JP2003180822A - Blood component separator - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a blood component separator which can suppress applying of unnecessary pressure to its filter part, can shorten a filtering time and can nearly fix the removing (filtering) time of white blood cell. <P>SOLUTION: The blood component separator has the filter part 4 formed by forming a filter 6 by stacking a plurality of filters (A), (B) and (C) having at least different average fiber diameters D and mounting the filter 6 to a flexible housing 7. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a blood component separator used in blood transfusion, extracorporeal circulation of blood, and the like. More specifically, it relates to an improvement of a blood component separator that efficiently removes leukocytes in a short time. Is.

[0002]

2. Description of the Related Art In a conventional blood component separating device, a non-woven fabric having a fiber diameter of 1 to 10 μm is loaded in a disk-shaped rigid housing and arranged between a blood collecting bag and a separating bag. However, (1) In general, separation of arbitrary components such as white blood cells from whole blood components is subject to individual differences depending on the blood donor and the blood thereof, which causes variations in component separation efficiency. Possible factors are differences in blood viscosity due to differences in blood hematocrit value, protein concentration such as albumin and globulin, and lipid concentration. The pressure applied to the filter section and the pressure loss generated in the filter section are different due to the difference in viscosity, and therefore it is necessary to keep it as constant as possible. (2) In order to filter the blood by loading the non-woven fabric into the hard housing, the blood flows through the gap created between the hard housing and the non-woven fabric. For this reason, there is a difference between the volume of the non-woven fabric itself and the volume inside the hard housing, which cannot be calibrated because the housing does not have flexibility in the hard housing.Therefore, residual blood remains in the housing after hemofiltration and is satisfactory. The blood recovery rate that can be obtained is not obtained. (3) In order to load a non-woven fabric into the hard housing and to function as a filter, the non-woven fabric is punched into a filter shape and the end of the non-woven fabric is crimped and crimped so that blood components do not leak from the peripheral part. Therefore, the actual effective filter area is smaller than the size of the nonwoven fabric. Moreover, the outside diameter of the housing must be larger than the effective area of the filter and the non-woven fabric punched into the filter shape. (4) Satisfactory removal efficiency cannot be achieved in a satisfactory time due to insufficient layer structure of the nonwoven fabric. It is generally known that the leukocyte removal efficiency is improved by reducing the average fiber diameter of the non-woven fabric if the leukocyte removal time is ignored. However, the increase in leukocyte removal time is unsatisfactory from the industrial viewpoint of blood product production. Both the leukocyte removal rate and the leukocyte removal time must be satisfied. (5) Further, if the rigid housing is simply replaced with a flexible housing, the member that forms the flexible housing and the filter portion are crimped (adhered) due to their flexibility, so that the blood flow remains. It cannot function as a blood separation device. More specifically, when the inner surface of the flexible housing and the surface of the blood outlet side filter section are crimped (adhered) to each other, the adhesion between them is prevented and the blood flow path in the space between the inner surface of the flexible housing and the blood outlet side filter section is prevented. Must be secured. Therefore, as a result of intensive studies to solve the above problems, the present inventors have arrived at the next invention.

[0003]

