JP2006043297A - Blood treatment filter, and blood treatment filter system - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a blood treatment filter for easily and reliably discharging air in a container which stores the filtered blood when incorporated in a blood treatment filter system, and to provide the blood treatment filter system including the blood treatment filter. <P>SOLUTION: The blood treatment filter 10 comprises a flexible housing 12; a filter member 15 which is arranged to partition the housing 12 into a flow-in side space 13 and a flow-out side space 14, and which has a filtering material 52; a flow-in port 16 which is arranged at one end of the housing 12 so as to communicate with the flow-in side space 13; a flow-out port 17 which is arranged at the other end of the housing 12 so as to communicate with the flow-out side space 14; and an air storage part 18 at the end of the flow-in port 16 side of the flow-out side space 14, which is formed by no presence of the filtering material 52 so as to store the air. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a blood processing filter and a blood processing filter system.

  In a blood processing filter system for processing blood, for example, a blood processing filter system in which a leukocyte removal filter and bags are connected in advance, the blood in the first container is filtered with a filter (white blood cells are filtered) The blood component is stored in a second container.

  The second container containing the blood component is separated from the blood processing filter system and stored.

  By the way, in this blood processing filter system, when the blood in the first container is filtered by the filter and stored in the second container, the air previously contained in the filter or the like is also stored in the second container.

  When a blood component is stored in a state where air is mixed, there is a problem that the blood component is likely to be altered or deteriorated. For this reason, prior to separating the second container from the blood processing filter system, the air is removed from the second container.

  For example, in the filter (leukocyte remover) described in Patent Document 1, the housing for storing the filter medium is made of a soft resin, and the second container is pressed to discharge the air contained therein into the filter. can do.

  However, in the filter described in Patent Document 1, the volume in the filter is not sufficiently ensured, and a large force is applied to the pressing of the second container when air is discharged from the second container into the filter. There is a problem that it is necessary (load is applied) and operability is poor.

JP 2000-342680 A

  An object of the present invention is, for example, a blood processing filter capable of easily and reliably discharging air in a container for storing blood after filtration when incorporated in a blood processing filter system, and a blood processing including such a blood processing filter. It is to provide a filter system.

Such an object is achieved by the present inventions (1) to (8) below.
(1) a flexible housing;
A filter member provided to partition the inside of the housing into an inflow side space and an outflow side space, and comprising a filter medium;
An inlet provided on one end of the housing and communicating with the inflow side space;
An outlet provided on the other end of the housing and communicating with the outflow side space;
A blood processing filter, characterized in that an air storage part for storing air is provided at the end of the outflow side space on the inflow side and formed by the absence of the filter medium.

(2) The housing is formed by sealing a sheet material with a seal portion,
The distance between the edge of the filter medium and the inner edge of the seal part is larger than the other part at the end on the inlet side of the outflow side space,
The blood processing filter according to (1), wherein the air reservoir is formed in a portion where the distance is large.

(3) The filter member includes a sheet-like frame provided along an edge of the filter medium,
The filter member is fixed to the housing by sealing the sheet material at a portion where the sheet-like frame is sandwiched in a state where the sheet-like frame is sandwiched by the sheet material constituting the housing. The blood processing filter according to 2).

  (4) The blood processing filter according to any one of (1) to (3), wherein a volume of the inflow side space is substantially equal to a volume of the outflow side space.

  (5) The blood processing filter according to any one of (1) to (4), wherein a plurality of convex portions are provided on at least a part of a surface of the housing facing the filter member.

(6) The blood treatment filter according to any one of (1) to (5) above,
A first container for storing blood;
A second container for storing the blood permeated through the filter medium;
A first flow path having one end side communicating with the inflow port and the other end side communicating with the first container;
A blood processing filter system comprising: a second flow path having one end side communicating with the outflow port and the other end side communicating with the second container.

  (7) The blood processing filter system according to (6), wherein the air storage unit can store an amount of air that is approximately equal to an amount of air preliminarily present in the second container.

