JP2001276212A - Method and circuit for blood component collection - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a blood component collection method and a blood component collection circuit used therefor which can obtain plasma with a limited mixing of erythrocytes and leukocytes. SOLUTION: The blood component collection method employs at least a bag 2 for drawing whole blood, a bag 3 for colleting plasma, a bag 4 for collecting erythrocyte liquid and a filter 5 for removing leucocytes. In the method, there are arranged a process to separate the whole blood in the bag for drawing whole blood into plasma and blood corpuscle liquid by centrifuge after the drawing of the whole blood into the bag 2 for drawing whole blood, a process in which the plasma components separated by the centrifugal process is passed through a filter 5 to be collected into the bag 3 for collecting plasma and a process in which, thereafter, the blood corpuscle liquid in the bag 2 for drawing whole blood is passed through the filter 5 to be collected into a bag 4 for collecting erythrocytes.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for collecting blood components and a blood component collection circuit.

[0002]

2. Description of the Related Art In recent years, instead of whole blood transfusion, component transfusion for transfusing only necessary components in blood to a patient, and plasma collection for producing a plasma preparation have been performed. . As a method for separating and collecting such blood, Japanese Patent Publication No. 6-59304 and Japanese Patent Publication No. 6-59
No. 305 discloses a method in which blood collected in a blood collection bag is passed through a leukocyte removal filter to remove white blood cells, and then centrifuged to collect blood components separated by a difference in specific gravity. However, since the buffy coat component is removed by filtration, the boundary between the upper plasma layer and the lower erythrocyte layer after centrifugation is unclear, and red blood cells may be mixed in when the plasma component is separated.

[0003] Also, Japanese Patent Application Laid-Open Nos. Hei 6-197962 and Hei 4-200550 disclose a method of collecting blood components collected through a blood collection bag through a leukocyte removal filter after centrifugation. I have. However, in JP-A-4-200550,
Since the plasma does not pass through the filter, a large amount of leukocyte contamination occurs in the plasma preparation. 400ml blood sampling 1
It can be as high as 2 × 10 ⁷ in bag-derived plasma. In general, when considering the side effect of blood transfusion caused by leukocyte contamination in a blood product, n (integer) × 10 ⁶ levels are regarded as a borderline that causes antibody production. It can be said that the incorporation of leukocytes at a level exceeding × 10 ⁶ threatens the safety of blood transfusion. Further, when transferring the plasma, a part of the red blood cells may be mixed into the plasma. The mixing amount is 4
In some cases, as many as 5 × 10 ⁸ cells can be collected from one bag of blood collected from a 00 ml blood collection. Since plasma preparations are usually stored frozen, contaminated red blood cells are lysed and hemoglobin is suspended in plasma. When a large amount of free hemoglobin is transfused, it causes a harmful effect on the kidney and the like, which poses a problem in clinical use. Further, even in Japanese Patent Application Laid-Open No. Hei 6-197962 using a leukocyte removal filter having a hard housing, the leukocyte removal ratio from plasma components is not at a sufficient level. Therefore, an object of the present invention is to solve the above-described problems and to perform a blood component collection method for separating components of whole blood, particularly when separating plasma components, so that erythrocytes and leukocytes are hardly mixed, and blood used therefor. A component sampling circuit is provided.

[0004]

Means for achieving the above object are to collect a blood component comprising at least a bag for collecting whole blood, a bag for collecting plasma, a bag for collecting red blood cells, and a soft housing type leukocyte removal filter. A blood component collection method using a circuit, wherein the blood component collection method includes:
A step of centrifuging the blood component collection circuit to separate the whole blood in the whole blood collection bag into a plasma component and a blood cell fluid after collecting the whole blood in the whole blood collection bag; and A blood cell component in the whole blood collection bag, after the poor leukocyte plasma collection step in which the plasma component in the bag for blood is passed through the leukocyte removal filter and collected in the plasma collection bag; Is passed through the leukocyte removal filter and collected in the erythrocyte fluid collection bag. The red blood cell fluid collection bag is filled with a red blood cell preservation solution, and the blood component collection method is performed after the poor leukocyte plasma collection process and before the poor leukocyte red blood cell collection process. An erythrocyte preservation solution injecting step is performed to inject the erythrocyte preservation solution in the erythrocyte solution collection bag into the erythrocyte solution in the whole blood collection bag. It is preferable that Further, it is preferable that the step of collecting white blood cell plasma is performed in a state where the plasma collection bag is positioned below the white blood cell removal filter.

