JP2011072816A - Blood processing filter and filtering method of blood - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a blood processing filter capable of easily constructing an environment where a flexible container and a blood processing filter material hardly adhere to each other even when the positive pressure on the inlet side and the negative pressure on the outlet side are generated on filtering, easy to secure a uniform flow of blood without obstruction, and capable of efficient blood processing. <P>SOLUTION: The blood processing filter 1A includes the flexible container 7 having an inlet 5 and an outlet 6 for blood and the sheet-like blood processing filter material 9 which is arranged to separate the inside of the container into the inlet side and the outlet side, wherein the flexible container 7 includes a container body 10 for accommodating the blood processing filter material 9 and an inlet side port 13 which is fixed to the container body 10 to form the inlet 5 or outlet 6, the inlet side port 13 has an inlet side main tube section 21a connected to a conduit that transports the blood and a fixed part which communicates the inlet side main tube section 21a into the container body 10 and fixes the inlet side main tube section 21a to the outer surface of the container body 10, and the axis of main tube section inclines relative to the tangent of the outer surface of the container body. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a blood treatment filter for removing undesirable components such as aggregates and leukocytes from blood. In particular, it relates to a precise and disposable blood treatment filter used for the purpose of removing microaggregates and white blood cells that cause side effects from whole blood preparations for blood transfusion, erythrocyte preparations, platelet preparations, plasma preparations, etc. In particular, the present invention relates to a flexible filter in which a resin material or the like is used as a material of a container, and a blood filtering method using the filter.

  It is becoming common for whole blood collected from a donor to be separated into blood component preparations such as erythrocyte preparations, platelet preparations, plasma preparations, etc., stored, and then transfused. In addition, since microaggregates and leukocytes contained in these blood products cause various side effects of blood transfusion, these undesired components are removed before blood transfusion or blood transfusion, or after blood collection, these are undesirable. Many methods are used for transfusion after removing the components and storing them.

  The most common method for removing leukocytes from a blood product is to treat the blood product with a leukocyte removal filter. For the leukocyte removal filter, a filter element made of nonwoven fabric or porous material is used for the container, which is the same as or similar to that used for the bag of the blood collection separation set, and has excellent flexibility and vapor permeability. Two types are used: a leukocyte removal filter in a flexible container, or a filter element made of a nonwoven fabric or a porous material filled in a hard container such as polycarbonate.

  Normally, when processing blood with these leukocyte removal filters, the bag containing the blood product to be processed, which is connected to the blood inlet side of the filter via a conduit, is positioned 20 to 100 cm higher than the filter. The blood product is passed through the filter by the action of gravity, and the filtered blood product is stored in a collection bag connected to the blood outlet side of the filter via a conduit. In the case of the leukocyte removal filter of the flexible container, a pressure loss occurs due to the resistance of the filter element during the filtration, and the space on the filter inlet side becomes a positive pressure. In the case of a filter made of a flexible container, since the container is flexible, this positive pressure causes the container to expand in a balloon shape, and the filter element is pressed against the container on the outlet side.

  On the other hand, the gap between the outlet-side container and the filter element is for storing blood after filtration, which is placed at a position 50 to 100 cm lower than the normal filter, because the blood in the conduit connected to the outlet falls by gravity. This action causes a negative pressure, and the flexible container tends to adhere to the filter element. That is, the filter element comes into close contact with the outlet-side container by double force, and the blood flow is inhibited.

  In order to prevent the filter element and the outlet side container from being in close contact with each other, it is also possible to adopt a hard container such as polycarbonate that can be used at the time of relatively inexpensive autoclave sterilization. However, considering that the entire apparatus needs to be sterilized because it is used for processing blood products, when the hard container is filled, the vapor permeability is poor and a long sterilization time is required. Moreover, since long-term autoclave sterilization causes deterioration of the blood preservation solution, etc., it was necessary to carry out complicated work such as sterilization after connecting the blood bag, circuit, etc. after sterilization with a filter .

  An object of the present invention is to easily construct an environment in which it is difficult to make a close contact between a flexible container and a blood treatment filter material even if a positive pressure on the inlet side and a negative pressure on the outlet side occur during filtration. An object of the present invention is to provide a blood processing filter that can easily ensure a uniform flow without being hindered and that enables efficient blood processing, and a blood filtration method using the blood processing filter.

  In a conventional blood processing filter provided with a flexible container, a port serving as a blood inlet / outlet is provided. Therefore, for example, by pulling the blood tube connected to the port on the outlet side, it is possible to prevent the outlet side container from being in close contact with the filter element. However, in the case of the conventional blood processing filter, for example, a tangential port protruding in the tangential direction of the outer surface of the flexible container is employed. In this type of blood processing filter, the outlet side container is separated from the filter element. There is room for improvement because there is a possibility that the conduit such as a blood tube may be broken and the flow path may be blocked when pulled in the direction to be pulled. The inventors of the present invention have obtained the present invention as a result of earnest research to achieve both the prevention of the blockage of the flow path between the conduit for transporting blood and the port and the prevention of the close contact between the outlet side container and the filter element. It was.

