WO2009128435A1 - 凝集物除去フィルター材及び血液製剤のろ過方法 - Google Patents
凝集物除去フィルター材及び血液製剤のろ過方法 Download PDFInfo
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- WO2009128435A1 WO2009128435A1 PCT/JP2009/057476 JP2009057476W WO2009128435A1 WO 2009128435 A1 WO2009128435 A1 WO 2009128435A1 JP 2009057476 W JP2009057476 W JP 2009057476W WO 2009128435 A1 WO2009128435 A1 WO 2009128435A1
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D39/00—Filtering material for liquid or gaseous fluids
- B01D39/02—Loose filtering material, e.g. loose fibres
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D39/00—Filtering material for liquid or gaseous fluids
- B01D39/08—Filter cloth, i.e. woven, knitted or interlaced material
- B01D39/083—Filter cloth, i.e. woven, knitted or interlaced material of organic material
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
- A61M1/3633—Blood component filters, e.g. leukocyte filters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
- A61M2205/7545—General characteristics of the apparatus with filters for solid matter, e.g. microaggregates
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/04—Additives and treatments of the filtering material
- B01D2239/0414—Surface modifiers, e.g. comprising ion exchange groups
- B01D2239/0421—Rendering the filter material hydrophilic
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/04—Additives and treatments of the filtering material
- B01D2239/0471—Surface coating material
- B01D2239/0478—Surface coating material on a layer of the filter
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
- B01D2239/0604—Arrangement of the fibres in the filtering material
- B01D2239/0609—Knitted
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
- B01D2239/0604—Arrangement of the fibres in the filtering material
- B01D2239/0613—Woven
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
- B01D2239/0604—Arrangement of the fibres in the filtering material
- B01D2239/0618—Non-woven
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
- B01D2239/0604—Arrangement of the fibres in the filtering material
- B01D2239/0622—Melt-blown
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
- B01D2239/0604—Arrangement of the fibres in the filtering material
- B01D2239/0627—Spun-bonded
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
- B01D2239/0604—Arrangement of the fibres in the filtering material
- B01D2239/0636—Two or more types of fibres present in the filter material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
- B01D2239/065—More than one layer present in the filtering material
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
- B01D2239/065—More than one layer present in the filtering material
- B01D2239/0659—The layers being joined by needling
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
- B01D2239/065—More than one layer present in the filtering material
- B01D2239/0663—The layers being joined by hydro-entangling
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/06—Filter cloth, e.g. knitted, woven non-woven; self-supported material
- B01D2239/065—More than one layer present in the filtering material
- B01D2239/0668—The layers being joined by heat or melt-bonding
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/08—Special characteristics of binders
- B01D2239/086—Binders between particles or fibres
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/12—Special parameters characterising the filtering material
- B01D2239/1216—Pore size
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/12—Special parameters characterising the filtering material
- B01D2239/1225—Fibre length
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- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01D—SEPARATION
- B01D2239/00—Aspects relating to filtering material for liquid or gaseous fluids
- B01D2239/12—Special parameters characterising the filtering material
- B01D2239/1233—Fibre diameter
Definitions
- the present invention relates to an aggregate removal filter material and a blood product processing method using a filter device including the filter material. Specifically, an aggregate removing filter material for efficiently removing aggregates contained in blood products for blood transfusion and causing transfusion side effects, and a filter device including the filter material and a filter material for removing leukocytes are used.
- the present invention relates to a filtration method for removing aggregates and leukocytes contained in blood products.
- leukocyte-removed blood transfusion in which transfused leukocytes contained in blood products are removed, has become widespread.
- This includes relatively minor side effects such as headache, nausea, chills, and non-hemolytic fever reactions associated with blood transfusions, alloantigen sensitization, viral infection, and post-transfusion GVHD ( This is because it became clear that serious side effects such as Graft Versus Host Dissease were caused mainly by leukocytes mixed in the blood product used for blood transfusion.
- Methods for removing leukocytes from blood products are roughly divided into a centrifugal separation method in which leukocytes are separated and removed using a centrifugal separator utilizing the specific gravity difference of blood cell components, and a porous structure having fiber aggregates such as nonwoven fabric and continuous pores.
- a filter method that uses a filter material composed of a body to remove leukocytes by adhering to the filter material or by sieving the pores of the filter material.
- the filter method is widely used because it has advantages such as simple operation, low cost, and high leukocyte removal performance.
- leukocyte removal filter devices currently on the market are composed of multiple types of filter materials, and the upstream part close to the blood inlet is open to remove aggregates contained in blood products.
- An agglomerate removal filter material is arranged.
- a fine leukocyte removal filter material for removing leukocytes is disposed in the downstream portion on the outlet side.
- Aggregates are formed by aggregation of red blood cells, white blood cells, platelets, fibrin, fibrinogen, other denatured proteins, fat globules and the like. Aggregates can be of a “macro-aggregate” that is about the same size as leukocytes, or a relatively small one called “micro-aggregate” of about several tens of ⁇ m.
- aggregates There are a variety of large-scale products called “aggregates”, and they are highly adhesive.
- the number of aggregates tends to increase as the storage time of the blood product increases and / or as the storage temperature decreases. For this reason, if the blood product is filtered only with the leukocyte removal filter material without using the aggregate removal filter material, the leukocyte removal filter material is clogged with the aggregate, and it becomes difficult to maintain the expected flow rate. .
- Patent Document 1 discloses that 0.1 to 1.0 g / cm selected from the group consisting of a nonwoven fabric, a woven fabric, and a knitted fabric upstream of a filter material for removing leukocytes.
- a filter device having a structure in which two or more kinds of filter materials for removing aggregates having different bulk densities in the range of 3 are arranged and the bulk density of the aggregate removal filter material is increased toward the downstream side is disclosed.
- Patent Document 2 discloses a filter device composed of a plurality of types of fibrous materials and defined by a product XY of an average fiber diameter X and an average fiber interval Y of fibers.
- a filter material with XY> 50 is arranged upstream of the filter device to capture large agglomerates, and a filter material with 50 ⁇ XY> 7 is arranged downstream thereof to capture relatively small agglomerates.
- a filter material of 7 ⁇ XY is further arranged downstream of the structure to remove leukocytes.
- Patent Document 3 has at least two types of hole groups, a hole group A having an individual hole diameter of 500 ⁇ m or more and an hole group B having an individual hole diameter of 150 to 500 ⁇ m.
- the average hole diameter of the hole group A is 600 to 1500 ⁇ m
- a filter material for removing agglomerates having an average pore diameter of 200 to 450 ⁇ m and an aperture ratio of 40% or more is disclosed.
- Patent Document 4 includes first to third elements.
- JP-A-3-173824 Japanese Patent Laid-Open No. 1-236064 Japanese Unexamined Patent Publication No. 7-67958 Japanese National Patent Publication No. 3-502094
- the filter device including the aggregate removing filter material disclosed in Patent Documents 1 to 3 described above can be used without any problem when a blood product containing a small amount of aggregate is filtered.
- blood products that have been stored for a long period of time blood products that have been stored at a low temperature below 4 ° C, or blood products that have been prepared with insufficient mixing of the anticoagulant and blood after blood collection, etc.
- the filtration flow rate is significantly reduced due to clogging.
- the fibrous aggregate removal filter material used in Patent Documents 1 to 3 has a dense structure in which the fiber axes are oriented in the plane direction. It is guessed that this is because.
- the filter material having such a structure has a relatively thin thickness and is excellent in strength if embossed or the like is applied, which is advantageous for mass production.
- the aggregates are It is thought that it stays near the surface of the filter material and causes clogging.
- the first element disclosed in Patent Document 4 is a needle fiber in which a needle is pierced and mechanically entangled with the fiber, and the basis weight exceeds 70 g / m 2 and is relatively thick (about 3 to 5 mm or more).