Also, what achieves the above object is a blood component collection circuit for use in the above blood component collection method, wherein the blood component collection circuit includes a whole blood collection bag,
A plasma collection bag, a red blood cell collection bag, and one end connected to the whole blood collection bag and having a bifurcated branch portion, and one branched end connected to the plasma collection bag; A blood component collection circuit comprising: a connection tube having the other end branched and connected to the red blood cell collection bag; and a leukocyte removal filter disposed between the branch portion of the connection tube and the whole blood collection bag. . It is preferable that the red blood cell fluid collection bag is filled with a red blood cell storage solution.

[0006]

DESCRIPTION OF THE PREFERRED EMBODIMENTS A blood component collecting method and a blood component collecting circuit according to the present invention will be described with reference to the embodiments shown in the drawings. FIG. 1 is an external view of a blood component collection circuit used in the blood component collection method according to the embodiment of the present invention. The blood component collection method of the present invention uses a blood component collection circuit 1 including at least a whole blood collection bag 2, a plasma collection bag 3, a red blood cell collection bag 4, and a soft housing type leukocyte removal filter 5. Things. In the blood component collection method, after whole blood is collected in the whole blood collection bag 2, the blood component collection circuit 1 is centrifuged to separate the whole blood in the whole blood collection bag into a plasma component and a red blood cell solution. Centrifugation step, and the plasma components separated in the whole blood collection bag 2 by the centrifugation step.
, And after the poor leukocyte plasma collection step of collecting the red blood cell fluid in the whole blood collection bag 2 through the leukocyte removal filter 5, And a step of collecting the leukocyte-leukocyte fluid to be collected in the bag 4 for use.

In the blood component collection circuit 1 of the present invention, a whole blood collection bag 2, a plasma collection bag 3, a red blood cell collection bag 4, and one end are connected to the whole blood collection bag 2. A connecting tube 10 having a bifurcated branch portion 13, one end of which is connected to the plasma collection bag 3, and the other end of which is connected to the red blood cell collection bag 4; The leukocyte removal filter 5 is provided between the branch portion 13 and the whole blood collection bag 2. And the connection tube 10 is the tube 1
1, 12, 14, 15 and a branching section 13. Further, the erythrocyte fluid collection bag 4 may be filled with a erythrocyte preservation solution (not shown), and the blood component collection method is performed after the poor leukocyte plasma collection process and in the poor leukocyte red blood cell collection process. Before, a red blood cell preservation liquid injection step of injecting the red blood cell storage liquid in the red blood cell liquid collection bag 4 into the red blood cell liquid in the whole blood collection bag 2 is provided. It may collect red blood cell fluid.

In the embodiment shown in FIG. 1, the whole blood collection bag 2 is formed in a bag shape by stacking two sheet materials and fusing (thermal fusing, high frequency fusing) or bonding the periphery thereof. A storage space for storing collected blood is formed in an inner space surrounded by the seal portion. The storage space is filled in advance with an anticoagulant such as heparin sodium solution, ACD-A solution, CPD solution, CPDA solution and the like. And the whole blood collection bag 2
Is connected to the blood inflow port 5a of the leukocyte removal filter 5 by a tube 11. And tube 11
Is provided with a rupturable communication member 23 to prevent the anticoagulant in the blood bag from being transferred to the plasma component collection container before blood collection. In addition, a blood collecting means 7 for collecting blood is provided on the upper part of the whole blood collecting bag 2.
The blood collection means includes a blood collection needle 21 and a tube 22 for introducing blood from the blood collection needle 21 into the storage section. In addition, a suspension opening 2a is formed in a lower portion of the whole blood collection bag 2 so that the whole blood collection bag 2 can be suspended with the upper portion of the bag 2 facing down. As a constituent material of the whole blood collection bag 2, the same soft resin as the housing 30 of the leukocyte removal filter 5 described above is used so as to be pressable.

