JP4326893B2 - Separation material for plasma or serum, filter for plasma or serum, and production method thereof - Google Patents

Description

  The present invention relates to a plasma or serum separation material, a plasma or serum filter, and methods for producing them.

  Conventionally, biochemical tests have been widely performed for diagnosis of various diseases. In this biochemical test, plasma or serum is separated from blood in order to eliminate the influence of blood cells such as red blood cells. As this separation method, there is a method in which blood is coagulated and then centrifuged. However, this separation method has a problem that it takes time. Therefore, a method for separating plasma or serum using a filter has been proposed.

  For example, Japanese Patent Laid-Open No. 10-211277 (Patent Document 1) states that “an ultrafine fiber assembly is made of ultrafine fibers having an average fiber diameter of 0.5 to 3.5 μm and an average hydrodynamic radius of 0.5 to 3.0 μm. Plasma comprising the nonwoven fabric alone or a laminate of a plurality of nonwoven fabrics, wherein the blood cell separation layer has a length of 5 mm or more, and the blood flow direction is a horizontal direction with respect to the surface of the nonwoven fabric, "Serum separation filter" is disclosed, and the nonwoven fabric obtained by the melt blow method is disclosed. However, the nonwoven fabric obtained by the melt-blowing method has a large variation in fiber diameter, so that it is difficult to obtain a good separation action. In addition, in order to manufacture a filter by stacking nonwoven fabrics, it is necessary to cut or punch the nonwoven fabric into a predetermined shape, which is not only complicated, but the usage rate of the nonwoven fabric is low and wasteful of resources. , Which led to increased costs.

JP-A-10-211277 (Claim 1, Claim 8, etc.)

  The present invention has been made to solve the above-described problems, and provides a plasma or serum separation material and a plasma or serum filter capable of obtaining a good separation action, and is excellent in manufacturing workability. It is an object of the present invention to provide a method for producing a plasma or serum separation material and a method for producing a plasma or serum filter that can use resources without waste and suppress an increase in cost.

  The invention according to claim 1 of the present invention is directed to “plasma or serum formed from a fiber aggregate mainly composed of ultra-fine drawn fibers having a fiber diameter of 4 μm or less, formed using gas as a dispersion medium, into a desired shape. Separating material ". Since the stretched ultrafine stretched fibers have the same fiber diameter, this ultrafine stretched fiber is mainly used as a separation material with small variations in fiber diameter, that is, a plasma or serum separation material that exhibits a good separation action. . Moreover, since a separation material with small density unevenness can be obtained by using a gas as a dispersion medium, it is a separation material for plasma or serum showing a good separation action.

  The invention according to claim 2 of the present invention states that “a value (σ / d) obtained by dividing the standard deviation value (σ) of the fiber diameter distribution of the ultrafine drawn fiber by the average fiber diameter (d) of the ultrafine drawn fiber is 0.00. The plasma or serum separation material according to claim 1, which is 2 or less. Because the fiber diameters of ultra-fine drawn fibers are uniform, the mean pore size distribution curve is sharp and the plasma or serum separating material has a uniform pore size, so blood cell components and plasma or serum components can be separated efficiently. Can do.

  The invention according to claim 3 of the present invention is the “separator for plasma or serum according to claim 1 or 2, wherein the ultrafine stretched fibers are fused”. Since the ultrafine stretched fibers are fused, the shape retention is excellent and the handleability is excellent.

  The invention according to claim 4 of the present invention is such that “the average flow hole diameter of 1 mm thickness including a certain surface is 1 μm to 4 μm, and the average flow hole diameter of 1 mm thickness including the opposite surface facing the surface is 0.5 μm. The plasma or serum separation material according to any one of claims 1 to 3, comprising a pair of surfaces satisfying a relationship of ~ 3 µm. If the surface with an average flow pore size of 1 μm to 4 μm is the blood supply side, blood cell components having a larger particle size can be captured in order and separated efficiently.

  The invention according to claim 5 of the present invention is as follows: “The fiber assembly is regularly oriented and molded, and the separation surface when the plasma or serum separating material is separated in a direction parallel to the orientation direction is depressed. The percentage of the recess depth (d) (= (d / R) × 100) with respect to the diameter (R) of the recess opening is 20% or less. Item 5. The plasma or serum separation material according to any one of Items 4 above. When blood is supplied from the direction orthogonal to the orientation direction of the fiber assembly, there are many fibers oriented in the direction perpendicular to the direction of blood flow, and many fibers can participate in the separation, so that plasma or serum components are uniformly stabilized. Can be separated.

  The invention according to claim 6 of the present invention is characterized by comprising a region where a value (Pmax / Pav) obtained by dividing a maximum pore diameter (Pmax) at a thickness of 1 mm by an average flow pore diameter (Pav) is 5 or less. The plasma or serum separation material according to any one of claims 1 to 5. Thus, since the pore size distribution is narrow, the blood cell component and the plasma or serum component can be separated efficiently.

  The invention according to claim 7 of the present invention is characterized by comprising a pair of surfaces satisfying a relationship that "the area of a certain surface is different from the area of the opposite surface opposite to the surface." The plasma or serum separating material according to any one of claims 1 to 6. When a plasma or serum separation material is inserted into a separation container having a cross-sectional area narrower than this surface from a surface having a larger area, the separation container and the plasma or serum separation material are brought into close contact with each other. Since no gap is formed between the serum separation material and the blood cell component is not captured, there is no problem of passing through the plasma or serum separation material.

  The invention according to claim 8 of the present invention is a “plasma or serum filter obtained by loading the plasma or serum separation material according to any one of claims 1 to 7 into a separation container”. Therefore, it is a filter for plasma or serum showing a good separation effect.

  The invention according to claim 9 of the present invention is the plasma according to claim 8, wherein a part or all of the plasma or serum separation material is loaded in a state compressed by the separation container. Or a serum filter ". Since no gap is formed between the separation container and the plasma or serum separation material, the problem of passing through the plasma or serum separation material does not occur without capturing blood cell components. In addition, even if there is density unevenness in the plasma or serum separation material, the plasma or serum separation material is compressed, so that the density unevenness of the plasma or serum separation material is alleviated and the pore sizes are more uniform. Therefore, the blood cell component and the plasma or serum component can be separated efficiently.

  The invention according to claim 10 of the present invention is “using gas as a dispersion medium to separate and disperse a fiber group mainly composed of ultrafine drawn fibers having a fiber diameter of 4 μm or less into individual fibers. A method for producing a separation material for plasma or serum, comprising: a fiber assembly forming step for collecting individual fibers to form a fiber assembly; and a molding step for forming the fiber assembly into a desired shape. is there. According to this production method, the plasma or serum separation material according to claim 1 can be produced. In addition, since there is no need for cutting or punching in particular, it is excellent in manufacturing workability, and resources can be used without waste, thereby suppressing an increase in cost.

  According to an eleventh aspect of the present invention, “the fiber assembly forming step causes a fiber group mainly composed of ultrafine drawn fibers having a fiber diameter of 4 μm or less to be ejected from a dispersion nozzle into a gas by the action of a compressed gas. The method for producing a separating material for plasma or serum according to claim 10, characterized in that it is a step of separating and dispersing into individual fibers and accumulating the dispersed individual fibers to form a fiber assembly. Method. The fibers ejected into the gas from the dispersion nozzle by the action of the compressed gas are very well separated and dispersed into individual fibers, and the aggregated fiber aggregate has a very small apparent density and is uneven due to molding. Therefore, it is easy to produce a separation material for plasma or serum that can efficiently separate blood cell components from plasma or serum components.

  The invention according to claim 12 of the present invention is characterized in that, in the fiber assembly forming step, the dispersed individual fibers are accumulated in a preforming support to form a preformed fiber assembly. , A method for producing a plasma or serum separation material according to claim 10 or claim 11. According to this production method, it is easy to produce a plasma or serum separation material having a high degree of fiber orientation. That is, it is easy to produce a plasma or serum separation material that can stably and stably separate plasma or serum components.

  The invention according to a thirteenth aspect of the present invention is the plasma or the plasma according to any one of the tenth to twelfth aspects, wherein the molding step is a step of filling a molding container and molding. “Method for producing serum separating material”. According to this molding step, the fiber assembly can be efficiently and quickly (rapidly) molded.