- Nonwoven fabric In the example of Patent Document 4, the fiber diameter is 20 to 26 ⁇ m (corresponding to 4.3 to 7.3 dtex in terms of fineness) and a thick non-woven fabric is used. The Therefore, fiber structure changes such as elongation deformation and breakage are likely to occur, and the fragile structure changes during the filtration of blood, and quality problems such as unstable removal of aggregates may occur.
- the first element of Patent Document 4 is subjected to complicated processing such as hot compression when filling the filter device. Although the shape of the first element is maintained by this hot compression, the filter material becomes finer, so that the problem of reduced clogging resistance due to aggregates remains.
- An object of the present invention is to provide an agglomerate removal filter material that solves the above-described conventional problems.
- the present invention also uses a filter device in which such an aggregate removal filter material is disposed on the upstream side close to the blood product introduction port, and further, a leukocyte removal filter material is disposed on the downstream side near the blood outlet, and gravity or a pump is used. It is an object of the present invention to provide a blood product filtration method that efficiently removes aggregates and white blood cells of various sizes, which are contained in the blood product, by filtering the blood product using the.
- a base fabric composed of short fibers having a fineness of 0.7 to 4.0 dtex and a fiber length of 1 to 80 mm and a long fiber having a fiber axis oriented in the plane direction is entangled with the base fabric. It was found that the object of the present invention can be achieved by using an aggregate removal filter material having a total basis weight of 10 to 80 g / m 2 and a short fiber layer forming a three-dimensional structure. It came to do.
- an aspect of the present invention is an aggregate removal filter material for removing aggregates in a blood product, and the filter material has a fineness of 0.7 to 4.0 dtex and a fiber length of 1 to 80 mm.
- the filter material has a fineness of 0.7 to 4.0 dtex and a fiber length of 1 to 80 mm.
- the short fibers are entangled with the base fabric to have a total basis weight of 10 to 80 g / m 2 , and the short fiber layer has a three-dimensional structure.
- the gist of the present invention is a blood product filtration method using a filter device including at least the aggregate removal filter material that is formed and the filter material and leukocyte removal filter material.
- the aggregate removal filter material of the present invention By using the aggregate removal filter material of the present invention, it is possible to efficiently remove aggregates while preventing clogging due to aggregates even in blood products containing a large amount of various aggregates.
- the filtration flow rate (ml / min) caused by clogging of aggregates is reduced over time, An increase in pressure loss (Pa) with time is suppressed, and stable filtration can be performed.
- the aggregate removal filter material of the present invention is further excellent in shape stability. That is, the aggregate removal filter material of the present invention has sufficient strength not to cause defects such as structural deformation during the production process or at the stage of filtration of blood products, and thus the aggregate removal performance is stable. Turn into. As a result, the quality of the filter device including the aggregate removing filter material of the present invention can be stabilized.
- FIG. 1 is a cross-sectional electron micrograph of an aggregate removal filter material illustrating the present invention.
- the present embodiment an embodiment of the present invention (hereinafter referred to as “the present embodiment”) will be described in more detail.
- this invention is not limited to the following embodiment, It can implement by changing variously within the range of the summary.
- the aggregate removal filter material according to this embodiment is for efficiently removing aggregates of various sizes, large and small, contained in blood products used for blood transfusions such as whole blood products, concentrated erythrocyte products, and concentrated platelet products.
- An agglomerate-removing filter material comprising a base fabric comprising a short fiber having a fineness of 0.7 to 4.0 dtex and a fiber length of 1 to 80 mm, and a long fiber having a fiber axis oriented in a planar direction.
- the aggregate removal filter material according to the present embodiment is a filter material in which short fibers are entangled with a base fabric made of long fibers having fiber axes oriented in a planar direction.
- the base fabric composed of long fibers as used herein refers to a sheet-like fiber assembly in which the fiber axes of almost all the fibers contained therein are oriented in the plane direction of the sheet. More specifically, examples of a spunbond nonwoven fabric obtained by processing a spunbond fiber formed by a spunbond method into a sheet shape, and a knitted fabric or a woven fabric as a base fabric made of long fibers can be given. In the case of a spunbonded nonwoven fabric, it is preferable to impart strength by appropriate embossing.
- the long fibers constituting the knitted or woven fabric have a twist coefficient (K) represented by the following formula (1) of 3,000 to 30,000, preferably 5,000 to 10,000. Is preferable from the viewpoint of strength and ease of entanglement with short fibers.
- K twist coefficient
- T Number of twists (number of revolutions / m)
- D Fineness (dtex)
- T is the number of twists per unit length (m).
- D is the total fineness of the laminated multifilament yarn, and in the case of a composite yarn of the laminated multifilament yarn and other yarns, the total of the composite yarn. (Refers to fineness)
- short fibers are uniformly dispersed and laminated on a base fabric made of long fibers, and then the external fibers are applied to the laminate to entangle the short fibers, the long fibers, and the short fibers, and the short fibers fall off the base fabric. Do not.
- the aggregate removal filter material of the present invention is obtained by such a method.
- Examples of the method for laminating short fibers on a base fabric include a card method and a papermaking method. In the papermaking method, an appropriate surfactant or thickener for the purpose of uniformly dispersing the short fibers in water. Is generally used.
- a method for tangling short fibers to a base fabric made of long fibers various known methods such as a thermal bond method, a chemical bond method, a needle punch method, a spun lace method, and a steam jet method can be used.
- the needle punch method and the spunlace method are preferable from the viewpoints of ease of processing, safety as a medical device, and the like.
- the spunlace method hydroentanglement method in which short fibers are pushed into the base fabric made of long fibers with a high-pressure water flow.
- a desired filter material can be obtained by setting the water pressure to 40 to 200 kgf / cm 2 and the nozzle diameter for jetting water to 80 to 150 ⁇ m. .
- the fiber axis of the short fiber is oriented not only in the plane direction but also in the longitudinal direction and the oblique direction. Furthermore, short fibers themselves change to a crimp-like shape due to an external force such as hydraulic pressure, and some of them no longer show a clear fiber axis orientation. As a result, the portion of the short fiber layer becomes a three-dimensional structure. Such a three-dimensional structure has a function of drawing and capturing large agglomerates to the inside of the filter material, and as a result, clogging in the vicinity of the filter material surface due to the large agglomerates is reduced.
- the fiber axis of the base fabric made of long fibers has a dense structure oriented in the plane direction.
- a base fabric made of long fibers entangled with short fibers has a very low fiber mobility compared to short fibers, so its structure is maintained even after treatment with a spunlace method, etc.
- the pore diameter is smaller than that. Since the base fabric has such a structural characteristic, it is considered that it effectively acts on the removal of relatively small aggregates.
- the aggregate removal filter material of the present invention removes large aggregates with the short fiber layer and small aggregates with the long fiber layer that is the base fabric, so the entire volume of the filter material is effective. For this reason, it becomes a structure that can efficiently remove aggregates of various sizes.
- FIG. 1 shows a cross-sectional photograph of a filter material in which short fibers are laminated on a spunbond long fiber layer and then entangled by a spunlace method as an example of the aggregate removal filter material of the present invention.
- the fiber axis of the spunbond fiber layer as the base fabric is oriented in the plane direction, but the fiber axis of the short fiber layer above it is random and has a constant orientation. Not shown.
- the presence or absence of a three-dimensional structure can also be determined by the method described below.
- the thickness of the filter material is measured from the photograph as shown in FIG. 1, and this value is compared with the numerical value of the thickness obtained by a constant pressure thickness meter applying a constant load of 0.4 N per area of 1.8 cm 2.
- the value is 10% or more of the former, more preferably 30% or more and a small numerical value, it is determined that a three-dimensional structure is formed in the short fiber layer. Since the three-dimensional structure formed of short fibers is very soft and easily compressed, the thickness measured at a constant load is extremely smaller than the thickness measured in an unloaded state.