The red blood cell fluid collection bag 4 is made in the same manner as the whole blood collection bag 2, and has a storage space inside. The storage space in the red blood cell fluid collection bag 4 may be filled in advance with a red blood cell storage solution such as a MAP or a SAGM solution. The red blood cell fluid collection bag 4 is connected to the outflow side blood chamber 44 (the blood outflow port 5) of the leukocyte removal filter 5 by the tubes 12 and 14.
Communication with b) is possible. The tube 14 is provided with a rupturable communication member 24 to prevent the transfer of the red blood cell storage solution to other bags. In addition, two tube openings are formed in the upper part, which are opened and sealed by peel tabs.
It is a portion through which an infusion needle can be inserted when transfusing the separated red blood cell component. In addition, a suspension opening 4a is formed in the lower part of the red blood cell fluid collection bag 4 so that the suspension can be suspended. The constituent material of the red blood cell fluid collection bag 4 is preferably made of the same resin as the housing of the white blood cell removal filter 5 described above so as to be able to be pressed.

The plasma collection bag 3 is prepared similarly to the whole blood collection bag 2 and has a storage space inside, and is usually empty before storing the plasma. The plasma collection bag 3 communicates with the blood outflow port 5b of the leukocyte removal filter 5 through the tubes 15 and 12. In addition, a tube opening which is opened and sealed by a peel tab is formed at an upper portion of the plasma collection bag 3, and this portion is a portion through which an infusion needle can be inserted when infusing the separated plasma component. It has become. In addition, a suspension opening 3a is formed at a lower portion of the plasma collection bag 3 so as to be suspended. Further, as a constituent material of the plasma collection bag 3, it is preferable that the bag is made of the same resin as the housing of the leukocyte removal filter 5 described above so as to be pressable. In the embodiment, a three-pronged connector is used as the branching part 13. However, the present invention is not limited to this, and a three-way cock may be used as the branching part. Further, the tubes may be integrally formed so as to be three-pronged.

Tubes 22, 11, 12, 14 and 1
Examples of the constituent material 5 include thermoplastics such as polyvinyl chloride, polyethylene, polypropylene, polyester such as PET and PBT, ethylene-vinyl acetate copolymer, polyurethane, polyester elastomer, and styrene-butadiene-styrene copolymer. It is preferable to use an elastomer or the like. The branch portion 13 is preferably made of the same resin as the blood inflow port 5a and the blood outflow port 5b described later.

The leukocyte removal filter 5 is of a soft housing type. As shown in FIGS. 2 to 5, the soft resin bag-shaped housing 30 includes two thermoplastic soft resin sheets 31 and 32, the sheet 31 being the inflow side blood chamber 43 side, and the sheet 32 being the outflow side. The blood chamber 44 side is used. And the outflow side sheet 32
On the inner surface 30a, in other words, on the surface facing the surface of the outflow side blood chamber 44 of the leukocyte removal filter member 35,
The unevenness 33 having a height difference of 0.2 to 2 mm is formed. By making the inner surface 30a of the outflow side sheet 32 uneven as described above, the leukocyte removing filter member 35 presses the inner surface 30a of the soft resin bag-shaped housing 30 (the inner surface 30a of the outflow side sheet 32). In this case, the filter member 35 for removing leukocytes and the inner surface of the housing (the inner surface of the outflow side sheet 32) 30
a to secure a blood flow path and prevent a decrease in filtration speed.

In the leukocyte removal filter 5, the leukocyte removal filter member 35 is composed of a thermoplastic soft resin sheet-like frame 51 and a filtering function member 52 whose peripheral edge is fixed directly or indirectly to the frame 51. Become. The filtration function member 52 is formed of a laminate of a plurality of filter media. The leukocyte removal filter member 35 used here has a filtering function portion formed by the filtering function member 52 and a non-filtering function portion formed on the entire periphery of the filtering function portion. The leukocyte removal filter member 35 is sandwiched between two thermoplastic soft resin sheets, and the peripheral edge of the thermoplastic soft resin sheet frame 51 has two thermoplastic soft resin sheets. It is thermally fused to the resin sheet. Thereby, the leukocyte removal filter member 35 divides the space (in the housing 30) in the two thermoplastic soft resin sheets 31 and 32 into an inflow-side blood chamber 43 and an outflow-side blood chamber 44.

Then, the soft resin tube constituting the blood inflow port 5a is communicated with the inflow side blood chamber 43, in other words, such that one end opening of the soft resin tube is opened in the inflow side blood chamber 43. It is heat-sealed at the center of one end (upper end) between two thermoplastic soft resin sheets. Similarly, two pieces of the soft resin tube constituting the blood outflow port 5b are connected to the outflow side blood chamber 44, in other words, one end of the soft resin tube is opened in the outflow side blood chamber 44. Are heat-sealed to the center of the other end (lower end) between the thermoplastic soft resin sheets.