(8) a blood collection needle for collecting blood from a donor;
The blood processing filter system according to (6) or (7) above, wherein one end side communicates with the first container and the other end side communicates with the third flow path communicating with the blood collection needle.

  According to the present invention, since the air reservoir is provided, for example, when incorporated in a blood treatment filter system, the air in the container for storing the blood after filtration can be easily and reliably discharged, and the operability is improved. good.

  In addition, by providing the air storage part at the end of the outflow side space on the inlet side, it prevents blood before and after filtration from remaining in the blood processing filter and prevents a reduction in blood processing efficiency. Can do.

  Hereinafter, a blood processing filter and a blood processing filter system of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.

  1 is a front view of the blood treatment filter of the present invention as seen from the outflow side space side (partially cut away), and FIG. 2 is a rear view of the blood treatment filter shown in FIG. 1 as seen from the inflow side space. 3 is a cross-sectional view taken along line AA in FIG. 1, and FIG. 4 is a cross-sectional view taken along line BB in FIG. In the following description, the upper side in FIGS. 1 to 3 is referred to as “upper” and the lower side is referred to as “lower”.

  The blood processing filter 10 shown in each figure includes a flexible housing 12, a filter member 15 provided to partition the housing 12 into an inflow side space 13 and an outflow side space 14, and one end side of the housing 12 ( An inflow port 16 provided on the upper side in FIG. 1 and communicating with the inflow side space 13, and an outflow port 17 provided on the other end side (lower side in FIG. 1) of the housing 12 and communicating with the outflow side space 14. Have.

  The blood treatment filter 10 supplies blood from the inlet 16, and when the blood passes (permeates) the filter member 15, it filters off (separates) desired unwanted substances from the blood, and filters the filtered blood ( The filtered blood) is collected from the outlet 17.

  Here, the blood includes not only whole blood but also blood component-containing liquids containing blood components such as red blood cells, plasma, and platelets.

  In addition, examples of unnecessary substances include white blood cells, platelets, fine aggregates, viruses, bacteria, prions, and pathogenic substances.

  In addition, when an unnecessary thing is a leukocyte, the blood processing filter 10 may isolate | separate 1 or 2 or more of a lymphocyte, a granulocyte, and a monocyte.

  Further, when the unwanted substance is a virus, examples of the virus include HAV, HBV, HCV, HIV, HTLV-I, CMV, parvovirus B19, filovirus, hantavirus and the like.

  In the present embodiment, the housing 12 is constituted by two sheet materials 21 and 22, and the filter member 15 is constituted by a filter medium 52 and a sheet-like frame 51 provided along the edge of the filter medium 52. ing.

  Then, in a state where the sheet-like frame (intermediate film member) 51 is sandwiched between the two sheet members 21 and 22 constituting the housing 12, the sheet members 21 and 22 are sealed at the portion sandwiching the sheet-like frame 51. Thus, the filter member 15 is fixed to the housing 12. Thereby, a seal portion 23 is formed along the outer periphery of the housing 12.

  In addition, as a method of fixing (adhering) the filter medium 52 to the sheet-like frame 51 and a method of sealing, for example, methods such as fusion (thermal fusion, high frequency fusion) can be cited.

  As shown in FIG. 1, the seal portion 23 has other distances between the inner edge portion 231 and the edge portion 521 of the filter medium 52 at the end of the outflow side space 14 on the inlet 16 side (upper side in FIG. 1). The air storage part 18 for storing air is formed in the part which is larger than the part and this distance is large. The area between the inner edge 231 of the seal part 23 and the edge 521 of the filter medium 52 is an area where the sheet-like frame 51 exists, and therefore the filter medium 52 does not exist in the air reservoir 18. The function of the air storage unit 18 will be described later.

  As shown in FIG. 2, also in the inflow side space 13, the seal portion 23 has an end portion on the inlet 16 side (upper side in FIG. 2) where the distance between the inner edge portion 231 and the edge portion 521 of the filter medium 52. It is larger than other parts. That is, the configuration of the inflow side space 13 is the same as the configuration of the outflow side space 14. Thereby, a space having a volume corresponding to the volume of the air reservoir 18 is also formed in the inflow side space 13, and the volume of the inflow side space 13 and the volume of the outflow side space 14 are substantially equal.