  The invention according to claim 14 of the present invention is “the forming step is a step of discharging the fiber assembly from the filling nozzle and sucking gas from the outside of the porous forming container, filling and forming. The method for producing a separation material for plasma or serum according to any one of claims 10, 11, or 13. According to this molding process, the fiber assembly can be filled into the molding container efficiently and quickly (rapidly), and the workability of manufacturing the plasma or serum separating material is excellent.

  The invention according to claim 15 of the present invention is characterized in that “the discharge port of the filling nozzle is moved to an unfilled region as the fiber assembly is filled, or “Method for producing serum separating material”. According to this production method, it is easy to produce a plasma or serum separation material having a high degree of fiber orientation. That is, it is easy to produce a plasma or serum separation material that can stably and stably separate plasma or serum components.

  The invention according to claim 16 of the present invention is as follows. "Manufacture of a separation material for plasma or serum according to any one of claims 10 to 15, characterized in that, in the molding step, ultrafine drawn fibers are fused. Method. According to this molding process, it is easy to produce a separation material for plasma or serum that is excellent in form retention and handling properties.

  The invention according to claim 17 of the present invention is “following the method for producing a plasma or serum separator according to any one of claims 10 to 15, the plasma or serum separator is loaded into a separation container. A method for producing a filter for plasma or serum, comprising a loading step of: According to this manufacturing method, the plasma or serum filter according to claim 8 can be manufactured. That is, it is possible to produce a plasma or serum filter that exhibits a good separation action.

  The invention according to claim 18 of the present invention is such that, in the loading step, the cross-sectional area is constant from the loading port for loading plasma or serum separation material as a separation container toward the sealing port facing the loading port. And the separation material for plasma or serum is such that the cross-sectional area of the surface in contact with the sealing port is larger than the cross-sectional area of the sealing port of the separation container, Item 20. A method for producing a plasma or serum filter according to Item 17. According to this manufacturing method, the separation container and the plasma or serum separation material are in close contact, and no gap is formed between the separation container and the plasma or serum separation material, so that blood cell components are captured. Therefore, it is possible to manufacture a filter for plasma or serum that does not cause the problem of passing through the separation material for plasma or serum.

  The invention according to claim 19 of the present invention is such that, in the loading step, the cross-sectional area is continuous from the loading port for loading plasma or serum separation material as a separation container toward the sealing port facing the loading port. Use a material that becomes smaller in size or discontinuously, and use a separator for plasma or serum that has a larger cross-sectional area than the cross-sectional area at the sealing port of the separation container. The method for producing a filter for plasma or serum according to claim 17, wherein: According to this manufacturing method, the separation container and the plasma or serum separation material are in close contact, and no gap is formed between the separation container and the plasma or serum separation material, so that blood cell components are captured. Therefore, it is possible to manufacture a filter for plasma or serum that does not cause the problem of passing through the separation material for plasma or serum. Moreover, since it can be used as a plasma or serum separation material having a region with a high apparent density as it approaches the sealing port, plasma or serum that can be captured in order from blood cell components having a large particle size and separated efficiently. Filters can be manufactured.

  The separation material for plasma or serum of the present invention exhibits a good separation action.

  The plasma or serum filter of the present invention exhibits a good separation effect.

  According to the method for producing a plasma or serum separation material of the present invention, it is possible to produce a plasma or serum separation material that exhibits a good separation action. In addition, it is a method for producing a plasma or serum separation material that is excellent in manufacturing workability, uses resources without waste, and can suppress an increase in cost.

  According to the method for producing a plasma or serum filter of the present invention, it is possible to produce a plasma or serum filter exhibiting a good separation action. In addition, it is a method for producing a filter for plasma or serum that is excellent in manufacturing workability, uses resources without waste, and can suppress an increase in cost.

  The plasma or serum separation material of the present invention (hereinafter sometimes simply referred to as “separation material”) has a uniform fiber diameter and a small density unevenness to provide a separation material exhibiting a good separation action. In addition, a fiber aggregate mainly composed of ultrafine drawn fibers having a fiber diameter of 4 μm or less, which is formed using a gas as a dispersion medium, is used.

  The ultra-stretched fibers that make up this fiber assembly efficiently separate blood into blood cell components and plasma or serum components, and have a short time to filter only plasma or serum components, and the blood cell components and blood cell destruction products in the filtrate The fiber diameter needs to be 4 μm or less, preferably 3 μm or less, and more preferably 2 μm or less so as not to contain (hemolysis) as much as possible. On the other hand, if the finely drawn fiber is too thin, the pore size of the separation material becomes too small, blood cells are likely to be clogged, the filtration time becomes too long, and plasma or serum components may not be filtered. The fiber diameter of the fiber is preferably 0.01 μm or more.

  “Fiber diameter” in the present invention is a fiber diameter measured from an electron micrograph, and when the cross-sectional shape of the fiber is circular, it refers to the diameter, and when the cross-sectional shape of the fiber is non-circular Refers to the diameter of a circle with the same cross-sectional area and area.

  The fiber length of the ultrafine drawn fiber is not particularly limited, but is preferably 3 mm or less, and more preferably 2 mm or less so that the dispersibility of the ultrafine drawn fiber is excellent. The lower limit of the fiber length of the ultrafine stretched fiber is not particularly limited, but about 0.1 mm is appropriate. Moreover, it is preferable that it is the cut | pulled ultra fine stretched fiber so that fiber length may be uniform.

  The “fiber length” in the present invention refers to the length obtained by JIS L 1015 (chemical fiber staple test method) B method (corrected staple diagram method).

  The ultrafine stretched fiber may be composed of any component as long as it does not inhibit the filtration of plasma or serum components. For example, polyamide-based resin, polyvinyl alcohol-based resin, polyvinylidene chloride-based resin, Vinyl chloride resin, polyester resin, polyacrylonitrile resin, polyolefin resin (eg, polyethylene resin, polypropylene resin, etc.), polystyrene resin (eg, crystalline polystyrene, amorphous polystyrene, etc.), wholly aromatic It can be comprised from organic components, such as a polyamide-type resin and a polyurethane-type resin. Moreover, as long as the filtration of plasma or a serum component is not inhibited, it is not limited to these components, You may be comprised from the inorganic component. Further, the ultrafine drawn fiber may be subjected to a surface treatment (for example, a surface treatment so that the fiber surface does not have a positive charge) so as not to adsorb proteins.

  In addition, since the ultrafine stretched fibers are fused, the separation material is excellent in form stability and handleability. Therefore, it is preferable that the ultrafine stretched fibers can be fused. It is sufficient that at least a part of the components constituting the surface of the ultrafine stretched fiber is composed of a thermoplastic resin. For example, the component constituting the surface of the ultrafine drawn fiber is a polyolefin resin (for example, polyethylene resin, polypropylene resin, etc.), polyvinylidene chloride resin, polyester resin, polyamide resin, crystalline polystyrene resin, etc. It may be composed of a crystalline thermoplastic resin or an amorphous thermoplastic resin such as polyvinyl chloride resin, amorphous polystyrene resin, polyacrylonitrile resin, or polyvinyl alcohol resin.

  When this meltable ultrafine stretched fiber is composed of two or more types of components, even if one type of thermoplastic resin constituting the fiber surface is fused, the fiber form is maintained by at least one type of component. This is preferable. The cross-sectional shape of the ultrafine stretched fiber composed of two or more kinds of components can be, for example, a core-sheath type, an eccentric type, a sea-island type, a side-by-side type, a multiple bimetal type, and an orange type. A sheath type, an eccentric type, or a sea-island type is preferable.