A tube 11 for introducing a substance to be filtered (not shown) into a leukocyte removal filter is provided in each of the blood inflow port 5a and the blood outflow port 5b.
A tube 12 for discharging the filtrate is connected.
Thus, the tube 11 communicates with the inflow side blood chamber 43 via the blood inflow port 5a, and the tube 12 communicates with the outflow side blood chamber 44 via the blood outflow port 5b. The connection between the tubes 11 and 12 and the blood inflow port 5a and the blood outflow port 5b is performed by inserting and fusing the tubes 11 and 12 inside the soft tubes constituting the ports 5a and 5b. For this reason, the outer diameter of the tube is
Preferably, it is made to be approximately the same size as the inner diameter of the port. As a material for forming the tube, a resin which is easily fused to the blood inflow port 5a and the blood outflow port 5b is preferable, and particularly, the same or similar resin as the resin used for the blood inflow port 5a and the blood outflow port 5b is preferable. It is.

The thermoplastic soft resin sheets 31 and 32 constituting the housing 30 and the filter member 35 for removing leukocytes are provided.
The fixing of the sheet 51 made of thermoplastic soft resin, the blood inflow port 5a and the blood outflow port 5b is preferably performed by fusion without using an adhesive. The welding may be external heating welding by heat sealing, or internal welding by a high frequency welder or an ultrasonic welder. Further, the welding method may be such that all of the above members are fused at the same time or may be performed in separate steps. And the filtration function part 52 of the leukocyte removal filter member 35 is a laminate of a plurality of filter media made of a porous material or a nonwoven fabric. In addition, as a lamination number of filter media, 2-10 sheets are suitable.

The porous material used for the filtering function portion 52 means a liquid-permeable structure having a large number of fine holes communicating from one surface to the other surface. Examples of the body include porous bodies made of natural, synthetic, semi-synthetic, and regenerated organic or inorganic fibers, organic and inorganic porous bodies such as sponge foam, and elution of pore components, sintering, stretching, and forming pores. And a porous body filled or bonded with organic or inorganic fine particles or fine particles. As the filtering function part (filter medium) 52 of the leukocyte removal filter member 35, among the above-mentioned porous bodies, a sponge-like polyurethane porous body and a polyvinyl formal porous body are particularly preferable. In addition, as for the pore diameter of the porous body, if the porous body has large pores, a thick one may be used or a thin one may be laminated and used, and a small pore may be used as it is. is there. Any porous body can be used as long as blood cells can pass through by appropriately selecting the pore diameter and thickness of the porous body. In particular, those having an average pore diameter of 5 to 20 μm are effective for leukocyte removal.

The thermoplastic soft resin sheets 31 and 32 constituting the housing 30 and the filter member 35 for removing leukocytes
As a material for forming the thermoplastic soft resin sheet frame 51, the blood inflow port 5a and the blood outflow port 5b, a flexible thermoplastic resin is used. Specifically, a soft vinyl chloride resin (polychlorinated resin) is used. Vinyl, vinyl chloride-vinyl acetate copolymer, vinyl chloride-ethylene copolymer, vinyl chloride-vinylidene chloride copolymer, polyvinyl chloride
Urethane copolymer, polyvinyl chloride-acrylonitrile copolymer, vinyl chloride-methyl methacrylate copolymer,
And a thermoplastic elastomer such as a hydrogenated product of a styrene-butadiene-styrene copolymer, a styrene-isoprene-styrene copolymer or a hydrogenated product thereof, and a soft polyvinyl chloride modified product comprising the above polymer and a plasticizer. Mixture of thermoplastic elastomer and polyolefin, softener such as ethylene-ethyl acrylate, polyurethane (polyester polyurethane, polyether polyurethane), polyolefin (polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, polypropylene) And polyethylene or polybutene), polyesters (polyethylene terephthalate, polybutylene terephthalate), and polyamides. Preferred are soft vinyl chloride resins, styrene-butadiene-styrene copolymers, polyesters, styrene-ethylene-butylene-styrene copolymers, and thermoplastic elastomers containing these as main components.