  That is, the present invention is a blood processing filter comprising a flexible container having a blood inlet and outlet, and a sheet-like blood processing filter material arranged so that the inside of the container is separated from the inlet side and the outlet side. The flexible container includes a container main body that contains the blood processing filter material, and an inclined port portion that is fixed to the container main body and forms an inlet or an outlet. The inclined port portion is connected to a conduit that transfers blood. A main pipe part, and a fixing part that connects the main pipe part to the inside of the container main body and fixes the main pipe part to the outer surface of the container main body, and the axis of the main pipe part is tangent to the outer surface of the container main body The present invention relates to a blood processing filter that is inclined with respect to the surface.

  For example, even when a tensile force is applied to a conduit such as a blood tube in an attempt to separate the container main body and the blood processing filter material, in this blood processing filter, the axis of the main pipe portion to which the conduit is connected is the container Since it is inclined with respect to the tangent to the outer surface of the main body, the conduit is not easily broken and it is difficult to induce blockage of the flow path. Furthermore, the container main body and the blood processing filter material can be easily separated by applying a pulling force to the main pipe portion. Therefore, according to the blood treatment filter described above, an environment in which it is difficult for the flexible container and the blood treatment filter material to be in close contact with each other even when a positive pressure on the inlet side and a negative pressure on the outlet side occur during filtration is easily constructed. Thus, it is easy to ensure a uniform flow without hindering blood flow, and efficient blood processing is possible.

  Further, the inclined port portion may be a blood processing filter that is an inlet-side port portion forming an inlet.

  Furthermore, the inclined port portion can be a blood processing filter that is an outlet-side port portion that forms an outlet.

  Furthermore, the inclined port portion may be a blood processing filter that is both an inlet-side port portion that forms an inlet and an outlet-side port portion that forms an outlet.

  The present invention also uses a blood processing filter comprising a flexible container having an inlet and an outlet for blood and a sheet-like blood processing filter material arranged so that the inside of the container is separated from the inlet side and the outlet side. A flexible container, comprising: a container body that contains a blood treatment filter material; and an inclined port portion that is fixed to the container body to form the inlet or the outlet, and the inclined port The part has a tubular main pipe part, and a fixing part that connects the main pipe part to the inside of the container body and fixes the main pipe part to the outer surface of the container body, and the main pipe part is connected to the outer surface of the container body. In addition, the present invention relates to a blood filtration method that performs filtration while securing a space between the blood treatment filter material and a container body by applying a pulling force to the main tube portion in a direction away from the blood treatment filter material.

  In this filtration method, since the main pipe part is inclined with respect to the outer surface of the container body, the conduit connected to the main pipe part is difficult to break and it is difficult to induce blockage of the flow path. Further, by applying a pulling force to the main tube portion in a direction away from the blood processing filter material and filtering while securing a space between the blood processing filter material and the container body, An environment that is difficult to adhere to the blood processing filter material can be easily constructed, it is easy to ensure a uniform flow without hindering blood flow, and efficient blood processing is possible.

  According to the present invention, even when a positive pressure on the inlet side and a negative pressure on the outlet side occur during filtration, it is possible to easily construct an environment in which the flexible container and the blood treatment filter material are difficult to adhere to each other, and blood flow It is easy to ensure a uniform flow without being obstructed, and efficient blood processing becomes possible.

FIG. 1 is a plan view of a blood processing filter according to the first embodiment of the present invention. 2 is a longitudinal sectional view taken along line II-II in FIG. FIG. 3 is an explanatory diagram showing a cross-section in a state where blood is filtered using the blood processing filter according to the present embodiment. FIG. 4 is an explanatory diagram showing a cross-section in a state where blood is filtered using the blood processing filter according to the comparative example. FIG. 5 is an enlarged cross-sectional view of the inlet port portion of the blood processing filter according to the second embodiment of the present invention. FIG. 6 is an enlarged cross-sectional view of the outlet port portion of the blood processing filter according to the second embodiment of the present invention.

  Embodiments of the present invention will be described below with reference to the drawings. The blood described in the embodiments includes blood products such as whole blood products for transfusion, erythrocyte products, platelet products, and plasma products. In addition, the outer shape of the blood treatment filter can adopt various forms such as a rectangular shape, a disc shape, an oblong disc shape, and an elliptical shape, but a rectangular shape is preferable in order to reduce material loss during manufacturing. In the embodiment, a rectangular shape will be described as an example.

  First, the blood processing filter 1A according to the first embodiment will be described with reference to FIG. 1 and FIG. The blood processing filter 1A is a sheet-like blood processing filter in which a flexible container 7 having a blood inlet 5 and an outlet 6 and a flexible container 7 are arranged so as to be separated from the inlet 5 side and the outlet 6 side. The material 9 is provided. In the following description, when the plane along the blood treatment filter material 9 is assumed to be the first plane, and the virtual plane including the center of the inlet 5 and the center of the outlet 6 is assumed to be the second plane, the first plane A direction along the line of intersection with the second plane is defined as a vertical direction Da, and a direction perpendicular to the vertical direction Da and along the first plane is defined as a horizontal direction Db.