Moreover, it is preferable that the fiber diameters of the ultrafine drawn fibers of the present invention are approximately the same so that good filtration performance of plasma or serum can be easily obtained. Specifically, the value (σ / d) obtained by dividing the standard deviation value (σ) of the fiber diameter distribution of the ultrafine drawn fiber by the average fiber diameter (d) of the ultrafine drawn fiber is 0.2 or less (preferably 0.00. 1 or less). In addition, since the standard deviation value (σ) is 0 when the fiber diameters of the ultrafine drawn fibers are all the same, the lower limit value of the value (σ / d) is 0. The “average fiber diameter (d) of the ultrafine drawn fibers” is taken by taking an electron micrograph of the separating material, measuring the fiber diameters of 100 or more ultrafine drawn fibers in this electron micrograph, and measuring the measured fiber diameters. Arithmetic mean value. In addition, the “standard deviation value (σ)” of the ultrafine drawn fiber is a value calculated from the measured diameter (X) of each of the n (100 or more) ultrafine drawn fibers by the following formula.
Standard deviation = {(nΣX ² − (ΣX) ² ) / n (n−1)} ^1/2

  The ultra-fine drawn fibers of the present invention have no variation in fiber diameter, and the diameters of the individual ultra-fine drawn fibers are substantially the same in the fiber axis direction so that the separation material can exhibit good filtration performance of plasma or serum. Is preferred.

  As described above, the ultrafine drawn fibers having substantially the same fiber diameter between the ultrafine drawn fibers and the ultrafine drawn fibers whose diameters are substantially the same in the fiber axis direction include, for example, the sea component of the sea-island fiber obtained by the composite spinning method. It can be obtained by removing.

  The ultrafine drawn fibers of the present invention are in a drawn state so that the fiber diameters are uniform and have appropriate fiber strength characteristics. The “stretched state” in the present invention means that it has been stretched by a stretching process different from the spinning process (for example, a stretching process by a stretching yarn machine). For example, the resin is melt extruded as in a melt blow method. On the other hand, the fiber formed by blowing hot air into the fiber is not considered to be drawn because the spinning process and the drawing process are the same and the degree of drawing is low. In addition, when generating ultra-fine drawn fibers from sea-island type fibers, it is not necessary to go through a drawing process after generation, and if the sea-island type fibers have undergone a drawing process before generation, the ultra-fine drawn fibers are in a drawn state It is in.

  In addition, the fiber assembly of the present invention may contain two or more types of ultrafine drawn fibers having different fiber diameters, fiber lengths, and / or components.

  The fiber assembly of the present invention is mainly composed of the above-mentioned ultrafine stretched fibers (that is, 50 mass% or more) so that the filtration performance of plasma or serum is excellent. Since it is excellent in performance, it is preferable that 70 mass% or more is contained in the fiber assembly, more preferably 80 mass% or more, more preferably 90 mass% or more, more preferably 100 mass%. Most preferably, it is made of ultrafine drawn fibers.

  Examples of fibers other than the ultrafine drawn fibers that can constitute the fiber assembly of the present invention include fine drawn fibers having a fiber diameter exceeding 4 μm. By including such finely drawn fibers, the form stability of the separating material can be further enhanced. The upper limit of the fiber diameter of the finely drawn fiber is not particularly limited, but is preferably 15 μm or less. The fiber length of the finely drawn fibers is preferably 10 mm or less, more preferably 8 mm or less, and even more preferably 5 mm or less so that the dispersibility is excellent. The lower limit of the fiber length of the finely drawn fiber is not particularly limited, but about 0.1 mm is appropriate. Moreover, it is preferable that it is the finely drawn fiber cut | disconnected so that fiber length may be uniform.

  The finely drawn fiber may be composed of any component as long as it does not inhibit the filtration of plasma or serum components, and can be composed of the same component as the above-mentioned ultrafine stretched fiber. It is preferable that this finely drawn fiber can be fused so that the shape stability of the separating material is excellent. As for the finely drawn fiber that can be fused, the thermoplastic resin similar to the ultrafine drawn fiber may occupy at least a part of the surface of the finely drawn fiber. Further, the finely stretchable fiber that can be fused is also preferably composed of two or more kinds of components, as in the case of the ultrafine stretched fiber. In this case, the arrangement state in the cross section is a core-sheath type, an eccentric type, Alternatively, it is preferably a sea-island type. The fiber assembly of the present invention may contain two or more kinds of finely drawn fibers having different fiber diameters, fiber lengths, and / or components.

The fiber assembly of the present invention is mainly composed of the finely drawn fibers as described above, but preferably does not contain any deposits that impair the filtration performance of plasma or serum components. More specifically, the percentage of the mass of the deposit with respect to the mass of the fiber assembly, defined by the following formula, is preferably 0.5 mass% or less, more preferably 0.3 mass% or less, It is more preferably 0.1 mass% or less, further preferably 0.08 mass% or less, still more preferably 0.06 mass% or less, still more preferably 0.04 mass% or less, and It is more preferable that it is 02 mass% or less.
A = (ms / mf) × 100
Here, A means the adhesion rate (%) of the adhered material, ms means the adhered mass (g) of the adhered material, and mf means the mass (g) of the fiber assembly. This deposit is obtained by immersing the fiber assembly in hot water (for example, water at 80 to 100 ° C.) for 15 minutes and by immersing the fiber assembly in a hot methanol solution for 15 minutes. Both extracted extracts are included.

  Although the fiber assembly of the present invention is mainly composed of the above-described ultrafine drawn fibers, it is formed by using a gas as a dispersion medium. Therefore, the finely drawn fibers have good dispersibility and separation with small density unevenness. Can be wood. In particular, a fiber assembly can be formed by dropping and depositing ultrafine drawn fibers dispersed in a gas. For example, it can be formed by the method described in JP-A-2002-155458.

  More specifically, a fiber group mainly composed of the above-described ultrafine drawn fibers is prepared. This fiber group is a group of ultrafine drawn fibers as described above, and the number thereof is not particularly limited. Also, the state is not particularly limited, and examples thereof include a bundle state in which ultrafine drawn fibers are regularly aligned in a certain direction, a randomly-aggregated state, and the like. Among these, the bundle state is preferable because of excellent dispersibility due to the action of the compressed gas described later. In addition, when the ultra fine stretched fiber is in an entangled state, it tends to be difficult to separate the ultra fine stretched fiber into individual ultra fine stretched fibers and disperse them even by the action of a compressed gas as described later. It is preferable that the ultrafine drawn fiber is not in an entangled state. For example, it is preferable not to use an aggregate of ultra-fine stretched fibers obtained by beating mechanically separable fibers using a beater or the like, or pulp or the like beaten by a beater or the like because the ultra-fine stretched fibers are in an entangled state. It should be noted that ultra-fine drawn fibers are generated by the action of compressed gas, and the ultra-fine drawn fibers are in an entangled state (for example, fully aromatic polyamide fiber, cellulose fiber obtained by solvent extraction method, etc.) A group of can be used.

  For example, the ultra-fine drawn fiber group is produced by removing the sea component of the sea-island type fiber produced by the composite spinning method or the mixed spinning method, thereby generating the ultra-fine drawn fiber composed of the island component or by the super draw method. be able to. According to the former method, a bundle of ultrafine stretched fibers can be formed, and no adherent such as a surfactant or a paste is attached, and the filterability of plasma or serum components is inhibited. It is preferable because there is no.

  Next, a fiber group mainly composed of ultrafine drawn fibers is supplied to the dispersion nozzle, and is blown into the gas from the dispersion nozzle by the action of the compressed gas to be separated into individual ultrafine drawn fibers and dispersed.

  If the flow of the compressed gas supplied to the dispersion nozzle is spiral, fibers tend to be entangled with each other to generate pills or evenly disperse. The flow is preferably substantially laminar. As a dispersion nozzle capable of supplying compressed gas that is substantially laminar in this way, for example, a Venturi tube can be mentioned.

  In addition, in order to collide with the fiber group of ultrafine stretched fibers, etc., in front of the dispersion nozzle ejection part, to promote separation into individual ultrafine stretched fibers, or to promote dispersion of the generated ultrafine stretched fibers, Is preferably provided. This collision member may have any shape, but in order to achieve the above-mentioned effect, a flat collision member, a bell-shaped collision member, a conical collision member, a bell-shaped projection and a flat collision member It is preferable to use a collision member in which the ring-shaped collision part and the conical protrusion and the flat collision part are integrated, and the bell-shaped protrusion and the flat collision part are integrated. It is more preferable to use a collided member in which a conical protrusion or a flat collision is integrated.