  With such a configuration, it is possible to prevent the pressure in the inflow side space 13 from becoming extremely higher than the pressure in the outflow side space 14 when blood is supplied into the blood processing filter 10. As a result, the unwanted matter once trapped (filtered) by the filter medium 52 is unintentionally (forcedly) discharged to the outflow side space 14 due to the pressure difference between the inflow side space 13 and the outflow side space 14. That is, it is possible to prevent the filtration performance of the filter medium 52 from being lowered.

  Further, a plurality of vertical ribs (convex portions) extending substantially parallel from the one end side of the housing 12 to the other end side on the inner surface of the sheet material 22 on the outflow side space 14 side (surface facing the filter member 15 of the housing 12). 22a and a plurality of horizontal ribs (convex portions) 22b substantially orthogonal to the vertical ribs 22a are provided.

  In this case, the interval between the vertical ribs 22a and the horizontal ribs 22b is preferably about 1 to 5 mm, and the ribs are preferably provided at substantially equal intervals.

  The widths of the vertical ribs 22a and the horizontal ribs 22b are each preferably about 0.5 to 1 mm.

  The height (height difference) of the vertical ribs 22a is preferably about 0.2 to 2 mm (particularly about 0.5 to 1 mm). On the other hand, the height (height difference) of the lateral ribs 22b is preferably about 0.2 to 1 mm (particularly about 0.2 to 0.5 mm).

  As shown in FIGS. 3 and 4, the height of the horizontal rib 22b is preferably lower than that of the vertical rib 22a. Specifically, the height of the horizontal rib 22b is 0 than that of the vertical rib 22a. It is preferably about 3 to 1 mm lower.

  Further, as shown in FIGS. 1 and 2, the interval between the horizontal ribs 22b is preferably wider than the interval between the vertical ribs 22a. Specifically, the interval between the horizontal ribs 22b is 1 than the interval between the vertical ribs 22a. It is preferably about 2 mm wide.

  By providing such a rib on the inner surface of the sheet material 22, even when the filter member 15 is pressed against the inner surface of the housing 12, the close contact between both is prevented, and the filter member 15 and the inner surface of the housing 12 are It is possible to secure a blood flow path between them and prevent a decrease in the filtration rate.

  Moreover, the effect | action which guide | induces the blood to the filter member 15 from the inflow port 16 and the effect | action which guide | induces filtered blood to the outflow port 17 are exhibited.

  In addition, as for the cross-sectional shape of each rib, what has a width | variety narrowing toward a front-end | tip like a triangle, semicircle shape, respectively is suitable.

  Further, the ribs are not limited to the configuration shown in the figure, and may not be equidistant or parallel, for example. Further, the ribs are not limited to those that extend linearly, but may extend from the one end side of the housing 12 to the other end side while being curved.

  Further, the convex portions are not limited to those formed by ribs, and may be, for example, a large number of protrusions scattered on the surface of the housing 12 facing the filter member 15.

  Moreover, a convex part may be provided in the inner surface of both the sheet materials 21 and 22, and may be provided in a part of inner surface.

  Examples of the constituent material of the tubes constituting the sheet materials 21 and 22 constituting the housing 12, the inlet 16 and the outlet 17 include soft vinyl chloride resin (polyvinyl chloride, vinyl chloride-vinyl acetate copolymer, chloride). A flexible thermoplastic resin such as a vinyl-ethylene copolymer is preferably used.

  Note that a hard resin can also be used as a constituent material of the tubes constituting the inflow port 16 and the outflow port 17. Examples of the hard resin include hard or semi-hard vinyl chloride, polycarbonate, acrylic resin, styrene resin, and the like.

  The filter medium 52 of the filter member 15 is composed of a plurality of (six in the present embodiment) porous body or a laminated body such as a nonwoven fabric. In the filter medium 52, the number of porous bodies and nonwoven fabrics to be laminated is preferably about 2 to 10.