As a material for forming the blood inflow port 5a and the blood outflow port 5b, a hard resin may be used. As the hard resin, hard or semi-hard vinyl chloride, polycarbonate, acrylic resin, styrene resin and the like can be used. The blood component collection circuit 1 described above is mounted on a blood component separation device as shown in Japanese Patent Publication No. 2547636 and used for collecting blood components. The blood component separation device is not limited to the above publication. Further, a device using a so-called head without using a blood component separation device may be used.

Next, the blood component collecting method of the present invention will be described by taking a case where a blood component separating apparatus is used as an example. First, whole blood is collected in the whole blood collecting bag 2 using the blood collecting means 7. Then, after blood collection, the vicinity of the root of the tube 22 is sealed using a tube sealer, and the blood collection means 7 is separated. Next, a step of installing the blood component collection circuit 1 in a centrifuge and performing centrifugation is performed. The centrifuged whole blood in the whole blood collection bag 2 includes a plasma layer mainly composed of plasma at the upper part of the bag 2 and a red blood cell layer mainly composed of red blood cells at the lower part of the bag 2. Although depending on the degree of centrifugation, leukocytes are usually mixed in the upper plasma layer, and leukocytes are also usually mixed in the red blood cell layer. And the white blood cells are 400ml
N × 10 ⁶ in the plasma and erythrocyte fluid from the blood collection bag
The presence of more than one undesirably causes an antibody production reaction.

Next, a poor leukocyte plasma collection step is performed in which the plasma layer separated in the whole blood collection bag 2 by the centrifugation step is passed through the leukocyte removal filter 5 and collected in the plasma collection bag 3. The leukocyte removal filter 5 is set up with the blood inflow port 5a side down and the blood outflow port 5b side up, and the whole blood collection bag 2 is provided at a position lower than the leukocyte removal filter 5. It is stored in a storage section of a separation device (not shown), the plasma collection bag 3 is installed at a position lower than the leukocyte removal filter 5, and the red blood cell collection bag 4 is hung at a position higher than the leukocyte removal filter 5. And the whole blood collection bag 2
To send out the plasma layer on the upper part in the whole blood collection bag 2 to the plasma collection bag 3. The plasma flows into the plasma collection bag 3 after passing through the leukocyte removal filter 5 and filtering the leukocytes. Then, as the compression is continued, the interface between the plasma layer and the blood cell layer in the container gradually rises, and the interface of the blood cell fluid is compressed by the detection of the liquid detection unit (not shown) of the blood component separation device. finish. Although plasma remains on the inlet side or outlet side of the filter 5, most of the residual plasma is collected in the plasma collection bag 3 by disposing the plasma collection bag 3 at a position lower than the leukocyte removal filter 5. Then, after the separation, the tube 15 is sealed using a tube sealer, and the plasma collection bag 3 is cut off, and a bag containing the plasma preparation is produced.

Further, since the plasma component passes through the leukocyte removal filter 5 at the time of plasma separation, a special air removal operation is not required. Further, in the poor leukocyte plasma collection step in which the plasma layer is passed through the leukocyte removal filter 5 and collected in the plasma collection bag 3, the filter 5 is not pressed (particularly, the blood chamber 43 on the inflow side of the filter is not pressed). ) It is desirable to perform in the state. By doing so, the inflow-side blood chamber 43 of the filter 5 expands, so that the force for pushing the liquid component into the filter medium is reduced, the filtration flow rate is reduced, and the leukocyte removal performance is improved (generally, the filtration speed is increased). Has an inverse correlation with leukocyte removal performance). In addition, the plasma in which a small amount of red blood cells float also stays in the blood chamber 43 on the inflow side of the filter 5 due to a decrease in the filtration flow rate. Therefore, the plasma that easily passes through the filter medium preferentially passes, and the red blood cells are caught by the filter medium and removed.

Next, after the blood leukocyte plasma collection step and before the blood leukocyte red blood cell collection step, the red blood cell preservation liquid in the red blood cell liquid collection bag 4 is injected into the red blood cell liquid in the whole blood blood collection bag 2. A red blood cell preservation solution injection step is performed. The communication member 24 provided in the tube 14 communicating with the red blood cell fluid collection bag 4 is folded, and the red blood cell storage solution (MAP) is filtered from the red blood cell fluid collection bag 4 into the white blood cell removal filter 5.
, The erythrocyte preservation solution (MA)
P) is fed to mix with the blood cell fluid in the whole blood collection bag 2. At this time, the red blood cell collection bag 4, the white blood cell removal filter 5, and the whole blood collection bag 2 are arranged in this order from the top. Thereby, the erythrocyte preservation solution in the erythrocyte fluid collection bag 4 can be transferred into the whole blood collection bag 2 with almost no remaining in the leukocyte removal filter.

