CN211885768U - Blood treatment filter - Google Patents
Blood treatment filter Download PDFInfo
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- CN211885768U CN211885768U CN202020245930.4U CN202020245930U CN211885768U CN 211885768 U CN211885768 U CN 211885768U CN 202020245930 U CN202020245930 U CN 202020245930U CN 211885768 U CN211885768 U CN 211885768U
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Abstract
The utility model relates to a blood treatment filter. The blood treatment filter comprises a flexible container and a filter element, wherein the flexible container clamps the filter element and is sealed, the filter element at least comprises an inlet side filtering layer, an intermediate filtering layer and an outlet side filtering layer which are arranged in a stacking mode, the inlet side filtering layer and the outlet side filtering layer are made of polyethylene terephthalate, the intermediate filtering layer is made of polybutylene terephthalate, and the flexible container and the filter element are fused and mixed to form a composite material layer. The utility model discloses a blood treatment filter can improve resistant centrifugation nature effectively.
Description
Technical Field
The utility model relates to a filter technical field especially relates to a blood treatment filter.
Background
Whole blood collected from a donor is used as a raw material for blood component preparations such as red blood cell preparations, platelet preparations, and plasma preparations. Whole blood includes undesirable components such as microaggregates and leukocytes that cause various transfusion side effects. Therefore, it is common to remove unwanted components after blood collection and before the blood component preparation is used.
Methods for removing undesirable components (e.g., leukocytes) from whole blood and blood component preparations include removal using fiber aggregates (e.g., nonwovens) and porous structures with continuous pores, which are simple to operate and relatively low in cost. Filtration methods using blood treatment filters comprising a filter medium have become popular.
Conventionally, a blood processing filter in which a rigid container such as polycarbonate is filled with a filter material made of nonwoven fabric or porous material has been widely used, but since the gas permeability of the container is low, the method of steam sterilization is widely used for sterilization of a blood collection and separation device, but it is difficult to use the method in the container. In addition, the closed system includes the following cases: in the latter case, the blood processing filter is required to be centrifugally separated together with the blood collection tube separation device. At this point, the rigid container may damage the bag or tube, or the rigid container itself may not withstand the stresses of centrifugation.
As a method for solving these problems, a flexible blood treatment filter using a material having the same or similar flexibility as that of a bag for a blood collection tube/separation set and excellent vapor permeability has been developed and used.
When a soft polyvinyl chloride sheet represented by a life buoy, a blood bag, a plastic bag, and the like and a melt of a non-porous material such as an olefin film are welded to each other, a pressure and a load are applied to a joint portion during use, and therefore, excellent peeling resistance and excellent centrifugation resistance have been required. As a technique for producing a melt that meets the requirements, welding techniques such as high-frequency welding and heat sealing have been widely used (for example, japanese patent laid-open No. 2007-253374A, WO03059611), but products having sufficient centrifugal force resistance and peel resistance have not been obtained at all times.
SUMMERY OF THE UTILITY MODEL
Based on the above-mentioned defect among the prior art, the utility model aims to provide a can improve its blood treatment filter of resistant centrifugation.
Therefore, the utility model provides the following technical scheme.
The utility model provides a blood treatment filter, which comprises a flexible container and a filter element,
the flexible container clamps the filter element and is sealed,
the filter element includes at least an inlet-side filter layer, an intermediate filter layer, and an outlet-side filter layer, which are disposed in layers, the inlet-side filter layer and the outlet-side filter layer being made of polyethylene terephthalate, the intermediate filter layer being made of polybutylene terephthalate,
the flexible container is melt mixed with the filter element to form a composite layer.
In at least one embodiment, the blood treatment filter includes a first seal portion formed in an annular band shape by welding the flexible container and the filter element.
In at least one embodiment, the blood treatment filter includes a second seal portion formed on an outer side thereof so as to surround the first seal portion, and is formed by welding the flexible container.
In at least one embodiment, the flexible container includes an inlet-side flexible container and an outlet-side flexible container, the inlet-side filtration layer, and the intermediate filtration layer melt-mix to form a first composite material layer.
In at least one embodiment, the flexible container includes an inlet-side flexible container and an outlet-side flexible container, and the intermediate filtration layer, the outlet-side filtration layer, and the outlet-side flexible container are melt-mixed to form a second composite layer.
In at least one embodiment, the fiber diameter or pore size of the filter element decreases stepwise or continuously from the portion of the filter element contacting the flexible container in the thickness direction of the filter element.
In at least one embodiment, the fiber diameter or pore size of the inlet-side filtration layer is greater than the fiber diameter or pore size of the intermediate filtration layer, and the fiber diameter or pore size of the outlet-side filtration layer is greater than the fiber diameter or pore size of the intermediate filtration layer.