- the thickness measurement in the photograph if the surface layer fiber is irregular and uneven, and it is difficult to determine the starting point of the measurement, the outermost layer part where the majority of fibers are present is determined as the starting point, and the starting point-starting point Is measured as the thickness. Measurement with a photograph is performed three or more times at different locations, and the average value is taken as the thickness of the filter material. Similarly, when the thickness is measured by applying a constant load, the measurement is performed three times or more and the average value is used.
- the structure of the aggregate removal filter material of the present invention is composed of a short fiber layer and a long fiber layer as a base fabric as described above. More specifically, the short fiber layer is laminated on the long fiber layer. Examples thereof include a layer structure (short fiber layer-long fiber layer) and a three-layer structure (short fiber layer-long fiber layer-short fiber layer) in which the long fiber layer is sandwiched between the short fiber layers.
- the fineness of the short fibers used in the aggregate removal filter material according to this embodiment is 0.7 to 4.0 dtex. If it is less than 0.7 dtex, the so-called pore diameter formed by the short fibers becomes too small, and the removal efficiency of large aggregates tends to decrease. When it exceeds 4.0 dtex, the entanglement between the short fibers tends to decrease, and the falling of the short fibers tends to increase. Preferably it is 1.0 to 2.4 dtex, more preferably 1.2 to 1.8 dtex.
- the “fineness” is a value determined from the length and weight of the fiber as defined in Japanese Industrial Standard (JIS) L 0104 and JIS L 1013. Or when a fiber is a substantially columnar shape, you may obtain
- JIS Japanese Industrial Standard
- For measurement of the fiber diameter first, arbitrarily sample five or more locations from the filter material, and use a scanning electron microscope or the like to take a photograph at an appropriate magnification that can measure the fiber diameter. Next, a lattice-like sheet is placed on the photograph, and the diameter of 100 or more fibers at the lattice points is measured.
- the diameter means the width of the fiber in the direction perpendicular to the fiber axis.
- the value obtained by dividing the sum of the measured fiber diameters by the number of fibers (average value) may be used as the fiber diameter, and the “fineness” may be obtained using this value and the fiber density.
- the fiber diameter may be used as the fiber diameter, and the “fineness” may be obtained using this value and the fiber density.
- the respective finenesses are obtained from the average value of the respective fiber diameters, and when the obtained fineness falls within 0.7 to 4.0 dtex, It shall be contained in the short fiber of this embodiment. However, when the measurement number is as small as 10% or less, it is excluded from the object of fineness calculation.
- the cross-sectional shape of the short fiber that can be used in the aggregate removal filter material according to the present embodiment is not limited to a circular shape, and any shape can be used.
- any shape can be used.
- variants such as those described in JP-A-8-170221, JP-A-8-291424, JP-A-2002-61023, JP-A-2004-225184, JP-A-2005-82939, etc.
- a cross-sectional structure may be used.
- a circular cross-sectional structure is preferred from the viewpoint of ease of fiber dispersibility when processing with a high-pressure water stream and high production efficiency of the fiber itself.
- the fineness of the long fiber that can be used as the base fabric in the aggregate removal filter material according to the present embodiment is not particularly limited as long as it can be entangled with the short fiber, but it is more entangled if the fineness is almost the same as the short fiber. It is preferable because it is easy to make. If the fineness of the short fibers is too small relative to the fineness of the long fibers, the short fibers may go too deep into the base fabric made of long fibers, which may reduce the removal efficiency of large aggregates. This is because if the fineness is too large, there is a concern that the confounding will be insufficient and drop off. From this, the fineness ratio of long fibers and short fibers is 1: 0.5 to 1: 2, more preferably 1: 0.8 to 1: 1.5, and long fibers and short fibers having substantially the same fineness. It is good to use.
- the aggregate removal filter material according to the present embodiment has a three-layer structure of a short fiber layer, a long fiber layer, and a short fiber layer, and the short fiber layer (1) —the long fiber layer—the short fiber from the side closer to the blood introduction port side.
- positioning with a layer (2) it is preferable that the fineness of a short fiber layer (1) and (2) is the same, or the fineness of a short fiber layer (1) is larger than the fineness of a short fiber layer (2).
- the short fiber layer (1) is 1.0 times or more, preferably 1.5 times or more the fineness of the short fiber layer (2).
- the fineness of the fibers should be reduced in the order of short fiber layer (1) ⁇ long fiber layer ⁇ short fiber layer (2). This is because very large aggregates are removed by the short fiber layer (1), and small aggregates are removed by the long fiber layer and the short fiber layer (2) having a smaller fineness downstream from the short fiber layer (1).
- the fiber length of the short fibers used in the aggregate removal filter material according to this embodiment is 1 to 80 mm. If it is less than 1 mm, the interlaced fibers are insufficient and the strength tends to decrease. If it exceeds 80 mm, the fiber component oriented in the longitudinal direction is insufficient, and clogging resistance due to aggregates tends to decrease. .
- the thickness is preferably 5 to 70 mm, more preferably 20 to 60 mm.
- the “fiber length” is an average value obtained by taking a photograph of arbitrarily sampled short fibers and measuring the length of 30 or more short fibers having a clear starting point and ending point using an image analyzer or the like. Say.
- Wave-shaped crimp yarns are preferred over straight fibers because the fibers tend to be entangled with each other by the spunlace method and consequently contribute to improvement in strength.
- the total weight of the aggregate removal filter material according to this embodiment is 10 to 80 g / m 2 .
- the total basis weight is less than 10 g / m 2 , there is a tendency that the efficiency of removing aggregates is reduced and the strength is insufficient. If it exceeds 80 g / m 2 , it may be difficult to fill the filter device.
- the leukocyte removal filter material can be compressed to reduce the filtration flow rate of the blood product. It is preferably 15 to 60 g / m 2 , more preferably 20 to 50 g / m 2 .
- total basis weight of the filter material is a sample of 3 or more locations from any location that seems to be homogeneous in an arbitrary size such as 5 cm x 5 cm, and the average value is obtained by measuring the weight of each filter material, This is calculated by converting the weight per square meter.
- the basis weight of the base fabric made of long fibers used in the aggregate removal filter material according to this embodiment is 5 g / m 2 or more, preferably 5 to 40 g / m 2 , more preferably 15 to 30 g / m 2 . This is because if the basis weight of the base fabric made of long fibers is less than 5 g / m 2 , the strength of the filter material may be reduced.
- the basis weight ratio between the base fabric made of long fibers and the short fibers is preferably 1: 0.1 to 1:10, and more preferably 1: 0.8 to 1: 3. In the case of a filter material having a three-layer structure, it is preferable that the basis weights of the short fibers on both sides are added together and are within the above-mentioned range compared with the basis weight of the long fibers.
- the thickness of the aggregate removal filter material according to this embodiment is preferably 0.1 to 1.0 mm. If the thickness is less than 0.1 mm, there is a concern about a decrease in aggregate removal efficiency and insufficient strength, and if it exceeds 1.0 mm, the filter device must be enlarged when filled with a plurality of filter materials, or This is because the leukocyte removal filter material disposed downstream may be compressed to increase the density, and as a result, the flow rate may be reduced. More preferably, it is 0.2 to 0.8 mm, more preferably 0.3 to 0.6 mm. In addition, the thickness said here is measured according to the following procedures.
- one filter material was cut into a size of 5 cm ⁇ 5 cm, and the thickness of a total of 9 sides (4 places), corners (4 places), and center (1 place) was measured with a constant pressure thickness gauge, The average value is the thickness.
- the pressure applied with the constant-pressure thickness meter is 0.4 N, and the area of the measurement part is 1.8 cm 2 .
- the bulk density of the aggregate removal filter material according to this embodiment is preferably 0.05 to 0.10 g / cm 3 .
- the bulk density is less than 0.05 g / cm 3 , there is a tendency that the aggregate removal efficiency is lowered and the strength is insufficient.