Next, a poor leukocyte red blood cell liquid collecting step is performed in which the blood cell liquid in the whole blood collection bag 2 is passed through the leukocyte removal filter 5 and collected in the red blood cell collection bag 4. In the embodiment, the whole blood collection bag 2, the leukocyte removal filter 5, and the red blood cell collection bag 4 are removed from the blood component separation device, and the whole blood collection bag 2, the white blood cell removal filter 5, and the red blood cell collection bag 4 are taken from the higher side. The red blood cell liquid in the whole blood collection bag 2 is sent to the leukocyte removal filter 5 for filtration. Then, after separating the red blood cell fluid into the red blood cell fluid collection bag 4, the tube 14 is sealed using a tube sealer, the red blood cell fluid collection bag 4 is cut off, and a bag containing a red blood cell preservation liquid-enriched red blood cell preparation is produced. .

In the present invention, the red blood cell preservation liquid injecting step is performed before collecting the poor leukocyte red blood cell liquid into the red blood cell liquid collecting bag. However, the present invention is not limited to this. Without performing, red blood cell collection bags (filled with red blood cell preservation solution,
Whichever may be used), it may be one that collects poor leukocyte red blood cell fluid. In all the blood component collection circuits described above, a whole blood collection bag, a plasma collection bag, a red blood cell collection bag, a leukocyte removal filter, and the like are not completely connected as circuits by tubes, in other words, , One or more locations are not linked in advance, and for those locations immediately before use,
It may be of a type that performs connection using an aseptic joining device.

(Experiment 1) (Example 1) The blood component collecting circuit shown in FIG. 1 and configured as described above was used. 400 ml of whole blood was collected in a soft vinyl chloride resin whole blood collection bag, and then centrifuged. As a result, the inside of the whole blood collection bag was separated into an upper plasma layer and a lower red blood cell layer. Subsequently, with the plasma collection bag arranged below the soft leukocyte removal filter,
The whole blood collection bag was pressed, and the plasma component separated in the whole blood collection bag was passed through a soft leukocyte removal filter to collect plasma in the plasma collection bag. Then, the erythrocyte preservation solution in the erythrocyte solution collection bag was injected into the erythrocyte solution in the whole blood collection bag. Then, the erythrocyte liquid added with the erythrocyte preservation solution in the whole blood collection bag was passed through a soft leukocyte removal filter, and the erythrocyte liquid was collected in the erythrocyte liquid collection bag.

As the soft leukocyte removal filter, a housing forming member is 110 mm long and 7 mm wide.
A soft polyvinyl chloride sheet, 5 mm in thickness and 0.4 mm in thickness and having a matte surface, has a length of 1 such that it is on the blood inflow side.
10mm, width 75mm, thickness 0.4mm on one side,
A soft polyvinyl chloride sheet having a height of 0.8 mm, a bottom width of 1 mm, and ribs having a substantially triangular cross section formed in the length direction at intervals of 2 mm was used so as to be on the blood outflow side. The blood inflow port and the blood outflow port are injection-molded soft polyvinyl chloride tubes (length 2).
3 mm, inner diameter 4 mm, outer diameter 6 mm). As a filter medium for leukocyte removal, a polyurethane porous material (about 1 m thick)
m, average pore diameter 5μm, length about 85mm, width about 65mm)
Were punched out in an elliptical shape, six sheets were laminated, and the outer periphery thereof was heat-sealed. In the filter medium for removing leukocytes, the thickness of the outer peripheral sealing portion is 1 mm, and the thickness of the non-sealing portion is about 10 mm. Sheet-shaped frame (length 110 mm, width 75 mm, frame width 10 to 25 m
m, thickness 0.4 mm) is made by forming a sheet made using a resin obtained by mixing a polyurethane resin and a polyvinyl chloride resin in a ratio of 1: 1. The part is made one size smaller than the filter medium. And the filter member for leukocyte removal,
The sheet-like frame is applied to the filter medium for leukocyte removal, and the entire outer periphery of the filter medium for leukocyte removal and the entire inner periphery of the sheet-like frame are externally heat-welded.