  The porous body used for the filter medium 52 means a liquid-permeable structure having a large number of fine pores communicating from one surface to the other surface. Examples of the porous body include For example, porous bodies made of natural, synthetic, semi-synthetic, regenerated organic or inorganic fibers, organic or inorganic porous bodies such as sponge foam, pores formed by elution, sintering, stretching, perforation, etc. And porous bodies filled or bound with fine particles or organic or inorganic fine particles or strips.

  As the nonwoven fabric used for the filter medium 52, one having a fiber diameter of about 0.3 to 20 μm is suitable.

  In addition, the constituent material of the filter medium 52 is appropriately selected according to the type of unwanted matter to be captured. For example, when the unwanted substance to be captured is leukocytes, examples of the constituent material of the filter medium 52 include polyesters such as polyurethane and polyethylene terephthalate, polyamides, polyolefins (for example, polypropylene and polyethylene), polyacrylonitrile, and the like.

  As a constituent material of the sheet-like frame 51, a resin (polymer blend) in which the filter medium 52 and a resin having a good adhesive property and a housing 12 and a resin having a good adhesive property are mixed is suitably used. Thereby, the sheet-like frame 51 becomes compatible with both the filter medium 52 and the housing 12, and is firmly fused to both. After the fusion, even if a high pressure is applied to the joint, pinholes are generated but are surely prevented, and problems such as liquid (blood) leakage can be prevented.

  “Good compatibility” means that the thermodynamic mutual solubility is good, in other words, that it does not separate between the two after curing.

  Such a blood processing filter 10 is used by being incorporated in a blood processing filter system.

FIG. 5 is a schematic diagram showing the overall configuration of the blood processing filter system of the present invention.
The blood processing filter system 1 shown in FIG. 5 includes a blood collection bag (first container) 2 for storing the collected blood, the blood processing filter 10 described above, and a collection for storing the blood filtered by the blood processing filter 10. And a bag (second container) 3.

  As shown in FIG. 5, one end of a flexible tube 6 is connected to the lower side of the blood collection bag 2 so as to communicate with the inside of the blood collection bag 2 (blood storage portion). The blood collection needle 5 is attached via the hub 50. Further, a cap (not shown) for enclosing the blood collection needle 5 is attached to the hub 50. The main part of the third flow path is constituted by the lumen of the tube 6.

  Further, one end of a flexible tube 7 is connected to the lower side of the blood collection bag 2 so as to communicate with the blood collection bag 2, and the other end of the tube 7 is connected to the inlet 16 of the blood processing filter 10. Has been. A main portion of the first flow path is configured by the lumen of the tube 7.

  Further, it is preferable that an anticoagulant is placed in the blood collection bag 2 in advance. This anticoagulant is usually a liquid, and examples thereof include an ACD-A solution, a CPD solution, a CPDA-1 solution, and a heparin sodium solution. The amount of these anticoagulants is an appropriate amount according to the planned blood collection amount.

  As a constituent material of the blood collection bag 2, for example, polyvinyl chloride, soft polyvinyl chloride, a material mainly composed of soft polyvinyl chloride (for example, a copolymer with a small amount of other polymer material, polymer blend, polymer alloy) Etc.), ethylene-vinyl acetate copolymer and the like.

  One end of a flexible tube 8 is connected to the outflow port 17 of the blood processing filter 10 so as to communicate with the outflow side space 14, and the other end of the tube 8 is connected to the upper side of the collection bag 3 in FIG. Moreover, it connects so that it may communicate with the inside of the collection | recovery bag 3 (blood storage part). The lumen of the tube 8 constitutes the main part of the second flow path.

  As the constituent material of each of the tubes 6, 7 and 8, for example, polyvinyl chloride, soft polyvinyl chloride, soft polyvinyl chloride (for example, co-weight with a small amount of other polymer materials), respectively. A polymer, a polymer blend, a polymer alloy, etc.), an ethylene-vinyl acetate copolymer, and the like.

  Moreover, as a constituent material of the said collection bag 3, the thing similar to the said blood collection bag 2 can be used, for example.

