WO2012090834A1 - 血液処理フィルター - Google Patents
血液処理フィルター Download PDFInfo
- Publication number
- WO2012090834A1 WO2012090834A1 PCT/JP2011/079705 JP2011079705W WO2012090834A1 WO 2012090834 A1 WO2012090834 A1 WO 2012090834A1 JP 2011079705 W JP2011079705 W JP 2011079705W WO 2012090834 A1 WO2012090834 A1 WO 2012090834A1
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- filter material
- blood
- filter
- space
- outlet
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/02—Blood transfusion apparatus
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/02—Blood transfusion apparatus
- A61M1/0209—Multiple bag systems for separating or storing blood components
- A61M1/0218—Multiple bag systems for separating or storing blood components with filters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
- A61M1/3621—Extra-corporeal blood circuits
- A61M1/3627—Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
- A61M1/3633—Blood component filters, e.g. leukocyte filters
- A61M1/3635—Constructional details
- A61M1/3636—Constructional details having a flexible housing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2202/00—Special media to be introduced, removed or treated
- A61M2202/04—Liquids
- A61M2202/0413—Blood
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
- A61M2205/7563—General characteristics of the apparatus with filters with means preventing clogging of filters
Definitions
- the present invention relates to a blood treatment filter for removing undesirable components such as aggregates and leukocytes from blood.
- the present invention 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. .
- leukocyte removal filter The most common method for removing leukocytes from a blood product is to treat the blood product with a leukocyte removal filter.
- the treatment of blood products by this leukocyte removal filter was often performed at the bedside when performing a blood transfusion operation, but in recent years for the purpose of quality control of leukocyte removal products and the improvement of the effectiveness of leukocyte removal processing, It is common in developed countries to be done at the blood center before storage.
- leukocyte removal performed before storage is referred to as “pre-storage leukocyte removal”.
- a blood collection / separation set including a blood collection needle has been used for some time.
- a system in which a leukocyte removal filter is incorporated in the above blood collection separation set is widely used as one that can be suitably used for “leukocyte removal before storage”, and is named “closed system” or “integrated system”. It is called by.
- leukocyte removal filters in which a filter element made of a nonwoven fabric or a porous material is filled in a hard container such as polycarbonate have been widely used.
- the rigid container has a problem that it is difficult to apply steam sterilization, which is widely used as a sterilization process of a blood collection / separation set, because the gas permeability of the container is low.
- the whole blood product is first subjected to leukocyte removal after blood collection, the leukocyte removal filter is cut off, and then the centrifugation operation for component separation is performed, and the whole blood is separated into multiple blood components by centrifugation. In some cases, leukocyte removal is performed later.
- the leukocyte removal filter is also centrifuged together with the blood collection set.
- the hard container may damage the bag or the conduit, or the hard container itself may be damaged without being able to withstand the stress during centrifugation.
- a flexible leukocyte removal filter using a flexible and vapor-permeable material that is the same as or similar to that used for a bag of a blood collection separation set.
- a product in which a flexible container is directly welded to a filter material see JP-A-7-267871, pamphlet of WO95 / 017236) or the like is known.
- a flexible container is formed of a flexible sheet-like material, and the internal space of the flexible container is partitioned into one side and the other side by a filter material.
- the one side and the other side partitioned by the filter material are respectively provided with ports serving as blood inlets and outlets, and the blood flowing in from the inlet is discharged from the outlet after passing through the filter material once. .
- the leukocyte removal filter described above if the material of the filter material is the same, it is possible to improve the removal performance of leukocytes and the like with a thicker and smaller one than with a thin and large one.
- ease of filter assembly especially ease of sealing, the thinner the filter material, the easier it is, and the thinner and larger the easier it is for blood flow (improvement of filtration speed) Convenient. That is, in the leukocyte removal filter described above, it has been difficult to obtain a leukocyte removal filter that has both conflicting problems and advantages when the filter material is thin and thick, and that can enjoy both advantages.
- the present invention provides a blood treatment filter that easily obtains desired filtration performance while enjoying the benefits of a thin filter material.
- one embodiment of the present invention is a blood treatment filter including a flexible container having an inlet and an outlet for blood, and a sheet-like filter material housed in the flexible container, A sealing part that seals the flexible container and the filter material to form an effective filtration part of the filter material, and a separator part that seals the flexible container and the filter material to divide the effective filtration part into a plurality of parts And the seal part and the partition part are partitioned into three or more internal spaces including an inlet space communicating with the inlet and an outlet space communicating with the outlet through cooperation of the filter material.
- the present invention relates to a blood processing filter that forms a path that passes through three or more internal spaces and passes through a filter material a plurality of times.
- the blood in the present invention includes blood products such as whole blood preparations for blood transfusion, erythrocyte preparations, platelet preparations and plasma preparations.
- this blood processing filter As a blood path from the inlet to the outlet, a path that passes through the filter material a plurality of times while passing through the plurality of internal spaces is formed. According to this blood processing filter, even if it is a thin filter material, blood passes through the filter material a plurality of times. As a result, the removal performance of white blood cells or the like equivalent to that when the filter material is thick can be expected. Therefore, the advantages obtained when the filter material is thick can be enjoyed while maintaining the advantage in terms of production or filtration speed obtained when the filter material is thin.
- the flexible container includes a first container forming portion and a second container forming portion which is overlapped with the first container forming portion with the filter material interposed therebetween and sealed by the first container forming portion.