  The flexible container 7 is a rectangular flat container. The flat shape is intended to be a shape with a small thickness and a wide surface. The flexible container 7 includes a rectangular sheet-shaped inlet-side container 11 on the inlet 5 side and a rectangular sheet-shaped outlet-side container 12 on the outlet 6 side. The inlet side container 11 and the outlet side container 12 are overlapped with each other via a rectangular blood processing filter material 9, and are bonded so as to sandwich the peripheral edge of the blood processing filter material 9. The band-like adhesion region along the periphery of the blood treatment filter material 9 is the inner seal portion 7a, and the inner region inside the inner seal portion 7a is a filtration region where blood flows.

  In addition, the inlet side container 11 and the outlet side container 12 are bonded to each other at the outer periphery outside the inner seal portion 7a. The belt-like adhesion region where the inlet side container 11 and the outlet side container 12 are directly adhered is the outer seal portion 7b. The inlet side container 11 and the outlet side container 12 form a container body 10 that houses the blood processing filter material 9.

  The inlet side container 11 is integrally formed with an inlet side port portion (inclined port portion) 13 to which a conduit 14A such as a blood tube for transferring blood is connected. The inlet-side port portion 13 is disposed so as to be shifted toward the one end portion 10a side in the longitudinal direction Da of the container body 10.

  The inlet-side port portion 13 includes an inlet-side main tube portion 13a that is connected to the conduit 14A and receives blood, and an inlet-side fixing portion 13b that fixes the inlet-side main tube portion 13a to the inlet-side container 11. The inlet side fixing portion 13b is a base portion formed in the inlet side container 11, and the inlet side main pipe portion 13a is provided so as to be bent and protrude with respect to the inlet side fixing portion 13b.

  An inlet 5 is formed at the tip of the inlet-side main pipe portion 13a, and a connecting hole 20A in which a conduit 14A is fitted and fixed is formed in the inlet 5. An inlet channel 13c communicating with the inlet 5 is formed inside the inlet-side main pipe portion 13a. The inlet channel 13c communicates with the inside (filtering region) of the container body 10 through a communication hole 13d formed in the inlet side fixing portion 13b. In addition, although the inlet side port part 13 which concerns on this embodiment is integrally molded by the inlet side container 11, the inlet side port part 13 and the inlet side container 11 were formed by another member, and were integrated by welding etc. An aspect may be sufficient.

  The axis line La of the inlet side main pipe portion 13a is inclined at an inclination angle θa with respect to the tangent line Ta of the outer surface 11a of the inlet side container 11. The inclination angle θa is 0 ° <θa <90 °, and more preferably 30 ° <θa <90 °. In addition, the inclination angle θa is intended to be a narrow angle with respect to the upper side when the blood processing filter 1A is arranged vertically so that the inlet 5 side is up and the outlet 6 side is down.

  The outlet-side container 12 is integrally formed with an outlet-side port portion (inclined port portion) 15 that forms the blood outlet 6. The outlet side port portion 15 is arranged so as to be point-symmetric with the inlet side port portion 13 with respect to the center of the container body 10.

  The outlet-side port portion 15 includes an outlet-side main pipe portion 15a to which the conduit 14B is connected and discharges blood, and an outlet-side fixing portion 15b that fixes the outlet-side main pipe portion 15a to the outlet-side container 12. The outlet side fixing part 15b is a base part formed in the outlet side container 12, and the outlet side main pipe part 15a is provided so as to bend and protrude with respect to the outlet side fixing part 15b.

  The outlet 6 is formed at the tip of the outlet side main pipe portion 15a, and the outlet 6 is formed with a connecting hole 20B into which the conduit 14B is fitted and fixed. An outlet flow path 15c communicating with the outlet 6 is formed inside the outlet side main pipe portion 15a. The proximal end side of the inlet side main pipe part 13a is connected to the outlet side fixing part 15b, and the outlet channel 15c communicates with the inside of the container body 10 (filtration region) through a communication hole 15d formed in the outlet side fixing part 15b. is doing. In addition, although the exit side port part 15 which concerns on this embodiment is integrally molded by the exit side container 12, the exit side port part 15 and the exit side container 12 were formed by another member, and were integrated by welding etc. An aspect may be sufficient. The outlet port portion 15 is preferably a molded product. Further, injection molding is more preferable.

  The axis Lb of the outlet side main pipe portion 15a is inclined at an inclination angle θb with respect to the tangent line Tb of the outer surface 12a of the outlet side container 12. The inclination angle θb is 0 ° <θb <90 °, and more preferably 30 ° <θb <90 °. In addition, the inclination angle θb is intended to be a narrow angle with respect to the lower side when the blood processing filter 1A is arranged vertically so that the inlet 5 side is up and the outlet 6 side is down.