Then, the soft polyvinyl chloride sheet on the blood inflow side is placed on the lower side, and the filter member for leukocyte removal to which the filter medium is fused is placed thereon, and the upper end of the sheet-like frame of the filter member for leukocyte removal is extended. A tube made of soft polyvinyl chloride was arranged between the soft polyvinyl chloride sheet and the blood inflow side soft polyvinyl chloride sheet. Subsequently, a blood-outflow-side soft polyvinyl chloride sheet is placed on the leukocyte-removing filter member so that the rib-forming surface is overlapped with the leukocyte-removing filter member. Tubes made of soft polyvinyl chloride were placed between the outflow-side soft polyvinyl chloride sheets, and their peripheral portions were heat-sealed with a high-frequency welder. Finally, an extra portion was cut by a punching metal fitting to produce a leukocyte remover of the present invention.

(Example 2) In the plasma collection, the plasma collection bag was not arranged below the soft leukocyte removal filter, and at the end of the plasma collection, the soft leukocyte removal filter was lifted and the plasma collection bag was removed. The same operation as in Example 1 was performed, except that the operation of moving the plasma in the filter into the plasma collection bag by moving the filter upward or pressing the soft leukocyte removal filter was performed.

Example 3 As a blood component collection circuit, a circuit in which a red blood cell preservation solution was not filled in a red blood cell fluid collection bag was used. Example 1 was repeated except that the red blood cell fluid in the bag was passed through a soft leukocyte removal filter and collected in a plasma collection bag.

(Example 4) In the plasma collection, the plasma collection bag was not arranged below the soft leukocyte removal filter, and at the end of the plasma collection, the soft leukocyte removal filter was lifted and the plasma collection bag was removed. Example 3 was carried out in the same manner as in Example 3 except that the operation of flowing the plasma in the filter into the plasma collection bag was performed by moving the filter upward or by pressing the soft leukocyte removal filter.

(Comparative Example 1) A blood component collection circuit 50 shown in FIG. 6 is the same as Example 1 except that the arrangement position of the soft leukocyte removal filter is different from that shown in FIG. The blood was collected in a bag for collecting whole blood made of a vinyl chloride resin and then centrifuged. Subsequently, the plasma component separated in the whole blood collection bag was collected in the plasma collection bag. Then, the erythrocyte preservation solution in the erythrocyte solution collection bag was injected into the erythrocyte solution in the whole blood collection bag. Then, the erythrocyte liquid added with the erythrocyte preservation solution in the whole blood collection bag was passed through a soft leukocyte removal filter, and the erythrocyte liquid was collected in the erythrocyte liquid collection bag.

COMPARATIVE EXAMPLE 2 A blood component collecting circuit 60 having a configuration including a hard leukocyte removal filter 65 and a hard filter bypass line 16 like the blood component collecting circuit 60 shown in FIG. 7 was used. In the same manner as in Example 1, 400 ml of whole blood was collected in a whole blood collection bag made of a soft vinyl chloride resin and then centrifuged. Subsequently, the plasma component separated in the whole blood collection bag was passed through a hard leukocyte removal filter and collected in the plasma collection bag. Then, the erythrocyte preservation solution in the erythrocyte solution collection bag was injected into the erythrocyte solution in the whole blood collection bag. Then, the erythrocyte solution added with the erythrocyte preservation solution in the whole blood collection bag was passed through a hard leukocyte removal filter, and the erythrocyte solution was collected in the erythrocyte solution collection bag. The hard leukocyte removal filter has a length of 95 m as a housing forming member.
m, a width of 70 mm, and a thickness of 13 mm made of polycarbonate. As the blood inflow port and the blood outflow port, injection-molded soft polyvinyl chloride tubes (length 23 mm, inner diameter 4 mm, outer diameter 6 mm) were used.
The same filter medium as in Example 1 was used as a leukocyte removal filter medium.

Table 1 shows data on the level of contamination of the collected plasma with cellular components and the operation time in Examples 1 to 4 and Comparative Examples 1 and 2.

[0035]

[Table 1] The counting of each blood cell count was performed by sysmex XE2100, and the leukocyte count at the × 10 ⁶ level was performed by the nadget method.