- the seal part and the partition part form a plurality of internal spaces on one side of the filter material, and form one or a plurality of internal spaces on the other side of the filter material. It is also possible to form a path that alternately passes through the internal space formed on one side of the material and the internal space formed on the other side of the filter material and passes through the filter material a plurality of times.
- the seal part and the partition part form a plurality of internal spaces including an inlet space and an outlet space on one side of the filter material, and one side of the filter material on the other side of the filter material. It is also possible to form an internal space that is one fewer than the side.
- the seal portion and the partition portion form a plurality of internal spaces including an inlet space on one side of the filter material, and one of the filter materials including the outlet space on the other side of the filter material. It is also possible to form the same number of internal spaces as the side.
- the seal portion and the partition portion form an inlet space and an outlet space on one side of the filter material, and the inlet space and the outlet via the filter material on the other side of the filter material. It is also possible to form an intermediate space that can communicate with both the space and form a path that passes through the inlet space, the intermediate space, and the outlet space and passes through the filter material a plurality of times as a blood path. it can.
- the surface area of the filter material exposed in the inlet space is larger than the surface area of the region communicating with the outlet space among the surface areas of the filter material exposed in the intermediate space. You can also.
- FIG. 1 is a plan view showing a part of the blood processing filter according to the first embodiment of the present invention in a cutaway manner.
- FIG. 2 is a sectional view taken along line II-II in FIG.
- FIG. 3 is a front view showing an outline of a blood processing system including the blood processing filter according to the first embodiment.
- FIG. 4 is a plan view of a blood treatment filter according to the second embodiment of the present invention.
- FIG. 5 is a sectional view taken along line VV in FIG.
- FIG. 6 is a plan view of a blood treatment filter according to a third embodiment of the present invention.
- FIG. 7 is a sectional view taken along line VII-VII in FIG.
- FIG. 8 is a plan view showing a partially broken blood processing filter according to the fourth embodiment of the present invention.
- FIG. 9 is a sectional view taken along line IX-IX in FIG.
- the blood described in the following embodiments includes blood products such as whole blood products for blood transfusion, erythrocyte products, platelet products, and plasma products.
- 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.
- a rectangular shape will be described as an example.
- the blood processing filter 1A includes a flexible container 2A having a blood inlet port 3A and an outlet port 4A, and a sheet-like filter material 5 accommodated in the flexible container 2A.
- the flexible container 2A 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 2A includes a rectangular sheet-shaped first container forming section 9A and a rectangular sheet-shaped second container forming section 11A.
- the first container forming portion 9A and the second container forming portion 11A overlap with each other with the rectangular filter material 5 interposed therebetween, and the peripheral edges are in close contact with each other and sealed in a band shape.
- sealing means fixing by adhesion (including welding) to the extent that leakage of liquid can be prevented.
- the inlet port 3A and the outlet port 4A are sealed in the first container forming part 9A.
- the inlet port 3A is formed with an inlet channel 3a that communicates with the inside of the flexible container 2A and serves as an inlet.
- the outlet port 4A communicates with the interior of the flexible container 2A and serves as an outlet.
- An outlet channel 4a is formed.
- the blood treatment filter 1A includes a seal portion 6 that seals the flexible container 2A and the filter material 5 to form an effective filtration portion 5a of the filter material 5, and the flexible container 2A and the filter material 5.
- the partition part 7 which seals and divides the effective filtration part 5a into a plurality of parts is provided.
- the seal portion 6 and the partitioning portion 7 include a plurality of internal spaces S1, including an inlet space S1 and an outlet space S2 inside the flexible container 2A through cooperation with each part of the effective filtration portion 5a of the filter material 5.
- the inlet space S1 is an internal space that communicates with the inlet channel 3a of the inlet port 3A
- the outlet space S2 is an internal space that communicates with the outlet channel 4a of the outlet port 4A.
- the inlet space S1 and the outlet space S2 are formed on the side (one side) facing the first container forming portion 9A of the filter material 5, and the intermediate space S3 that is the third internal space is the second space of the filter material 5. It is formed on the side facing the container forming part 11A (the other side).
- the first container forming part 9 ⁇ / b> A and the second container forming part 11 ⁇ / b> A are sealed in a band shape with the filter material 5 sandwiched along the periphery of the filter material 5.
- a bonded portion sealed in a rectangular ring shape along the periphery of the filter material 5 is a seal portion 6.
- first container forming portion 9A and the filter material 5 are sealed in a circular ring shape and in a belt shape inside the area surrounded by the seal portion 6.
- a bonding portion that is annularly sealed inside the seal portion 6 is a partition portion 7.
- the seal part 6 and the partition part 7 form two internal spaces S1 and S2 on one side of the filter material 5 in cooperation with each part of the effective filtration part 5a of the filter material 5, A smaller number of internal spaces S3 are formed on the other side of the filter material 5 than on one side.
- an inlet space S1 and an outlet space S2 are formed between the filter material 5 and the first container forming portion 9A, and an intermediate space is formed between the filter material 5 and the second container forming portion 11A.
- a space S3 is formed.
- the intermediate space S3 exists without being partitioned by the partitioning portion 7, and is provided so as to be able to communicate with both the inlet space S1 and the outlet space S2 via the filter material 5.