  As described above, the container body 10 that houses the blood processing filter material 9 is formed by the inlet side container 11 and the outlet side container 12. The container body 10 is manufactured using a flexible resin, for example, preferably formed using a synthetic resin sheet-like member, and more preferably formed using a thermoplastic resin. The reason for using the sheet-like member is that the outer seal portion 7b needs to have a uniform thickness in the circumferential direction, and the inner seal portion 7a needs to have a uniform thickness in the circumferential direction. That is, as long as the outer seal portion 7b has a uniform thickness and the inner seal portion 7a is formed to have a uniform thickness, the container body can be formed from an embodiment formed using a film-like member or an injection molded product. The aspect etc. in which 10 was made may be sufficient.

  The flexible resin used for the inlet side container 11 or the outlet side container 12 according to the present embodiment can be used as long as it is a commercially available material as a sheet or a film. For example, soft polyvinyl chloride, polyurethane, ethylene-vinyl acetate copolymer, polyolefin such as polyethylene and polypropylene, styrene-butadiene-styrene copolymer hydrogenated product, styrene-isoprene-styrene copolymer or hydrogenated product thereof Suitable materials include thermoplastic elastomers such as products, and mixtures of thermoplastic elastomers and softeners such as polyolefin and ethylene-ethyl acrylate. Since contact with blood is considered, soft vinyl chloride, polyurethane, polyolefin, and thermoplastic elastomers based on these are preferably used as materials for medical products such as blood bags, and more preferably Soft vinyl chloride.

  The inlet side container 11 may be entirely made of a hard resin, or a part thereof may be a flexible resin. If the area of 10% or more of the area of the inlet side container 11 is a flexible container, the water vapor permeability during autoclave sterilization is improved, and the sterilization time can be shortened.

  The blood treatment filter material 9 according to the present embodiment is a known filtration medium such as a fibrous porous medium such as a nonwoven fabric or a woven fabric, or a porous body having three-dimensional network-like continuous pores such as a sponge-like structure. Those that can be used and do not have excellent weldability such as mesh and screen are not applicable. Examples of materials suitable for use as the blood treatment filter material 9 include polypropylene, polyethylene, styrene-isobutylene-styrene copolymer, polyurethane, and polyester. When the blood treatment filter material 9 is a nonwoven fabric, it is particularly preferable from the viewpoint of productivity.

  The sheet-like blood treatment filter material 9 may be a single filter element or may be formed from a plurality of filter elements. When formed from a plurality of filter elements, a first filter element that removes microaggregates arranged upstream (inlet 5 side) and a leukocyte arranged downstream of the first filter element are removed. Preferably it comprises a second filter element. For example, a filter material made of a nonwoven fabric having a fiber diameter of several to several tens of μm is arranged on the inlet 5 side as a first filter element for removing aggregates, and then the fiber diameter is 0.3 to 3.0 μm. A filter material made of a non-woven fabric can be used as a second filter element for removing white blood cells, and a post filter having a specific space on the downstream side can be laminated.

  Each of the first and second filter materials may further be composed of a plurality of types of filter materials, or only one of them may be composed of a plurality of types of filter materials. For example, the 1st filter which consists of a nonwoven fabric with a fiber diameter of 30-40 micrometers and / or a nonwoven fabric with a fiber diameter of 10-20 micrometers (it consists of at least one of a nonwoven fabric with a fiber diameter of 30-40 micrometers, and a fiber diameter of 10-20 micrometers) The material is disposed on the upstream side (inlet 5 side), and the nonwoven fabric having a fiber diameter of 1.5 to 2.5 μm and / or the nonwoven fabric having a fiber diameter of 0.5 to 1.8 μm is disposed downstream of the first filter material. A second filter material (consisting of at least one of a nonwoven fabric having a fiber diameter of 1.5 to 2.5 μm and a nonwoven fabric having a fiber diameter of 0.5 to 1.8 μm) may be used. Moreover, although the nonwoven fabric of a thick fiber diameter and the nonwoven fabric of a thin fiber diameter may be arrange | positioned alternately, it is more preferable that the nonwoven fabric of a thick fiber diameter is arrange | positioned upstream (inlet 5 side).

  Further, in order to form the inner seal portion 7a, the blood processing filter material 9 and the inlet side container 11 and the outlet side container 12 can be bonded by using high frequency welding. The container 12 and the blood processing filter material 9 may be welded together, or the inlet side container 11 and the blood processing filter material 9 are welded, and at that time, the blood processing filter material 9 and the inlet side container 11 are welded. You may do it. That is, the inlet side container 11, the blood treatment filter material 9, and the outlet side container 12 are arranged in this order, and even if blood is added, it does not leak out of the system, and from the inlet 5 provided in the inlet side container 11. If the structure is such that 99% or more of the blood (blood product) contained passes through the blood processing filter material 9 and then exits from the outlet 6 provided in the outlet side container 12, the container body 10 and the blood processing filter material The bonding method with 9 is not limited to welding, and other methods may be used.

  Next, the filtration method using the blood treatment filter 1A and the advantages of the blood treatment filter 1A will be described with reference to FIGS. FIG. 3 is an explanatory view showing a cross-section in a state where blood is filtered using the blood processing filter 1A, and FIG. 4 is a diagram showing blood filtering using the blood processing filter according to the comparative example. It is explanatory drawing which shows the cross section of the state which exists.