In at least one embodiment, the flexible container is made of a flexible polyvinyl chloride, vinylidene chloride, nylon, or polyurethane material.
In at least one embodiment, the flexible container includes an inlet-side flexible container having a blood inlet formed thereon for introducing blood to be filtered and an outlet-side flexible container.
In at least one embodiment, the outlet-side flexible container is formed with a blood outlet for discharging blood filtered through the filter element.
Through adopting foretell technical scheme, the utility model provides a blood treatment filter, through making the filter element at least including the entrance side filter layer, middle filter layer and the exit side filter layer of range upon range of setting, filter element and flexible container melting mix and form the combined material layer, can improve blood treatment filter's resistant centrifugation nature effectively.
Drawings
Fig. 1 shows a schematic structural view of a blood treatment filter according to the present invention.
Fig. 2 shows a schematic diagram showing an effective filtration area when the resistance to centrifugation is evaluated.
Fig. 3 is a partially enlarged view of fig. 2 showing a corner portion of the effective filter area.
Description of the reference numerals
1 a flexible container; 11 inlet side flexible container; 111 a blood inlet; 12 an outlet side flexible container; 13 a first seal portion; 14 a second seal portion;
2 a filter element; 21 an inlet side filter layer; 22 an intermediate filter layer; 23 outlet side filter layer.
Detailed Description
Exemplary embodiments of the present invention are described below with reference to the accompanying drawings. It should be understood that the detailed description is only intended to teach one skilled in the art how to practice the invention, and is not intended to exhaust all possible ways of practicing the invention, nor is it intended to limit the scope of protection of the invention.
A blood treatment filter according to the present invention will be described in detail with reference to fig. 1.
In the present embodiment, as shown in fig. 1, the blood processing filter includes a flexible container 1 and a filter element 2. Wherein the flexible container 1 clamps the filter element 2 and is sealed.
In the present embodiment, as shown in fig. 1, the flexible container 1 includes an inlet-side flexible container 11 and an outlet-side flexible container 12. The inlet-side flexible container 11 and the outlet-side flexible container 12 sandwich the filter element 2.
The inlet-side flexible container 11 is formed with a blood inlet 111, and the blood inlet 111 is used to introduce blood to be filtered. The outlet-side flexible container 12 is formed with a blood outlet for discharging blood filtered by the filter element 2.
The inlet-side flexible container 11 and the outlet-side flexible container 12 are sealed by a first seal portion 13 and a second seal portion 14. The first seal portion 13 is formed into an annular band shape by welding the flexible container 1 and the filter element 2, and performs primary sealing of the blood treatment filter. The second seal portion 14 is formed outside the first seal portion 13 so as to surround the first seal portion 13, and is formed by welding the flexible container 1.
In the present embodiment, as shown in fig. 1, the filter element 2 includes an inlet-side filtration layer 21, an intermediate filtration layer 22, and an outlet-side filtration layer 23 that are disposed in layers. Of these, the inlet-side filter layer 21 and the outlet-side filter layer 23 are made of polyethylene terephthalate, and the intermediate filter layer 22 is made of polybutylene terephthalate.
In the present embodiment, the inlet-side flexible container 11, the inlet-side filter layer 21, and the intermediate filter layer 22 are melt-mixed to form a first composite material layer. The intermediate filtration layer 22, the outlet-side filtration layer 23, and the outlet-side flexible container 12 are melt-mixed to form a second composite material layer. In this way, the filter element 2 and the flexible container 1, which are arranged in a multilayer manner, are melt-mixed to form a composite material layer, the physical structure of the composite material layer is complicated, and even if there is no adhesion between the flexible container 1 and the filter element 2, the flexible container 1 and the filter element 2 are not easily peeled, that is, the peeling resistance and the centrifugation resistance of the whole blood treatment filter are improved.
In the present embodiment, the composite material layer may be formed by: after laminating the materials (the flexible container 1 and the filter element 2), they are sandwiched in a mold to be subjected to high-frequency welding, pressurized under a certain pressure, and then applied with high frequency. The flexible container 1 heated by the high-frequency wave is softened and melted, and enters the voids of the fibers of the inlet-side filtration layer 21 and the outlet-side filtration layer 23 under the action of an appropriate punching pressure (the inlet-side filtration layer 21 and the outlet-side filtration layer 23 should have an appropriate pore size to allow the melted flexible container 1 to enter). At this time, since the inlet-side filtration layer 21 and the outlet-side filtration layer 23 are not heated to a temperature at which the fibers melt and have a higher melting point than the flexible container 1, the fibers of the inlet-side filtration layer 21 and the outlet-side filtration layer 23 remain without melting, and the flexible container 1 melts in the voids and further melt-mixes with the inlet-side filtration layer 21 and the outlet-side filtration layer 23 to form a composite material layer. On the other hand, the temperature of the intermediate filtration layer 22 rises from the substantially central portion in the thickness direction, and the intermediate filtration layer 22 in the vicinity of the central portion reaches the melting point by high-frequency heating and starts melting earlier than before the flexible container 1 enters the intermediate filtration layer 22 from above and below, and then melts and diffuses until it meets the above-described composite material layer. Finally, after the high-frequency application is stopped, the composite material layer is completed by a cooling step. It will be appreciated that the welded article of the present application can be obtained by selecting the appropriate construction and materials of the filter element 1, and setting the appropriate welding conditions, and the appropriate pressing pressure.