- the surface area of the filter material 5 exposed in the inlet space S1 is larger than the surface area of the region communicating with the outlet space S2 in the surface area of the filter material 5 exposed in the intermediate space S3.
- the seal part 6 and the partition part 7 form a path that passes through the internal spaces S1, S2, S3 and the filter material 5 a plurality of times as the blood path RA.
- the seal portion 6 and the partitioning portion 7 are configured as the blood path RA, the forward path Ra passing through the filter material 5 from the inlet space S1 toward the intermediate space S3, and the intermediate space S3 to the outlet space S2.
- a return path Rb passing through the filter material 5 is formed.
- the blood path RA is a path that alternately passes through the internal spaces S1 and S2 formed on one side of the filter material 5 and the internal space S3 formed on the other side of the filter material 5.
- the flexible container 2A is formed by the first container forming part 9A and the second container forming part 11A.
- the flexible resin used for the flexible container 2A can be used as long as it is a commercially available material as a sheet or a film.
- 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 flexible container 2A for example, a container described in JP-A-7-267871 or a container described in WO95 / 017236 can be used.
- the filter material 5 is manufactured using a filter material made of a fibrous aggregate such as a nonwoven fabric or a woven fabric or a porous material such as a sponge.
- a filter material made of a fibrous aggregate such as a nonwoven fabric or a woven fabric or a porous material such as a sponge.
- a filter material coated with a polymer may be used in order to make leukocytes easily adhere to the filter material 5.
- the first container forming portion 9A and the filter material 5 in which the inlet port 3A and the outlet port 4A are sealed at predetermined positions are prepared, and the first container forming portion 9A and the filter material 5 are predetermined.
- the installation process which arranges in a position is performed.
- a first sealing step is performed in which the first container forming portion 9A and the filter material 5 are sealed in a band shape so as to surround the formation portion of the outlet port 4A to form the separation portion 7.
- the second container forming part 11A is installed at a predetermined position so that the filter material 5 is sandwiched between the first container forming part 9A and the second container forming part 11A.
- the first container forming part 9A, the filter material 5 and the second container forming part 11A are sealed so as to surround the partition part 7 along the periphery of the filter material 5 to form a rectangular annular seal part 6. Execute the Niceal process.
- the formation of the separation portion 7 in the first sealing step that is, the sealing of the first container forming portion 9A and the filter material 5 can be performed using high-frequency welding, but is not limited thereto.
- Various bonding techniques such as sonic welding and heat welding can be used.
- the sealing for forming the seal portion 6 in the second sealing step can be performed using high-frequency welding, but is not limited to this, and various types such as ultrasonic welding and thermal welding are used. Adhesion techniques can be used.
- a third sealing step is performed in which the first container forming portion 9A and the second container forming portion 11A are overlapped with the filter material 5 interposed therebetween, and the peripheral edges are closely adhered and sealed in a band shape.
- the sealing between the first container forming portion 9A and the second container forming portion 11A can be performed using high frequency welding, but is not limited to this, and various bonding techniques such as ultrasonic welding and thermal welding. Can be used.
- a 3rd sealing process can also be performed simultaneously with a 2nd sealing process, or before a 2nd sealing process.
- the inlet port 3A and the outlet port 4A have been described in the form of being sealed in advance in the flexible container 2A.
- the separator 7 and the seal portion 6 may be sealed after being formed, Or you may go in the middle of them.
- in order to seal the inlet port 3A and the outlet port 4A to the flexible container 2A not only high-frequency welding but also any bonding technique such as heat welding can be used.
- materials for the inlet port 3A and the outlet port 4A various conventionally known materials can be used as in the flexible container 2A.
- a blood processing system 100 (see FIG. 3) configured to include the blood processing filter 1A according to the first embodiment will be described.
- the blood treatment filter 1A can be used for filtration using gravity.
- the blood processing system 100 to which the blood processing filter 1A is applied includes a storage bag 101 that contains blood after blood collection, a blood processing filter 1A, and a collection bag 103 that stores blood after filtration.
- the storage bag 101 and the inlet port 3A of the blood processing filter 1A are connected to each other by a conduit 102a such as a blood tube, and the recovery bag 103 and the outlet port 4A of the blood processing filter 1A are connected to each other by a conduit 104a such as a blood tube.
- a conduit 102a such as a blood tube
- the recovery bag 103 and the outlet port 4A of the blood processing filter 1A are connected to each other by a conduit 104a such as a blood tube.
- the upstream side conduit 102a is provided with an opening / closing means 102b such as a roller clamp for opening and closing the flow path, a chamber 102c, and the like, and the inlet side circuit 102 is formed by the conduit 102a, the opening / closing means 102b, the chamber 102c, and the like. Is done. Further, the outlet side circuit 104 is formed by the downstream side conduit 104a and the like.
- the storage bag 101 containing the collected blood is placed at a position about 50 cm higher than the blood treatment filter 1A, and the collection bag 103 for accumulating the filtered blood is placed at a position about 100 cm lower than the blood treatment filter 1A. ing. Blood is filtered by opening the flow path of the blood processing system 100.
- the blood processing filter 1A As a blood path RA from the inlet flow path 3a to the outlet flow path 4a, a path that passes through the filter material 5 a plurality of times while passing through the plurality of internal spaces S1, S2, and S3 is formed.