[1] According to the present invention, a filter 6 is formed by laminating a plurality of filters (A), (B) and (C) having at least different average fiber diameters D, and Flexible housing 7 with filter 6
There is provided a blood component separation device having a filter part 4 formed by loading the blood component. [2] The present invention provides the blood component separation device according to [1], wherein the filter 6 is formed by laminating a plurality of filters (A), (B) and (C) having different average fiber diameters D respectively. provide. [3] The present invention provides the blood component separation device according to [1] or [2], in which a spacer SP capable of preventing close contact between the filter 6 and the flexible housing 7 is disposed between the filter 6 and the flexible housing 7. . [4] In the present invention, the spacer SP is (a) 50 μm.
Porous body or non-woven fabric or mesh having a pore size of not less than m and not more than 5000 μm, or (b) height 50
The blood component separation device according to [1] to [3], which is formed of at least one of protrusions or ridges having a size of 0 μm or more and 8000 μm or less. [5] In the present invention, (A) the flexible housing 7 is composed of two flexible sheets S and S, and the filter 6 fixed to the supporting member 10 is provided between the sheets S and S. And the blood inlet 8 and the blood outlet 9 are attached between the sheets S and S, or (B) the blood inlet 8 and the blood outlet 9 are provided at the approximate centers of the two flexible sheets S and S, respectively. The blood component separation device according to any one of [1] to [4], in which the filter 6 fixed to the support member 10 is disposed between the sheets S and S. [6] The present invention provides a blood inlet 8 upstream of the filter unit 4.
The blood component separation device according to [1] to [5], wherein the blood collection bag 3 is connected via the blood collection bag 3, and the blood component separation bag 20 is connected downstream from the filter portion 4 via the blood outlet 9. [7] In the present invention, the filter 6 comprises at least a prefilter (A) having an average fiber diameter D of 5.0 μm or more and 10.0 μm or less, and an average fiber diameter D of more than 1.0 μm and 5.0 μm or less. No. 1 book filter (B)
And the average fiber diameter D of the second main filter (C) is 1.5 μm or less, the average fiber diameter D of the second main filter (C) is the same as the first filter. The average fiber diameter D of the present filter (B) is 50% to 90% of the average fiber diameter D, and the filters (A), (B), and (C) are formed from the blood inlet 8 to the blood outlet. The blood component separation device 1 according to [1] to [6], in which (A), (B), and (C) are laminated in this order toward 9, and the spacer SP is attached to the filter (C). To do. [8] In the present invention, the filter (A) has a stacking number of 5 to 30 and a thickness of 0.7 to 4.2 mm, and the filter (B) has a stacking number of 20 to 35. And a thickness of 2.0 to 5.1 mm, the filter (C) has a stacking number of 5 to 15 and a thickness of 0.
5 to 1.5 mm, the spacer SP has a thickness of 0.5
The blood component separation device 1 according to [7], which is 5 mm to 5 mm.
I will provide a. [9] The invention according to [7], wherein at least one or more of the filters (B) and / or the filters (C) are arranged between the filters (B) and (C). Provided is a component separation device 1. [10] The present invention provides the filters (A), (B),
The arrangement of (C) is (1) (A), [(B), (C), (B)] × n,
(C) (n> = 1) (2) (A), (B), [(C), (B)] × n,
(C) (n> = 1) (3) (A), (B), [(B), (C)] × n,
(C) (n> = 1) (4) Blood component according to [7] or [9], which is any of (A), [(B), (C)] × n (n> = 2). A separation device 1 is provided. [11] In the present invention, the filter (A) has a total number of stacked sheets of 10 to 25 and a thickness of 1.4 to 3.
5 mm, the total number of layers of the filter (B) is 2
The thickness of the filter (C) is 0 to 35 and the thickness is 2.0 to 5.1 mm.
A single sheet and having a thickness of 0.5 to 2.5 mm [7],
A blood component separation device 1 according to [9] and [10] is provided.

[0004]

1 is a schematic view showing an example of a blood component separation device 1 of the present invention, and FIG. 2 is a filter section 4 of FIG.
It is a partially enlarged view of the vicinity. Blood component separation device 1 of the present invention
Forms a filter 6 by laminating a plurality of filters (A), (B), (C) having different average fiber diameters D, and the filter 6 is formed into a flexible housing 7
, A blood collecting bag 3 connected to the upstream side of the filter portion 4 via a blood inlet 8 (or a blood transfer tube), and a blood outlet 9 downstream of the filter portion 4 (or Blood transfer tube 1
The blood component separation bag 20 is connected via 1). Further, the filter portion 4 has an average fiber diameter D.
The filter 6 is formed by laminating a plurality of different filters (A), (B), and (C). Further, a spacer SP is disposed between the filter 6 and the flexible housing 7 so as to prevent them from adhering (pressing) to each other. Spacer SP is (a) 50 μm
From the above, a porous body or a non-woven fabric or a mesh having a pore size of 5000 μm or less, or (b) a height of 500
It is formed from at least one of protrusions or ridges having a size of not less than μm and not more than 8000 μm. That is, the porous body, the non-woven fabric, the mesh, the protrusions, or the ridges may be formed as a single substance, or may be formed by combining them. In the present invention, any of the porous body or the non-woven fabric or the mesh, or the protrusions or ridges can be attached to the filter 6 and can be any form as long as blood can pass as whole blood without losing blood components. Can be adopted. The protrusions may be, for example, a plurality of island-shaped ones, a linear one, or a combination thereof. Further, the ridge-like material may be, for example, a plurality or one-piece distribution distributed in a mountain range, or a combination thereof.

