JP2001252353A - Blood component separating device and blood component separating method - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a blood component separating method which is good in workability in separating red blood cells, short in filtration time and high in red blood cell recovery rate and is high in white blood cell removal rate, and a blood component separating device used for the same. SOLUTION: The blood component separating device 10 is used for a blood component collection circuit 100 having a bag 105 for total blood component collection, a bag 106 for blood plasma collection, a bag 107 for red blood cell liquid collection and a white blood cell removing filter 101. The blood component separating device has a thrusting mechanism for thrusting the bag 105 for total blood collection housing the total blood separated to a blood plasma layer of an upper layer and a blood cell layer of a lower layer and discharging the housed blood component and a filter stand 150 for holding the white blood cell removing filter at a nearly perpendicular state.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a method for separating blood components and an apparatus for separating blood components.

[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 preparing a plasma preparation have been performed. . For this reason, a blood bag called a so-called multi-bag connected by a plurality of bags or tubes is used for transfusion of blood components and adjustment of blood products. In this blood bag, blood is collected in a whole blood collection bag and centrifuged to separate the inside of the bag into an upper plasma component layer and a lower blood cell component layer. And
It is necessary to separate and collect the separated plasma component and blood cell component through a leukocyte removal filter into a plasma collection bag and a red blood cell collection bag (containing a red blood cell preservation solution) so that other components are not mixed as much as possible.

[0003] However, since the filter is primed with a plasma or red blood cell storage solution,
It is necessary to discharge air. Residual air in the filter reduces the effective area of the filter media, thereby reducing filtration efficiency. However, conventionally, there was no jig for fixing the filter, so that the operator had to hold the filter by hand during that time. Also, when performing the leukocyte removal by introducing the concentrated red blood cells diluted with the red blood cell preservation solution into the filter, if the dilution of the concentrated red blood cells in the previous step is insufficient, the filtration time, the leukocyte removal performance and the red blood cell collection The rate is affected. If the dilution is insufficient, the concentration of the red blood cells to be filtered will increase, and the viscosity will increase. Insufficient dilution of concentrated red blood cells is often caused by an inappropriate head-to-head positional relationship among a whole blood collection bag, a red blood cell collection bag (containing red blood cell preservation solution), and a filter. If the relative positional relationship is inappropriate, the red blood cell preservation solution stays in the filter or the bag containing the red blood cell preservation solution, and as a result, the red blood cell preservation solution does not sufficiently flow into the bag containing the collected blood. Because it will be. Therefore, an object of the present invention is to solve the above-mentioned problems and perform blood component separation excellent in workability, filtration time, red blood cell recovery rate, and white blood cell removal rate when performing component separation of whole blood, particularly when separating red blood cell components. It is an object of the present invention to provide a method and an apparatus for separating blood components.

[0004]

The above object can be achieved by 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 leukocyte removing filter. The blood component separation device presses a whole blood collection bag containing whole blood separated into an upper plasma layer and a lower blood cell layer, and removes the stored blood components. A blood component separation device including a pressing mechanism for discharging, a filter stand for holding a leukocyte removal filter in a substantially vertical state, and a filter stand mounting portion.

[0005] The stand includes a main body for accommodating the leukocyte removal filter, and the main body includes opposed flat plate-shaped portions that are substantially parallel to each other and come into contact with the leukocyte removal filter during use. It is preferable that the interval between the flat plate portions facing each other is equal to or greater than the thickness of the leukocyte removal filter. Further, it is preferable that the stand is detachably attached to the filter stand attachment portion. In addition, the blood component separation device is configured such that, in use, the first hanging portion (in other words, the red blood cell liquid collecting bag) located above the whole blood collecting bag and the filter stand mounting portion pressed by the pressing mechanism. (Hanging part). In addition, the blood component separation device is configured such that, in use, the first hanging portion (in other words, the red blood cell liquid collecting bag) located above the whole blood collecting bag and the filter stand mounting portion pressed by the pressing mechanism. It is preferable to include a hanging portion) and a second hanging portion (in other words, a hanging portion for a bag for collecting plasma after collecting plasma).

Further, according to the blood component separation method of the present invention, a whole blood collection bag, a plasma collection bag, a leukocyte removal filter, and a red blood cell preservation solution are filled using the blood component separation device described above. A blood component collection circuit comprising at least a red blood cell fluid collection bag or a whole blood blood collection bag, a plasma collection bag, a leukocyte removal filter, a red blood cell fluid collection bag, and a red blood cell preservation solution filling bag. A method for separating blood components, comprising: mounting a blood component collection circuit in a state in which whole blood separated into an upper plasma layer and a lower blood cell layer is contained in a whole blood collection bag. The blood collection bag is located below the stand, and the red blood cell storage bag or red blood cell storage liquid filled with the red blood cell storage liquid is filled. Bags, in a state arranged such that the above said stand, said and performs injection of erythrocyte preserving liquid to the whole blood for blood collection bags.

Further, according to the blood component separation method of the present invention, a whole blood collection bag, a plasma collection bag, a leukocyte removal filter, and a red blood cell preservation solution are filled using the blood component separation device described in any of the above. A blood component collection circuit comprising at least a red blood cell fluid collection bag or a whole blood blood collection bag, a plasma collection bag, a leukocyte removal filter, a red blood cell fluid collection bag, and a red blood cell preservation solution filling bag. A method for separating blood components, wherein the method for separating blood components is performed by mounting a blood component collection circuit in a state in which whole blood separated into an upper plasma layer and a lower blood cell layer is contained in a whole blood collection bag. A step of allowing a liquid initially flowing into the filter to flow from a lower portion of the leukocyte removal filter stored substantially vertically in the stand. It is as it has.

The bag for collecting whole blood is positioned below the stand, and the bag for collecting red blood cell liquid or the bag filled with red blood cell storage liquid filled with the red blood cell storage liquid is positioned above the stand. Preferably, the red blood cell preservation solution is injected into the whole blood collection bag in such a state that the red blood cell preservation liquid is injected.

[0009]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A blood component separation apparatus 10 according to the present invention will be described with reference to the illustrated embodiment. The blood component separation device 10 of the present invention includes a bag 10 for collecting whole blood, a bag 106 for collecting plasma, and a bag 107 for collecting red blood cell fluid.
And a blood component separation device used in a blood component collection circuit including at least the leukocyte removal filter 101. The blood component separation device includes a whole blood collection bag 105 containing whole blood separated into an upper plasma layer and a lower blood cell layer.
And a filter mechanism 150 for pressing the plate and discharging the stored blood component, an upper flat portion 10a, and a filter stand 150 mounted on the upper flat portion 10a and holding the leukocyte removal filter in a substantially vertical state. . As shown in FIG. 1, a blood component collection circuit 100 is mounted on the blood component separation device 10.

The blood component separation apparatus 10 of the present invention is shown in FIG.
As shown in FIGS. 2 and 5, whole blood containing the whole blood separated into an upper plasma layer and a lower blood cell layer by being centrifuged between the first plate member 62 and the first plate member 62. Blood collection bag 105
And a pressing mechanism including pressing means for pressing the second plate-shaped member 63 in the direction of the first plate-shaped member 62. As shown in FIG. 3, the leukocyte-removing filter hard stand 150 that can be used for both the soft-housing type and the hard-housing type leukocyte removing filters includes a main body 152 for accommodating the leukocyte removing filter 101. Main unit 1
52 are opposed flat plate-shaped portions 152 formed substantially in parallel with the leukocyte removal filter 101 in use.
a, 152b. The interval between the opposed flat plate portions 152a and 152b of the main body 152 is equal to or greater than the thickness of the leukocyte removal filter 101.

The blood component separation device 10 includes a housing 10
And a lid 11. And the housing 10
Has a liquid separating device 55 for separating a plasma layer and a blood cell layer in the whole blood collection bag 105, and a hard stand 150 for a leukocyte removal filter. As shown in FIG. 5, the liquid separation device 55 includes a plasma layer (upper layer) between the first plate-shaped member 62 and the first plate-shaped member 62 in advance.
A second plate-shaped member 63 forming a storage portion 69 of the whole blood collection bag 105 containing a liquid separated into a blood cell layer (lower layer); and a second plate-shaped member 63 formed of a first plate-shaped member. A pressing mechanism for pressing in the direction of the member 62 is provided. The pressing mechanism includes a pressing member 64, a pressing member 64 and a second plate-like member 63.
, A shaft member 67 inserted into the spring member 65 and movably inserted into the pressing member 64, and driving the pressing member 64 in the direction of the second plate-shaped member 63. And a second plate-like member 63
Is configured to be performed via a spring member 65. The pressing mechanism automatically presses the second plate-shaped member 63, and furthermore, the whole blood collection bag 105.
It has a function of pressing the second plate-shaped member 63 by gradually reducing the pressing force after the state in which the upper liquid (plasma component) flows out.