  The tube 7 is separated into a tube on the blood collection bag 2 side and a tube on the blood processing filter 10 side before blood filtration, and may be configured to be connected when blood is filtered.

Next, the operation (usage method) of the blood processing filter system 1 will be described.
The case where the blood processing filter system 1 is applied to a system that filters (separates) white blood cells from blood (that is, when a leukocyte removal filter is used as the blood processing filter 10) will be described as a representative.

  <1> First, a predetermined amount of blood is collected in the blood collection bag 2 from a donor (blood donor) using the blood collection needle 5.

  Then, if necessary, the tube 6 is sealed with a tube sealer or the like by fusion, the sealed portion is cut, and the tube 6 on the blood collection needle 5 side is separated and removed.

  <2> Next, blood is filtered by the blood treatment filter 10, that is, white blood cells are separated (separated) from the blood.

  In this case, for example, the blood collection bag 2 in which the blood is stored may be hung on a stand to place the blood collection bag 2 at a high position, and gravity may be used. For example, JP-A-1-288238 may be used. You may pressurize the blood collection bag 2 using the bag pressurization apparatus described in gazette etc.

  Thereby, the blood stored in the blood collection bag 2 flows in the tube 7 and flows into the inflow side space 13 from the inlet 16 of the blood processing filter 10, and the leukocytes are separated (separated) by the filter medium 52. .

  The blood (filtered blood) that has passed through the filter medium 52 and from which white blood cells have been separated flows into the outflow side space 14, outflows from the outflow port 17 of the outflow side space 14, flows through the tube 8, and is introduced into the collection bag 3. (Collected).

  <3> Next, the collection bag 3 is pressed to discharge (send out) the air stored in the collection bag 3 to the blood processing filter 10. The air discharged from the collection bag 3 is supplied into the outflow side space 14 via the outflow port 17, and a part thereof is stored in the air storage unit 18.

  Here, since the housing 12 has flexibility, the blood processing filter 10 can store the air discharged from the collection bag 3 when the housing 12 extends.

  In particular, in the blood processing filter 10 of the present invention, since the air reservoir 18 is provided, a large force is not required during the operation of pressing the collection bag 3 (good operability), and the air in the collection bag 3 is surely obtained. Can be discharged into the blood treatment filter 10.

  It is preferable that the air storage unit 18 can store an amount of air that is approximately equal to the amount of air that exists in advance in the collection bag 3. Thereby, the air in the collection bag 3 can be more easily and reliably discharged into the blood processing filter 10.

  Further, in the blood processing filter 10 of the present invention, the filtered blood remains in the discharge side space 14 by providing the air reservoir 18 at the upper end of the discharge side space 14 (end on the inlet 16 side). It can also be surely prevented.

<4> After almost all of the air stored in the collection bag 3 is stored in the blood processing filter 10, the tube 8 is sealed by, for example, a tube sealer, and the sealed portion The blood processing filter 10 and the collection bag 3 are separated.
Through the above steps, the collection bag 3 containing the blood from which the white blood cells have been removed is obtained.

  The blood processing filter and the blood processing filter system according to the present invention have been described based on the illustrated embodiment. However, the present invention is not limited to this, and the configuration of each unit may be any arbitrary function having the same function. It can be replaced with that of the configuration.

Next, specific examples of the present invention will be described.
<Production of blood treatment filter and blood treatment filter system>
(Example)
A blood treatment filter as shown in FIGS. 1 to 4 was produced. The specification of this blood processing filter is as follows.

1. Housing-Constituent material: Polyvinyl chloride-Sheet material thickness: 1.3 mm
・ Volume of air reservoir: 40 mL
・ Vertical rib size: height 1.0mm x width 1.0mm, spacing 3.0mm (equal spacing)
・ Horizontal rib size: height 0.5mm x width 0.5mm, spacing 4.5mm (equal spacing)

2. 2. Filter member 2-1. Filter media (6 sheets)
-Constituent material: Polyurethane-Form: Porous body 2-2. Sheet frame:
-Constituent material: Polymer alloy of polyurethane and polyvinyl chloride-Sheet material thickness: 1.3 mm

3. Inlet forming tube and Outlet forming tube-Constituent material: Polyvinyl chloride-Size: Outer diameter 6 mm x Inner diameter 5 mm x Length 20 mm
Using this blood processing filter, a blood processing filter system as shown in FIG. 5 was produced.