- the According to this blood treatment filter 1A even if the filter material 5 is thin, blood passes through the filter material 5 a plurality of times. As a result, the removal performance of white blood cells or the like equivalent to that when the filter material 5 is thick can be expected. .
- the same effect as when using a thick filter material can be obtained, and it is effective for reducing the material as the filter material 5, and is less Even the material can maintain the removal performance of leukocytes and the like.
- the same effect as that of a difficult-to-assemble aspect when using a small and thick filter material can be obtained even though the thin filter material 5 is used. Therefore, the welding load when sealing the filter material 5 is reduced, which is advantageous from the viewpoint of the work load when assembling, and it is possible to obtain benefits in terms of ease of assembly and ease of sealing.
- the first filtration when blood passes through the filter material 5 in the forward path Ra of the blood path RA, and the blood passes through the filter material 5 in the return path Rb of the blood path RA.
- the second filtration (secondary filtration) is performed.
- the primary filtration mainly removes aggregates and the like, and the secondary filtration filters only blood after removal of aggregates and the like.
- the primary filtration there is a loss such as inflow of aggregates, so a certain area is required.
- the secondary filtration since the blood has been filtered once, there is no aggregate and the white blood cells are reduced. An area smaller than the filtration area on the side is sufficient.
- the area ratio between the filtration area on the primary filtration side and the filtration area on the secondary filtration side can be set to an arbitrary area ratio, so that it is easy to optimize. That is, in the blood treatment filter 1A, not only the number and the entire area of the nonwoven fabric constituting the filter material 5 according to the target blood to be filtered, the use conditions, and the required performance, but also the filtration area on the primary filtration side and the secondary filtration side
- the area ratio with the filtration area can be arbitrarily optimized.
- the surface area of the filter material 5 exposed in the inlet space S1 is larger than the surface area of the region communicating with the outlet space S2 among the surface areas of the filter material 5 exposed in the intermediate space S3. ing. Therefore, the primary filtration function can be improved and secondary filtration can be performed effectively.
- the frame sheet or the like may be sealed and integrated with the filter material 5.
- FIG. 4 is a plan view of a blood processing filter according to the second embodiment of the present invention
- FIG. 5 is a cross-sectional view taken along the line VV of FIG.
- the blood processing filter 1B according to the second embodiment includes substantially the same elements and structures as the blood processing filter 1A according to the first embodiment, and therefore the same elements and structures are denoted by the same reference numerals. Therefore, detailed description is omitted, and in the following description, different elements and structures will be mainly described.
- the blood treatment filter 1B includes a flexible container 2B having a blood inlet port 3B and an outlet port 4B, and a sheet-like filter material 5 accommodated in the flexible container 2B.
- the flexible container 2B includes a rectangular sheet-shaped first container forming portion 9B and a rectangular sheet-shaped second container forming portion 11B.
- the first container forming part 9B and the second container forming part 11B overlap with each other via the rectangular filter material 5, and the peripheral edges are in close contact with each other and sealed in a band shape.
- the blood processing filter 1B seals the flexible container 2B and the filter material 5, and the inside of the flexible container 2B includes a plurality of internal spaces S4, S5, S6 including an inlet space S4 and an outlet space S5.
- a seal part 21 and a partition part 23 are provided.
- the inlet space S4 is an internal space communicating with the inlet flow path 3a of the inlet port 3B
- the outlet space S5 is an internal space communicating with the outlet flow path 4a of the outlet port 4B.
- the inlet space S4 and the outlet space S5 are formed on the side (one side) facing the first container forming portion 9B of the filter material 5, and the intermediate space S6 that is the third internal space is the second space of the filter material 5. It is formed on the side facing the container forming part 11B (the other side).
- the first container forming part 9B and the second container forming part 11B are sealed in a band shape with the filter material 5 sandwiched along the periphery of the filter material 5.
- a bonded portion sealed in a rectangular ring shape along the periphery of the filter material 5 is a seal portion 21.
- first container forming part 9B and the filter material 5 are sealed in a strip shape so that the effective filtration part 5a formed by the seal part 21 is divided into two parts.
- the adhesion part sealed so as to partition the effective filtration part 5 a is a partition part 23.
- the seal part 21 and the partition part 23 form two internal spaces S4 and S5 on one side of the filter material 5 in cooperation with each part of the effective filtration part 5a of the filter material 5, A smaller number of internal spaces S6 are formed on the other side of the filter material 5 than on the one side.
- an inlet space S4 and an outlet space S5 are formed between the filter material 5 and the first container forming portion 9B, and an intermediate space is formed between the second container forming portion 11B and the filter material 5.
- a space S6 is formed.
- the intermediate space S6 exists without being partitioned by the partition portion 23, and is provided so as to be able to communicate with both the inlet space S4 and the outlet space S5 via the filter material 5.
- the surface area of the filter material 5 exposed in the inlet space S4 is larger than the surface area of the region communicating with the outlet space S5 in the surface area of the filter material 5 exposed in the intermediate space S6.
- the seal part 21 and the partition part 23 form a path that passes through the internal spaces S4, S5, and S6 and passes through the filter material 5 a plurality of times as the blood path RB.
- the seal part 21 and the partition part 23 serve as the blood path RB, the forward path Rc passing through the filter material 5 from the inlet space S4 toward the intermediate space S6, and the filter material 5 from the intermediate space S6 toward the outlet space S5.