- it is 0.10 g / cm 3 or more, the short fibers are close to each other and large aggregates are easily captured on the surface, and as a result, the capture efficiency of the aggregates tends to decrease.
- the “bulk density of the filter material” is obtained by cutting out the filter material in an arbitrary size such as 5 cm ⁇ 5 cm from a place considered to be homogeneous, and measuring the basis weight with the above-described method with a thickness constant pressure thickness meter. Calculate by dividing the basis weight by the thickness. However, the part to be cut out is changed and the measurement is performed three times or more, and the average value is defined as the bulk density.
- the ventilation resistance of the aggregate removal filter material according to this embodiment is preferably 4 to 11 Pa ⁇ s ⁇ m / g.
- the ventilation resistance is a value measured as a differential pressure generated when air of a constant flow rate is passed through the filter material. More specifically, the pressure loss (Pa ⁇ s / m) generated when a filter material is placed on a vent hole having a diameter of 2.8 cm and air of 4 ml / s ⁇ cm 2 per unit area is vented for 10 seconds or more. This value is a value obtained by dividing this value by the basis weight (g / m 2 ) of the filter material and further multiplying by 10.
- a large value means that the air is difficult to pass through and the fibers are entangled in a dense state or has a structure with a low porosity, which indicates that the blood product is difficult to flow.
- this value when this value is small, the number of fibers is small, indicating that the structure is scarce. That is, when this value is larger than 11 Pa ⁇ s ⁇ m / g, the filtration time of the blood product is prolonged, and clogging due to contained aggregates is likely to occur.
- it is less than 4 Pa ⁇ s ⁇ m / g, aggregates cannot be captured efficiently, and the risk of clogging the surface of the filter material downstream thereof, lack of strength, etc. increases. . More preferably, it is 6 to 9 Pa ⁇ s ⁇ m / g.
- the short fiber and long fiber used in the aggregate removal filter material according to the present embodiment can be any fiber as long as it does not adversely affect blood, but is highly versatile, easy to process, and inexpensive. For this reason, it is preferable to use a synthetic polymer as a raw material.
- a synthetic polymer for example, polyamide, polyester, polyacrylonitrile, polyurethane, polyvinyl formal, polyvinyl acetal, polytrifluorochloroethylene, poly (meth) acrylate, Polysulfone, polystyrene, polyethylene, polypropylene, cellulose, cellulose acetate and the like can be mentioned.
- polyesters such as polyethylene terephthalate and polybutylene terephthalate, which are particularly versatile and easily entangle with fibers by the spunlace method, are preferable.
- the aggregate removal filter material according to the present embodiment has a strength that does not cause the shape deformation that causes a substantial problem. This is because short fibers having a fineness and a fiber length suitable for this application are entangled with a base fabric made of high-strength long fibers by a spunlace method or the like. More specifically, it means that the filter material has a tensile strength of 3% or less when the filter material is cut into an arbitrary width and stretched with a force of 0.4 N / cm. As a result of having sufficient strength as described above, it is possible to realize stable production without causing a shape change even if the filter material according to the present embodiment is processed in various manufacturing processes such as washing with water and heat treatment. Is possible. In addition, since the shape change is small, the aggregate capturing performance is stabilized and the quality stability is excellent.
- the filter device When the filter device is filled with the aggregate removing filter material of the present invention, it is arranged on the blood inlet side.
- the short fiber layer is disposed on the blood inlet side
- the long fiber layer which is the base fabric, is disposed on the downstream leukocyte removal filter material side.
- the aggregate removal filter material has a three-layer structure of a short fiber layer-long fiber layer-short fiber layer, it is preferable to dispose the short fiber layer having a higher fineness on the blood inlet side.
- the leukocyte removal filter material is disposed downstream of the aggregate removal filter material.
- a porous structure having continuous pores or a fiber structure having an ultrafine fiber diameter may be used, but it is excellent in productivity, inexpensive, and quality. Fibrous structures, especially non-woven fabrics are preferred because of their stability.
- the leukocyte removal filter material is a porous structure having continuous pores
- examples of the material include polyacrylonitrile, polysulfone, cellulose, cellulose acetate, polyvinyl formal, polyester, poly (meth) acrylate, and polyurethane.
- the pore size of the porous structure is preferably 3 to 25 ⁇ m. If the pore diameter is less than 3 ⁇ m, the treatment time may be prolonged due to the passage resistance of a large amount of red blood cells contained in the blood product, which is not preferable. If the pore diameter exceeds 25 ⁇ m, the collision frequency between the leukocytes and the porous structure is lowered, and the leukocyte removal performance may be lowered. A more preferable pore size is 5 to 15 ⁇ m.
- the pore diameter referred to here is an average flow diameter obtained by a method according to the half dry method (ASTM E1294-89).
- the leukocyte removal filter material is a fiber structure
- fiber structures such as paper, woven fabric, and knitted fabric can be used in addition to non-woven fabric manufactured by the melt-blowing method, flash spinning method, or papermaking method.
- a non-woven fabric with a very fine fiber diameter and a large surface area that increases the adhesion point is preferred.
- the materials include polyamide, polyester, polyacrylonitrile, polytrifluoroethylene, polymethyl methacrylate, polystyrene, polyethylene, polypropylene, and other synthetic fibers, regenerated fibers such as cellulose, refined fibers, and semi-synthetic materials such as cellulose acetate.
- the fineness of the fiber structure used as the leukocyte removal filter material is preferably 0.001 to 0.07 dtex (corresponding to a fiber diameter of 0.3 to 2.6 ⁇ m in the case of a polyester fiber having a cylindrical cross section). . If the fineness is less than 0.001 dtex, the mechanical strength of the fiber is low, and there is a possibility that it cannot be stably produced. If the fineness exceeds 0.07 dtex, the frequency of contact with white blood cells is reduced, and the white blood cell removal performance may be lowered, which is not preferable. A more preferable fineness is 0.003 to 0.03 dtex, and further 0.005 to 0.02 dtex. In addition, the fineness said here is the value calculated
- the ventilation resistance of the leukocyte removal filter material is preferably in the range of 250 to 700 Pa ⁇ s ⁇ m / g. This is because if it is less than 250 Pa ⁇ s ⁇ m / g, there is a risk that the leukocyte removal performance is insufficient, and if it exceeds 700 Pa ⁇ s ⁇ m / g, it is difficult to ensure a sufficient filtration flow rate of blood. More preferably, 350 to 600 Pa ⁇ s ⁇ m / g is suitable.
- the airflow resistance of the leukocyte removal filter material is also a value measured by the same method as the airflow resistance of the aggregate removal filter material.
- the surface of the leukocyte removal filter material or the aggregate removal filter material may be modified for the purpose of increasing the affinity between the blood product and the filter material or facilitating introduction of the blood into the filter device. good.
- materials suitable for such surface modification include polymers having nonionic hydrophilic groups and basic nitrogen-containing functional groups.
- As the surface modification means various known methods such as a coating method, a plasma discharge treatment method, an electron beam irradiation method, and a radiation graft method can be applied.
- the material of the container filled with the filter material of the present invention may be either a hard resin or a flexible resin.
- a hard resin examples of the material include acrylic resin, silicon resin, ABS resin, nylon, polyurethane, polycarbonate, vinyl chloride, polyethylene, polypropylene, polyester, and styrene-butadiene copolymer.
- polycarbonate, styrene- Butadiene copolymers are preferred from the standpoint of strength and versatility.
- a hard resin made of polycarbonate is a particularly preferable container material because it is excellent in safety, has high pressure strength, and has little denaturation to sterilization such as ⁇ rays and high-pressure steam sterilization.
- the inner wall of the container on the blood product inlet side has a height of 0.5 to 5.0 mm, preferably 1.5 to 3.3 in order to suppress poor blood filtration due to contact between the filter material and the container.