  When performing blood filtration using the blood treatment filter 1A, place the first bag containing the blood (blood product) to be treated at a position about 20 to 100 cm higher than the blood treatment filter 1A, 1 is connected to the inlet 5 side of the blood treatment filter 1A through a conduit 14A. In this state, the blood processing filter 1A is suspended by a conduit 14A on the inlet 5 side. The inlet-side main pipe portion 13a to which the conduit 14A is connected has an axis La of the inlet-side main pipe portion 13a that is inclined with respect to the tangent line Ta of the outer surface 11a of the inlet-side container 11, so that the inlet-side main pipe portion 13a On the other hand, a tensile force Fa is applied in a direction away from the blood processing filter material 9.

  On the other hand, the second bag for storing the filtered blood is placed at a position 50 to 100 cm lower than the blood treatment filter 1A, and the second bag and the outlet 6 side of the blood treatment filter 1A are connected via the conduit 14B. Connecting. In this state, the blood processing filter 1A is in a state where the second bag is suspended from the outlet 6 side via the conduit 14B. The outlet side main pipe portion 15a connected to the conduit 14B is stored in the second bag because the axis Lb of the outlet side main pipe portion 15a is inclined with respect to the tangent line Tb of the outer surface 12a of the outlet side container 12. In accordance with the increase in blood to be obtained, a tensile force Fb is applied to the outlet side main pipe portion 15a in a direction away from the blood processing filter material 9.

  When the valve is opened after the above setting is completed to open the flow path, blood filtration is started, blood flows into the blood treatment filter 1A from the first bag by the action of gravity, and further, the blood treatment filter 1A. The blood filtered in (1) flows from the blood treatment filter 1A into the second bag.

  Here, on the inlet 5 side of the blood processing filter 1A, pressure loss occurs due to the resistance of the blood processing filter material 9, and the space Sa on the inlet 5 side of the flexible container 7 becomes positive pressure. This positive pressure causes the inlet 5 side of the flexible container 7 to swell in a balloon shape, and the blood processing filter material 9 is pushed to the outlet 6 side. Further, at the outlet 6 side of the blood processing filter 1A, blood is sucked out by gravity from the outlet 6 to generate a negative pressure. Therefore, the space Sb between the outlet side container 12 and the blood processing filter 9 has a force in a narrowing direction. Works.

  However, on the inlet 5 side of the blood processing filter 1A, a tensile force Fa is applied to the inlet-side main pipe portion 13a in a direction away from the blood processing filter material 9. Therefore, the force for pressing the blood treatment filter material 9 toward the outlet 6 can be reduced, and filtration is performed while ensuring a space between the blood treatment filter material 9 and the container body 10.

  Further, on the outlet 6 side of the blood processing filter 1A, a tensile force Fb is applied to the outlet side main pipe portion 15a in a direction away from the blood processing filter material 9. Accordingly, the outlet side container 12 can be actively separated from the blood processing filter material 9, and filtration is performed while ensuring the space Sb between the blood processing filter material 9 and the container body 10.

  On the other hand, as shown in FIG. 4, the blood processing filter (hereinafter referred to as “comparison filter”) 100 according to the comparative example has ports 101 and 102 serving as inlets and outlets at tangents Tk and Tm of the outer surface 103 a of the container body 103. Are formed along. Therefore, even if the comparison filter 100 is set in the same manner as described above, the pulling force Fk generated by the suspension of the comparison filter 100 on the inlet side acts upward along the outer surface 103a of the container body 103, and the outlet side The pulling force Fm generated by the suspension of the second bag at the above acts downward along the outer surface 103 a of the container body 103.

  The outer surface 103a of the container body 103 is substantially parallel to the blood processing filter material 104 accommodated therein. Therefore, even if the pulling forces Fk and Fm are applied vertically, it cannot be said that the force is acting in the direction in which the blood processing filter material 104 and the container body 103 are separated from each other. Adhesion with the container body 103 cannot be prevented.

  In addition, when the conduits 14C and 14D connected to the ports 101 and 102 are forcibly pulled to separate the container main body 103 from the blood processing filter material 104, the ports 101 and 102 are connected to the tangents Tk and Tw of the container main body 103. Therefore, it is necessary to apply a force in the direction in which the conduits 14C and 14D are bent. Therefore, the conduits 14C and 14D are crushed and block the flow path.

  According to the blood processing filter 1A with respect to the comparison filter 100, the inlet-side main pipe portion 13a to which the conduit 14A is connected has an axis La of the inlet-side main pipe portion 13a with respect to the tangent line Ta of the outer surface 11a of the inlet-side container 11. Since it is inclined, it is difficult for a force to be applied in the direction in which the conduit 14A is bent. The same applies to the outlet side main pipe portion 15a to which the conduit 14B is connected, and the axis Lb of the outlet side main pipe portion 15a is inclined with respect to the tangent line Tb of the outer surface 12a of the outlet side container 12. It is difficult to apply a force in the direction of bending, and therefore the channel is not easily blocked.