Any gas may be used as the compressed gas, but air is suitable for manufacturing. The compressed gas is separated from the group of ultrafine drawn fibers into individual ultrafine drawn fibers, and the gas passing speed at the dispersion nozzle outlet is 100 m / sec. So that the ultrafine drawn fibers can be sufficiently dispersed. The above is preferable. For the same reason, the pressure of the compressed gas is preferably ² kg / cm ² or more. The “gas passage speed” means a value obtained by dividing the flow rate (m ³ / sec) of the gas ejected from the dispersion nozzle at 1 atm by the transverse area (m ² ) at the dispersion nozzle ejection port.

  Moreover, the gas as a dispersion medium for dispersing the ultrafine stretched fibers ejected from the dispersion nozzle is not particularly limited, but air is suitable for production.

  Subsequently, the dispersed individual ultrafine drawn fibers are accumulated to form a fiber assembly. Accumulation of this ultrafine stretched fiber can be carried out using a collector such as a porous roll or a net. It should be noted that the ultrafine stretched fiber or the like may be naturally dropped and accumulated, or may be accumulated by sucking gas from below the collector. However, in the present invention, in order to easily form a uniform fiber aggregate with a low apparent density, the surface wind speed on the collector is lowered by natural dropping or using a collector having a large area. Is preferred.

  The separating material of the present invention is obtained by molding the fiber assembly as described above into a desired shape. Since the separation material of the present invention is used as a separation material for a filter for separating blood cell components and filtering plasma or serum, it is molded according to the shape of a container (referred to as a separation container) constituting the filter. It is a thing. For example, if the separation container is a columnar shape, it is a separation material formed into a columnar shape, and if the separation container is a columnar shape with an elliptical cross-sectional shape, the cross-sectional shape is formed into an elliptical columnar shape. If the separation container is a polygonal column, the separation material is formed into a polygonal column.

  The molding method is not particularly limited. For example, the fiber assembly can be filled in a molding container that is the same as or similar to the separation container, and if necessary, heated and molded. In particular, as in the latter case, heating and fusing the ultrafine drawn fiber is preferable because it is possible to obtain a separation material having excellent shape stability and excellent handleability.

  Here, the perspective view of the separation material of this invention which can be used for a cylindrical separation container is shown in FIG. As shown in FIG. 1, the separating material 1 also has a cylindrical outer shape. In such a separating material 1, the average flow hole diameter of 1 mm in thickness including the A surface in FIG. 1 is 1 μm to 4 μm, and includes the B surface (see FIG. 1) that is the opposite surface facing the A surface. When the average flow pore diameter of 1 mm is 0.5 μm to 3 μm, when the A-side is the blood supply side, blood cell components with larger particle diameters are captured in order from the blood particle, and can be separated efficiently, and plasma or serum can be filtered. Is preferred. That is, if the average flow pore diameter of 1 mm in thickness including the A surface is less than 1 μm, clogging is likely to occur due to blood cell components, and if the average flow pore diameter exceeds 4 μm, the blood cell component tends to be poorly captured. In addition, when the average flow pore diameter with a thickness of 1 mm including the B surface is less than 0.5 μm, clogging is likely to occur due to blood cell components, and when the average flow pore diameter exceeds 3 μm, the trapping property of blood cell components tends to be poor. . Thus, in the separating material 1 of the present invention, the average flow pore diameter of 1 mm in thickness including a certain surface (A surface in FIG. 1) is 1 μm to 4 μm, and faces the surface (A surface in FIG. 1). It is provided with a pair of surfaces (A surface and B surface in FIG. 1) that satisfy the relationship that the average flow hole diameter of 1 mm in thickness including the opposite surfaces (B surface in FIG. 1) is 0.5 μm to 3 μm. preferable. The “average flow pore size” in the present invention refers to a value obtained by the method defined in ASTM-F316, and is measured by the mean flow point method using, for example, a porometer (Polometer, manufactured by Coulter). it can.

  Separation material 1 of the present invention is, for example, a separation material 1 as shown in FIG. 1 formed by regularly orienting a fiber assembly (direction D in FIG. 1). When peeled in a direction parallel to the orientation direction (D direction), a depression 1a as shown in FIG. 2A, which is a perspective view of the separation material 1 peeled off, is formed on the peeling surface, and this depression opening 1b ( The depth of the depression (d, see FIG. 2 (c) when the peeled separating material is seen from the side) with respect to the diameter (R) of the separated separating material (see FIG. 2 (b) seen from above). The percentage (= (d / R) × 100) is preferably 20% or less. Since such a ratio means that the fibers are oriented in a direction nearly parallel to the A plane, the direction is perpendicular to the orientation direction of the fiber assembly (from the A or B plane in FIG. 1). When supplying blood from, there are many fibers oriented in the direction perpendicular to the direction of blood flow, and there are many fibers that can participate in the separation, so the plasma or serum components can be uniformly and stably separated and filtered, Is preferred. Therefore, the smaller the ratio, the better. The ratio is preferably 10% or less, more preferably 5% or less, and ideally 0%. In addition, although the hollow opening part 1b in FIG. 2 is circular, when it is non-circular, the diameter of the circle of the same area as the area is considered as the diameter of a hollow opening part. In addition, “the fiber aggregates are regularly oriented” means that the fibers can be easily peeled off when an external force is applied by hand as described above, and they are completely oriented in the same direction. Does not mean that.

  The separating material of the present invention preferably has a region where the value (Pmax / Pav) obtained by dividing the maximum pore diameter (Pmax) at a thickness of 1 mm by the average flow pore diameter (Pav) is 5 or less. A small value (Pmax / Pav) means that the difference between the maximum pore size and the average flow pore size is small, that is, the pore size is uniform and the pore size distribution is narrow. The components can be separated efficiently. A more preferable value (Pmax / Pav) is 4 or less, and ideally the maximum pore diameter and the average flow pore diameter are 1. Such a region may be provided anywhere on the separating material, but the entire separating material is most preferably the region. The “maximum pore diameter” in the present invention refers to a value measured by a bubble point method using a porometer (Polometer, manufactured by Coulter).

  In the separating material of the present invention, as in the separating material 1 as shown in FIG. 1, the area of the A surface and the area of the B surface, which is the opposite surface opposite to the A surface, can be the same. Like the separating material 10 shown in FIG. 5, the area of the A ′ surface and the area of the B ′ surface that is the opposite surface facing the A ′ surface may be different. By loading the separation material 10 as shown in FIG. 3 into a separation container having a cross-sectional area smaller than the area of the B ′ surface of the separation material, the separation container and the separation material come into close contact with each other. Since no gap is formed between the blood and the plasma or serum separation material, the problem of passing through the plasma or serum separation material does not occur without trapping blood cell components. Thus, the separating material 10 of the present invention has an area of a certain surface (A ′ surface in FIG. 3) and an area of the opposite surface (B ′ surface in FIG. 3) opposite to the surface (A ′ surface in FIG. 3). It is preferable to have a pair of surfaces that satisfy the relationship of

  The separating material of the present invention uses, for example, a gas as a dispersion medium to separate and disperse a fiber group mainly composed of ultrafine drawn fibers having a fiber diameter of 4 μm or less into individual fibers. Can be manufactured by a fiber assembly forming step of forming the fiber assembly by forming the fiber assembly and a molding step of forming the fiber assembly into a desired shape.

  In the fiber assembly forming step, the fiber group mainly composed of ultra-fine stretched fibers as described above is ejected from the dispersion nozzle into the gas by the action of the compressed gas, and separated and dispersed into individual fibers. It is preferable to collect individual fibers to form a fiber aggregate, but any method that uses gas as a dispersion medium may be used, and there is no particular limitation.

  In the fiber assembly forming step, the dispersed individual fibers can be accumulated in a state corresponding to the shape of the separating material. This production method is suitable because it is easy to produce a separating material having a high degree of fiber orientation. In the above-described method, dispersed fibers are accumulated on a collector such as a porous roll or a net. For example, a perforated plate having a large number of through-holes 2a formed in a cylindrical shape as shown in FIG. In a state where the (preliminary forming support 2) is placed on the collecting body as described above, the dispersed individual fibers are accumulated in the through holes 2a of the preliminarily forming support 2, and the preformed fibers are collected. Aggregates can be formed. Since this preformed fiber assembly has a cylindrical outer shape along the shape of the through-hole 2a, by laminating a large number of this preformed fiber assembly, as shown in FIG. A separating material having a height can be produced. The preforming support 2 shown in FIG. 4 is a perforated plate having a number of through-holes 2a that are hollowed out in a cylindrical shape, but the preforming support is appropriately selected according to the outer shape of the separating material. Can do. Also, a preformed fiber assembly having different sizes is formed by using a single perforated plate having a plurality of through holes 2a having different sizes or a plurality of perforated plates having through holes 2a having different sizes. (Preferably, a plurality of preformed fiber aggregates having different sizes are continuously formed), and then a large number of these preformed fiber aggregates are laminated (preferably laminated so that the size continuously changes). A separator, for example, a separator as shown in FIG. 3, can be manufactured.

