing plasma preparation.