The flexible housing 7 is composed of two flexible sheets S and S (in the present invention, film-like sheets are also included in the sheet), and these sheets S and S are used.
The filter 6 fixed to the support member 10 is disposed between the sheets S, and the blood inlet 8 and the blood outlet 9 are mounted between the sheets S and S via the support member 10. More specifically, the blood inlet 8 (or blood transfer tube) is mounted between the support member 10 and the lower sheet S, and the blood outlet 9 (or blood transfer tube 11) is provided between the upper sheet S and the indicating member 10. ) Is installed. The form of the filter part 4 of the present invention is not limited to that shown in FIG. 2, and for example, the approximate center of the two flexible sheets S, S (in the present invention, a film-like one is also included in the sheet). Respectively,
The blood inlet and the blood outlet are directly attached, the filter 6 fixed to the support member 10 is arranged between the sheets S and S, and the sheets S and S and the end portions of the indicating member 10 are welded. Then, a disc-shaped one can also be used. In the present invention, the pre-filter (A), the first main filter (B), and the second main filter (C) are laminated in a predetermined number in order from the blood inlet 8 to the blood outlet 9. It is loaded into the flexible housing 7. In the present invention, the blood inlet 8 and the blood outlet 9
May be a short tubular member made of hard synthetic resin, the blood inlet 8 may be a short flexible blood transfer tube, and the blood outlet 9 may be a long flexible blood transfer tube. In the present invention, the filter portion 6 and the supporting member 10 are made of a material that is easily adhered and fixed to each other by heat welding or an adhesive agent, and the supporting member 10, the flexible housing 7 and the blood inlet 8, blood Exit 9
Are composed of materials that are easily heat-welded to each other. In the present invention, when the blood flows into the filter portion 4, the flexible housing 7 can maintain the pressure applied to the filter portion 4 to some extent. Also flexible housing 7
Is made of the same material as the blood collection bag 3 and is made of an elastic material.

Further, according to the present invention, in order to prevent the filter portion 6 and the flexible housing 7 from being pressure-bonded (adhered), the spacer SP is located at the blood outlet 9 side of the filter portion 6 and is the second main filter. By attaching to (C), when blood flows into the flexible housing 7, it is possible to prevent pressure (adhesion) between the inner surface of the flexible housing 7 and the surface of the filter portion 6 and to prevent the blood from exiting from the blood outlet 9 side. A blood flow path can be secured. This can dramatically reduce the leukocyte removal time. The material and shape of the spacer SP of the present invention may be any as long as it is water-insoluble. The flexible housing 7 and the blood collection bag 3
As the constituent material of (3), for example, a thermoplastic resin such as polyvinyl chloride, polyolefin resin, polyester resin, or the like is used. The supporting member 10, the blood inlet 8 and the blood outlet 9 are also made of thermoplastic resin such as polyvinyl chloride, polyolefin resin, polyester resin and the like.

Further, the filter 6 is made of non-woven fabrics having different average fiber diameters D, one having a large fiber diameter and the other having a small fiber diameter, in the order of the flow path in which blood flows into the filter portion 4 (from the blood inlet 8 direction to the blood outlet direction 9). (3) as a pre-filter (A), a first main filter (B) and a second main filter (C). More specifically, the plurality of filters include at least a prefilter (A) having an average fiber diameter D of 5.0 μm or more and 10.0 μm or less, and an average fiber diameter D of more than 1.0 μm and 5.0 μm or less. No. 1 book filter (B)
And a second main filter (C) having an average fiber diameter D of 1.5 μm or less. The size of the average fiber diameter D of the second main filter (C) is between 50% and 90% as compared with the size of the average fiber diameter D of the first main filter (B). ing. Each of the filters (A), (B) and (C) is laminated in the order of (A), (B) and (C) from the blood inlet to the outlet, and has a blood inlet and a blood outlet. Placed inside.