  Therefore, according to the blood processing filter 1A according to the present embodiment, even if a positive pressure on the inlet 5 side and a negative pressure on the outlet 6 side are generated during filtration, the blood processing filter 1A is connected between the flexible container 7 and the blood processing filter material 9. An environment that is difficult to adhere to can be easily constructed, blood flow is not hindered and a uniform flow can be easily ensured, and efficient blood processing can be performed. In the blood processing filter 1A according to the present embodiment, the inclined port portion is formed on both the inlet side and the outlet side, but only one of the inlet side and the outlet side can be the inclined port portion. .

  Next, a blood processing filter 1B according to a second embodiment will be described with reference to FIGS. In addition, about the blood processing filter 1B which concerns on this embodiment, about the element and member similar to the blood processing filter 1A which concerns on 1st Embodiment, the same code | symbol is attached | subjected and detailed description is abbreviate | omitted. Moreover, the blood processing filter 1B according to the present embodiment can be manufactured using basically the same material as the blood processing filter 1A according to the first embodiment.

  As shown in FIGS. 5 and 6, the blood processing filter 1 </ b> B according to the second embodiment has the shapes of the inlet-side port portion (inclined port portion) 21 and the outlet-side port portion (inclined port portion) 23 in the first embodiment. It is different from the blood processing filter 1A according to the embodiment.

  The inlet-side port portion 21 (see FIG. 5) according to the present embodiment is formed so as to protrude linearly from the inlet-side vessel 11, and the root portion coupled to the inlet-side vessel 11 is the inlet-side fixing portion 21b. The outer tubular portion protruding from the inlet side fixing portion 21b is the inlet side main pipe portion 21a. The inlet 5 is formed at the tip of the inlet-side main pipe portion 21a, and the inlet 5 is formed with a connecting hole 20C into which the conduit 14A is fitted and fixed. An inlet channel 21c that connects the inlet 5 and the inside of the container body 10 is formed in the inlet-side main pipe portion 21a.

  The axis Lc of the inlet side main pipe portion 21 a is inclined at an inclination angle θc with respect to the tangent line Ta of the outer surface 11 a of the inlet side container 11. The inclination angle θc is 0 ° <θc <90 °, and more preferably 30 ° <θc <90 °. In addition, the inclination angle θc is intended to be a narrow angle with respect to the upper side when the blood treatment filter 1B is arranged vertically so that the inlet 5 side is up and the outlet 6 side is down.

  Moreover, the inlet side port part 21 which concerns on this embodiment is provided with the spacer 25 for hold | maintaining the inlet side main pipe part 21a with predetermined inclination-angle (theta) c. The spacer 25 is, for example, a member having a triangular cross-section, a cross-sectional fan shape, or a quadrangular cross-section (such as a rhomboid or a cross-sectional parallelogram), and is fixed to the narrow angle side where the inclination angle θc is obtained. 21a is held at a predetermined inclination angle θc. Further, the spacer 25 may be a member that can form a predetermined space on the narrow angle side that becomes the inclination angle θc of the inlet side main pipe portion 21a.

  The outlet side port portion 23 (see FIG. 6) is formed so as to protrude linearly from the outlet side container 12, and the root portion coupled to the outlet side container 12 is the outlet side fixing portion 23b. An outer tubular portion protruding from 23b is an outlet side main pipe portion 23a. An outlet 6 is formed at the tip of the outlet-side main pipe portion 23a, and a connecting hole 20D is formed in the outlet 6 to which the conduit 14B is fitted and fixed. An outlet channel 23c that connects the outlet 6 and the inside of the container body 10 is formed inside the outlet-side main pipe portion 23a.

  The axis Ld of the outlet side main pipe portion 23a is inclined at an inclination angle θd with respect to the tangent line Tb of the outer surface 12a of the outlet side container 12. The inclination angle θd is 0 ° <θd <90 °, and more preferably 30 ° <θd <90 °. In addition, the inclination angle θd is intended to be a narrow angle with respect to the upper side when the blood processing filter 1B is arranged vertically so that the inlet 5 side is up and the outlet 6 side is down.

  Further, the outlet side port portion 23 according to the present embodiment includes a spacer 27 for holding the outlet side main pipe portion 23a at a predetermined inclination angle θd. The spacer 27 is, for example, a member having a triangular cross-section, a cross-sectional fan shape, or a quadrangular cross-section (such as a rhomboid or a cross-sectional parallelogram), and is fixed to the narrow angle side where the inclination angle θd is obtained. 23a is held at a predetermined inclination angle θd. In addition, the spacer 27 may be a member that can form a predetermined space on the narrow angle side that becomes the inclination angle θd of the outlet-side main pipe portion 23a.

  According to the blood processing filter 1B according to the present embodiment, even when a positive pressure on the inlet side and a negative pressure on the outlet side are generated during filtration, the environment is difficult to adhere between the flexible container 7 and the blood processing filter material 9. Therefore, it is easy to secure a uniform flow without hindering the blood flow, and an efficient blood treatment is possible.