- a structure in which a protrusion called a 0 mm rib is provided and a space is secured between the aggregate removal filter material and the inner wall of the blood product inlet port is preferable.
- the materials are soft polyvinyl chloride, polyurethane, ethylene-vinyl acetate copolymer, polyolefin such as polyethylene and polypropylene, styrene-butadiene-styrene copolymer, thermoplastic elastomer and polyolefin
- a suitable material may be a mixture with a softening agent such as ethylene-ethyl acrylate.
- Preferred are soft vinyl chloride, polyurethane, ethylene-vinyl acetate copolymer, polyolefin, and thermoplastic elastomers containing these as main components, and more preferred are soft vinyl chloride and polyolefin.
- the sheet on which the blood product introduction port and the discharge port are laid is provided with an uneven portion, and 0.5 to 5.0 mm, preferably between the sheet and the filter material. Is preferably processed to ensure a space of 1.5 to 3.0 mm.
- a blood product filtration method using a filter device including both the aggregate removal filter material of the present invention and the above-described leukocyte removal filter material will be described.
- a filter device is prepared in which the above-described aggregate removing filter material of the present invention is disposed on the blood inlet side and the leukocyte removing filter material is disposed on the blood outlet port side.
- Another filter material may be filled between the aggregate removal filter material of the present invention and the leukocyte removal filter material.
- One or a plurality of aggregate removal filter materials are filled, and a sufficient amount of leukocyte removal filter material that can sufficiently remove leukocytes is filled downstream.
- the filter device In the case of filtering a whole blood product or a concentrated erythrocyte product with a large amount of white blood cells among blood products, the filter device is roughly 0.2 to 1.0 g of the aggregate removal filter material and 4.0 to 7 of the white blood cell removal filter material. 0.0 g is filled, and the filtration area of the filter device (the effective filtration cross-sectional area of the filter device for filtering blood products) is 30 to 60 cm 2 , and the internal volume (the void volume of the filter device) with the filter material filled Is preferably designed to be 20 to 50 ml.
- the kit in this state is filtered at a constant flow rate using a gravity drop or a pump.
- a gravity drop or a pump When filtering by gravity, suspend the original bag and set the height (head) to the collection bag to 0.3 to 2.0 m.
- the flow rate When filtration is performed at a constant flow rate, the flow rate may be set according to the capacity of the pump. From the viewpoint of avoiding problems such as the strength of the filter device and hemolysis, filtration may be performed within the range of 10 to 100 ml / min. good.
- the blood products to be filtered in the present invention are all blood products for transfusion such as whole blood products, concentrated erythrocyte products, and concentrated platelet products.
- the excellent effect of the present invention is clearly exhibited when the whole blood preparation or concentrated erythrocyte preparation containing a large amount of aggregates, which is refrigerated, is used as a target.
- the whole blood preparation or concentrated erythrocyte preparation stored at 1 to 6 ° C. for 12 to 80 hours has a large amount of aggregates, the clogging resistance effect of the aggregate removal filter material of the present invention becomes remarkable.
- the “clogging resistance” effect due to the aggregate mentioned here means that when the blood product containing the aggregate is filtered through a filter, the flow rate (g / min or ml / min) at the start of filtration and the blood product There is no significant difference in the filtration flow rate (g / min or ml / min) when almost the entire amount has been filtered. More specifically, the filtration flow rate at the end of filtration is 0.5% of the filtration flow rate at the start of filtration. The case where the above can be secured. Alternatively, when it is assumed that filtration is performed at a constant flow rate, the pressure loss due to the blood product at the end of filtration is less than twice the pressure loss (Pa) at the start of filtration.
- blood products vary greatly from individual to individual, and the filtration flow rate and filtration pressure are affected by the temperature of the blood product and the like, and are exemplified here as an indication of clogging resistance.
- the aggregate removal filter material according to this embodiment When the aggregate removal filter material according to this embodiment is disposed on the most upstream side of the leukocyte removal filter device, clogging due to aggregates is prevented, and the blood product can be filtered while maintaining a good flow rate. In general, blood products that have not been filtered must be discarded, but the aggregate removal filter material according to the present embodiment is excellent in clogging resistance. Can also be remedied. As a result, it can greatly contribute to the effective use of precious blood products and is extremely useful socially.
- Experiment A Evaluation of a filter device including only a two-layer aggregate removal filter material (Examples 1 to 3, Comparative Examples 1 and 2) Aggregate removal filter materials with different fineness of short fibers and long fibers were prepared by the spunlace method shown below, and the basis weight, thickness and ventilation resistance were measured by the method described above, and the elongation rate and blood products were used. Evaluation was performed.
- the stored whole blood product was connected to the filter device via a blood circuit having a clamp, and a collection bag for collecting the filtered blood product was further attached downstream thereof.
- the collection bag was placed on a balance and filtered at a drop of 30 cm in a refrigerator at 4 to 6 ° C.
- the time required for the blood product to reach the collection bag and the balance to show 50 g was measured, and the filtration flow rate (initial speed, g / min) during that time was determined.
- the time required when the blood product in the collection bag increased from 350 g to 400 g was measured, and the filtration flow rate (final speed, g / min) during that time was determined.
- a value obtained by dividing the filtration flow rate (final speed) by the filtration flow rate (initial speed) thus measured was calculated as a flow rate change rate.
- Experiment B Evaluation of a filter device including an aggregate removal filter material having a two-layer structure and a leukocyte removal filter material (Examples 4 to 14, Comparative Examples 3 to 8) Similar to Experiment A, a short fiber of polyethylene terephthalate was placed on a spunbonded nonwoven fabric made of polyethylene terephthalate as a base fabric made of long fibers, and an agglomerate removing filter material was prepared by the spunlace method. In Examples 4 to 6, the same aggregate removal filter material as in Examples 1 to 3 was used, and in Comparative Examples 3 to 4, the same aggregate removal filter material as in Comparative Examples 1 and 2 was used.
- agglomerate-removing filter materials in which various physical property values such as fiber length of short fibers, fineness and basis weight of short fibers and long fibers were changed were used. Moreover, the following were used as a leukocyte removal filter material. Two types of non-woven fabric were produced by the melt blow method, and this was used as a leukocyte removal filter material. One is a non-woven fabric made of polyethylene phthalate (X) having a fineness of 0.032 dtex and a basis weight of 40 g / m 2 , and the other is a non-woven fabric made of polyethylene terephthalate having a fineness of 0.016 dtex and a basis weight of 40 g / m 2.
- X polyethylene phthalate
- each leukocyte removal filter material was 300 Ps ⁇ s ⁇ m / g (filter material X) and 475 Pa ⁇ s ⁇ m / g (filter material Y).
- the aggregate removal filter material and leukocyte removal filter material (X, Y) are cut into a size of 7.4 cm ⁇ 7.4 cm, and 32 leukocyte removal filter materials (Y) are placed thereon, and the leukocyte removal filter material (X 2) Two sheets were placed, and three aggregate removal filter materials prepared by the spunlace method were placed thereon so that the long fiber surface side would be down.
- the filter device thus laminated is filled into a polycarbonate container having an inlet and an outlet so that the aggregate removal filter material is on the blood product inlet side, and ultrasonically welded. Created.
- the effective filtration area of the filter is 45 cm 2
- the inner wall of the blood product inlet side container has a rib of 1.8 mm in height
- the inner wall of the blood product outlet port side container has a height of 0.6 mm. Laying of ribs.
- Experiment B only the aggregate removal filter material was changed, and the leukocyte removal filter material, container, and blood product filtration method were all the same.
- Comparative Examples 9-12 The same evaluation was performed using the same materials (leukocyte removal filter material, container, blood preparation) as in Example 4 except that the following were used as the aggregate removal filter material.
- a filter material having a basis weight of 40 g / m 2 consisting only of a base fabric made of spunbond long fibers having the same fineness as in Example 1 was used as an agglomerate removing filter material.