More specifically, the bottom of the first plate-shaped member 62 is pivotally supported on the front surface of the housing 10 and is rotatable from a position shown by a broken line to a position shown by a solid line in FIG. After the whole blood collection bag 105 is stored, it is fixed at the position indicated by the solid line. The upper end of the second plate member 63 is pivotally supported near the front surface of the housing 10 at the back of the first plate member 62.
It is rotatable in the direction of the plate member 62. The first and second plate members are preferably flat members, and may be appropriately curved. The driving unit 66
It is constituted by a motor 76 which is a driving source, and a transmission section 74 which transmits the rotation of the motor 76 to the rotating shaft 72. The rotation of the rotation shaft 72 causes the pressing member 64 to move in the direction of the second plate member 63. Pressing member 6
A shaft 67 is movably inserted through the shaft 4, and furthermore, a shaft 67 positioned between the pressing member 64 and the second plate-like member 63.
Is provided with a spring member 65. Therefore, when the pressing member 64 moves, the rear end of the spring member 65 is pressed, and the front end of the spring member 65 presses the second plate-like member 63 and the pressing member 64 and the second plate-like member 63 It is configured to be compressed between the spaces. In addition, it is preferable that the shaft 67 also moves with the movement of the spring member 65, and therefore, the spring member 65 is inserted through the shaft 67 so as not to be loosened too much. Further, if the spring member 65 does not bend, the shaft 67 may not be provided.

Next, the operation of the liquid separating device 55 will be described with reference to FIG.
This will be described with reference to FIG. FIG. 5 shows a liquid separation device 5.
5 shows a state in which the centrifuged whole blood collection bag 105 is attached. Then, by operating the driving unit 66, the pressing member 64 moves in the direction of the second plate member 63 as shown in FIG.
3, and the spring member 65 is compressed as shown in FIG. The driving of the driving unit 66 stops when the pressing member 64 reaches a preset position. The set position reaches a state where the liquid in the whole blood collection bag 105 flows out from at least the tube 114 (a state where the whole blood collection bag 105 is pressed by the first plate-shaped member 62 and the second plate-shaped member 63). Position.
More specifically, a position where about 90% of the liquid in the upper layer in the whole blood sampling 105 (about 45% of the total liquid amount if the ratio of the liquid in the upper layer is 50%) usually flows out. Is set to FIG. 6 shows a state in which the driving unit 66 has stopped. Subsequently, as shown in FIG. 7, the spring member 65 compressed by the second plate member 63 and the pressing member 64 presses the second plate member 63 by the restoring force, and the restoring force gradually increases. Since it becomes weak, the interface between the liquid in the upper layer and the liquid in the lower layer in the
The liquid in the upper layer in 5 can flow out from the tube 114. As described above, by using the spring member 65 to press the second plate-shaped member 63, the pressing force after the liquid in the upper layer of the whole blood collection bag 105 flows out is gradually reduced. Since the second plate-like member 63 is pressed, the upper layer liquid in the whole blood collection bag 105 is transferred to the tube without disturbing the interface between the upper layer liquid and the lower layer liquid in the whole blood collection bag 105. 114 can be discharged. A liquid detecting section 71 (lower liquid detecting section) is provided on the upper portion of the second plate-shaped member 63, and the lower liquid is detected by the liquid detecting section to close the tube 114. The part 58 is activated, and the liquid separating operation is completed. In the present invention, the liquid detecting section 71 is for detecting an interface between a plasma layer and a blood cell layer. As the liquid detection unit 71, for example, a photo sensor or the like is used.
Alternatively, the boundary surface can be detected based on the difference between the light transmittance and the light reflectance. The driving unit for driving the pressing member 64 is not limited to the above-described motor, but may be an air cylinder or a hydraulic cylinder. Thus, in the liquid separation device 55 of the present invention,
Since the automatic type is used, a complicated manual operation is not required, and the upper layer liquid can be easily collected. Further, in the liquid separating device 55, as shown in FIGS. 5 to 7, when the first plate-like member 62 is at the position indicated by the solid line, the upper end of the second plate-like member 63 has the first plate-like member. 62, and is fixed at that position. Then, the second plate-like member 6
The first plate-like member 6 is supported at the upper end by a shaft.
It is rotatable in two directions. For this reason, the whole blood collection bag 105 is pressed from the upper end side to the lower end side of the whole blood collection bag 105 by the rotation of the second plate-shaped member 63. Then, as the rotation of the second plate-like member 63 proceeds, as shown in FIG. 7, the distance between the first plate-like member 62 and the upper side of the second plate-like member 63 becomes shorter, and the whole blood collection bag 105 The amount of the liquid in the upper layer separated in the upper portion in the whole blood sampling bag 105 is extremely small.

Since the liquid separating device 55 is configured as described above, between the first plate member 62 and the second plate member 63, the whole blood collection bag 105 has an upper portion on both sides. Adhering. Therefore, a portion that does not contact the second plate-shaped member 63 is not formed at the upper end of the whole blood collection bag 105. Therefore, the interface between the upper liquid and the lower liquid separated in the whole blood sampling bag 105 can be detected at the upper part of the whole blood sampling bag 105. The first plate member 62 and the second plate member 6
3, the upper part of the whole blood collection bag 105 is in a flat state, so that the upper layer liquid separated in the whole blood collection bag 105 is placed in the upper part of the whole blood collection bag 105. The remaining amount is small. Therefore, the efficiency of collecting the liquid in the upper layer is high. Further, since the whole blood collection bag 105 does not rise, it is easy to set the automatic detection position of the interface.

Hard stand 15 for leukocyte removal filter
1 includes a main body 152 for accommodating the leukocyte removal filter 101, as shown in FIGS.
52 are opposed flat plate-shaped portions 152 formed substantially in parallel with the leukocyte removal filter 101 in use.
a, 152b, and the interval between the flat plate portions 152a, 152b facing the main body 152 is equal to or greater than the thickness of the leukocyte removal filter 101.

The hard stand 150 is provided on the main body 15.
2, an opening 153 for inserting a leukocyte removal filter provided at the upper end of the main body 152, and an opening 153 provided at the lower end of the main body 152.
2 is supported substantially vertically, thereby inserting a stand support 156 installed on the upper flat portion 10b and tubes 114 and 115 connected to the blood inflow port 6 or the blood outflow port 7 of the leukocyte removal filter 101. And a guiding notch 154 for guiding from the opening 153 to the lower end side of the main body 152.

The main body 152 is a portion for accommodating the bag-shaped housing 2 portion of the leukocyte removal filter 101 therein, and is formed to be larger in length, width and thickness than the bag-shaped housing 2 portion. For this reason, the rigid stand 15
Reference numeral 0 indicates that the entire housing 2 can be stored and the leukocyte removal filter 101 can be stored without pressing the bag-shaped housing 2. Further, since the internal shape of the hard stand 150 is made substantially the same as the outer diameter of the bag-shaped housing 2, the leukocyte removal filter 101 hardly moves in the hard stand 150 after being attached.

The main body 152 has opposed flat plate portions 152a and 152b formed substantially in parallel with both surfaces of the housing 2 of the leukocyte removal filter 101 during use (at the time of blood inflow). , 1
The interval of 52b is equal to or larger than the thickness of the leukocyte removal filter 101 when blood is not flowing (in a natural state), and more specifically, is slightly larger. Even when the hard stand 150 is attached to the leukocyte removal filter 101, the soft resin thermoplastic sheet 21 of the leukocyte removal filter does not adhere to the leukocyte removal filter member 5, and the leukocyte removal filter 10
1 does not hinder the flow of the substance to be filtered (blood) flowing into the inside. In other words, by using the hard stand 150, even when blood flows in, the leukocyte removal filter 101 can be brought into a state close to that when blood is not flowing (natural state, unused state), and in a state close to the design form. Leukocyte removal can be performed.

If the interval between the plate-like portions 152a and 152b is made as described above, even if the leukocyte removing filter member is made of a porous body, the leukocytes can be stored in the hard stand without crushing the holes. Since the removal filter can be accommodated, the filtration can be reliably performed. Further, the filtration speed of the leukocyte removal filter 101 can be adjusted by adjusting the interval between the opposed flat plate portions 152a and 152b of the hard stand 150. Further, the inside of the main body 152 is not limited to the above-described configuration, and cannot press the leukocyte removal filter from the outside during use, and the interval between the flat plate portions facing the hard stand is different from that of the leukocyte removal filter. Any shape and size may be used as long as the thickness is not less than the thickness.

The size of the interior of the main body 152 of the hard stand 150 is such that the opposed flat plate-like portions 152a, 152b
Is 0 to 3 with respect to the thickness of the leukocyte removal filter.
The length in the longitudinal direction of FIG. 3 increases by 0 to 3 mm with respect to the length of the leukocyte removal filter, and the length in the direction perpendicular to the longitudinal direction of FIG. It is preferable that it is increased by 〜3 mm. The insertion opening 153 is a portion into which the filter 101 is inserted when the leukocyte removal filter 101 is mounted on the hard stand 150. Since the cross-sectional area of the insertion opening 153 in the direction orthogonal to the longitudinal direction of FIG. 3 is larger than the cross-sectional area of the leukocyte removal filter along the line AA in FIG. The removal filter 101 can be easily inserted from above the hard stand 150. Further, it may be manufactured so that the diameter near the opening 153 is tapered toward the upper end so that the leukocyte removal filter 101 can be easily inserted.