- the blood path RB is a path that alternately passes through the internal spaces S4 and S5 formed on one side of the filter material 5 and the internal space S6 formed on the other side of the filter material 5.
- the flexible container 2B of the blood processing filter 1B described above can be formed of substantially the same material as the flexible container 2A of the blood processing filter 1A according to the first embodiment.
- the blood processing filter 1B can also be used in the blood processing system 100 instead of the blood processing filter 1A.
- this blood treatment filter 1B a path that passes through the plurality of internal spaces S4, S5, and S6 and passes through the filter material 5 a plurality of times is formed as a blood path RB from the inlet channel 3a to the outlet channel 4a. Is done.
- this blood treatment filter 1B even if the filter material 5 is thin, blood passes through the filter material 5 a plurality of times.
- the removal performance of white blood cells or the like equivalent to that when the filter material 5 is thick can be expected. . That is, by dividing the effective filtration part 5a of the filter material 5, the same effect as that obtained when a thick filter material is used can be obtained, and it is effective in reducing the material as the filter material 5. The removal performance can be maintained.
- the same effect as that of a difficult-to-assemble aspect when using a small and thick filter material can be obtained even though the thin filter material 5 is used. Therefore, the welding load when sealing the filter material 5 is reduced, which is advantageous from the viewpoint of the work load when assembling, and it is possible to obtain benefits in terms of ease of assembly and ease of sealing.
- FIG. 6 is a plan view of a blood treatment filter according to a third embodiment of the present invention
- FIG. 7 is a cross-sectional view taken along line VII-VII in FIG.
- the blood processing filter 1C according to the third embodiment includes substantially the same elements and structures as the blood processing filter 1A according to the first embodiment and the blood processing filter 1B according to the second embodiment.
- the same reference numerals are assigned to the elements and structures, and detailed description thereof is omitted. In the following description, different elements and structures will be mainly described.
- the blood treatment filter 1C includes a flexible container 2C having a blood inlet port 3C and an outlet port 4C, and a sheet-like filter material 5 accommodated in the flexible container 2C.
- the flexible container 2C includes a rectangular sheet-shaped first container forming portion 9C and a rectangular sheet-shaped second container forming portion 11C.
- the first container forming portion 9C and the second container forming portion 11C overlap with each other via the rectangular filter material 5, and the peripheral edges are in close contact with each other and sealed in a band shape.
- the outlet port 4C is provided not in the first container forming part 9C but in the second container forming part 11C.
- the blood processing filter 1C seals the flexible container 2C and the filter material 5, and the inside of the flexible container 2C includes a plurality of internal spaces S7, S8, S9 including an inlet space S7 and an outlet space S10. , S10, a separator 27, a separator 28, and a separator 29 are provided.
- the inlet space S7 is an internal space that communicates with the inlet flow path 3a of the inlet port 3C
- the outlet space S10 is an internal space that communicates with the outlet flow path 4a of the outlet port 4C.
- the inlet space S7 and the inner space S8 are formed on the side (one side) facing the first container forming portion 9C of the filter material 5, and the inner space S9 and the outlet space S10 are the second container forming of the filter material 5. It is formed on the side facing the portion 11C (the other side).
- the first container forming portion 9C and the second container forming portion 11C are sealed in a band shape with the filter material 5 sandwiched along the periphery of the filter material 5.
- a bonded portion sealed in an annular shape along the periphery of the filter material 5 is a seal portion 27.
- first container forming portion 9C and the filter material 5 are sealed in a band shape so as to partition the upper region of the effective filtration portion 5a surrounded by the seal portion 27.
- a bonding portion where the first container forming portion 9C and the filter material 5 are sealed so as to divide the region above the effective filtration portion 5a is a separation portion 28.
- the filter material 5 and the second container forming portion 11C are sealed in a band shape so as to partition the lower region of the effective filtration portion 5a surrounded by the seal portion 27.
- the adhesion part where the filter material 5 and the second container forming part 11C are sealed so as to partition the region below the effective filtration part 5a is a partition part 29.
- the seal part 27 and the partition part 28 form two internal spaces S7 and S8 on one side of the filter material 5 in cooperation with each part of the effective filtration part 5a of the filter material 5. Yes. Further, the seal part 27 and the partition part 29 form the same number of internal spaces S9 and S10 as the one side on the other side of the filter material 5. Specifically, an inlet space S7 and an intermediate space S8 are formed between the filter material 5 and the first container forming portion 9C, and an intermediate space is formed between the filter material 5 and the second container forming portion 11C. A space S9 and an exit space S10 are formed.
- the intermediate space S9 is formed so as to straddle the partition portion 28, and is provided so as to be able to communicate with the inlet space S7 and the intermediate space S8 via the filter material 5. Further, the intermediate space S8 is formed so as to straddle the partition portion 29, and is provided so as to be able to communicate with the intermediate space S9 and the outlet space S10 via the filter material 5.
- the seal part 27, the partition part 28, and the partition part 29 form a path that passes through the internal spaces S7, S8, S9, and S10 and the filter material 5 a plurality of times as the blood path RC.
- the delimiter 30 serves as the blood path RC
- the first forward path Re that passes through the filter material 5 from the inlet space S7 toward the intermediate space S9, and the intermediate space S9 toward the intermediate space S8.
- a return path Rf passing through the filter material 5 and a second forward path Rg passing through the filter material 5 from the intermediate space S8 toward the exit space S10 are formed.