- the fineness and the fiber length were the same as the short fibers used in Example 1, but a spunlace nonwoven fabric composed of only short fibers and having a basis weight of 40 g / m 2 was used as the aggregate removal filter material.
- Comparative Examples 11 and 12 a non-woven fabric made only of short fibers prepared by the needle punch method was used as an agglomerate removing filter material. In each case, the basis weight is 40 g / m 2 , but Comparative Example 11 uses short fibers having the same fiber length and fineness as Example 1, and Comparative Example 12 uses short fibers having the same fiber length and fineness as Comparative Example 2. .
- the results of Comparative Examples 9 to 12 are also summarized in Table 2.
- Example 15 The material of the short fiber and long fiber is changed from polyethylene terephthalate to polybutylene terephthalate, and the long fiber (fineness: 1.7 dtex, basis weight: 15 g / m 2 ) and short fiber (fiber length: 50 mm, fineness: 1) made of spunbond
- An agglomerate-removing filter material comprising 8 dtex, basis weight: 25 g / m 2 ) was prepared.
- Three filter materials were filled as an agglomerate removal filter material, and the same evaluation as in Example 4 was performed. The results are shown in Table-2.
- Example 16 A filter device in which only 34 leukocyte removal filter materials (X) were arranged on the downstream side of the same aggregate removal filter material as in Example 4 was prepared. Otherwise, the same evaluation as in Example 4 was performed. The results are shown in Table 2.
- Example 17 Two leukocyte removal filter materials (X) are provided on the downstream side of the same aggregate removal filter material as in Example 4, and further on the downstream side, the fineness is 0.013 dtex, the basis weight is 40 g / m 2 , and the ventilation resistance is 600 Pa ⁇ s ⁇ m.
- a filter device in which 32 leukocyte removal filter materials (Z) of / g were arranged was prepared. Otherwise, the same evaluation as in Example 4 was performed. The results are shown in Table 2.
- Example 18 The same aggregate removal filter material as in Example 4 is used as one sheet, and three sheets of spunbond nonwoven fabric having a basis weight of 30 g / m 2 , a ventilation resistance of 11.5 Pa ⁇ s ⁇ m / g, and a fineness of 1.6 dtex are provided downstream.
- a filter device was prepared, in which two and 32 leukocyte removal filter materials (X) and (Y) were further arranged downstream thereof. Otherwise, the same evaluation as in Example 4 was performed. The results are shown in Table 2.
- Example 19 The concentrated erythrocyte preparation was filtered with the same filter device as in Example 18.
- the concentrated erythrocyte preparation used here was prepared by centrifuging human whole blood collected using CPD as an anticoagulant, and then adding MAP solution, which is a storage solution for erythrocytes, and storing it at 4 ° C. for 72 hours (270 g, hematocrit. Value 68%). Evaluation was performed in the same manner as in Example 18 except that the drop was set to 1.8 m and the filtration flow rate was increased to the final speed while the blood product in the collection bag increased from 170 g to 220 g. The results are shown in Table 2.
- Experiment C Evaluation of a filter device including an aggregate removal filter material having a three-layer structure and a leukocyte removal filter material (Examples 20 to 24, Comparative Examples 13 to 16)
- a multifilament made of polyethylene terephthalate was obtained by drawing an undrawn yarn obtained at a spinning temperature of 270 ° C. and a spinning speed of 1500 m / min.
- the multifilament was twisted and processed into a woven fabric to obtain a base fabric.
- Short fibers made of polyethylene terephthalate were dispersed in water and laminated on top and bottom of the base fabric by a papermaking method.
- the filter material for removing aggregates according to the present embodiment, and the blood product filtration method using the filter device including the filter material and the leukocyte removal filter material can be used in the medical industry.
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Abstract
Description
本発明の目的は、上述した従来の課題を解決した凝集物除去フィルター材を提供することにある。本発明はまた、かかる凝集物除去フィルター材を血液製剤の導入口に近い上流側に配置し、さらに血液導出口に近い下流側に白血球除去フィルター材を配置したフィルター装置を用い、重力あるいはポンプ等を用いて血液製剤をろ過することで、その中に含まれている大小様々な大きさの凝集物と白血球を効率よく除去する、血液製剤のろ過方法を提供することにある。