  Subsequent to the fiber assembly forming process as described above, a forming process for forming the fiber assembly into a desired shape is performed. The forming step is not particularly limited as long as it is a method capable of forming the fiber assembly into a desired shape. For example, the fiber assembly can be filled into a forming container and formed. This molding container has an inner wall surface corresponding to the outer shape of the separating material.

  Examples of the method for filling the fiber aggregate include a method in which the fiber aggregate is supplied to the molding container and compressed regardless of whether the fiber aggregate is a preformed fiber aggregate. When the preformed fiber aggregate is supplied to the molding container, the preformed fiber aggregate may or may not be fused. If it is fused as in the former, it has the advantage of excellent shape stability and easy handling, and if it is not fused as in the latter, individual fibers have a high degree of freedom of deformation, leading to a container for molding. By supplying and compressing, the density unevenness of the separating material is alleviated, the pore diameter is more uniform, and the separating performance is enhanced.

  Further, when the fiber assembly is not a preformed fiber assembly but is simply accumulated on the collection body, an air-permeable porous molding container is used as the molding container, and the fiber assembly is used. Can be discharged from the filling nozzle to supply the fiber assembly to the porous molding container, and at the same time, the gas can be sucked and filled from the outside of the porous molding container. According to this method, it is possible to perform filling quickly, simply and efficiently. The filling nozzle is not particularly limited as long as it can discharge the fiber assembly together with the gas into the porous molding container, and examples thereof include an ejector and a hollow pipe. The apparatus for sucking the gas from the outside of the porous molding container is not particularly limited as long as it can suck more than the amount of gas discharged from the filling nozzle. For example, a suction blower, A vacuum cleaner can be mentioned.

  As described above, when filling the fiber assembly using the filling nozzle and the porous molding container, the discharge port of the filling nozzle is moved to an unfilled region as the fiber assembly is filled. It is preferable to fill it while making it easy to produce a separating material having a high degree of fiber orientation. For example, as shown in FIG. 5 which is an explanatory view (perspective perspective view) showing a filling state for producing the cylindrical separator 1 as shown in FIG. 1, first, the fiber assembly is still in the porous molding container 3. In a state where the body is not filled, the fiber assembly f is discharged in a state where the filling nozzle 4 is inserted to the vicinity of the bottom of the porous molding container 3 (see FIG. 5A). In this state, since the fiber assembly is not filled, each fiber tends to be oriented toward the bottom of the porous molding container 3 or the outer wall direction of the porous molding container 3 connected to the bottom. Then, as the porous molding container 3 is filled with the fiber assembly, the discharge port of the filling nozzle 4 is moved above the porous molding container 3 that is not yet filled with the fiber assembly. The body f is discharged (see FIG. 5B). In this state, since the fiber assembly is already filled in the bottom direction of the porous molding container 3 and the gas suction force in the bottom direction is relatively lowered, each fiber is in the porous molding container 3. It is easy to orient toward the outer wall direction. By moving the filling nozzle 4 in this manner, a separation material in which each fiber is oriented in a direction parallel to the bottom of the porous molding container 3, for example, a depression with respect to the diameter (R) of the depression opening as described above. It is easy to produce a separating material having a depth (d) percentage of 20% or less.

  In the molding step of the present invention, the ultrafine drawn fibers may be fused or not fused, but are preferably fused. It is because it is excellent in form stability by fusing the ultrafine stretched fiber. The fusion of the ultrafine drawn fibers can be performed by, for example, a hot air dryer, an oven, an infrared heater, or the like. Even if the ultrafine stretched fibers of the preformed fiber assembly are fused and then filled into a molding container, it is preferable to fuse the ultrafine stretched fibers again to improve the shape stability of the separating material. .

  A pair satisfying the relationship that an average flow hole diameter of 1 mm in thickness including a certain surface is 1 μm to 4 μm and an average flow hole diameter of 1 mm in thickness including an opposite surface facing the surface is 0.5 μm to 3 μm. The separation material provided with the above surface can be produced, for example, by laminating separation materials having different average flow pore diameters.

  In addition, a separation material having a region where the value (Pmax / Pav) obtained by dividing the maximum pore diameter (Pmax) at a thickness of 1 mm by the average flow pore diameter (Pav) is 5 or less is, for example, (1) value (σ / d ) Is 0.2 or less, or (2) a bundle of ultrafine stretched fibers oriented in a certain direction is used, or (3) a compressed gas or a collision member is used. The ultra-fine stretched fiber group is sufficiently separated into individual fibers, or (4) a compact in which a fiber assembly is filled and then compressed, or the dispersed individual fibers are accumulated in a preforming support. When using a molded fiber assembly or discharging the fiber assembly from a filling nozzle and sucking gas from the outside of the porous molding container and filling and molding, the discharge port of the filling nozzle is connected to the fiber assembly. Not filled as you fill your body And the like are moved to the region, the orientation direction of the fibers to a direction perpendicular to the separation direction of the separation material can be prepared by adjusting various conditions such as.

  Furthermore, the separating material having a pair of surfaces satisfying the relationship that the area of a certain surface is different from the area of the opposite surface opposite to the surface is a container for molding having different bottom and opening areas. It can be manufactured by using.

  The plasma or serum filter of the present invention (hereinafter sometimes simply referred to as a filter) is obtained by loading the separation material of the present invention as described above into a separation container. Therefore, it is a filter for plasma or serum showing a good separation effect.

  In the filter of the present invention, it is preferable that a part or all of the separation material is loaded in a state compressed by the separation container. Since it is loaded in such a compressed state, no gap is formed between the separation container and the plasma or serum separation material. This is because the problem of passing through the separating material does not occur. Further, even if the separation material has density unevenness, the separation material is compressed, so that the density unevenness of the separation material is alleviated and the pore diameter is more uniform, and the blood cell component and plasma or serum component are efficiently mixed. This is because they can be separated.

  The filter of the present invention can be produced by performing a loading step of loading the separation material into the separation container following the method for producing the separation material as described above. In the loading process, as shown in FIG. 6, the separation container 5 has a constant cross-sectional area from the loading port 5a for loading the separating material to the sealing port 5b facing the loading port 5a. , And the separation material 10 having a larger cross-sectional area than the cross-sectional area of the sealing port 5b of the separation container 5 is used as the separation material. A filter filled with a part or all of 10 compressed by the separation container 5 can be manufactured. In FIG. 6, as the separating material 10, a material having a different area between the A ′ surface and the B ′ surface which is the opposite surface opposite to the A ′ surface is used, but the area between the A ′ surface and the B ′ surface is different. It may be the same. Moreover, it is preferable that the cross-sectional area in any place of the separating material 10 is wider than the cross-sectional area of the separating container 5 in the place where the separating material 10 finally comes into contact.

  Further, as shown in FIG. 7, as the separation container 5 ′, the cross-sectional area continuously decreases from the loading port 5 a ′ for loading the separation material 1 toward the sealing port 5 b ′ facing the loading port. When a separation member 1 is used, the separation area 1 has a cross-sectional area larger than the cross-sectional area of the sealing port 5b ′ of the separation container 5 ′. A filter filled with a part or all of the separating material 1 being compressed by the separation container 5 'can be manufactured. In FIG. 7, the same material is used as the separating material 1 for the A surface and the B surface, which is the opposite surface, but the A surface and the B surface are different. good. Further, it is preferable that the separation material 1 has a wider cross-sectional area at any location than the cross-sectional area of the separation container 5 ′ where the separation material 1 finally comes into contact. Further, in FIG. 7, a separation container having a continuously reduced cross-sectional area is used. However, a separation container that becomes discontinuously small, such as a stepwise decrease, can be used.