- the blood path RC is a path that alternately passes through the internal spaces S7 and S8 formed on one side of the filter material 5 and the internal spaces S9 and S10 formed on the other side of the filter material 5. .
- the flexible container 2C of the blood processing filter 1C described above can be formed of substantially the same material as the flexible container 2A of the blood processing filter 1A according to the first embodiment.
- the blood processing filter 1C can also be used in the blood processing system 100 instead of the blood processing filter 1A.
- this blood processing filter 1C As a blood path RC from the inlet channel 3a to the outlet channel 4a, a path that passes through the filter material 5 a plurality of times while passing through the plurality of internal spaces S7, S8, S9, and S10. Is formed. According to this blood processing filter 1C, even if the filter material 5 is thin, blood passes through the filter material 5 a plurality of times. As a result, the removal performance of white blood cells or the like equivalent to that when the filter material 5 is thick can be expected. . That is, by dividing the effective filtration part 5a of the filter material 5, the same effect as that obtained when a thick filter material is used can be obtained, and it is effective in reducing the material as the filter material 5. The removal performance can be maintained.
- the same effect as that of a difficult-to-assemble aspect when using a small and thick filter material can be obtained even though the thin filter material 5 is used. Therefore, the welding load when sealing the filter material 5 is reduced, which is advantageous from the viewpoint of the work load when assembling, and it is possible to obtain benefits in terms of ease of assembly and ease of sealing.
- FIG. 8 is a plan view of a blood treatment filter according to a fourth embodiment of the present invention
- FIG. 9 is a cross-sectional view taken along line IX-IX in FIG.
- the blood processing filter 1D according to the fourth embodiment includes substantially the same elements and structures as the blood processing filter 1A according to the first embodiment, and therefore the same elements and structures are denoted by the same reference numerals. Therefore, detailed description is omitted, and in the following description, different elements and structures will be mainly described.
- the blood treatment filter 1D includes a flexible container 2D having a blood inlet port 3D and an outlet port 4D, and a sheet-like filter material 5 accommodated in the flexible container 2D.
- the flexible container 2D includes a rectangular sheet-shaped first container forming section 9D and a rectangular sheet-shaped second container forming section 11D.
- the first container forming portion 9D and the second container forming portion 11D are sealed in a belt shape with their peripheral edges in close contact with each other.
- the blood processing filter 1D seals the flexible container 2D and the filter material 5, and the inside of the flexible container 2D includes a plurality of internal spaces S11, S12, S13 including an inlet space S11 and an outlet space S12.
- a seal part 55 and a partition part 52 are provided.
- the inlet space S11 is an internal space that communicates with the inlet flow path 3a of the inlet port 3D
- the outlet space S12 is an internal space that communicates with the outlet flow path 4a of the outlet port 4D.
- the inlet space S11 and the outlet space S12 are formed on the side (one side) facing the first container forming portion 9D of the filter material 5, and the intermediate space S13 that is the third internal space is the second space of the filter material 5. It is formed on the side facing the container forming part 11D (the other side).
- the first container forming part 9D and the filter material 5 are sealed in a band shape along the periphery of the filter material 5.
- a bonded portion sealed in a rectangular ring shape along the periphery of the filter material 5 is a seal portion 55.
- An effective filtering portion 5 a of the filter material 5 is formed by the seal portion 55.
- first container forming portion 9D and the filter material 5 are sealed in a circular ring shape and in a belt shape inside the area surrounded by the seal portion 55.
- the bonding portion sealed in an annular shape inside the seal portion 55 is the partition portion 52.
- the seal part 55 and the partition part 52 form two internal spaces S11 and S12 on one side of the filter material 5 in cooperation with each part of the effective filtration part 5a of the filter material 5, A smaller number of internal spaces S13 are formed on the other side of the filter material 5 than on one side.
- an inlet space S11 and an outlet space S12 are formed between the filter material 5 and the first container forming portion 9D, and an intermediate space is formed between the filter material 5 and the second container forming portion 11D.
- a space S13 is formed.
- the intermediate space S13 exists without being partitioned by the partition portion 52, and is provided so as to be able to communicate with both the inlet space S11 and the outlet space S12 via the filter material 5.
- the surface area of the filter material 5 exposed in the inlet space S11 is larger than the surface area of the region communicating with the outlet space S12 in the surface area of the filter material 5 exposed in the intermediate space S13.
- the filter material 5 is not bonded to the second container forming portion 11D, and the seal material 55 is provided on the side (the other side) facing the second container forming portion 11D of the filter material 5.
- a rectangular annular recess is formed corresponding to the partitioning portion 52.
- the dent is formed by compressing the filter material 5 in close contact with the first container forming portion 9D and bonding the filter material 5 in that state. This dent is a trough provided on the other side of the filter material 5.
- the inlet port 3D and the outlet port 4D are sealed in the first container forming part 9D.
- the inlet port 3D is formed with an inlet channel 3a that communicates with the inside of the flexible container 2D and serves as an inlet.
- the outlet port 4D communicates with the interior of the flexible container 2D and serves as an outlet.
- An outlet channel 4a is formed.
- the seal part 55 and the partition part 52 form a path that passes through the internal spaces S11, S12, and S13 and passes through the filter material 5 a plurality of times as the blood path RD.