  For example, the blood processing filter 1B, like the blood processing filter 1A according to the first embodiment, tilts the inlet-side main pipe portion 21a and the outlet-side main pipe portion 23a with respect to the outer surfaces 11a and 12a of the container body 10, The inlet side main pipe portion 21a and the outlet side main pipe portion 23a are filtered while securing a space between the blood processing filter material 9 and the container body 10 by applying a pulling force in a direction away from the blood processing filter material 9. be able to.

By using the spacers 25 and 27, the inclination angle (θc in FIG. 5 and θd in FIG. 6) can be fixed. Therefore, it is easy to create the target space Sb simply by pulling the inlet-side and outlet-side conduits 14A and 14B. Furthermore, since the strength of the inlet-side port portion 21 or the outlet-side port portion 23 is improved, it has the effect of preventing the welded portions between the outer surfaces 11a, 12a and the port portions 21, 23 from being damaged by being pulled.
In the blood processing filter 1B according to the present embodiment, the inclined port portion is formed on both the inlet side and the outlet side, but only one of the inlet side and the outlet side may be the inclined port portion. .

  EXAMPLES Hereinafter, although an Example demonstrates this invention further in detail, this invention is not limited by an Example.

[Method for quantifying the number of white blood cells in blood]
The leukocyte concentration in the blood was determined by flow cytometry. Using a flow cytometer (FACSCalibur manufactured by BECTON DICKINSON), the number of leukocytes in 100 μL of sampled blood was counted using a Leucocount kit with beads (Nippon Becton Dickinson).
The remaining white blood cell count was determined using the following formula.

Remaining white blood cell count (number) = white blood cell concentration after filtration (number / μL) × [(weight recovered blood after filtration (g) ÷ 1.08 (specific gravity of blood after filtration)) × 10 ³ ]

[Example 1]
Red blood cell preparation (white blood cell count: 9.6 × 10 ⁹ ) using a FlexRC filter (manufactured by Asahi Kasei Medical Co., Ltd., effective filtration membrane area 42.2 cm ² ) having an inlet port portion and an outlet port portion shown in FIG. 320 ml) was filtered. The drop between the blood bag and the FlexRC filter (hereinafter referred to as the first embodiment filter) was 75 cm.

  The conduit connected to the filter of the first embodiment was pulled and fixed so that the space Sb in FIG. 3 was obtained. Each value of θa and θb in FIG. 2 was 45 °.

The initial linear velocity was 0.21 ml / min / cm ² , the average linear velocity was ml / min / cm ² , and the final linear velocity was 0.15 ml / min / cm ² . The filtration time was 42.1 minutes, and the number of remaining leukocytes in the erythrocyte preparation after filtration through the first example filter was 5.0 (Log WBC). By using the inclined port portion according to the first embodiment of the present invention, it has been clarified that an environment (space) in which the flexible container and the blood processing filter material are hardly adhered can be easily constructed. As a result of ensuring a uniform flow without hindering blood flow and enabling efficient blood treatment, filtration time and leukocyte removal ability were improved as compared with Comparative Example 1.

[Example 2]
The same operation as in Example 1 was performed except that the values of θa and θb in FIG. Hereinafter, this FlexRC filter is referred to as a second embodiment filter.

The initial linear velocity was 0.24 ml / min / cm ² , the average linear velocity was 0.20 ml / min / cm ² , and the final linear velocity was 0.17 ml / min / cm ² . The filtration time was 37.9 minutes, and the number of remaining leukocytes in the erythrocyte preparation after filtration by the second example filter was 4.8 (Log WBC). By using the inclined port portion according to the second embodiment of the present invention, it has been clarified that an environment (space) in which the flexible container and the blood processing filter material are hardly adhered can be easily constructed. As a result of ensuring a uniform flow without hindering blood flow and enabling efficient blood treatment, filtration time and leukocyte removal ability were improved as compared with Comparative Example 1.

[Example 3]
Using a FlexRC filter (manufactured by Asahi Kasei Medical Co., Ltd., effective filtration membrane area 42.2 cm ² ) having an inlet side port portion shown in FIG. 5 and an outlet side port portion shown in FIG. 6 × 10 ⁹ ) 320 ml was filtered. The drop between the blood bag and the FlexRC filter (hereinafter referred to as the third embodiment filter) was 75 cm.

  The conduit connected to the filter of Example 3 was pulled and fixed so as to obtain the space Sb in FIG. Using spacers, the respective values of θc in FIG. 5 and θd in FIG. 6 were set to 30 °.

The initial linear velocity was 0.19 ml / min / cm ² , the average linear velocity was 0.17 ml / min / cm ² , and the final linear velocity was 0.14 ml / min / cm ² . The filtration time was 44.6 minutes, and the number of remaining white blood cells in the red blood cell preparation after filtration through the third example filter was 5.1 (Log WBC). By using the inclined port portion according to the third embodiment of the present invention, it has become clear that an environment (space) in which the flexible container and the blood processing filter material are hardly adhered can be easily constructed. As a result of ensuring a uniform flow without hindering blood flow and enabling efficient blood treatment, filtration time and leukocyte removal ability were improved as compared with Comparative Example 1.