In the embodiment shown in FIG. 3, the guide notch 154 is formed only on one side surface of the main body 152 so as to be linear from the opening 153 to the lower end. The notch 154 for guiding is formed from the lower end to the opening 153.
It is formed to have substantially the same width up to near the lower side, but is formed so as to increase in diameter in a tapered shape from near the lower side of the opening 153 toward the opening 153. The guide notch 154 is not limited to a straight line, and may be bent in the middle from the opening to the lower end. The notch 154 for guiding after the tube is guided is connected to the blood inflow port 6.
Or a tube 11 connected to the blood outflow port 7
4 and 115 allow the blood cell layer to flow into the leukocyte removal filter 101 even when the hard stand 150 is mounted.

The width of the guide notch 154 is -1 mm or more with respect to the outer diameter of the tubes 114 and 115 connected to the blood inflow port 6 or the blood outflow port 7.
It is preferable to make it within 10 mm. -1
mm, the tube can be advanced to the lower end side due to the flexibility of the tube even if it is made slightly smaller than the outer diameter of the tube. On the other hand, if the size of the leukocyte removal filter is larger than 10 mm, the capacity of the leukocyte removal filter cannot be properly regulated.

The hard stand 150 is a stand support 1
The lower surface of the housing 56 is attached to the hard stand mounting portion 10b formed on the upper flat portion 10a of the housing 10, so that the housing 56 is installed so as to be substantially perpendicular to the upper flat portion 10a. The hard stand 150 is removably installed on the hard stand mounting portion 10b. Further, the support 156 has a tube storage groove 15 for storing the tubes 114 and 115 connected to the blood inflow port 6 or the blood outflow port 7 after storing the leukocyte removal filter 101.
7. When the leukocyte removal filter 101 is stored, as shown in FIG.
The tube 114 connected to the lower port of the tube 1 contacts the lower surface of the stand and bends.
It goes outside through 57. Therefore, the tube connected to the lower port is accommodated in the tube accommodating groove 157 near the port and gently bent by the above-described configuration, so that the tube does not kink and does not obstruct the inflow of blood. Further, the stand mounting portion 10b may include a weight sensor.

The thickness of the hard stand 150 is preferably 2 mm or more in most parts. This is because, even if the container is made of a hard resin, if the wall thickness is thin, the expansion of the leukocyte removal filter causes the hard stand to be pushed out, so that the capacity cannot be appropriately regulated. Also, most of them are hard stand 1
This is because the above object can be achieved even when a part of 50 is less than 2 mm. As a material for forming the hard stand,
Polypropylene, hard vinyl chloride, polystyrene, polyethylene and the like are used, and polypropylene is more preferable. In addition, the thickness of the hard stand is more preferably 2 to 3 mm in a range of 2 mm or more. Further, it is preferable that the hard stand 150 is made of a highly transparent resin. Thereby, it is possible to confirm in what state the substance to be filtered is circulating, and it is possible to quickly cope with a situation where the substance to be filtered is clogged. Styrene resins such as polystyrene and styrene-butylene copolymer, and polyolefin resins such as polycarbonate, polypropylene, and polyethylene are used as the highly transparent resin. It is not necessary to be completely transparent as long as the state inside the leukocyte removal filter can be confirmed, and the filter may be made of a translucent resin. Further, the hard stand may be one in which tube guide notches 164 and 165 are formed on both side surfaces of the main body 162 like the hard stand 160 shown in FIG. The rigid stand 160 is the same as the rigid stand 150 except that tube guide notches 164 and 165 are formed on both side surfaces of the main body 162.

Further, as shown in FIG.
An operation panel 59 having a power switch, various switches, and the like is provided on a front surface of the device. By setting using the operation panel 59, the blood component separation described above is automatically performed. As shown in FIG. 1, tubes 114 and 11 are provided on the flat upper surface 10a of the housing 10.
Clamps 56, 5 that can open and close the flow paths of 7 and 118
7, 58 are provided. Clamps 56, 57, 58
Opens and closes the flow passages of the tubes 114, 117, and 118 by the solenoids attached to them.

As shown in FIG. 1, one end of the lid 11 is rotatably attached to the housing 10, and can be raised substantially perpendicularly to the upper flat portion 10a. The fixing jig 54 for suspending the plasma collection bag 106 and the red blood cell collection bag 107 is attached inside the lid 11. The fixing jig 54 is provided with two hooks 54a at both ends, one of which is a first suspension (the suspension of the red blood cell collection bag) and the other is a second suspension.
(A suspension portion for a bag for collecting plasma after collection of plasma). Opening 1 for hanging
13 and 119, the plasma collection bag 106 and the red blood cell collection bag 107 are suspended. Further, the fixing jig 54 may be capable of adjusting the height from the upper surface flat portion 10a.

Next, the blood separation method of the present invention will be described. FIG. 8 is an external view of a blood component collection circuit used in the blood component separation method according to the embodiment of the present invention. The blood component collection circuit 100 includes a whole blood collection bag 105, a plasma collection bag 106, an erythrocyte liquid collection bag 107, and a branch portion 116 having one end connected to the whole blood collection bag 105 and bifurcated. And a connecting tube 102 having one end connected to a plasma collection bag 106 and the other end connected to an erythrocyte liquid collection bag 107, a branch portion 116 of the connection tube 102, and a whole blood collection device. A leukocyte removal filter 101 disposed between the bags 105. The connecting tube 102 is connected to the tubes 114, 115, 117, 118 and the branch portion 1.
It consists of 16. As shown in FIG. 1, the blood component collection circuit 100 described above is mounted on, for example, a blood component separation device 10 described below and used for collecting blood components. The blood component separation device is not limited to this embodiment.

Next, a blood component separation method performed by using the above-described blood component collection circuit 100 will be described with reference to a case where the blood component separation device 10 is used. According to the blood component separation method of the present invention, the above-described blood component separation device 10 includes the whole blood collection bag 105, the plasma collection bag 106, the leukocyte removal filter 101, and the red blood cell collection bag 107 filled with the red blood cell storage solution. Using a blood component collection circuit 100 having at least
This is a blood component separation method performed by mounting a blood component collection circuit 100 in which whole blood separated into an upper plasma layer and a lower blood cell layer is housed. Further, in the blood component separation method of the present invention, the whole blood collection bag 105 includes the filter 101.
(Specifically, a red blood cell preservation solution-filled bag 107 or a red blood cell preservation solution-filled bag (not shown) filled with a red blood cell preservation solution so as to be below the filter held by the stand). The blood component separation is performed in a state where the blood component is disposed above a filter 101 (specifically, a filter held on a stand).

Further, the blood component separation method of the present invention comprises a step of flowing the liquid which first flows into the leukocyte removal filter from the lower part of the leukocyte removal filter which is stored almost vertically in the stand. . The blood component collection circuit includes at least a whole blood collection bag 105, a plasma collection bag 106, a white blood cell removal filter 101, a red blood cell collection bag 107, and a red blood cell storage liquid filling bag (not shown). There may be.

The blood component separation method of the present invention will be specifically described. First, whole blood is collected in the whole blood collecting bag 105 using the blood collecting means 104. And after blood collection,
Using a tube sealer, the vicinity of the base of the tube 109 is sealed, and the blood sampling means 104 is separated.

Next, a step of installing the blood component collection circuit 100 in a centrifuge and performing centrifugation is performed. The centrifuged whole blood in the whole blood collection bag 105 is composed of a plasma layer mainly composed of plasma at the upper part of the bag 105 and a red blood cell layer mainly composed of red blood cells at the lower part of the bag 105. Although depending on the degree of centrifugation, the upper plasma layer usually contains leukocytes and erythrocytes, and the erythrocyte layer also usually contains leukocytes. If the number of leukocytes is n × 10 ⁶ or more in red blood cells derived from a 400 ml blood collection bag, an antibody production reaction is caused, which is not preferable.

Next, the whole blood collection bag 10 is subjected to a centrifugation step.
A poor leukocyte plasma collection step is performed in which the plasma layer separated in 5 passes through the leukocyte removal filter 101 and is collected in the plasma collection bag 106. As shown in FIG. 1, the leukocyte removal filter 101 is housed in a hard stand 150 with the blood inflow port 6 side downward and the blood outflow port 7 side upward, and the whole blood collection bag 105 is removed from the leukocyte removal filter 101. The plasma collection bag 106 is stored in the storage section 69 of the liquid separation device 55 provided at a low position.
Is installed at a position lower than the leukocyte removal filter 101,
The red blood cell collection bag 107 is hung at a position higher than the leukocyte removal filter 101 using the hook 54 a of the fixing jig 54 provided on the lid 11. In addition, tube 11
4, 117 and 118 are fixed to clamps 56, 57 and 58 as shown in FIG.