- the partitioning portion 52 is configured as the blood path RD, the forward path Rh passing through the filter material 5 from the inlet space S11 toward the intermediate space S13, and the filter material from the intermediate space S13 toward the outlet space S12. And a return path Rj passing through 5.
- the blood path RD is a path that alternately passes through the internal spaces S11 and S12 formed on one side of the filter material 5 and the internal space S13 formed on the other side of the filter material 5.
- the first container forming portion 9D and the filter material 5 in which the inlet port 3D and the outlet port 4D are sealed at predetermined positions are prepared, and the first container forming portion 9D and the filter material 5 are predetermined.
- the installation process which arranges in a position is performed.
- the first container forming part 9D and the filter material 5 are sealed in a band shape so as to surround the site where the outlet port 4D is formed, and the separator 52 is formed on the periphery of the filter material 5
- the first container forming portion 9D and the second sealing step of sealing the filter material 5 so as to form the rectangular annular seal portion 55 so as to surround the partition portion 52 are performed.
- the formation of the separation part 52 in the first sealing step that is, the sealing of the first container forming part 9D and the filter material 5 can be performed using high-frequency welding, but is not limited thereto.
- Various bonding techniques such as sonic welding and heat welding can be used.
- the sealing for forming the seal portion 55 in the second sealing step can be performed using high-frequency welding, but is not limited to this, and various types such as ultrasonic welding and thermal welding are used. Adhesion techniques can be used. Note that the order of the first sealing step and the second sealing step may be reversed.
- a third sealing step is performed in which the first container forming portion 9D and the second container forming portion 11D are overlapped with the filter material 5 interposed therebetween, and the peripheral edges are closely contacted and sealed in a band shape.
- the sealing between the first container forming portion 9D and the second container forming portion 11D can be performed using high frequency welding, but is not limited to this, and various bonding techniques such as ultrasonic welding and thermal welding. Can be used.
- the inlet port 3D and the outlet port 4D have been described in the form of being sealed in advance in the flexible container 2D. Or you may go in the middle of them. Further, in order to seal the inlet port 3D and the outlet port 4D to the flexible container 2D, not only high frequency welding but also any bonding technique such as heat welding can be used. As materials for the inlet port 3D and the outlet port 4D, various conventionally known materials can be used as in the flexible container 2D.
- the flexible container 2D of the blood processing filter 1D described above can be formed of substantially the same material as the flexible container 2A of the blood processing filter 1A according to the first embodiment. Further, the blood processing filter 1D can be used in the blood processing system 100 instead of the blood processing filter 1A.
- a path that passes through the plurality of internal spaces S11, S12, and S13 and passes through the filter material 5 a plurality of times is formed as a blood path RD from the inlet channel 3a to the outlet channel 4a.
- the According to this blood processing filter 1D even if the filter material 5 is thin, blood passes through the filter material 5 a plurality of times. As a result, the removal performance of white blood cells or the like equivalent to that when the filter material 5 is thick can be expected. . That is, by dividing the effective filtration part 5a of the filter material 5, the same effect as that obtained when a thick filter material is used can be obtained, and it is effective in reducing the material as the filter material 5. The removal performance can be maintained.
- the same effect as that of a difficult to assemble mode using a small and thick filter material can be obtained despite the use of the thin filter material 5. Therefore, the welding load when sealing the filter material 5 is reduced, which is advantageous from the viewpoint of the work load when assembling, and it is possible to obtain benefits in terms of ease of assembly and ease of sealing.
- the first filtration when blood passes through the filter material 5 in the forward path Rh of the blood path RD, and the blood passes through the filter material 5 in the return path Rj of the blood path RD.
- the second filtration (secondary filtration) is performed.
- the primary filtration mainly removes aggregates and the like, and the secondary filtration filters only blood after removal of aggregates and the like.
- the primary filtration there is a loss such as inflow of aggregates, so a certain area is required.
- the secondary filtration since the blood has been filtered once, there is no aggregate and the white blood cells are reduced. An area smaller than the filtration area on the side is sufficient.
- the area ratio of the filtration area of the primary filtration side and the filtration area of the secondary filtration side can be made into arbitrary area ratios, it is easy to optimize. That is, in the blood treatment filter 1D, not only the number and the entire area of the nonwoven fabric constituting the filter material according to the target blood to be filtered, the use conditions, and the required performance, but also the filtration area on the primary filtration side and the filtration on the secondary filtration side The area ratio with the area can be arbitrarily optimized.
- the frame sheet or the like may be sealed and integrated with the filter material 5.
- a flow path securing sheet in which a flow path hole is formed on the other side of the filter material 5 is disposed so as to overlap the effective filtration portion 5a, and this flow path securing sheet is sealed to the filter material 5 by, for example, a seal portion 55. May be integrated.
- the flow path securing sheet By arranging the flow path securing sheet, there is a gap between the filter material 5 and the second container forming portion 11D in the intermediate space S13, and even if a negative pressure is generated in the intermediate space S13 during the filtration process, 2nd container formation part 11D becomes difficult to adhere. As a result, it becomes easy to perform homogeneous filtration.
- a similar flow path securing sheet can be disposed in the exit space S12. In this case, the filter material 5 and the first container forming portion 9D are prevented from being in close contact with each other, and uniform filtration is facilitated.