  Examples of the present invention will be described below, but the present invention is not limited to the following examples.

1. Preparation of various fibers (extra fine drawn fiber A)
Sea island type fiber obtained by the composite spinning method (25 mins fineness: 1.7 dtex, length: 1 mm) in which 25 island components consisting of high density polyethylene and polypropylene are present in the sea component consisting of polylactic acid ) Was prepared. This sea-island type fiber is immersed in a 10 mass% sodium hydroxide aqueous solution, and polylactic acid, which is a sea component, is extracted and removed by hydrolysis, then air-dried, and ultra-fine drawn fiber A in which high-density polyethylene and polypropylene are mixed ( Fiber diameter: 2 μm, cut fiber length: 1 mm, σ / d = 0.06, not fibrillated, having substantially the same diameter in the fiber axis direction, cross-sectional shape: sea-island type) was bundled, A bundle group of ultrafine stretched fibers A was prepared.

(Extremely fine drawn fiber B)
Sea island type fiber obtained by the composite spinning method (25 mins fineness: 1.7 dtex, length: 1 mm) in which 25 island components consisting of high density polyethylene and polypropylene are present in the sea component consisting of polylactic acid ) Was prepared. This sea-island type fiber is immersed in a 10 mass% sodium hydroxide aqueous solution, and polylactic acid, which is a sea component, is extracted and removed by hydrolysis, then air-dried, and ultra-fine drawn fiber B in which high-density polyethylene and polypropylene are mixed ( Fiber diameter: 1 μm, cut fiber length: 1 mm, σ / d = 0.06, non-fibrillated, having substantially the same diameter in the fiber axis direction, cross-sectional shape: sea-island type) is bundled, A bundle group of ultrafine stretched fibers B was prepared.

(Extremely fine drawn fiber C)
A sea-island type fiber (fineness: 1.7 dtex, length: cut to 2 mm) obtained by a composite spinning method in which 25 island components made of polypropylene are present in a sea component made of polylactic acid was prepared. This sea-island type fiber is immersed in a 10 mass% sodium hydroxide aqueous solution, and polylactic acid, which is a sea component, is extracted and removed by hydrolysis, and then air-dried to draw ultrafine drawn fiber C made of polypropylene (fiber diameter: 2 μm, cut) A bundle group of ultrafine drawn fibers C was prepared in which a fiber length: 2 mm, σ / d = 0.06, non-fibrillated, and having substantially the same diameter in the fiber axis direction) was bundled.

(Extremely fine fiber D)
A sea-island fiber (fineness: 2.1 dtex, length: cut to 2 mm) obtained by a composite spinning method in which 25 island components made of polyester exist in a sea component made of polystyrene was prepared. This sea-island type fiber is immersed in dimethylformamide (DMF) to extract and remove polystyrene, which is a sea component, and then air-dried to draw ultra-fine stretched fibers D (fiber diameter: 2 μm, cut fiber length: 2 mm, A bundled group of ultrafine stretched fibers D was prepared in which σ / d = 0.06, non-fibrillated, and having substantially the same diameter in the fiber axis direction).

2. Method for forming fiber assembly (Method A for forming fiber assembly)
Various ultra-fine stretched fiber groups are transferred from a compressed gas inlet to compressed air (pressure: 6 kg / cm ² , substantially layered) into a Venturi tube (dispersion nozzle) having a circular cross-sectional shape at the jet outlet (diameter: 8.5 mm). ) To supply the ultra-thin drawn fiber group to the venturi pipe, and eject the ultra-thin drawn fiber group from the venturi pipe into the air (gas passage speed at the vent outlet of the venturi pipe: 147 m / s, jet outlet The amount of ejection from the nozzle is approximately 0.5 m ³ / min., And the collision member provided in front of the vent outlet of the venturi tube (the collision member in which the conical protrusion and the flat collision portion are integrated, the collision member) The distance between the colliding part and the dispersion nozzle ejection part side surface was 15 mm), and the ultra-fine drawn fibers were dispersed in the air.

Subsequently, the dispersed ultrafine drawn fibers were accumulated on a wet nonwoven fabric (weight per unit area: 20 g / m ² ) placed on a moving collector (net) to form a fiber assembly. When accumulating, air was sucked (0.5 m ³ / min.) With a suction box installed under the collector.

(Fiber assembly forming method B)
Various ultra-fine stretched fiber groups are transferred from a compressed gas inlet to compressed air (pressure: 6 kg / cm ² , substantially layered) into a Venturi tube (dispersion nozzle) having a circular cross-sectional shape at the jet outlet (diameter: 8.5 mm). ) To supply the ultra-thin drawn fiber group to the venturi pipe, and eject the ultra-thin drawn fiber group from the venturi pipe into the air (gas passage speed at the vent outlet of the venturi pipe: 147 m / s, jet outlet The amount of ejection from the nozzle is approximately 0.5 m ³ / min., And the collision member provided in front of the vent outlet of the venturi tube (the collision member in which the conical protrusion and the flat collision portion are integrated, the collision member) The distance between the colliding part and the dispersion nozzle ejection part side surface was 15 mm), and the ultra-fine drawn fibers were dispersed in the air.

Next, a preforming support having a large number of through-holes drilled in a cylindrical shape with a diameter of 12 mm, further placed on a wet nonwoven fabric (weight per unit: 20 g / m ² ) placed on a moving collector (net). The dispersed ultrafine drawn fibers were accumulated in the through holes to form a disk-shaped preformed fiber aggregate (diameter: 12 mm). In addition, when making it accumulate | store, air was suck | inhaled (0.7 m < ³ > / min.) With the suction box installed under the collector.

Example 1
A fiber assembly was formed by the method of forming a fiber assembly A using 100% of the ultrafine stretched fiber A. Next, the fiber assembly is discharged from a filling nozzle (a pipe having an inner diameter of 9 mm), and air is sucked from the outside of the cylindrical porous molding container having an inner diameter of 12 mm by a vacuum cleaner, so The fiber assembly was filled. In addition, the fiber nozzle was discharged in the state in which the filling nozzle was fixed near the upper end of the cylindrical porous molding container.

Then, after compressing the filled fiber assembly, the porous molding container is supplied to an oven set at a temperature of 130 ° C., the high-density polyethylene component of the ultrafine stretched fiber A is fused, cooled, and then porous. 1 to produce a cylindrical separating material having a diameter of 12 mm, a height of 20 mm, and an apparent density of 0.16 g / cm ³ as shown in FIG. did. In addition, the average flow hole diameter of 1 mm in thickness including one surface (A surface in FIG. 1) of this cylindrical separator is 2.3 μm, and includes the surface (B surface in FIG. 1) facing the surface. The average flow hole diameter of 1 mm was 2.3 μm. Moreover, when the separating material is peeled by hand in the direction parallel to the AB plane, the release surface forms a recess, and the percentage of the recess depth (d) with respect to the diameter (R) of the recess opening (= ( d / R) × 100) was 20%. Further, the Pmax / Pav value of the entire separating material (from the A surface to the B surface) was 4.9.

  Next, a frustoconical separation container having a continuously reduced cross-sectional area from the loading port (diameter: 11.5 mm) to the sealing port (diameter: 11.0 mm) is prepared. The filter of the present invention was manufactured by loading the separator so that the separator was brought into contact with a cellulose acetate membrane (pore diameter: 0.45 μm). In this filter, all of the separation material was filled in a state compressed by the separation container.

(Example 2)
Except that the fiber assembly was discharged while the filling nozzle was inserted to the bottom of the cylindrical porous molding container and then gradually moved to the vicinity of the upper end of the cylindrical porous molding container, exactly the same as in Example 1. Then, the fiber aggregate of the ultrafine stretched fiber A is filled, and the fusion treatment and the cooling treatment are performed, and a circle having a diameter of 12 mm, a height of 20 mm, and an apparent density of 0.16 g / cm ³ as shown in FIG. A columnar separator (the area of the A surface and the area of the B surface were the same) was produced. In addition, the average flow hole diameter of 1 mm in thickness including one surface (A surface in FIG. 1) of this cylindrical separator is 2.2 μm, and the thickness including the surface (B surface in FIG. 1) facing the surface. The average flow hole diameter of 1 mm was 2.2 μm. Moreover, when the separating material is peeled by hand in the direction parallel to the AB plane, the release surface forms a recess, and the percentage of the recess depth (d) with respect to the diameter (R) of the recess opening (= ( d / R) × 100) was 17%. Furthermore, the Pmax / Pav value of the entire separating material (from the A surface to the B surface) was 4.5.