The filter (A) has a stacking number of 15
The number of sheets is 25 to 25 and the thickness is 2.1 to 4.2 mm. The filter (B) has 20 to 35 layers and the thickness is 2.0 to 5.1 mm.
It is preferable to use a stack of 5 to 15 sheets and a thickness of 0.5 to 1.5 mm. The thickness of the filter (C) is formed between 10% and 75% as compared with the thickness of the filter (B). If it is less than 10%, the leukocyte removal efficiency decreases, which is not preferable. On the other hand, when it exceeds 75%, the filter is clogged and the blood filtration rate becomes slow, which is not preferable.

In the present invention, as the prefilter (A), for example, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene (P) produced by a spunbond method or a meltblown method are used.
P), polyethylene (PE), polyurethane (PU),
Nonwoven fabric such as polyamide (PA) is used. In the present invention, as the first main filter (B) and the second main filter (C), for example, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polypropylene (P) manufactured by a melt blown method are used.
Nonwoven fabrics such as P) and polyethylene (PE) are used.
The above-mentioned non-woven fabric does not limit the production method, and has an average fiber diameter D corresponding to the pre-filter (A), the first main filter (B) and the second main filter (C). A non-woven fabric manufactured by any method may be used. Further, the constituent member of the spacer SP used in the present invention is a porous body or a non-woven fabric or mesh having a pore size of 50 μm or more and 5000 μm or less, or a protrusion or a ridge having a height of 500 μm or more and 8000 μm or less and blood. May be made of any material and manufacturing method as long as it is a member that allows passage of whole blood without losing blood components, and is not limited to the above.

As described above, the filter 6 of the present invention is formed by combining the filters (A), (B), and (C) each having a unique average fiber diameter D, the number of layers and the thickness (1). ) Shortening the filtration time of blood (for example, 15 minutes or less, more preferably 10 minutes or less), and (2) significantly reducing the number of residual leukocytes in blood after filtration to 1 (piece). / ΜL) or less, more preferably 0.5 (pieces / μL) or less and leukocytes are 99.99.
Performance such as percent removal can be achieved.
Even if the white blood cell removal rate is simply expressed as a percentage, the white blood cell count may be 3000 to 10000 in adults due to individual differences.
It is said to be individual / μL. The number of remaining white blood cells is the same 1 / μ
Even if it is L, the number of white blood cells before removal is 3000 cells / μ
If it is L, the removal rate will be 99.967%, and if the number of white blood cells before removal is 10000 / μL, it will be 99.990%. Similarly, if the remaining white blood cell count is 0.5 / μL, the white blood cell count before removal is 300
When 0 cells / μL, the removal rate was 99.9983%, and when the white blood cell count before removal was 10000 cells / μL, it was 9%.
Since it is 9.995%, it is difficult to accurately specify the performance of the leukocyte removal filter by the leukocyte removal rate. Therefore, in the present invention, the performance required as the filter 6 is that (1) the filtration time of blood is 15 minutes or less, more preferably 10 minutes or less, and (2) the number of residual white blood cells in the blood after filtration is 1 or less. (Pieces / μL) or less, more preferably 0.5 (pieces / μL) or less. The leukocyte removal rate is preferably 99.99% or more, but the number of leukocytes varies among individuals as described above. Therefore, if the number of residual leukocytes in the blood after filtration is 1 (cells / μL) or less, more preferably 0.5 (cells / μL) or less, the leukocyte removal rate is 99.96 to 99.98% or more. However, it can be considered that the leukocyte removal filter 1 of the present invention has the required performance.