In this state, when the separation start switch of the blood component separation device 10 is pressed, the clamp 5 is operated by the solenoid.
6, 57, 58 are closed and tubes 114, 117 and 118 are closed. At this stage, the tube 114
The breakable communication member 110 provided on the tube 117 and the breakable communication member 111 provided on the tube 117 are broken. When the separation start switch of the blood component separation device 10 is pressed again, the tube 11 is actuated by the solenoid.
4 and 118 are opened, the pressing mechanism presses the whole blood collection bag 105, and the upper plasma layer in the whole blood collection bag 105 is sent out to the plasma collection bag 106. At the time of the plasma transfer, the air in the filter 101 is removed by the plasma collection bag 106 prior to the transfer of the plasma.
Surely flows into. For this reason, priming, which is a work of replacing the air and liquid in the filter, is reliably performed.
Then, the plasma passes through the leukocyte removal filter 101 and is filtered, and then flows into the plasma collection bag 106. Then, as the compression is continued, the interface between the plasma layer and the blood cell layer in the container gradually rises, and when the liquid detection unit 71 detects the interface of the blood cell fluid, the clamp 58 is closed and the tube 114 is closed. When the tube 114 is closed, the plasma still remains on the inlet side or the outlet side of the filter 101, but the plasma collection bag 106
Is disposed at a position lower than the leukocyte removal filter 101, most of the residual plasma is collected in the plasma collection bag. In addition, when the plasma component passes through the leukocyte removal filter 101 during the plasma separation, the plasma will prime the leukocyte removal filter, and it is necessary to sufficiently exhaust air at that time. If the priming is not performed properly, air will be trapped in the leukocyte removal filter, and a portion of the filter medium will be damaged, which will make it impossible to fully utilize the performance of the filter.

In the blood component separation method of the present invention, the blood filter flows from the blood inflow port 6 located below the leukocyte removal filter 101 by arranging the leukocyte removal filter by the hard stand 150 as described above. Since the leukocyte removal filter member 5 gets wet sequentially, air is appropriately discharged in accordance therewith, and finally the air is discharged from the blood outflow port 7 provided above the leukocyte removal filter. Thereby, priming of the leukocyte removal filter 101 is appropriately performed. Further, since the leukocyte removal filter 101 is housed in the rigid stand 150 having the above-described configuration, the filter member 5
The space between the fluid and the thermoplastic soft resin sheet 21, in other words, the capacity of the inflow-side blood chamber 3 is regulated, so that the head (liquid to be filtered) inside the leukocyte removal filter 101 is maintained and Is increased to push the filter into the filter medium 52, and the filtration speed is improved.

Next, after the leukocyte plasma collection step and before the leukocyte red blood cell collection step, the red blood cell storage solution in the red blood cell collection bag 107 is stored in the whole blood collection bag 105.
A red blood cell preservation liquid injection step of injecting into the red blood cell liquid in the inside is performed.
In the embodiment, when the residual plasma in the leukocyte removal filter 101 is collected and the leukocyte removal filter 101 reaches the set weight, the clamp 57 is closed and the compression of the pressing mechanism is automatically released after the tube 118 is closed. Thereafter, the tubes 114 and 117 are opened. Next, the clamp 56 closing the tube 117 communicating with the red blood cell fluid collection bag 107 is opened, and the red blood cell storage solution (MA
The red blood cell preservation solution (MAP) is sent to the whole blood collection bag 105 via the white blood removal filter 101 through the white blood removal filter 101, and is mixed with the blood cell solution in the whole blood collection bag 105. On this occasion,
As shown in FIG. 1, a red blood cell fluid collection bag 1
07, the leukocyte removal filter 101, and the whole blood collection bag 105 can be arranged in this order, so that the red blood cell storage solution of the red blood cell collection bag 107 hardly remains in the white blood cell removal filter. Can be transferred to Then, the plasma collection bag from which the plasma has been collected is sealed with a tube 118 using a tube sealer, and the plasma collection bag 106 is cut off, thereby producing a bag containing a plasma preparation.

Next, a poor leukocyte / erythrocyte liquid collection step is performed in which the blood cell liquid in the whole blood collection bag 105 is passed through the leukocyte removal filter 101 and collected in the red blood cell collection bag 107. In the embodiment, the whole blood collection bag 105, the leukocyte removal filter 101, and the red blood cell collection bag 107 are used.
Is removed from the blood component separation device 10, the whole blood collection bag 105 is suspended at a high place, and the red blood cell liquid in the whole blood collection bag 105 is subjected to the leukocyte removal filter 101 using the head.
To perform leukocyte removal. As a result, the number of white blood cells in the red blood cell layer can be removed until it becomes 1 × 10 ⁶ or less.

Further, since the leukocyte removal filter 101 is housed in the rigid stand 150 having the above-described structure, the space between the leukocyte removal filter member 5 and the thermoplastic soft resin sheet 21, in other words, the inflow side Since the capacity of the blood chamber 3 is regulated, the head of the blood cell component in the leukocyte removal filter 101 is maintained, the pressure for pushing the blood cells into the filter medium 52 is increased, the filtration speed is improved, and the filtration can be performed quickly. After the erythrocyte fluid was separated into the erythrocyte fluid collection bag 107, the tube 117 was sealed using a tube sealer, and the erythrocyte fluid collection bag 107 was separated to prepare a bag containing a MAP-enriched erythrocyte preparation.

FIG. 9 is an external view of another blood component collection circuit used in the blood separation apparatus and the blood separation method of the present invention. The blood component collection circuit 120 of this example includes a blood component except that the leukocyte removal filter 130 is of a hard housing type and the connecting tube 103 includes a bypass line 133 that bypasses the leukocyte removal filter 130. It is the same as the sampling circuit 100. Hereinafter, the differences will be mainly described. As shown in FIG. 9, the blood component collection circuit 120 of the present invention includes a whole blood collection bag 105, a plasma collection bag 106, a red blood cell collection bag 107, and a connection tube 103. The connecting tubes 103 are tubes 123 and 12 for connecting the leukocyte removal filter 130 and the whole blood collection bag 105.
4 and tubes 125, 127, 128, and 129 that branch and connect the leukocyte removal filter 130, the plasma collection bag 106, and the red blood cell collection bag 107.
A bypass line 133 that bypasses the branch part 126, the leukocyte removal filter 130, the blood inflow port 136, and the blood outflow port 137;
33, tubes 123, 124 and tube 125,
.
Whole blood collection bag 105, plasma collection bag 106, red blood cell collection bag 107, tubes 123 and 124,
125, 127, 128 and 129, branching section 126,
The above-mentioned thing is used for blood component separation device 10.

The leukocyte removal filter 130 has the same configuration as the leukocyte removal filter 101 except for the constituent materials of the housing. Since the outer diameter of the housing is made of a hard resin, it does not expand even if the liquid flows. The bypass line 133 is made of the same resin as the tube described above. Each of the branch portions 134 and 135 includes a check valve (not shown) so that blood cell components that have not passed through the leukocyte removal filter 130 do not flow therein. This regulates the flow of the liquid from the tube 124 to the tube 133 and the flow of the liquid from the tube 133 to the tube 125. Further, since the flow of the liquid in the opposite direction is not regulated, the air from the plasma collection bag 106 is separated from the branch 135, the bypass line 133, and the branch 13 as described later.
4 and can be injected into the whole blood collection bag 105. As the check valve, known ones can be used, and for example, a ball valve check valve, an umbrella valve check valve and the like are preferable.

Next, the blood component separation method of this embodiment will be described. First, a blood leukocyte plasma collection step of centrifuging the blood component collection circuit 120 to cause the plasma component separated in the whole blood collection bag 105 to pass through the leukocyte removal filter 130 and collect the plasma component in the plasma collection bag 106 is performed. . Specifically, the leukocyte removal filter 130 is stored in the hard stand 150 with the blood inflow port 136 side downward and the blood outflow port 137 side upward as described above, and the whole blood collection bag 105 is The plasma collection bag 106 is stored in the storage section 69 of the liquid separation device 55 provided at a position lower than the filter 130.
Is installed at a position lower than the leukocyte removal filter 130. The red blood cell collection bag 107 is hung at a position higher than the leukocyte removal filter 130 using the hook 54a of the fixing jig 54 provided on the lid 11. Also,
Whole blood collection bag 105 and red blood cell collection bag 1
In 07, a certain amount of air is sealed in advance. Also, tubes 124, 127 and 128
Are fixed to clamps 58, 56 and 57, respectively.