- 1A, 1B, 1C, 1D ... blood processing filter 2A, 2B, 2C, 2D ... flexible container, 5 ... filter material, 6, 21, 27, 55 ... seal part, 7, 23, 28, 29, 30 , 52 ... Separator, S1, S4, S7, S11 ... Inlet space, S2, S5, S10, S12 ... Outlet space, RA, RB, RC, RD ... Blood pathway, 9A, 9B, 9C, 9D ... First container Formation part, 11A, 11B, 11C, 11D ... 2nd container formation part.
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Abstract
Description
Claims (6)
- 血液の入口と出口とを有する可撓性容器と、前記可撓性容器の内部に収容されたシート状のフィルター材と、を備えた血液処理フィルターであって、
前記可撓性容器と前記フィルター材とをシールして、前記フィルター材の有効濾過部を形成するシール部と、
前記可撓性容器と前記フィルター材とをシールして、前記有効濾過部を複数の部位に区切る区切り部と、を備え、
前記シール部と前記区切り部とは、前記フィルター材との協働によって前記可撓性容器の内部を前記入口に連通する入口空間、及び前記出口に連通する出口空間を含む三以上の内部空間に区画すると共に、血液経路として、三以上の前記内部空間をそれぞれ通過し、且つ前記フィルター材を複数回通過する経路を形成することを特徴とする血液処理フィルター。 - 前記可撓性容器は、第1容器形成部と、前記フィルター材を挟んで前記第1容器形成部に重なり、且つ前記第1容器形成部にシールされた第2容器形成部と、を有し、
前記シール部と前記区切り部とは、前記フィルター材の一方側に複数の前記内部空間を形成し、前記フィルター材の他方側に単数または複数の前記内部空間を形成すると共に、前記血液経路として、前記フィルター材の一方側に形成された前記内部空間と、前記フィルター材の他方側に形成された前記内部空間とを交互に通過し、且つ前記フィルター材を複数回通過する経路を形成することを特徴とする請求項1記載の血液処理フィルター。 - 前記シール部と前記区切り部とは、前記フィルター材の一方側に前記入口空間、及び前記出口空間を含む複数の前記内部空間を形成し、前記フィルター材の他方側に、前記フィルター材の一方側よりも一つ少ない数の前記内部空間を形成することを特徴とする請求項2記載の血液処理フィルター。
- 前記シール部と前記区切り部とは、前記フィルター材の一方側に前記入口空間を含む複数の前記内部空間を形成し、前記フィルター材の他方側に、前記出口空間を含む前記フィルター材の一方側と同数の数の前記内部空間を形成することを特徴とする請求項2記載の血液処理フィルター。
- 前記シール部と前記区切り部とは、前記フィルター材の一方側に、前記入口空間と前記出口空間とを形成し、前記フィルター材の他方側に、前記フィルター材を介して前記入口空間と前記出口空間との両方に連通可能な中間空間を形成すると共に、前記血液経路として、前記入口空間、前記中間空間、及び前記出口空間を通過し、且つ、前記フィルター材を複数回通過する経路を形成することを特徴とする請求項2記載の血液処理フィルター。
- 前記入口空間内に露出した前記フィルター材の表面積は、前記中間空間内に露出した前記フィルター材の表面積のうち、前記出口空間に連通する領域の表面積よりも大きいことを特徴とする請求項5記載の血液処理フィルター。
Priority Applications (4)
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JP2012550890A JP5661804B2 (ja) | 2010-12-27 | 2011-12-21 | 血液処理フィルター |
EP11853910.5A EP2659917B1 (en) | 2010-12-27 | 2011-12-21 | Blood processing filter |
KR1020137014392A KR101501047B1 (ko) | 2010-12-27 | 2011-12-21 | 혈액 처리 필터 |
CN201180063154.XA CN103313738B (zh) | 2010-12-27 | 2011-12-21 | 血液处理过滤器 |
Applications Claiming Priority (2)
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US201061427313P | 2010-12-27 | 2010-12-27 | |
US61/427313 | 2010-12-27 |
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WO2012090834A1 true WO2012090834A1 (ja) | 2012-07-05 |
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PCT/JP2011/079705 WO2012090834A1 (ja) | 2010-12-27 | 2011-12-21 | 血液処理フィルター |
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US (1) | US8857627B2 (ja) |
EP (1) | EP2659917B1 (ja) |
JP (1) | JP5661804B2 (ja) |
KR (1) | KR101501047B1 (ja) |
CN (1) | CN103313738B (ja) |
WO (1) | WO2012090834A1 (ja) |
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JPWO2018030119A1 (ja) * | 2016-08-10 | 2019-06-20 | 川澄化学工業株式会社 | 血液処理器 |
JP7036727B2 (ja) | 2016-08-10 | 2022-03-15 | Sbカワスミ株式会社 | 血液処理器 |
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JP5661804B2 (ja) | 2015-01-28 |
CN103313738B (zh) | 2016-11-09 |
CN103313738A (zh) | 2013-09-18 |
JPWO2012090834A1 (ja) | 2014-06-05 |
KR101501047B1 (ko) | 2015-03-11 |
EP2659917B1 (en) | 2016-05-04 |
EP2659917A4 (en) | 2015-08-05 |
US8857627B2 (en) | 2014-10-14 |
US20120160763A1 (en) | 2012-06-28 |
EP2659917A1 (en) | 2013-11-06 |
KR20130086624A (ko) | 2013-08-02 |
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