(Comparative example)
A blood treatment filter was produced in the same manner as in the above example except that no air reservoir was provided, and a blood treatment filter system as shown in FIG. 5 was produced using this blood treatment filter.

<Evaluation>
Leukocytes were removed by filtering 476 mL of blood using the blood treatment filter systems of the examples and comparative examples.

  Thereafter, the collection bag was pressed by an automatic blood separator AC-212 (manufactured by Terumo Corporation), and the maximum pressure and the minimum pressure when almost all the air in the collection bag was discharged to the blood treatment filter were measured.

  As a result, in the example, the maximum pressure was 11 kPa and the minimum pressure was 9 kPa, whereas in the comparative example, the maximum pressure was 15.6 kPa and the minimum pressure was 13.2 kPa.

  Thus, in the embodiment, a large force is not required for the pressing force of the collection bag, and the air in the collection bag can be surely discharged to the blood treatment filter, whereas in the comparative example, the collection bag is pressed. It took a lot of power.

It is the front view (a part is not shown) which looked at the blood processing filter of this invention from the outflow side space side. It is the rear view which looked at the blood processing filter shown in FIG. 1 from the inflow side space side. It is the sectional view on the AA line in FIG. It is the BB sectional view taken on the line in FIG. It is a mimetic diagram showing the whole blood processing filter system composition of the present invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Blood processing filter system 2 Blood collection bag 3 Collection bag 5 Blood collection needle 50 Hub 6, 7, 8 Tube 10 Blood processing filter 12 Housing 13 Inflow side space 14 Outflow side space 15 Filter member 51 Sheet-like frame 52 Filter medium 521 Edge 16 Flow Inlet 17 Outlet 18 Air reservoir 21, 22 Sheet material 22 a Vertical rib 22 b Horizontal rib 23 Seal portion 231 Inner edge

Claims (8)

A flexible housing;
A filter member provided to partition the inside of the housing into an inflow side space and an outflow side space, and comprising a filter medium;
An inlet provided on one end of the housing and communicating with the inflow side space;
An outlet provided on the other end of the housing and communicating with the outflow side space;
A blood processing filter, characterized in that an air storage part for storing air is provided at the end of the outflow side space on the inflow side and formed by the absence of the filter medium. The housing is formed by sealing a sheet material with a seal portion,
The distance between the edge of the filter medium and the inner edge of the seal part is larger than the other part at the end on the inlet side of the outflow side space,
The blood processing filter according to claim 1, wherein the air reservoir is formed in a portion where the distance is large. The filter member includes a sheet-like frame provided along an edge of the filter medium,
The filter member is fixed to the housing by sealing the sheet material at a portion where the sheet frame is sandwiched in a state where the sheet frame is sandwiched by the sheet material constituting the housing. 2. The blood processing filter according to 2.   The blood processing filter according to any one of claims 1 to 3, wherein a volume of the inflow side space is substantially equal to a volume of the outflow side space.   The blood processing filter according to any one of claims 1 to 4, wherein a plurality of convex portions are provided on at least a part of a surface of the housing facing the filter member. The blood treatment filter according to any one of claims 1 to 5,
A first container for storing blood;
A second container for storing the blood permeated through the filter medium;
A first flow path having one end side communicating with the inflow port and the other end side communicating with the first container;
A blood processing filter system comprising: a second flow path having one end side communicating with the outflow port and the other end side communicating with the second container.   The blood processing filter system according to claim 6, wherein the air storage unit can store an amount of air substantially equal to an amount of air existing in advance in the second container. A blood collection needle to collect blood from a donor;
The blood processing filter system according to claim 6 or 7, further comprising: a third flow path having one end side communicating with the first container and the other end communicating with the blood collection needle.

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