When the separation start switch is pressed in this state,
The pressing mechanism presses the whole blood collection bag 105, and the upper plasma layer in the whole blood collection bag 105 is sent out to the plasma collection bag 106. And at this time, filter 1
The air in 30 reliably flows into the plasma collection bag 106 prior to the movement of the plasma. For this reason, priming, which is a work of replacing the air and liquid in the filter, is reliably performed. Then, while the compression is continued, the interface between the plasma layer and the blood cell layer in the container gradually rises, and when the liquid detecting unit 71 detects the interface of the blood cell fluid, the clamp 58 is operated and the tube 124 is closed. . At the time when the tube 124 is closed, the plasma still remains on the inlet side or the outlet side of the filter 130. In order to recover this residual plasma, after the pressure of the pressing mechanism of the whole blood collection bag 105 is released and the blockage of the tube 124 is released, the plasma collection bag 106 is pressed to release the air in the plasma collection bag 106. The blood is sent to the whole blood collection bag 105 via the bypass line 133. Thereafter, the whole blood collection bag 105
Again, the air in the bag 105 is sent to the leukocyte removal filter 130, and the leukocyte removal filter 1
30 to push out the residual plasma from the plasma collection bag 106
Collect within. The tube 124 communicating with the whole blood sampling bag 105 is automatically closed when the liquid sensing unit 71 senses a blood cell layer. Bypass line 1 only for leukocyte removal filter 130 with rigid housing
The reason for having the plasma collection bag 33 is that the rigid housing does not change in volume unlike the soft housing, and thus the plasma collection bag 106
This is because the residual plasma is not naturally collected by placing the underside.

Also in the case of this embodiment, the leukocyte removal filter 130 is arranged with the blood inflow port 136 on the lower side and the blood outflow port 137 on the upper side.
It can be more appropriately primed with plasma. Further, since the leukocyte removal filter 130 has a hard housing, the capacity of the inflow-side blood chamber 3 can be regulated accurately, and the filtration speed is improved.

Next, as described above, after the leukocyte-leukocyte collection step and before the leukocyte-leukocyte collection step, the red blood cell preservation solution in the red blood cell collection bag 107 is stored in the whole blood collection bag 105. A red blood cell preservation liquid injection step of injecting into the red blood cell liquid is performed. The plasma collection bag from which the plasma was collected was sealed using a tube sealer to seal the tube 128, and the plasma collection bag 106 was cut off to produce a plasma preparation-containing bag. Next, the whole blood collection bag 105
The blood leukocyte liquid inside the cell is passed through the leukocyte removal filter 130 and collected in the red blood cell liquid collection bag 107 to perform a poor leukocyte red blood cell liquid collecting step. In this embodiment, the whole blood collection bag 105, the leukocyte removal filter 130, and the red blood cell collection bag 107 are removed from the blood component separation device 10,
The whole blood collection bag 105 is suspended at a high place, and the red blood cell fluid in the whole blood collection bag 105 is sent to the white blood cell removal filter 130 by utilizing the head to perform white blood cell removal. At this time, since the red blood cells containing the red blood cell preservation liquid remain near the inlet and the outlet of the leukocyte removal filter 130, the air in the red blood cell liquid collection bag 107 is supplied to the whole blood collection bag 105 via the bypass line 133. After being sent, the whole blood collection bag 105 is pressed again to push out the residual red blood cell fluid from the white blood cell removal filter 130 and collect it in the red blood cell fluid collection bag 107. After filtering the erythrocyte fluid,
Using a tube sealer, the tube 127 was sealed, and the red blood cell fluid collection bag 107 was cut off to prepare a bag containing a MAP-enriched red blood cell preparation.

Next, another example of a blood component collecting circuit used in the blood separating apparatus and the blood separating method of the present invention will be described with reference to the drawings. FIG. 10 is an external view of another example of a blood component collection circuit used in the blood separation device and the blood separation method of the present invention. FIG. 2 is a perspective view showing a state in which the blood component collection circuit is mounted on the blood component separation device of the present invention. The blood component separation method according to this embodiment includes a blood component collection bag including at least a whole blood collection bag 105, a plasma collection bag 106, a red blood cell collection bag 107 filled with a red blood cell storage solution, and a leukocyte removal filter 101. The circuit 140 is used. The blood component separation method includes the steps of centrifuging a blood component collection circuit after collecting whole blood in the whole blood collection bag 105 and plasma components separated in the whole blood collection bag 105 by the centrifugation process. And a red blood cell preservation liquid injecting the red blood cell preservation liquid in the red blood cell liquid collection bag 107 into the red blood cell liquid in the whole blood blood collection bag 105 after the plasma collection step. A red blood cell preservation liquid-added leukocyte red blood cell liquid collection step in which the red blood cell preservation liquid-added blood cell liquid in the whole blood blood collection bag 105 is passed through the leukocyte removal filter 101 and collected in the red blood cell liquid collection bag 105. I have.

As shown in FIG. 10, the blood component collection circuit 140 includes a whole blood collection bag 105, a plasma collection bag 106, a red blood cell collection bag 107 filled with a red blood cell storage solution, and one end. A bifurcated branch 146 connected to the whole blood collection bag 105 and bifurcated;
One end of the branch is connected to the plasma collection bag 106, and the other end is connected to the connection tube 141 connected to the red blood cell collection bag 107, and between the branch 146 of the connection tube 141 and the red blood cell collection bag 107. And a leukocyte removal filter 101 arranged at the same position. And
The connecting tubes 141 are tubes 144, 145,
7 and 148, and a branch portion 146. As shown in FIG. 2, the blood component separation circuit 30
40 is mounted. And the whole blood collection bag 105,
Leukocyte removal filter 101, plasma collection bag 10
6, tubes 144, 145, 147 and 148, branch portion 146, and blood component separation device 10 are as described above.

Next, a blood component separation method performed using the blood component collection circuit 140 of the present invention will be described. First, as in the case of the blood component collection circuit 100, a step of collecting blood in the whole blood collection bag 105 and then centrifuging it is performed. Next, a plasma collection step of collecting the plasma components separated in the whole blood collection bag 105 by the centrifugation step into the plasma collection bag 106 is performed. Specifically, the leukocyte removal filter 101 is placed on the rigid stand 15 with the blood inflow port 6 side upward and the blood outflow port 7 side downward.
0, and the whole blood collection bag 105 is placed at a position lower than the leukocyte removal filter 101.
5, and the plasma collection bag 106 and the red blood cell collection bag 107 are hung at a position higher than the leukocyte removal filter 101 using the hook 54a of the fixing jig 54 provided on the lid 11. Tube 1
44, 147 and 148 are clamps 56 and 5 respectively.
8 and 57 are fixed.

In this state, when the separation start switch is pressed in the same manner as described above, the clamps 56, 57, 5
8 is closed and tubes 144, 147 and 148 are closed. At this stage, the breakable communication member 110 provided on the tube 147 and the breakable communication member 111 provided on the tube 144 are broken. When the separation start switch of the blood component separation device 10 is pressed again, the tube 144 is closed, and the tube 14 is closed.
7 and 148 are opened, the pressing mechanism presses the whole blood collection bag 105, and the upper plasma layer in the whole blood collection bag 105 is sent out to the plasma collection bag 106.
Then, while the compression is continued, the interface between the plasma layer and the blood cell layer in the container gradually rises, and when the liquid detection unit 71 detects the interface of the blood cell fluid, the tube 147 is closed.

Next, a red blood cell preservation liquid injecting step of injecting the red blood cell preservation liquid in the red blood cell liquid collection bag 107 into the red blood cell liquid in the whole blood collection bag 105 is performed. Specifically, after the clamp 57 is automatically closed and the tube 148 is closed, the pressing of the pressing mechanism and the closed state of the tubes 147 and 144 are released, and the red blood cell storage solution in the red blood cell fluid collection bag 107 is released. Leukemia removal filter 10
1 and flows into the whole blood collection bag 105 to be mixed with red blood cells. As in the present invention, when the plasma component does not pass through the leukocyte removal filter during plasma separation,
Since the erythrocyte preservation solution primes the leukocyte removal filter, it is necessary to sufficiently exhaust air at that time. If the priming is not performed properly, air will be trapped in the leukocyte removal filter, and a portion of the filter medium will be damaged, which will make it impossible to fully utilize the performance of the filter.

In the blood component separation method of the present invention, by arranging the leukocyte removal filter 101 as described above, the erythrocyte preservation solution flows in from the blood outflow port 7 located below the leukocyte removal filter 101, and from below. Since the leukocyte removal filter member gets wet in order, the air is appropriately discharged accordingly, and finally the air is discharged from the blood inflow port 6 provided on the upper part of the leukocyte removal filter. Thereby, priming of the leukocyte removal filter 101 is appropriately performed. Further, since the leukocyte removal filter 101 is housed in the rigid stand 150 having the above-described configuration, the space between the leukocyte removal filter member 5 and the thermoplastic soft resin sheet 21, in other words, the inflow-side blood chamber 3. Is regulated, the head of the liquid (substance to be filtered) inside the leukocyte removal filter 101 is maintained, the pressure for pushing the substance to be filtered into the filter medium 52 is increased, and the filtration speed is improved. Further, as shown in FIG. 2, since the red blood cell fluid collection bag 107, the white blood cell removal filter 101, and the whole blood blood collection bag 105 can be arranged in this order from the highest side, the red blood cell storage solution in the red blood cell fluid collection bag 107 The blood can be transferred into the whole blood collection bag 105 with almost no residual in the leukocyte removal filter.
Then, using a tube sealer, the tube 148 was sealed, the bag for plasma collection 106 was cut off, and a bag containing a plasma preparation was produced.