また、編布あるいは織布を構成する長繊維としては、以下の式(1)で表される撚係数(K)が3,000~30,000、好ましくは5,000~10,000のものが強度及び短繊維との交絡の容易さの視点から好ましい。一般に編布あるいは織布の長繊維は、複数の繊維を合糸し、さらに撚った形状のため、非常に強度が強い特徴がある。
撚係数(K)=T×D0.5 (1)
T:撚数(回転数/m)、D:繊度(dtex)
(Tは単位長さ(m)あたりの撚数である。Dは積層型マルチフィラメント糸のトータル繊度であり、積層型マルチフィラメント糸と他の糸条との複合糸の場合は複合糸のトータル繊度をいう)
スパンレース法によって本実施形態に係るフィルター材を製造する場合、水の圧力は40~200kgf/cm2とし、水を噴出するノズル径を80~150μmにすると、所望のフィルター材を得ることができる。
また、以下に述べる方法によって、立体構造の有無を判断することもできる。まず図1のような写真からフィルター材の厚みを測定し、この値と1.8cm2の面積あたり、0.4Nの一定荷重を加える定圧厚み計で求めた厚みの数値を比較し、後者が前者の10%以上、より好ましい構造としては30%以上、小さい数値である場合に短繊維層で立体構造が形成されていると判断する。短繊維で形成された立体構造は非常にソフトで容易に圧縮されることから、無負荷状態で測定した厚みよりも一定荷重で測定した厚みは極端に小さくなる。但し、写真での厚み測定において、表層部の繊維が乱れ凹凸を形成し、測定の起点を定めることが困難な場合は、大多数の繊維が存在する最表層部を起点と定め、起点-起点の長さを厚みとして測定する。写真での測定は異なる箇所で3回以上測定し、その平均値をフィルター材の厚みとする。同様に、一定荷重を加えて厚みを測定する場合も3回以上測定を行い、その平均値を用いることとする。
なお、ここで「繊維長」とは、任意にサンプリングした短繊維を写真に取り、起点と終点が明確な30本以上の短繊維の長さを画像解析装置等を利用して測定した平均値を言う。
なお、長繊維からなる基布と短繊維の目付比は1:0.1~1:10とすることが良く、1:0.8~1:3であることがより相応しい。3層構造のフィルター材の場合は、両側の短繊維の目付を合算し、これを長繊維の目付と比較して上述した範囲に収まることが好ましい。
血液製剤の入口と出口を有する容器内に、上述した本発明の凝集物除去フィルター材を血液導入口側に、白血球除去フィルター材を血液導出口側に配置したフィルター装置を作成する。本発明の凝集物除去フィルター材と、白血球除去フィルター材の間にその他のフィルター材を充填しても良い。
凝集物除去フィルター材を1枚あるいは複数枚充填し、その下流に充分な白血球除去が行える分量の白血球除去フィルター材を充填する。血液製剤の中でも白血球が多い全血製剤や濃厚赤血球製剤をろ過する場合のフィルター装置には、おおよそ、凝集物除去フィルター材を0.2~1.0g、白血球除去フィルター材を4.0~7.0g充填し、また、フィルター装置のろ過面積(血液製剤をろ過するフィルター装置の有効ろ過断面積)は30~60cm2、フィルター材を充填した状態での内容積(フィルター装置の空隙体積)としては20~50mlに設計することが好ましい。
なお、ここで言う凝集物による「目詰まり耐性」効果とは、凝集物を含む血液製剤をフィルターでろ過したときに、ろ過開始時の流量(g/分あるいはml/分)と、血液製剤のほぼ全量をろ過し終えた時のろ過流量(g/分あるいはml/分)に大幅な差がないこと、より具体的にはろ過終了時のろ過流量がろ過開始時のろ過流量の0.5以上を確保できている場合を言う。あるいは一定流量でろ過することを想定した場合には、ろ過終了時の血液製剤による圧力損失が、ろ過開始時の圧力損失(Pa)の2倍以下である場合を言う。但し、血液製剤は非常に個体差が大きく、血液製剤の温度等によってろ過流量やろ過圧力が左右されるため、目詰まり耐性を示す目安としてここに例示するものである。
(実施例1~3、比較例1~2)
短繊維及び長繊維の繊度が異なる凝集物除去フィルター材を以下に示すスパンレース法で作成し、前述した方法で目付と厚みと通気抵抗を測定し、さらに伸び率の測定と血液製剤を用いた評価を行った。
長繊維からなる基布としてスパンボンド法によって製造した15g/m2のポリエチレンテレフタレート製不織布を用い、これに繊維長が50mmのポリエチレンテレフタレート製短繊維を25g/m2乗せ、この積層体に水流交絡機の支持ネット上で90μmのノズル径から圧力100kgf/cm2の水を噴射することで繊維同士を交絡させて40g/m2のスパンレース不織布からなるフィルター材を得た。
作成したフィルター材を幅5cm、長さ10cmに切断し、これをオートグラフ万能試験機(型式AG-1、島津製作所製)に装着した。除々にフィルター材を引っ張り、2Nの力(0.4N/cm)で引っ張ったときの長手方向への伸び長を測定し、以下の式(2)より伸び率(%)を求めた。
(荷重負荷後の長手方向の長さ/10-1)×100(%) (2)
作成した凝集物除去フィルター材を20枚積層し、これを血液製剤の導入口と導出口を有し、有効ろ過断面積が25cm2(5cm×5cm)のポリカーボネート製容器に充填して、超音波溶着を行うことでフィルター装置を作成した。ここで、血液製剤の導入口側容器の内壁には高さが1.8mmのリブを有し、導出口側容器の内壁には高さが0.6mmのリブを敷設した。
ヒト全血(400ml)を、抗凝固剤としてCPD(56ml)が入った血液バッグに採血することで全血製剤を得、この製剤を2℃の冷蔵庫内で48時間保存した。保存後の全血製剤に、クランプを有する血液回路を介して上記のフィルター装置と接続し、さらにその下流にろ過した血液製剤を回収する回収バッグを取り付けた。回収バッグを天秤の上に置き、4~6℃の冷蔵室内で、落差30cmでろ過を行った。ろ過に際し、回収バッグに血液製剤が到達し、天秤が50gを示すまでに要した時間を計測し、その間のろ過流量(初速、g/分)を求めた。さらにろ過を続け、回収バッグの血液製剤が350gから400gまで増える時に要した時間を計測し、その間のろ過流量(終速、g/分)を求めた。このようにして測定したろ過流量(初速)でろ過流量(終速)を除した値を流量変化率として算出した。
フィルター材の凝集物除去性能を評価するため、次の評価を行った。ろ過後の回収バッグの血液製剤をよく混和し、この中から50mlを採取した。これを40μmメッシュフィルターでろ過し、生理食塩水で余分な血球成分等を洗い流し、その後ろ過に使用したメッシュフィルターを光学顕微鏡(×100倍)で観察した。全視野を観察し、メッシュの開口部に微小凝集物が捕捉されている場合にはろ過後血液製剤に凝集物有りと判断した。
実施例1~3及び比較例1~2で用いた凝集物除去フィルター材の物性特性値及び血液製剤を用いた評価結果を表-1にまとめる。
(実施例4~14、比較例3~8)
実験Aと同様に長繊維からなる基布としてポリエチレンテレフタレート製のスパンボンド不織布に、ポリエチレンテレフタレートの短繊維を乗せ、スパンレース法で凝集物除去フィルター材を作成した。実施例4~6は実施例1~3と同じ凝集物除去フィルター材を使用し、比較例3~4は比較例1~2と同じ凝集物除去フィルター材を使用した。実施例7~14及び比較例5~8は、短繊維の繊維長や、短繊維及び長繊維の繊度や目付などの様々な物性特性値を変更した凝集物除去フィルター材を用いた。また、白血球除去フィルター材として、以下のものを用いた。メルトブロー法によって2種類の不織布を製造し、これを白血球除去フィルター材とした。1つは、繊度が0.032dtexで目付が40g/m2のポリエチレンフタレート製の不織布(X)であり、もう1つは繊度が0.016dtexで目付は同じく40g/m2のポリエチレンテレフタレート製不織布(Y)である。この白血球除去フィルター材のそれぞれの通気抵抗は300Ps・s・m/g(フィルター材 X)、475Pa・s・m/g(フィルター材 Y)であった。
凝集物除去フィルター材、白血球除去フィルター材(X、Y)を7.4cm×7.4cmの大きさに切断し、白血球除去フィルター材(Y)を32枚、その上に白血球除去フィルター材(X)2枚を乗せ、さらにその上にスパンレース法で作成した凝集物除去フィルター材3枚を、長繊維面側が下となるように乗せた。このようにして積層したフィルター材を、凝集物除去フィルター材が血液製剤の導入口側になるように、導入口と導出口を有するポリカーボネート製容器に充填し、超音波溶着することでフィルター装置を作成した。フィルターの有効ろ過面積は45cm2であり、血液製剤の導入口側容器の内壁には高さが1.8mmのリブがあり、血液製剤の導出口側容器の内壁には高さが0.6mmのリブを敷設した。なお、実験Bでは凝集物除去フィルター材のみを変更し、白血球除去フィルター材、容器、血液製剤のろ過の方法は全て同じとした。
実験Aと同様の凝集物除去フィルター材の伸び率の測定、凝集物除去性能の評価、ろ過流量の変化率測定以外に残存白血球数を以下の手順で測定した。
ろ過後の血液製剤をポリエチレン製のスピッツ管にサンプリングし、アクリジンオレンジ液で漏れてきた白血球を染色した後、蛍光顕微鏡を用いて測定した。測定した白血球濃度に回収した血液製剤の液量を乗じることで回収バッグに含まれる残存白血球数を測定した。なお、残存白血球数は106/回収バッグ以下であれば、そのフィルター装置は充分に高い白血球除去性能を発揮したと見做すことができる。
実施例4~14及び比較例3~8で用いた凝集物除去フィルター材の物性特性値及び血液製剤を用いた評価結果を表-2にまとめる。
凝集物除去フィルター材として次のものを用いた以外は実施例4と同じ材料(白血球除去フィルター材、容器、血液製剤)を用いて同様の評価を行った。
比較例9は、繊度が実施例1と同じスパンボンド製の長繊維からなる基布のみからなり、目付が40g/m2のフィルター材を凝集物除去フィルター材として使用した。
比較例10は、繊度及び繊維長が実施例1で用いた短繊維と同じであるが、短繊維のみからなり、目付が40g/m2のスパンレース不織布を凝集物除去フィルター材として使用した。