  Next, a frustoconical separation container having a continuously reduced cross-sectional area from the loading port (diameter: 11.5 mm) to the sealing port (diameter: 11.0 mm) is prepared. The filter of the present invention was manufactured by loading the separator so that the separator was brought into contact with a cellulose acetate membrane (pore diameter: 0.45 μm). In this filter, all of the separation material was filled in a state compressed by the separation container.

(Example 3)
A fiber assembly was formed by the method of fiber assembly formation method A using 100% ultrafine stretched fiber D. Next, the fiber assembly is discharged from a filling nozzle (a pipe having an inner diameter of 9 mm), and air is sucked from the outside of a cylindrical porous molding container having an inner diameter of 12 mm by using a vacuum cleaner. The fiber assembly was filled. In addition, after inserting the filling nozzle to the bottom of the cylindrical porous molding container, the fiber assembly was discharged while gradually moving to the vicinity of the upper end of the cylindrical porous molding container. Then, the filled fiber assembly is compressed and fixed with a jig, and the portion of the fiber assembly has a diameter of 12 mm, a height of 20 mm, and an apparent density of 0.23 g / cm ³ as shown in FIG. A material (A surface area and B surface area are the same) was manufactured. In addition, the average flow hole diameter of 1 mm in thickness including one surface (A surface in FIG. 1) of this cylindrical separator is 2.2 μm, and the thickness including the surface (B surface in FIG. 1) facing the surface. The average flow hole diameter of 1 mm was 2.2 μm. Moreover, when the separating material is peeled by hand in the direction parallel to the AB plane, the release surface forms a recess, and the percentage of the recess depth (d) with respect to the diameter (R) of the recess opening (= ( d / R) × 100) was 16%. Further, the Pmax / Pav value of the entire separating material (from the A surface to the B surface) was 4.4.

  Next, a frustoconical separation container having a continuously reduced cross-sectional area from the loading port (diameter: 11.5 mm) to the sealing port (diameter: 11.0 mm) is prepared. The filter of the present invention was manufactured by loading the separator so that the separator was brought into contact with a cellulose acetate membrane (pore diameter: 0.45 μm). In this filter, all of the separation material was filled in a state compressed by the separation container.

(Example 4)
A disk-shaped preformed fiber assembly (diameter: 12 mm) was formed by the method of fiber assembly formation method B using 100% ultrafine stretched fiber A. Next, 75 disk-shaped preformed fiber assemblies were filled into a cylindrical molding container having an inner diameter of 12 mm. And after compressing the filled fiber assembly, the cylindrical molding container is supplied to an oven set at a temperature of 130 ° C., and after cooling the high-density polyethylene component of the ultrafine stretched fiber A, it is cooled, Take out from the cylindrical molding container, and form a cylindrical separator (diameter A and area B are the same) having a diameter of 12 mm, a height of 20 mm, and an apparent density of 0.16 g / cm ³ as shown in FIG. Manufactured. In addition, the average flow hole diameter of 1 mm in thickness including one surface (A surface in FIG. 1) of this cylindrical separator is 2.0 μm, and the thickness including the surface (B surface in FIG. 1) facing the surface. The average flow hole diameter of 1 mm was 2.0 μm. Moreover, when the separating material is peeled by hand in the direction parallel to the AB plane, the release surface forms a recess, and the percentage of the recess depth (d) with respect to the diameter (R) of the recess opening (= ( d / R) × 100) was 8%. Further, the Pmax / Pav value of the entire separating material (from the A surface to the B surface) was 3.9.

  Next, a frustoconical separation container having a continuously reduced cross-sectional area from the loading port (diameter: 11.5 mm) to the sealing port (diameter: 11.0 mm) is prepared. The filter of the present invention was manufactured by loading the separator so that the separator was brought into contact with a cellulose acetate membrane (pore diameter: 0.45 μm). In this filter, all of the separation material was filled in a state compressed by the separation container.

(Example 5)
A disk-shaped preformed fiber assembly (diameter: 12 mm) was formed by the method of fiber assembly formation method B using 100% ultrafine stretched fiber A. Next, this disk-shaped preformed fiber aggregate was supplied to an oven set at a temperature of 130 ° C. to form a disk-shaped preformed fiber aggregate having an apparent density of 0.05 g / cm ³ . Next, 80 disk-shaped pre-thermoformed fiber assemblies were filled into a cylindrical molding container having an inner diameter of 12 mm. And after compressing the filled fiber assembly, the cylindrical molding container is supplied to an oven set at a temperature of 130 ° C., and after cooling the high-density polyethylene component of the ultrafine stretched fiber A, it is cooled, Take out from the cylindrical molding container, and form a cylindrical separator (diameter A and area B are the same) having a diameter of 12 mm, a height of 20 mm, and an apparent density of 0.16 g / cm ³ as shown in FIG. Manufactured. In addition, the average flow hole diameter of 1 mm in thickness including one surface (A surface in FIG. 1) of this cylindrical separator is 2.0 μm, and the thickness including the surface (B surface in FIG. 1) facing the surface. The average flow hole diameter of 1 mm was 2.0 μm. Moreover, when the separating material is peeled by hand in the direction parallel to the AB plane, the release surface forms a recess, and the percentage of the recess depth (d) with respect to the diameter (R) of the recess opening (= ( d / R) × 100) was 3%. Further, the Pmax / Pav value of the whole separating material (from the A surface to the B surface) was 3.6.

  Next, a frustoconical separation container having a continuously reduced cross-sectional area from the loading port (diameter: 11.5 mm) to the sealing port (diameter: 11.0 mm) is prepared. The filter of the present invention was manufactured by loading the separator so that the separator was brought into contact with a cellulose acetate membrane (pore diameter: 0.45 μm). In this filter, all of the separation material was filled in a state compressed by the separation container.

(Example 6)
Except for using 100% of ultrafine stretched fiber B instead of ultrafine stretched fiber A, the same procedure as in Example 5 was performed, and the diameter was 12 mm, the height was 20 mm, and the apparent density was 0.13 g / cm. ³ cylindrical separators (the area of the A surface and the area of the B surface were the same) were produced. In addition, the average flow hole diameter of 1 mm in thickness including one surface (A surface in FIG. 1) of this cylindrical separator is 1.2 μm, and the thickness including the surface (B surface in FIG. 1) facing the surface. The average flow hole diameter of 1 mm was 1.2 μm. Moreover, when the separating material is peeled by hand in the direction parallel to the AB plane, the release surface forms a recess, and the percentage of the recess depth (d) with respect to the diameter (R) of the recess opening (= ( d / R) × 100) was 5%. Further, the Pmax / Pav value of the entire separating material (from the A surface to the B surface) was 4.0.

  Next, a frustoconical separation container having a continuously reduced cross-sectional area from the loading port (diameter: 11.5 mm) to the sealing port (diameter: 11.0 mm) is prepared. The filter of the present invention was manufactured by loading the separator so that the separator was brought into contact with a cellulose acetate membrane (pore diameter: 0.45 μm). In this filter, all of the separation material was filled in a state compressed by the separation container.

(Example 7)
1 mm in diameter and height as shown in FIG. 1 in the same manner as in Example 5 except that instead of the ultrafine drawn fiber A 100 mass%, the ultrafine drawn fiber A was used in an amount of 25 mass% and the ultrafine drawn fiber C was used in an amount of 75 mass%. A cylindrical separator having an apparent density of 0.16 g / cm ³ (the area of the A surface and the area of the B surface are the same) was produced. In addition, the average flow hole diameter of 1 mm in thickness including one surface (A surface in FIG. 1) of this cylindrical separator is 2.0 μm, and the thickness including the surface (B surface in FIG. 1) facing the surface. The average flow hole diameter of 1 mm was 2.0 μm. Moreover, when the separating material is peeled by hand in the direction parallel to the AB plane, the release surface forms a recess, and the percentage of the recess depth (d) with respect to the diameter (R) of the recess opening (= ( d / R) × 100) was 4%. Furthermore, the Pmax / Pav value of the entire separating material (from the A surface to the B surface) was 3.8.