The average fiber diameter D of the prefilter (A) is set to 5.0 μm or more and 10.0 μm or less because the prefilter plays the role of an agglomerate larger than the diameter of blood cells such as red blood cells and white blood cells. The purpose of the present invention is to remove leukocytes efficiently with the following filter except for the above, and if it is less than 5.0 μm, clogging is likely to occur due to the simultaneous acquisition of blood cells and aggregates, and if it exceeds 10.0 μm, the prefilter This is because agglomerates and the like leak to the subsequent filter to cause clogging of the filter, which reduces the leukocyte removal rate or prolongs the filtration time. The reason why two kinds of filters (B) and (C) having different average fiber diameters D are laminated on the present filter is that it is impossible to simultaneously achieve the above-mentioned (1) and (2) by themselves. . Since the fiber diameter of the first main filter (B) is not thin enough, even if the above (1) is achieved, the above (2) cannot be achieved. Second book filter (C)
Since the fiber diameter is sufficiently small, clogging is likely to occur and the above (1) cannot be achieved, but the above (2) can be achieved.
Therefore, for the purpose of compensating for each other's drawbacks, the present filter is used as a filter (B) having two different average fiber diameters D,
(C) was laminated.

The average fiber diameter D of the first main filter (B) is set to more than 1.0 μm and 5.0 μm or less, because when it is less than 1.0 μm, clogging of blood is likely to occur and 5.0 μm This is because the leukocyte removal rate decreases when it exceeds. Even when the first main filter (B) having an average fiber diameter D of more than 1.0 μm and 5.0 μm or less is used alone, (2) the number of white blood cells remaining in the blood after filtration is significantly increased. Decrease to 1 (pieces / μL) or less, more preferably 0.5 (pieces / μL) or less, and leukocytes 99.99
Performance such as percent removal cannot be achieved. The average fiber diameter D of the second main filter (C) is set to 1.5 μm or less because the leukocyte removal rate decreases when it exceeds 1.5 μm. Further, even when the second main filter (C) having an average fiber diameter D of 1.5 μm or less is used alone, (1) the filtration time of blood is shortened (for example, 15 minutes or less, more preferably 10 minutes). It should not be set below a minute.)
In the present invention, the size of the average fiber diameter D of the second main filter (C) is 50% to 90% of that of the average fiber diameter D of the first main filter (B). If the ratio is less than 50%, the fiber diameter of the filter (C) becomes too small or the fiber diameter of the filter (B) becomes too large, and the above-mentioned (1) and (2) are set.
Can not achieve the performance of. On the other hand, when it exceeds 90%, the filters (B) and (C) approach the same fiber diameter, so that the performances of (1) and (2) cannot be cleared. As a preferred example of the present invention, a non-woven fabric having an average fiber diameter of 7 μm is used as the filter (A), a non-woven fabric having an average fiber diameter of 1.5 μm is used as the filter (B), and a non-woven fabric having an average fiber diameter of 1 μm is used as the filter (C). To be done.

Further, in the present invention, the filter (B)
Between the filter and the filter (C), at least one or more of the filters (B) and / or the filters (C)
Is disposed within the housing. As an example of the arrangement of the filters (A), (B) and (C), for example, they can be arranged as follows from the blood inlet to the outlet. (1) (A), [(B), (C), (B)] × n,
(C) (n> = 1) In this example, [(B), (C), (B)] between (A) and (C) may be arranged twice or more. Regarding the number of layers of each filter (A), (B), (C), the total number of layers of the filter (A) is 10 to 25, and the total number of layers of the filter (B) is 20. From 35 sheets, the filter (C)
Can be set in the range of 5 to 20 sheets in total. (B) in [(B), (C), (B)]
It is possible to set the number of overlapping sheets of 1 to 20 and the number of overlapping sheets of (C) to 1 to 10. (2) (A), (B), [(C), (B)] × n,
(C) (n> = 1) In this example, [(C),
(B)] may be arranged twice or more.
The repeating unit of [(C), (B)] is preferably 2 to 5. Each filter (A), (B), (C)
As for the number of layers, the filter (A) has a total number of layers of 10 to 25, the filter (B) has a total number of layers of 20 to 35, and the filter (C).
Can be set in the range of 5 to 20 sheets in total. The number of (B) in [(C) and (B)] is from 1 to 20, and the number of (C) is from 1 to 10.
It can be set in the range of one sheet.