比較例11及び12はニードルパンチ法で作成した、短繊維のみからなる不織布を凝集物除去フィルター材として使用した。いずれも目付は40g/m2であるが、比較例11は繊維長及び繊度が実施例1と同じ短繊維を用い、比較例12は繊維長及び繊度が比較例2と同じ短繊維を用いた。
比較例9~12の結果も表-2にまとめる。
短繊維及び長繊維の素材をポリエチレンテレフタレートからポリブチレンテレフタレートに変更し、スパンボンド製の長繊維(繊度:1.7dtex、目付:15g/m2)と短繊維(繊維長:50mm、繊度:1.8dtex、目付:25g/m2)からなる凝集物除去フィルター材を作成した。このフィルター材3枚を凝集物除去フィルター材として充填し、実施例4と同様の評価を行った。結果を表-2に示す。
実施例4と同じ凝集物除去フィルター材の下流側に白血球除去フィルター材(X)のみを34枚配置したフィルター装置を作成した。それ以外は実施例4と同様の評価を行った。結果を表-2に示す。
実施例4と同じ凝集物除去フィルター材の下流側に白血球除去フィルター材(X)を2枚、さらにその下流に繊度が0.013dtex、目付が40g/m2、通気抵抗が600Pa・s・m/gの白血球除去フィルター材(Z)を32枚配置したフィルター装置を作成した。それ以外は実施例4と同様の評価を行った。結果を表-2に示す。
実施例4と同じ凝集物除去フィルター材を1枚とし、その下流に目付が30g/m2、通気抵抗が11.5Pa・s・m/g、繊度が1.6dtexのスパンボンド不織布を3枚配置し、さらにその下流に白血球除去フィルター材(X)及び(Y)をそれぞれ2枚、32枚配置したフィルター装置を作成した。それ以外は実施例4と同様の評価を行った。結果を表-2に示す。
実施例18と同じフィルター装置で濃厚赤血球製剤をろ過した。ここで使用した濃厚赤血球製剤は、CPDを抗凝固剤として採血したヒト全血を遠心分離し、その後赤血球の保存液であるMAP液を添加し、4℃で72時間保存した製剤(270g、ヘマトクリット値68%)である。落差1.8mとし、回収バッグの血液製剤が170gから220gまで増える間のろ過流量を終速とした以外は実施例18と同様の評価を行った。結果を表-2に示す。
(実施例20~24、比較例13~16)
ポリエチレンテレフタレートからなるマルチフィラメントを紡糸温度270℃、紡糸速度1500m/分で得た未延伸糸を延伸することで得、このマルチフィラメントを撚糸し、織布に加工することで基布とした。
ポリエチレンテレフタレート製の短繊維を水中に分散させ、この基布の上下に抄造法により積層した。その後、孔径150μmのノズルから圧力100kgf/cm2の水を噴射することで基布と短繊維、及び短繊維同士を交絡させ、3層構造の凝集物除去フィルター材を得た。
凝集物除去フィルター材の強度として、実施例1と同じ方法で伸び率を測定した。次に血液製剤を用いた評価は実施例4と同じ方法、条件で行った。なお、血液製剤の導入口側に近い方を短繊維層(1)、白血球除去フィルター材に近い方を短繊維層(2)とした凝集物除去フィルター材を配置し、血液製剤の導出口側に白血球除去用のフィルター材を配置した。
実施例20~24及び比較例13~16で使用した凝集物除去フィルター材の特性値、伸び率、凝集物目詰まり耐性(流量変化率)の結果を表-3に示す。
Claims (16)
- 血液製剤の凝集物を除去するための凝集物除去フィルター材であって、 該フィルター材は繊度が0.7~4.0dtex、繊維長が1~80mmの短繊維と、平面方向に繊維軸が配向した長繊維からなる基布を含み、該短繊維を該基布に交絡させて総目付を10~80g/m2とし、該短繊維の層が立体構造を形成していることを特徴とする凝集物除去フィルター材。
- 長繊維からなる基布の目付は5g/m2以上である請求項1記載の凝集物除去フィルター材。
- 長繊維からなる基布と短繊維の目付の比が1:0.1~1:10である請求項1または2に記載の凝集物除去フィルター材。
- 長繊維と短繊維の繊度の比は1:0.5~1:2である請求項1ないし3のいずれかに記載の凝集物除去フィルター材。
- 長繊維がスパンボンド繊維である請求項1ないし4のいずれかに記載の凝集物除去フィルター材。
- 長繊維からなる基布と短繊維をスパンレース法(水流絡合法)で交絡させた請求項1ないし5のいずれかに記載の凝集物除去フィルター材。
- 通気抵抗が4~11Pa・s・m/gである請求項1ないし6のいずれかに記載の凝集物除去フィルター材。
- 長繊維の層と短繊維の層の2層構造からなる請求項1ないし7のいずれかに記載の凝集物除去フィルター材。
- 長繊維の層とその両面に短繊維の層を有する3層構造からなる請求項1ないし7のいずれかに記載の凝集物除去フィルター材。
- 繊度が0.7~4.0dtex、繊維長が1~80mmの短繊維を、平面方向に繊維軸が配向した長繊維からなる基布に交絡させて総目付を10~80g/m2とした凝集物除去フィルター材と白血球除去フィルター材を有するフィルター装置を用いた血液製剤のろ過方法。
- 交絡させた短繊維層が立体構造を形成している凝集物除去フィルター材を用いた請求項10に記載の血液製剤のろ過方法。
- 通気抵抗が250~700Pa・s・m/gの白血球除去フィルター材を充填したフィルター装置を用いた請求項10または11に記載の血液製剤のろ過方法。
- 繊度が0.001~0.07dtexの繊維構造体を白血球除去フィルター材として充填したフィルター装置を用いた請求項10ないし12のいずれかに記載の血液製剤のろ過方法。
- 1~6℃で12~80時間保存した血液製剤である請求項10ないし13のいずれかに記載の血液製剤のろ過方法。
- 血液製剤が全血製剤、濃厚赤血球製剤である請求項14記載の血液製剤のろ過方法。
- 繊度が0.7~4.0dtex、繊維長が1~80mmの短繊維を、平面方向に繊維軸が配向した長繊維からなる基布に交絡させて総目付を10~80g/m2とし、短繊維の層が立体的構造を形成している構造物の凝集物除去フィルター材としての使用。
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JP2010213820A (ja) * | 2009-03-16 | 2010-09-30 | Asahi Kasei Medical Co Ltd | 凝集物除去フィルター材 |
RU2633491C2 (ru) * | 2013-03-18 | 2017-10-12 | Асахи Касеи Медикал Ко., Лтд. | Удаляющий агрегаты фильтрующий материал, способ удаления агрегатов, фильтр для удаления лейкоцитов и способ фильтрования продукта крови |
WO2014148504A1 (ja) | 2013-03-18 | 2014-09-25 | 旭化成メディカル株式会社 | 凝集物除去フィルター材、凝集物除去方法、白血球除去フィルター及び血液製剤のろ過方法 |
US10188974B2 (en) | 2013-03-18 | 2019-01-29 | Asahi Kasei Medical Co., Ltd. | Aggregate-removing filter material, aggregate removal method, white blood cell-removing filter, and blood product filtering method |
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JP2020014865A (ja) * | 2013-10-28 | 2020-01-30 | ボストン サイエンティフィック サイムド,インコーポレイテッドBoston Scientific Scimed,Inc. | 再循環流体管理システム |
US10786619B2 (en) | 2013-10-28 | 2020-09-29 | Boston Scientific Scimed, Inc. | Fluid management system and methods |
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US11628244B2 (en) | 2013-10-28 | 2023-04-18 | Boston Scientific Scimed, Inc. | Fluid management system and methods |
JP2016086736A (ja) * | 2014-11-05 | 2016-05-23 | 日立化成株式会社 | 血中希少細胞含有液の製造方法 |
US11883626B2 (en) | 2019-06-27 | 2024-01-30 | Boston Scientific Scimed, Inc. | Detection of an endoscope to a fluid management system |
Also Published As
Publication number | Publication date |
---|---|
JP5422554B2 (ja) | 2014-02-19 |
TW201000158A (en) | 2010-01-01 |
TWI446939B (zh) | 2014-08-01 |
JPWO2009128435A1 (ja) | 2011-08-04 |
EP2286821A4 (en) | 2013-04-24 |
CN102006876B (zh) | 2012-07-25 |
US20110031191A1 (en) | 2011-02-10 |
EP2286821B1 (en) | 2014-04-02 |
BRPI0911314A2 (pt) | 2015-09-29 |
EP2286821A1 (en) | 2011-02-23 |
CN102006876A (zh) | 2011-04-06 |
US8932470B2 (en) | 2015-01-13 |
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