Next, a poor leukocyte / erythrocyte liquid collection step is performed in which the blood cell liquid in the whole blood collection bag 105 is passed through the leukocyte removal filter 101 and collected in the red blood cell collection bag 107. In this embodiment, the whole blood collection bag 105
Leukocyte removal filter 101, red blood cell fluid collection bag 1
07 is removed from the blood component separation device 10, the whole blood collection bag 105 is hung at a high place, and the red blood cell fluid in the whole blood collection bag 105 is subjected to the head drop by utilizing the head.
01 to perform leukocyte removal. As a result, the number of white blood cells in the red blood cell layer can be removed until it becomes 1 × 10 ⁶ or less.

After separating the red blood cell fluid into the red blood cell fluid collection bag 107, the tube 144 is sealed using a tube sealer, and the red blood cell fluid collection bag 107 is separated.
Was cut off to prepare a MAP-enriched red blood cell preparation bag. Further, another example of a blood component collection circuit used in the blood separation device and the blood separation method of the present invention will be described with reference to the drawings. FIG. 11 is an external view of another example of a blood component collection circuit used in the blood separation device and the blood separation method of the present invention. In the blood component collection circuit 150 used in the blood component separation method of this embodiment, the leukocyte removal filter 130 is of a hard housing type,
The connection tube is the same as the blood component collection circuit 140 except that the connection tube includes a bypass line 173 that bypasses the leukocyte removal filter 130. Hereinafter, the differences will be mainly described.

The blood component collection circuit 150 of the present invention is the same as that shown in FIG.
As shown in FIG. 1, a bag 105 for collecting whole blood, a bag 106 for collecting plasma, a bag 107 for collecting red blood cell fluid, and a connecting tube 170 are provided. The connection tube 170 includes the leukocyte removal filter 130 and the leukocyte removal filter 1.
30 and tubes 175 and 177 for branching and connecting the whole blood collection bag 105 and the plasma collection bag 106.
178 and 179, a branch 176, tubes 172 and 174 connecting the leukocyte removal filter 130 and the red blood cell collection bag 107, a bypass line 173 that bypasses the blood inflow port 136 and the blood outflow port 137, and a bypass line 173 and tube 17
Branch 18 connecting 2, 174 and 175, 179
4, 185. Then, the leukocyte removal filter 130, the whole blood collection bag 105, the plasma collection bag 106, the red blood cell collection bag 107, the tube 1
72, 174, 175, 177, 178 and 179;
The above-described components are used for the branch unit 176, the branch unit 184, the branch unit 185, and the blood component separation device 10. The bypass line 173 and the branch portions 184 and 185 are formed in the same manner as the bypass line 133 and the branch portions 134 and 135, so that blood that has not passed through the leukocyte removal filter 130 does not flow into the branch portions 184 and 185. Is provided with a check valve (not shown). The housing of the leukocyte removal filter 130 is made of a hard resin such as polycarbonate. The other structure of the leukocyte removal filter is as described above.

Next, a blood component separation method performed using the blood component collection circuit 150 of the present invention will be described. First, as in the case of the blood component collection circuit 100, a step of collecting blood in the whole blood collection bag 105 and then centrifuging it is performed. As described above, since the boundary between the upper plasma layer and the lower plasma layer is clarified based on the buffy coat layer by centrifuging before blood component separation, it is possible to minimize the mixing of red blood cells when separating the plasma layer. . Next, a plasma collection step of collecting the plasma components separated in the whole blood collection bag 105 by the centrifugation step into the plasma collection bag 106 is performed.

Specifically, the leukocyte removal filter 130 is housed in a hard stand 150 with the blood inflow port 136 side upward and the blood outflow port 137 side downward, and the whole blood collection bag 105 is 1
The plasma collection bag 106 and the red blood cell collection bag 107 are stored in the storage section 69 of the liquid separation device 55 provided at a position lower than 30 and the fixing jig 5 provided on the lid 11.
4, the leukocyte removal filter 130 is used.
Hang it at a higher position. In addition, tubes 177, 1
74 and 178 are clamps 58, 56, respectively.
57. In this state, when the separation start switch is pressed in the same manner as above, the clamp 5 is operated by the solenoid.
6, 57, 58 are closed and tubes 174, 177 and 178 are closed. At this stage, the tube 177
The rupturable communication member 110 provided on the tube 174 and the rupturable communication member 110 provided on the tube 174 are broken. When the separation start switch of the blood component separation device 10 is pressed again, the tube 17 is operated by the solenoid.
4 is closed and the tubes 177 and 178 are opened, the pressing mechanism presses the whole blood collection bag 105, and the upper plasma layer in the whole blood collection bag 105 is sent out to the plasma collection bag 106. Then, while the compression is continued, the interface between the plasma layer and the blood cell layer in the container gradually rises, and when the liquid detecting unit 71 detects the interface of the blood cell fluid, the tube 177 is closed by the clamp 58, and after a while , Most of the plasma components are in the plasma collection bag 106.
Transported in

Next, a red blood cell preservation liquid injecting step of injecting the red blood cell preservation liquid in the red blood cell liquid collection bag 107 into the red blood cell liquid in the whole blood collection bag 105 is performed. Specifically, with the pressure of the pressing mechanism released and the tubes 174 and 177 opened, the red blood cell preservation solution (MAP) is passed from the red blood cell fluid collection bag 107 through the white blood removal filter 130,
The blood is sent into the whole blood collection bag 105 and mixed with the red blood cells. At this time, as described above, the leukocyte removal filter 13
Since 0 is disposed on the hard stand 150, priming and filtration can be performed appropriately. Then, using a tube sealer, the tube 178 was sealed, the plasma collection bag 106 was cut off, and a bag containing a plasma preparation was produced.

Next, a poor leukocyte / erythrocyte liquid collection step is performed in which the blood cell liquid in the whole blood collection bag 105 is passed through the leukocyte removal filter 130 and collected in the red blood cell collection bag 107. In the embodiment, the whole blood collection bag 105, the leukocyte removal filter 130, the red blood cell collection bag 107
Is removed from the blood component separation device 10, the whole blood collection bag 105 is suspended at a high place, and the red blood cell liquid in the whole blood collection bag 105 is subjected to a leukocyte removal filter 130 using a head.
To perform leukocyte removal. When the filtration is stopped, red blood cell fluid remains on the inlet side or the outlet side of the filter. In order to collect this residual red blood cell fluid, a tube 17 is used.
3 is closed, the red blood cell fluid collection bag 107 is pressed, and the air in the red blood cell fluid collection bag 107 is sent to the whole blood blood collection bag 105 via the bypass line 173. , The residual red blood cell liquid is allowed to flow down and collected in the bag 107. Thereby, the number of white blood cells in the blood cell fluid can be removed until it becomes 1 × 10 ⁶ or less.

After separating the red blood cell fluid into the red blood cell fluid collection bag 107, the tube 174 is sealed using a tube sealer, and the red blood cell fluid collection bag 107 is removed.
Was cut off to prepare a MAP-enriched red blood cell preparation bag. Note that, 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 a plurality of portions may not be connected in advance, and the portion may be connected using an aseptic joining device immediately before use.

(Experiment 1) (Example 1) The blood component collection circuit having the above-described configuration shown in FIG. 8 was used. 400 ml of whole blood was collected in a soft vinyl chloride resin whole blood collection bag and then centrifuged. Subsequently, 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 blood inflow-side soft polyvinyl chloride sheet is placed on the lower side, and the leukocyte-removing filter member to which the filter medium is fused is placed thereon. A tube made of a soft polyvinyl chloride was placed 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.

Whole blood was collected in a whole blood collection bag. After centrifugation, the whole blood collection bag is pressed to transfer the plasma to the plasma collection bag via the leukocyte removal filter. At this time, the plasma collection bag was located below the filter. Pressing the whole blood collection bag causes the plasma to flow into the filter, and the filtered plasma is transferred to the plasma collection bag. The interface between the plasma layer and the red blood cell layer in the bag gradually rises as the whole blood collection bag press is continued. When the interface reaches a predetermined position, the press is stopped. When the press is stopped, plasma still remains on the inlet or outlet side of the filter, but due to the effect of keeping the plasma collection bag below the filter, almost all of this residual plasma will soon be used for plasma collection. Collected in bag. At this time, the filter stand was used, and the direction of mounting the filter was appropriate, so that air in the filter was sufficiently discharged. The tube attached to the plasma collection bag was sealed and cut to obtain a plasma preparation-containing bag. The contents of the red blood cell collection bag are transferred to the whole blood collection bag via the filter with the red blood cell collection bag facing upward. At this time, the filter stand was used, and since the head was appropriate, the contents of the red blood cell collection bag were sufficiently transferred to the whole blood collection bag without leaving the extra liquid in the filter. Could be done. The red blood cells in the whole blood collection bag to which the liquid content of the red blood cell collection bag was added were mixed, and blood filtration was performed with the whole blood collection bag facing upward. When the filtration was completed, the tube connecting the bag for collecting the red blood cell fluid and the filter was sealed to obtain a bag containing the MAP-enriched red blood cell preparation. By performing the operation using the filter stand, it was possible to reliably discharge the air from the filter and add the MAP solution to the concentrated red blood cells without any special operation.