[Example 4]
The same operation as in Example 3 was performed except that the values of θc in FIG. 5 and θd in FIG. 6 were set to 88 °. This FlexRC filter is hereinafter referred to as a fourth embodiment filter.

Initial linear velocity 0.26 ml / min / cm ^2, the average linear velocity 0.22 ml / min / cm ^2, and the final linear velocity 0.18 ml / min / cm ^2. The filtration time was 34.5 minutes, and the number of remaining leukocytes in the erythrocyte preparation after filtration with the filter of Example 4 was 5.5 (Log WBC). By using the inclined port portion according to the fourth embodiment of the present invention, it has been clarified that an environment (space) in which the flexible container and the blood processing filter material are hardly adhered can be easily constructed. As a result of ensuring a uniform flow without hindering blood flow and enabling efficient blood treatment, filtration time and leukocyte removal ability were improved as compared with Comparative Example 1.

[Comparative Example 1]
320 ml of erythrocyte preparation (white blood cell count: 9.6 × 10 ⁹ ) was filtered using a FlexRC filter (manufactured by Asahi Kasei Medical Co., Ltd., effective filtration membrane area: 42.2 cm ² ). The drop between the blood bag and the FlexRC filter (hereinafter referred to as the first comparative example filter) was 75 cm. The initial linear velocity was 0.18 ml / min / cm ² , the average linear velocity was 0.16 ml / min / cm ² , and the final linear velocity was 0.14 ml / min / cm ² . The filtration time was 47.4 minutes, and the remaining white blood cell count in the red blood cell preparation after filtration through the first comparative filter was 5.2 (Log WBC). At the time of filtration, the inlet side was filled with blood and was in a positive pressure state. Further, during the filtration, negative pressure was generated on the outlet side, and the flexible container and the blood treatment filter material were in close contact with each other. The structure and state of the first comparative filter during filtration were as illustrated in FIG.

[Comparative Example 2]
An attempt was made to create a space on the outlet side of the conduit of Comparative Example 1 (14C and 14D in FIG. 4) by pulling it. However, the conduit broke, resulting in no blood flow.

[Comprehensive evaluation]
As shown in the above embodiment, the filter according to each embodiment of the present invention provides a space between the blood processing filter material and the outlet side container, so that the blood flow is not hindered and a uniform flow is ensured. Moreover, as a result of enabling efficient blood treatment, filtration time and leukocyte removal ability were improved as compared with the comparative example.

  The blood treatment filter of the present invention has industrial applicability as a filtration membrane for pharmaceutical use, medical use, and general industrial use.

  DESCRIPTION OF SYMBOLS 1A, 1B ... Blood processing filter, 5 ... Inlet, 6 ... Outlet, 7 ... Flexible container, 9 ... Blood processing filter material, 10 ... Container body, 11a, 12a ... Outer surface, 13, 21 ... Inlet side port part (Inclined port part), 13a, 21a ... inlet side main pipe part, 13b, 21b ... inlet side fixing part, 15, 23 ... outlet side port part (inclined port part), 15a, 23a ... outlet side main pipe part, 15b, 23b ... exit side fixing part, La, Lb, Lc, Ld ... axis, Ta, Tb ... tangent.

Claims (5)

A blood processing filter comprising a flexible container having an inlet and an outlet for blood, and a sheet-like blood processing filter material arranged so that the inside of the container is separated from the inlet side and the outlet side,
The flexible container includes a container main body that houses the blood processing filter material, and an inclined port portion that is fixed to the container main body and forms the inlet or the outlet,
The inclined port part includes a main pipe part connected to a conduit for transferring blood, a fixing part that connects the main pipe part to the inside of the container main body, and fixes the main pipe part to an outer surface of the container main body, Have
The blood processing filter, wherein an axis of the main pipe portion is inclined with respect to a tangent to the outer surface of the container body.   The blood processing filter according to claim 1, wherein the inclined port portion is an inlet-side port portion that forms the inlet.   The blood processing filter according to claim 1, wherein the inclined port portion is an outlet-side port portion that forms the outlet.   The blood processing filter according to claim 1, wherein the inclined port portion is both an inlet-side port portion that forms the inlet and an outlet-side port portion that forms the outlet. A blood filtration method using a blood treatment filter comprising: a flexible container having a blood inlet and outlet; and a sheet-like blood treatment filter material arranged so that the inside of the container is separated from the inlet side and the outlet side. There,
The flexible container includes a container main body that contains the blood processing filter material, and an inclined port portion that is fixed to the container main body and forms the inlet or the outlet, and the inclined port portion stores blood. A main pipe part connected to the conduit to be transferred, and a fixing part for communicating the main pipe part with the inside of the container main body and fixing the main pipe part to the outer surface of the container main body,
The main pipe portion is inclined with respect to the outer surface of the container main body, and further, a tensile force is applied to the main pipe portion in a direction away from the blood processing filter material to provide a space between the blood processing filter material and the container main body. A blood filtration method for filtering while ensuring space.

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