(3) (A), (B), [(B),
(C)] × n, (C) (n> = 1) In this example, [(B) and (C)] in the middle may be arranged twice or more. The repeating unit of [(B), (C)] is preferably 3 to 6. Each filter (A), (B),
As for the number of layers of (C), the total number of layers of the filter (A) is 10 to 25, the number of layers of the filter (B) is
The total number of layers can be set to 20 to 35, and the total number of layers of the filter (C) can be set to 5 to 25. (B) in [(B), (C)]
It is possible to set the number of overlapping sheets of 1 to 20 and the number of overlapping sheets of (C) to 1 to 10. (4) (A), [(B), (C)] × n (n> = 2)
In this example, [(B) and (C)] in the middle are repeatedly arranged twice or more. The repeating unit of [(B), (C)] is preferably 3 to 15. Regarding the number of layers of each filter (A), (B), (C), the total number of layers of the filter (A) is 10 to 25, and the total number of layers of the filter (B) is 20. To 35
The number of sheets of the filter (C) can be set in the range of 5 to 15 sheets in total. [(B),
The number of (B) in (C)] is from 1 to 20,
The number of layers in (C) can be set in the range of 1 to 20. In the above examples (1) to (4), the filter (C) arranged between the filters (B) is at least one structural unit (B), (C), (B) The above arrangement is preferable.

The filter (A) has a total number of stacked sheets of 10 to 25 and a thickness of 1.4 to 3.5 m.
m, the filter (B) has a total stacking number of 20 to 35 and a thickness of 2.0 to 5.1 mm, and the filter (C) has a total stacking number of 5 to 25. Also, it is preferable to use the one having a thickness of 0.5 to 2.5 mm.

The hole diameter of the spacer SP of the present invention is 50 μm.
The reason why the thickness is set to 5000 μm or less is that if the thickness is less than 50 μm or exceeds 5000 μm, it is difficult to secure the blood flow path at the time of crimping, which is the role of the spacer. The hole diameter of the spacer SP is from 1000 μm to 3000 μm
The following are more preferable. Also, the thickness of the spacer SP is set from 0.5 mm or more to 5.0 mm or less,
If the thickness is less than 0.5 mm, it is difficult to secure the internal volume of the hole and it is difficult to secure the blood flow path that is the role of the spacer. If the thickness exceeds 5.0 mm, the residual blood volume after hemofiltration is allowed. This is because the amount cannot be achieved. The thickness of the spacer SP is preferably 0.5 mm or more and 2.0 mm or less. In addition, the height of the protrusions or ridges is 500
The height between 5 μm and 8000 μm is set to 5
This is because if the thickness is less than 00 μm, it becomes difficult to secure the blood flow path during pressure bonding. On the other hand, if the thickness exceeds 8000 μm, the sheet is too close to or in contact with the blood outlet 9 side sheet of the flexible housing 7, so that the housing is not flexible and its function is limited. Further, the protrusions or ridges are preferably provided on the entire surface of the filter 6 in order to effectively exert the role as the spacer SP.

[0017]

【Example】Examples and comparative examples (Assembly of blood component separation device) Made of soft synthetic resin up and down
Blood in a disk-shaped housing with blood inlet and blood outlet
In order from the liquid inlet to the blood outlet, each with a diameter of 29 mm
The pre-filter (A) in which a fixed number of layers are stacked, the first
The main filter (B) and the second main filter (C)
Layered in one or three layers, and further the second main filter
-(C) is a mesh spacer with a pore size of about 1500 μm
SP was loaded in layers. Blood inlet and blood in the housing
Connect a tube to each fluid outlet and
6 from the top of the tube to the bottom of the blood outlet tube.
It was set to 0 cm. Volume 50 upstream of the blood inlet tube
ml syringe [(ACD solution (60 m
Collect whole blood (400 ml) in a blood bag containing l)
Then, 45 ml was collected in the syringe. )] Connect to blood
Allow the liquid to spontaneously drop from the syringe and use the three-layer filter
Filtered.