Example 2 A blood component collecting circuit similar to that of Example 1 was used except that the position of the leukocyte removal filter was as shown in FIG. Whole blood was collected in a whole blood collection bag. After centrifugation, the whole blood collection bag was pressed to transfer the plasma to the plasma collection bag. The tube attached to the plasma collection bag was sealed and cut to obtain a plasma preparation-containing bag. The contents of the red blood cell collection bag were transferred to the whole blood collection bag with the red blood cell collection bag facing upward. At this time, the filter stand is used, and since the head is appropriate, the contents of the red blood cell collection bag are sufficiently transferred to the whole blood collection bag without excessively remaining the liquid in the filter. I was able to.
The red blood cells in the whole blood collection bag to which the liquid content of the red blood cell collection bag was added were mixed, and blood filtration was performed with the whole blood collection bag facing upward. When the filtration was completed, the tube connecting the bag for collecting red blood cell fluid and the filter was sealed to obtain a bag containing a MAP-enriched red blood cell preparation.

(Embodiment 3) The blood component collecting circuit shown in FIG. 9 and configured as described above was used. The hard leukocyte removal filter has a length of 95 mm as a housing forming member.
mm, 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. As the leukocyte removal filter medium, six polyester nonwoven fabrics (thickness: about 1 mm, fiber diameter: 5 μm, length: about 85 mm, width: about 65 mm) are punched out in an elliptical shape, and six layers are laminated.
It was produced by heat sealing the outer periphery. 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. This was filled in the housing described above. The bag for red blood cell fluid collection is previously filled with 15 to 30 ml of air in addition to the MAP solution. A check valve is provided in the bypass line, and its effect prevents blood that has not passed through the filter from flowing into the lower portion of the filter.

Whole blood was collected in a whole blood collection bag. After centrifugation, the whole blood collection bag was pressed and the plasma was transferred to the plasma collection bag via the filter. Pressing the whole blood collection bag causes the plasma to flow into the filter, but due to the rigid housing of the filter, the plasma sequentially passes through the filter. The interface between the plasma layer and the erythrocyte layer in the bag gradually increased while continuing to press the whole blood collection bag, but the press was stopped when the interface reached a predetermined position. At this time, since the filter stand was used and the direction of mounting the filter was appropriate, the air in the filter was sufficiently discharged. On the other hand, when the press is stopped, the plasma remains in the dead spaces on the inlet and outlet sides of the housing. To collect this residual plasma, after closing the tube between the blood outlet port on the filter outlet side and the tube branch, the whole blood collection bag press is loosened, and the plasma collection bag is pressed to collect the plasma. Send the air stored in the bag for blood to the bag for whole blood collection via the bypass line and wait for a while. Soon, all of this residual plasma was collected in a plasma collection bag. The tube attached to the plasma collection bag was sealed and cut to obtain a plasma preparation-containing bag.
The contents of the red blood cell collection bag were transferred to the whole blood collection bag via the filter with the red blood cell collection bag facing upward. At this time, the filter stand is used, and since the head is appropriate, the contents of the red blood cell collection bag are sufficiently transferred to the whole blood collection bag without excessively remaining the liquid in the filter. I was able to.
The red blood cells in the whole blood collection bag to which the contents of the red blood cell collection bag were added were mixed, and blood filtration was performed with the whole blood collection bag at the top and the red blood cell collection bag at the bottom. After closing the tube between the blood outlet port on the filter outlet side and the tube branch, air in the red blood cell collection bag is sent to the whole blood collection bag via the bypass line, and the whole blood collection bag is moved upward and the red blood cell is removed. Hemofiltration was continued with the liquid collection bag facing down. When the filtration was completed, the tube connecting the bag for collecting the red blood cell fluid and the filter was sealed to obtain a bag containing the MAP-enriched red blood cell preparation.

Example 4 A blood component collection circuit similar to that of Example 3 was used except that the position of the leukocyte removal filter was as shown in FIG. The bag for red blood cell fluid collection is previously filled with 15 to 30 ml of air in addition to the MAP solution. A check valve is provided in the bypass line, and its effect prevents blood that has not passed through the filter from flowing into the lower portion of the filter. Whole blood was collected in a whole blood collection bag. After centrifugation, the whole blood collection bag was pressed to transfer the plasma to the plasma collection bag. The tube attached to the plasma collection bag was sealed and cut to obtain a plasma preparation-containing bag. The contents of the red blood cell collection bag were transferred to the whole blood collection bag with the red blood cell collection bag facing upward. At this time, the filter stand is used, and since the head is appropriate, the contents of the red blood cell collection bag are sufficiently transferred to the whole blood collection bag without excessively remaining the liquid in the filter. I was able to. The red blood cells in the whole blood collection bag to which the contents of the red blood cell collection bag were added were mixed, and blood filtration was performed with the whole blood collection bag at the top and the red blood cell collection bag at the bottom. After closing the tube between the blood outlet port on the filter outlet side and the tube branch, air in the red blood cell collection bag is sent to the whole blood collection bag via the bypass line, and the whole blood collection bag is moved upward and the red blood cell is removed. Hemofiltration was continued with the liquid collection bag facing down. When the filtration was completed, the tube connecting the bag for collecting red blood cell fluid and the filter was sealed to obtain a bag containing a MAP-enriched red blood cell preparation.

Comparative Example 1 The same blood component collecting circuit as in Example 1 was used. The only difference from Example 1 is that the operator did not use the filter stand, and the operator held the filter by hand and performed the same blood separation and the addition of the MAP solution to the concentrated red blood cells as in Example 1.

Comparative Example 2 The same blood component collecting circuit as in Example 2 was used. The only difference from Example 2 is that the operator did not use the filter stand, and the operator held the filter by hand and performed the same blood separation and the addition of the MAP solution to the concentrated red blood cells as in Example 2.

Comparative Example 3 The same blood component collecting circuit as in Example 3 was used. The only difference from the third embodiment is that the filter stand was not used, and the operator held the filter by hand and performed the same blood separation and addition of the MAP solution to the concentrated red blood cells as in the third embodiment.

Comparative Example 4 The same blood component collecting circuit as in Example 4 was used. The only difference from Example 4 is that the filter stand was not used, and the operator held the filter by hand and performed the same blood separation and the addition of the MAP solution to the concentrated red blood cells as in Example 4.

Comparative Example 5 The same blood component collecting circuit as in Example 1 was used. The only difference from Example 1 is that no filter stand was used and no special holding of the filter was performed.

Comparative Example 6 The same blood component collecting circuit as in Example 2 was used. The only difference from Example 2 is that no filter stand was used and no special holding of the filter was performed.

Comparative Example 7 The same blood component collecting circuit as in Example 3 was used. The only difference from Example 3 is that no filter stand was used, and no special holding of the filter was performed.

Comparative Example 8 The same blood component collecting circuit as in Example 4 was used. The only difference from Example 4 is that no filter stand was used, and no special holding of the filter was performed. The net blood collection amount (excluding the anticoagulant) in each of Examples 1 to 4 and Comparative Examples 1 to 8 was 4
00 ml. Table 1 shows the results regarding the workability and MAP-added erythrocyte filtration in each case.

[0074]

[Table 1] 表: good, ×: bad (each n = 3; average ± standard deviation)

The count of each blood cell count is determined by sysmex XE
Done by 2000, it was performed by Najetto method for further 10 ⁶ levels of white blood cell count. The leukocyte removal rate was calculated according to the following equation. Leukocyte removal rate = −log ₁₀ (white blood cell count after filtration / white blood cell count before filtration) Including.

In Comparative Examples 1 to 4, workability was not good.
In particular, it was very complicated to perform other operations while holding the filter. In contrast, in Examples 1 to 4, workability was good because it was not necessary to hold the filter. In Comparative Examples 5 to 8, there was no problem in terms of workability because no special labor was required for setting the position of the filter. In Comparative Examples 5 to 8, the dilution of the concentrated erythrocytes with the MAP solution was sometimes insufficient, so that the viscosity of the blood to be filtered was increased, and as a result, the filtration time was longer than in Examples 1 to 4. In Comparative Examples 5 to 8, the dilution of the concentrated erythrocytes with the MAP solution was sometimes insufficient,
The hematocrit of the blood to be filtered was high, and as a result, the amount of red blood cell loss remaining in the filter medium of the filter was larger than in Examples 1 to 4, and the variation was large. That is, in Comparative Examples 5 to 8, the erythrocyte recovery rate was low and the variation was large. In Comparative Examples 5 to 8, the leukocyte removal rate was low and the variation was large. It was presumed that priming was not sufficient in some cases.