  Next, a frustoconical separation container having a continuously reduced cross-sectional area from the loading port (diameter: 11.5 mm) to the sealing port (diameter: 11.0 mm) is prepared. The filter of the present invention was manufactured by loading the separator so that the separator was brought into contact with a cellulose acetate membrane (pore diameter: 0.45 μm). In this filter, all of the separation material was filled in a state compressed by the separation container.

(Comparative Example 1)
A melt blown nonwoven fabric (average fiber diameter: 2 μm, σ / d = 0.95) made of 100% polypropylene fiber and having a basis weight of 40 g / m ² is prepared and punched into a disk shape having a diameter of 12 mm to form a disk-shaped melt blown nonwoven fabric. did. Next, 75 disk-shaped preformed fiber assemblies were filled into a cylindrical molding container having an inner diameter of 12 mm. Then, the filled fiber assembly is compressed and fixed with a jig, and the portion of the fiber assembly has a diameter of 12 mm, a height of 20 mm, and an apparent density of 0.16 g / cm ³ as shown in FIG. A material (A surface area and B surface area are the same) was manufactured. In addition, the average flow hole diameter of 1 mm in thickness including one surface (A surface in FIG. 1) of this cylindrical separator is 3.8 μm, and the thickness including the surface (B surface in FIG. 1) facing the surface. The average flow hole diameter of 1 mm was 3.8 μm. Moreover, when the separating material is peeled by hand in the direction parallel to the AB plane, the release surface forms a recess, and the percentage of the recess depth (d) with respect to the diameter (R) of the recess opening (= ( d / R) × 100) was 6%. Further, the Pmax / Pav value of the entire separating material (from the A surface to the B surface) was 6.2.

  Next, a frustoconical separation container having a continuously reduced cross-sectional area from the loading port (diameter: 11.5 mm) to the sealing port (diameter: 11.0 mm) is prepared. The filter of the present invention was manufactured by loading the separator so that the separator was brought into contact with a cellulose acetate membrane (pore diameter: 0.45 μm). In this filter, all of the separation material was filled in a state compressed by the separation container.

(Evaluation of separability)
First, 2 ml of blood obtained by adding heparin as a non-coagulant to the collected blood was prepared as test blood.

  Next, the test blood was injected from the loading port of each separation container kept in a vacuum state, and it was observed whether plasma or serum components were separated and filtered after 3 minutes.

  As a result, all of the filters of Examples 1 to 7 were able to separate and filter 0.1 to 0.2 ml of plasma or serum components, but the filter of Comparative Example 1 was clogged and became plasma or serum components. Could not be separated and filtered at all.

The perspective view of the separation material of this invention (A) Perspective view of peeled separating material, (b) Viewed from above peeled separating material, (c) Viewed from lateral direction of separated separating material Perspective view of separating material Perspective view of preforming support Explanatory drawing (a perspective perspective view) showing a filling state for producing a cylindrical separator, (a) a state where the filling nozzle is inserted near the bottom of the porous molding container, and (b) a discharge port of the filling nozzle. Moved upward of a porous molding container that is not yet filled with a fiber assembly The figure which shows the combination of the separating material and separation container which comprise a filter The figure which shows the combination of the separation material which comprises another filter, and the container for separation

Explanation of symbols

DESCRIPTION OF SYMBOLS 1, 10 Separation material 1a Indentation 1b Indentation opening part 2 Preliminary support body 2a Through-hole 3 Porous shaping container 4 Filling nozzle f Fiber assembly 5, 5 'Separation container 5a, 5a' Loading port 5b, 5b ' Sealing port

Claims (19)

A separator for plasma or serum, which is formed by using a gas aggregate as a dispersion medium and mainly formed from a fiber assembly mainly composed of ultrafine drawn fibers having a fiber diameter of 4 μm or less. The value (σ / d) obtained by dividing the standard deviation value (σ) of the fiber diameter distribution of the ultrafine drawn fiber by the average fiber diameter (d) of the ultrafine drawn fiber is 0.2 or less, The plasma or serum separation material according to 1. The separation material for plasma or serum according to claim 1 or 2, wherein the ultrafine drawn fibers are fused. A pair of surfaces satisfying the relationship that an average flow hole diameter of 1 mm in thickness including a certain surface is 1 μm to 4 μm and an average flow hole diameter of 1 mm in thickness including an opposite surface facing the surface is 0.5 μm to 3 μm The plasma or serum separation material according to any one of claims 1 to 3, characterized by comprising: The fiber assembly is regularly oriented and molded, and the release surface when the plasma or serum separation material is peeled in a direction parallel to the orientation direction forms a recess, and the diameter (R The percentage of the dent depth (d) (= (d / R) × 100) with respect to) is 20% or less, for plasma or serum according to any one of claims 1 to 4 Separation material. Any one of claims 1 to 5, wherein a region (Pmax / Pav) obtained by dividing a maximum pore diameter (Pmax) at a thickness of 1 mm by an average flow pore diameter (Pav) is 5 or less. A separator for plasma or serum according to claim 1. The plasma according to any one of claims 1 to 6, comprising a pair of surfaces satisfying a relationship that an area of a certain surface is different from an area of an opposite surface facing the surface. Or a serum separator. A plasma or serum filter obtained by loading the separation material for plasma or serum according to any one of claims 1 to 7 into a separation container. 9. The plasma or serum filter according to claim 8, wherein a part or all of the plasma or serum separation material is loaded in a compressed state by the separation container. Using a gas as a dispersion medium, a fiber group mainly composed of ultrafine drawn fibers having a fiber diameter of 4 μm or less is separated and dispersed into individual fibers, and the dispersed individual fibers are accumulated to form a fiber assembly. A method for producing a separation material for plasma or serum, comprising: a fiber assembly forming step that performs the forming step, and a molding step that forms the fiber assembly into a desired shape. In the fiber assembly forming step, a fiber group mainly composed of ultrafine drawn fibers having a fiber diameter of 4 μm or less is ejected from the dispersion nozzle into the gas by the action of the compressed gas, separated into individual fibers and dispersed, The method for producing a separation material for plasma or serum according to claim 10, wherein the method is a step of accumulating the dispersed individual fibers to form a fiber assembly. The plasma or the plasma according to claim 10 or 11, wherein, in the fiber assembly forming step, the dispersed individual fibers are accumulated in a preforming support to form a preformed fiber assembly. A method for producing a serum separation material. The method for producing a separation material for plasma or serum according to any one of claims 10 to 12, wherein the molding step is a step of filling a molding container and molding. The said shaping | molding process is a process of attracting | sucking gas from the outer side of the container for porous shaping | molding, and filling and shape | molding while discharging the said fiber assembly from a filling nozzle. A method for producing a plasma or serum separation material according to claim 11 or claim 13. The method for producing a separator for plasma or serum according to claim 14, wherein the discharge port of the filling nozzle is moved to a region not yet filled as the fiber assembly is filled. The method for producing a separator for plasma or serum according to any one of claims 10 to 15, wherein in the forming step, ultrafine drawn fibers are fused. The method for producing a separation material for plasma or serum according to any one of claims 10 to 15, further comprising a loading step of loading the separation material for plasma or serum into a separation container. A method for producing a filter for plasma or serum. In the loading process, a separation container for plasma or serum is used as a separation container having a constant cross-sectional area from a loading port for loading plasma or serum separating material to a sealing port facing the loading port. 18. The method for producing a plasma or serum filter according to claim 17, wherein a material having a cross-sectional area larger than a cross-sectional area at the sealing port of the separation container is used as a material. . In the loading process, as the separation container, use a container whose cross-sectional area decreases continuously or discontinuously from the loading port for loading the plasma or serum separation material toward the sealing port facing the loading port. The plasma or serum according to claim 17, wherein the plasma or serum separating material has a cross-sectional area larger than the cross-sectional area at the sealing port of the separation container, which is in contact with the sealing port. A method for producing a serum filter.

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