Table 1 shows each filter in Table 2, 10 sheets of pre-filter (A), 30 sheets of first main filter (B),
The present invention in which the spacer SP is further stacked on a filter 6 in which ten sheets of the second main filter (C) are stacked in three layers, and the spacer SP is loaded in a disk-shaped housing made of a soft synthetic resin and having a blood inlet and a blood outlet at the top and bottom. Filter unit 4 (Examples 1 to 1
4) and the same predetermined number of three layers, a filter part having spacers SP mounted in a disk-shaped housing made of hard synthetic resin and having a blood inlet and a blood outlet at the top and bottom (Comparative Examples 1 to 4), Further, a filter in which the same predetermined number of layers were stacked in three layers was made of a soft hard resin and was loaded in a disk-shaped housing having a blood inlet and a blood outlet at the top and bottom (without a spacer) (Comparative Example 5). The residual white blood cell count in blood, the blood cell count removal rate, and the blood filtration time were compared. The results are shown in Table 1. In addition, Example 1
4 and the pre-filter (A), the first main filter (B) and the second main filter (C) used in Comparative Examples 1-5.
Is a polybutylene terephthalate (PB
A filter made of T) and polypropylene (PP) was used. Average fiber diameter D of each filter, thickness, basis weight,
Physical properties such as bulk density and porosity are as shown in Table 2.

[Table 1]

[Table 2] (Explanation of Examples and Comparative Examples) From the results shown in Table 1, it can be understood that the filter part of this example is more stable than the filter part of the comparative example in filtering time in removing leukocytes. It can be understood from the comparative examples 1 to 4 that the filtration in the leukocyte removal using the hard housing of the comparative example is surely affected by the uncertain value of the property of blood (individual difference in hematocrit value, etc.). That is, in Comparative Example 1 having a low hematocrit value, the filtration time is short (9 minutes), while in Comparative Example 2 to Comparative Example 3 having a high hematocrit value, the filtration time tends to be long (12 minutes). It can be seen that a difference of 3 minutes or more occurs and the filtration time is influenced by the hematocrit value. Further, it can be seen that in the case of the filter portion which is made up of only the flexible housing without the spacers as in Comparative Example 5, the filtration time becomes extremely long, which is not satisfactory at all. As the filtration time increases, the filtration rate also increases due to an increase in the blood volume per unit time that is filtered by the filter unit, but this does not compensate for the disadvantages due to the increase in the filtration time. On the other hand, it can be understood that the filter portion in which the spacer is arranged in the flexible housing of the present invention is less susceptible to the influence than in the first to fourth embodiments. That is, in Example 1 having a low hematocrit value and Example 2 to Example 3 having a high hematocrit value, it can be understood that the difference in filtration time is more than 1 minute, and the filtration time is not easily influenced by the hematocrit value. Further, it can be understood that the spacer SP prevents the inner surface of the flexible housing from being pressure-bonded (adhered) to the surface of the filter 6 and ensures the blood flow path on the blood outlet side from beginning to end so that blood smoothly flows. From the above results, it can be understood that the stability of the filtration time in the removal of leukocytes can be obtained by the flexible housing equipped with the spacer SP.

[0019]

(1) Adopting a flexible housing has the effect of keeping the pressure applied to the filter part constant to a certain extent, thereby suppressing the excessive pressure applied to the filter part. . (2) By disposing the spacer SP in the filter portion 4, it is possible to prevent pressure bonding (adhesion) between the inner surface of the flexible housing 7 and the surface of the filter 6 and to secure the blood flow path on the blood outlet side from beginning to end, thus reducing the filtration time. With leukocyte removal (filtration)
It has the effect of making the time almost constant. (3) Reduction of leukocyte removal time In the present invention, both the leukocyte removal rate and the leukocyte removal time can be satisfied by appropriately forming the nonwoven fabrics having different average fiber diameters into a layered structure. More specifically, by forming a layer with a larger average fiber diameter of the non-woven fabric, the clogging of the filter part can be dispersed inside the filter. The clogging caused by the adhesion of blood components, which had been concentrated on the non-woven fabric, was dispersed inside the filter, resulting in an increase in the blood flow rate per unit time in the filter section and a reduction in leukocyte removal time without reducing leukocyte removal efficiency. be able to.

[Brief description of drawings]

FIG. 1 is a schematic view showing an example of a blood component separation device of the present invention.