[0036]

According to the blood component collecting method of the present invention, a blood component collecting circuit including at least a whole blood collecting bag, a plasma collecting bag, a red blood cell collecting bag, and a soft housing type leukocyte removing filter is used. A blood component collection method, wherein after collecting whole blood in a whole blood collection bag, the blood component collection circuit is centrifuged to collect whole blood in the whole blood collection bag as plasma. A centrifugation step of separating the blood cell fluid into blood cells, a leukocyte plasma collection step in which the plasma component in the whole blood collection bag is passed through the leukocyte removal filter and collected in the plasma collection bag, and the poor leukocyte plasma collection is performed. After the step, a poor leukocyte red blood cell liquid collecting step of collecting the blood cell liquid in the whole blood collection bag through the leukocyte removal filter and collecting the blood cell liquid in the red blood cell collection bag. To have. For this reason, it is possible to easily collect a plasma component containing almost no red blood cells and white blood cells.

A blood component collection circuit according to the present invention is a blood component collection circuit for use in the above blood component collection method, wherein the blood component collection circuit comprises a whole blood collection bag and a plasma collection circuit. A bag, an erythrocyte fluid collection bag, and a branch portion having one end connected to the whole blood collection bag and branching into two branches, and one branched end connected to the plasma collection bag and the other end A connection tube having an end connected to the red blood cell fluid collection bag, and a leukocyte removal filter disposed between the branch portion of the connection tube and the whole blood collection bag.

[Brief description of the drawings]

FIG. 1 is an external view of a blood component collection circuit according to an embodiment of the present invention.

FIG. 2 is a front view of the leukocyte removal filter used in the blood component collection circuit of the present invention, as viewed from the outflow side blood chamber side.

FIG. 3 is a rear view of the leukocyte removal filter of FIG. 2;

FIG. 4 is an AA diagram of the leukocyte removal filter of FIG. 2;
It is a line expanded sectional view.

FIG. 5 is a BB diagram of the leukocyte removal filter of FIG. 2;
It is a line sectional view.

FIG. 6 is an external view of a blood component collection circuit according to a comparative example.

FIG. 7 is an external view of a blood component collection circuit according to a comparative example.

[Brief description of reference numerals]

 Reference Signs List 1 blood component collection circuit 2 whole blood collection bag 3 plasma collection bag 4 red blood cell collection bag 5 leukocyte removal filter

Claims (5)

[Claims] 1. A blood component collection method using a blood component collection circuit including at least a whole blood collection bag, a plasma collection bag, a red blood cell collection bag, and a soft housing type leukocyte removal filter. The blood component collection method includes the steps of, after collecting whole blood in a whole blood collection bag, centrifuging the blood component collection circuit to separate the whole blood in the whole blood collection bag into a plasma component and a blood cell fluid. When,
A blood leukocyte plasma collection step in which the plasma component in the whole blood blood collection bag is passed through the leukocyte removal filter and collected in the plasma collection bag, and after the blood leukocyte plasma collection step, the whole blood blood collection bag A blood leukocyte-replenishing liquid collecting step, wherein the blood cell liquid in the inside passes through the leukocyte removing filter and is collected in the red blood cell liquid collecting bag. 2. The erythrocyte fluid collection bag is filled with an erythrocyte preservation solution, and the method for collecting blood components comprises:
An erythrocyte preservation solution that injects the erythrocyte preservation solution in the erythrocyte solution collection bag into the erythrocyte solution in the whole blood collection bag after the oligoleukocyte plasma collection step and before the leukocyte red blood cell collection step. 2. The blood component collecting method according to claim 1, further comprising an injecting step, wherein the red blood cell preserving solution-added poor leukocyte erythrocyte liquid is collected in the oligoleukocyte erythrocyte liquid collecting step. 3. The blood component collection method according to claim 1, wherein in the step of collecting the leukocyte-lean plasma, the plasma collection bag is positioned below the leukocyte removal filter. 4. A blood component collection circuit for use in the blood component collection method according to claim 1, wherein the blood component collection circuit includes a whole blood collection bag and a plasma collection device. A bag, an erythrocyte fluid collection bag, and a branch portion having one end connected to the whole blood collection bag and branching into two branches, and one branched end connected to the plasma collection bag and the other end A blood component collection circuit, comprising: a connection tube having an end connected to the red blood cell collection bag; and a leukocyte removal filter disposed between the branch portion of the connection tube and the whole blood collection bag. . 5. The blood component collection circuit according to claim 4, wherein the red blood cell solution collection bag is filled with a red blood cell preservation solution.