[0077]

The apparatus for separating blood components according to the present invention provides 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 leukocyte removal filter. Equipment for component separation,
The blood component separation device presses a whole blood collection bag containing whole blood separated into an upper plasma layer and a lower blood cell layer, and a pressing mechanism for discharging the stored blood components.
A filter stand for holding the leukocyte removal filter substantially vertically, and a filter stand mounting portion are provided. The blood component is discharged by the pressing mechanism for pressing the whole blood collection bag containing the whole blood separated into the upper plasma layer and the lower blood cell layer instead of the head, and discharging the stored blood component. Even with the device, since the filter stand that holds the leukocyte removal filter in a substantially vertical state is provided, the inflow and outflow of the blood component to be filtered into the filter is good, so that the leukocyte can be appropriately filtered. .

In addition, if the stand is detachably mounted on the filter stand mounting portion,
With the filter attached to the filter stand,
Since the stand can be mounted on the stand mounting portion, the work of mounting the filter to the device and the work of detaching the filter become easy.
In addition, the blood component separation device has a first suspension portion (a suspension portion for red blood cell fluid collection bag) located above the whole blood collection bag and the filter stand mounting portion pressed by the pressing mechanism during use. Is provided, it is possible to allow the liquid to flow into the filter by a drop without preparing a hanging stand. In addition, the blood component separation device has a first suspension portion (a suspension portion for red blood cell fluid collection bag) located above the whole blood collection bag and the filter stand mounting portion pressed by the pressing mechanism during use. And a second hanging part (a hanging part for a bag for collecting blood plasma after collecting blood plasma), the liquid can be introduced into the filter by the head and the head can be used by utilizing the head without preparing a hanging stand. (The flow of the liquid into the plasma collection bag after the plasma is collected) can be restricted.

Further, the blood component separation method of the present invention uses the above-described apparatus for separating blood components, and comprises a bag for collecting whole blood, a bag for collecting plasma, a leukocyte removal filter, and a red blood cell liquid filled with a red blood cell storage solution. A blood component collection circuit comprising at least a bag or a blood component collection circuit comprising a whole blood collection bag, a plasma collection bag, a leukocyte removal filter, a red blood cell fluid collection bag, and a red blood cell preservation liquid-filled bag. A blood component separation method performed by mounting a blood component collection circuit in a state of containing whole blood separated into an upper plasma layer and a lower blood cell layer in a blood collection bag, wherein the whole blood collection bag is The red blood cell preservation solution-filled bag or red blood cell preservation solution-filled bag filled with the red blood cell preservation solution so as to be below the stand, At the arranged state so that above the stand, the whole blood for blood collection bag is performed the injection of red blood cell storage solution. For this reason, the fall position between the whole blood collection bag, the red blood cell collection bag filled with the red blood cell storage solution, or the red blood cell storage liquid filled bag and the leukocyte removal filter becomes appropriate, and the red blood cell storage solution in the whole blood collection bag is obtained. Is ensured. Therefore, there is no increase in filtration time, decrease in red blood cell collection rate, and decrease in white blood cell removal rate due to poor dilution of the blood cell layer of the whole blood collection bag.

Further, the blood component separation method of the present invention uses the above-described apparatus for separating blood components, and comprises a bag for collecting whole blood, a bag for collecting plasma, a leukocyte removal filter, and a method for collecting a red blood cell liquid filled with a red blood cell storage solution. A blood component collection circuit comprising at least a bag or a blood component collection circuit comprising a whole blood collection bag, a plasma collection bag, a leukocyte removal filter, a red blood cell fluid collection bag, and a red blood cell preservation liquid-filled bag. A blood component separation method in which a blood component collection circuit in a state in which a whole blood separated into an upper plasma layer and a lower blood cell layer is contained in a blood collection bag is attached, and the blood component separation method first flows into the leukocyte removal filter. The liquid to be discharged from the lower part of the leukocyte removal filter in a state of being stored substantially vertically in the stand. As a result, the liquid that first flows into the filter flows in from the lower part of the filter, so the air in the filter is reliably discharged, leaving less air in the filter and effectively using the filter's ability to remove leukocytes. Thus, the filtration time can be reduced, and the red blood cell recovery rate and white blood cell removal rate can be increased.

[Brief description of the drawings]

FIG. 1 is a perspective view of a blood component separation device used in the blood component separation method of the present invention.

FIG. 2 is a perspective view of a blood component separation device used in the blood component separation method of the present invention.

FIG. 3 is an enlarged view of an embodiment of a stand used in the apparatus for separating blood components of FIG. 1;

FIG. 4 is an enlarged view of another embodiment of a stand used in the apparatus for separating blood components of the present invention.

FIG. 5 is an explanatory diagram of an embodiment of a liquid separation device used in the blood component separation device of the present invention.

FIG. 6 is an explanatory diagram illustrating an operation of the liquid separation device of FIG. 5;

FIG. 7 is an explanatory diagram illustrating the operation of the liquid separation device of FIG. 5;

FIG. 8 is an external view of a blood component collection circuit used in the blood component separation device according to the embodiment of the present invention.

FIG. 9 is an external view of an example of a blood component collection circuit used in the blood component separation device of the present invention.

FIG. 10 is an external view of an example of a blood component collection circuit used in the blood component separation device of the present invention.

FIG. 11 is an external view of an example of a blood component collection circuit used in the blood component separation device of the present invention.

FIG. 12 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. 13 is a rear view of the leukocyte removal filter of FIG. 12;

FIG. 14 is an enlarged cross-sectional view taken along line AA of the leukocyte removal filter of FIG.

FIG. 15 is a cross-sectional view of the leukocyte removal filter of FIG. 12, taken along the line BB.

[Explanation of symbols]

 Reference Signs List 10 blood component separation apparatus 100, 120, 140, 170 blood component collection circuit 101, 130 leukocyte removal filter 105 bag for whole blood collection 106 bag for plasma collection 107 bag for red blood cell collection

Claims (8)

[Claims] An apparatus for separating blood components used in a blood component collection circuit including at least a bag for collecting whole blood, a bag for collecting plasma, a bag for collecting red blood cells, and a filter for removing leukocytes. The separation device includes a pressing mechanism for pressing a whole blood collection bag containing whole blood separated into an upper plasma layer and a lower blood cell layer and discharging the stored blood components, and a leukocyte removal filter. An apparatus for separating blood components, comprising: a filter stand that is held substantially vertically; and a filter stand mounting portion. 2. The stand comprises a main body for accommodating the leukocyte removal filter, and the main body comprises substantially parallel opposed flat plate-shaped portions which come into contact with the leukocyte removal filter during use. The apparatus for separating blood components according to claim 1, wherein an interval between the opposed flat plate-shaped portions of the main body is equal to or greater than a thickness of the leukocyte removal filter. 3. The apparatus for separating blood components according to claim 1, wherein the stand is detachably attached to the filter stand attachment portion. 4. The blood component separation device includes a first suspension portion positioned above a whole blood collection bag and a filter stand mounting portion pressed by the pressing mechanism during use. 4. The apparatus for separating blood components according to any one of claims 3 to 3. 5. The blood component separation device according to claim 1, wherein, in use, the first suspension portion and the second suspension portion located above the whole blood collection bag and the filter stand mounting portion pressed by the pressing mechanism. Claims 1 to 4 provided
The apparatus for separating blood components according to any one of the above. 6. A red blood cell fluid collection device filled with a whole blood collection bag, a plasma collection bag, a leukocyte removal filter, and a red blood cell preservation solution, using the blood component separation device according to any one of claims 1 to 5. A blood component collection circuit comprising at least a bag; A blood component separation method performed by mounting a blood component collection circuit in a state of containing whole blood separated into an upper plasma layer and a lower blood cell layer in a blood collection bag, wherein the whole blood collection bag is The red blood cell liquid collection bag or the red blood cell storage liquid filled bag filled with the red blood cell storage liquid so as to be below the stand, A red blood cell preservation solution is injected into the whole blood collection bag in a state where the red blood cell preservation solution is placed above the blood component collection method. 7. A red blood cell fluid collection device filled with a whole blood collection bag, a plasma collection bag, a leukocyte removal filter, and a red blood cell preservation solution, using the blood component separation device according to any one of claims 1 to 5. A blood component collection circuit comprising at least a bag or a blood component collection circuit comprising a whole blood collection bag, a plasma collection bag, a leukocyte removal filter, a red blood cell fluid collection bag, and a red blood cell preservation liquid-filled bag. A blood component separation method in which a blood component collection circuit in a state in which a whole blood separated into an upper plasma layer and a lower blood cell layer is contained in a blood collection bag is attached, and the blood component separation method first flows into the leukocyte removal filter. Wherein the liquid to be removed flows in from the lower part of the leukocyte removal filter stored substantially vertically in the stand. Blood component separation method. 8. The red blood cell collection bag or red blood cell preservation liquid-filled bag filled with the red blood cell preservation liquid and the red blood cell preservation liquid-filled bag is positioned such that the whole blood blood collection bag is below the stand. The blood component separation method according to claim 7, wherein the red blood cell preservation solution is injected into the whole blood collection bag in a state where the blood component is arranged.