FIG. 2 is a cross-sectional view of the filter portion of FIG.

[Explanation of symbols]

1 Blood component separation device 3 blood collection bags 4 Filter section 6 filter (nonwoven fabric) S sheet (film) SP spacer 7 Flexible housing 8 blood inlet 9 blood outlet 10 Support member 11 Blood transfer tube 20 Blood component separation bag

Claims (11)

[Claims] 1. A filter 6 is formed by laminating a plurality of filters (A), (B), (C) having at least different average fiber diameters D, and the filter 6 is loaded into a flexible housing 7. A blood component separation device having a filter portion 4 formed by the above. 2. The filter 6 is formed by laminating a plurality of filters (A), (B) and (C) having different average fiber diameters D, respectively.
The blood component separation device according to 1. 3. A spacer SP between the filter 6 and the flexible housing 7 which can prevent them from adhering to each other.
3. The invention according to claim 1 or 2, characterized in that
The blood component separation device according to 1. 4. The spacer SP is (a) a porous body or nonwoven fabric or mesh having a pore size of 50 μm or more and 5000 μm or less, or (b) a height of 500 μm.
The blood component separation device according to claim 1, wherein the blood component separation device is formed of at least one of a protrusion or a ridge having a size of m or more and 8000 μm or less. 5. (A) The flexible housing 7 is composed of two flexible sheets S, S, and the filter 6 fixed to a support member 10 is arranged between these sheets S, S. Then, the blood inlet 8 and the blood outlet 9 are attached between the sheets S, S, or (B) the blood inlet 8 and the blood outlet 9 are provided substantially at the centers of the two flexible sheets S, S, respectively.
5. The blood component separation device according to claim 1, wherein the filter 6 fixed to the support member 10 is disposed between the sheets S and S, which is mounted. 6. A blood collection bag 3 is connected upstream of the filter portion 4 via a blood inlet 8, and a blood component separating bag 20 is connected downstream of the filter portion 4 via a blood outlet 9. The blood component separation device according to claim 1. 7. The filter 6 comprises at least a prefilter (A) having an average fiber diameter D of 5.0 μm or more and 10.0 μm or less, and a first filter having an average fiber diameter D of more than 1.0 μm and 5.0 μm or less. Including three types of filters, one main filter (B) and a second main filter (C) having an average fiber diameter D of 1.5 μm or less, wherein the average fiber diameter D of the second main filter (C) is The size is the average fiber diameter D of the first main filter (B).
Compared with the size of 50% to 90%, and each of the filters (A), (B), and (C) is provided with a blood inlet 8
To (A), (B), (C) in this order from the blood outlet 9 toward the blood outlet 9, and the spacer SP is attached to the filter (C). The blood component separation device 1 described. 8. The filter (A) has a stacking number of 5 to 30 and a thickness of 0.7 to 4.2 mm, and the filter (B) has a stacking number of 20 to 35. The thickness of the spacer SP is 2.0 to 5.1 mm, the filter (C) has a stacking number of 5 to 15 and a thickness of 0.5 to 1.5 mm.
The blood component separation device 1 according to claim 7, wherein the thickness is 0.5 mm to 5 mm. 9. The at least one filter (B) and / or the filter (C) is disposed between the filter (B) and the filter (C). The blood component separation device 1 according to 1. 10. The filters (A), (B),
The arrangement of (C) is (1) (A), [(B), (C), (B)] × n,
(C) (n> = 1) (2) (A), (B), [(C), (B)] × n,
(C) (n> = 1) (3) (A), (B), [(B), (C)] × n,
(C) (n> = 1) (4) (A), [(B), (C)] × n (n> = 2), The blood according to claim 7 or claim 9. Component separation device 1. 11. The filter (A) has a total stacking number of 10 to 25 and a thickness of 1.4 to 3.5 m.
m, the total number of layers of the filter (B) is 20 to 35 and the thickness is 2.0 to 5.1 mm, and the total number of layers of the filter (C) is 5 to 2
The blood component separation device 1 according to claim 7, claim 9 or claim 10, wherein the number is 5 and the thickness is 0.5 to 2.5 mm.