In the present embodiment, the flexible container 1 may be exemplified by: a sheet-like or film-like molded article made of a thermoplastic elastomer such as a hydrogenated product of a soft polyvinyl chloride, vinylidene chloride, nylon, polyurethane, an ethylene-vinyl acetate copolymer, a styrene-butadiene-styrene copolymer, a styrene-isoprene copolymer or a hydrogenated product thereof, or a mixture of a thermoplastic elastomer and a softening agent such as polyolefin or ethyl acrylate. Among them, soft polyvinyl chloride, vinylidene chloride, nylon or polyurethane is a preferable material, and soft polyvinyl chloride is a preferable material.
In the present embodiment, the fiber diameter or pore size of each layer in the filter element 2 may be different. The fiber diameter or pore size of the filter element 2 gradually or continuously decreases from the portion of the filter element 2 in contact with the flexible container 1 in the thickness direction of the filter element 2. For example, the fiber diameter or pore size of the inlet-side filtration layer 21 may be larger than that of the intermediate filtration layer 22, and the fiber diameter or pore size of the outlet-side filtration layer 23 may be larger than that of the intermediate filtration layer 22.
The centrifugal resistance of the present invention is explained, and here, the centrifugal resistance means that, for the purpose of component separation, a centrifugal process is performed on a blood treatment filter of a flexible container using a centrifugal separator, and the present invention has centrifugal resistance, that is, a filter capable of withstanding the centrifugation. Specifically, the present invention is a flexible blood treatment filter that can prevent the occurrence of a crack in the first seal portion 13 and the occurrence of leakage of blood to the outside.
The following describes in detail the evaluation method of the centrifugal resistance.
The blood processing filter subjected to steam heat sterilization was stored in a centrifuge (manufactured by Hitachi Co., Ltd., model number: CR7N) together with a blood bag, and specifically, the blood processing filter in a state where the blood bag into which blood was introduced and the blood channel were connected was folded together with the blood bag and the blood channel and stored in one centrifuge cup of the centrifuge. Then, centrifugation was performed under the following conditions so that the weights of the opposing centrifuge cups were as equal as possible.
That is, the rotation speed (g · sec) was set to 5000g · sec, the time was set to 19 minutes, the acceleration time from 0 to 500rpm was set to 2 minutes, the deceleration time from 500 to 0rpm was set to 4 minutes, the temperature was set to 22 ℃, and the Actual running timer (Actual running timer) was set to be invalid, that is, the set time was measured immediately after the start of the centrifugation.
After the centrifugation, whether or not a crack was generated in the first seal portion was checked. Specifically, ink (a flag marking oil (dedicated to a sol stamp pad) of red color) was injected into the blood inlet 111 of the filter for the centrifugal test using a syringe in an amount of 1cm per blood treatment filter20.80ml of ink was injected into the effective filter area (described later), and after 1 hour of injection, it was confirmed whether or not the ink leaked into the first seal portion 13.
As schematically shown in fig. 2, the effective filter area is the product of the lengthwise and widthwise lengths minus the partial area of the four corners. Specifically, as shown in fig. 3 in an enlarged manner, since the corner portion of the corner is regarded as the effective filter area, the effective filter area in the present application, that is, the effective filter area (cm) is calculated based on the radius of the corner portion2) Is lengthwise x crosswise of the filter- {4 (radius of R part)2- ((radius of R part)2X pi). The effective filtration area is an area of the filter element actually used for blood filtration, and is an area inside the first seal portion. Therefore, the calculation formula of the effective filter area is not limited to this formula.
Thus, whether or not the desired anti-eccentricity property is obtained is evaluated based on whether or not the ink leaks into the first seal portion 13.
Through adopting above-mentioned technical scheme, according to the utility model discloses a blood treatment filter has following advantage at least:
the utility model discloses an among the blood treatment filter, through making filter element at least including the inlet side filter layer, middle filter layer and the outlet side filter layer of range upon range of setting, filter element and flexible container melt-mixing form the combined material layer, can improve blood treatment filter's resistance to peeling off and resistant centrifugation nature effectively.
The above embodiments of the present invention have been described in detail, but it should be added that:
(1) although it is described in the above embodiments that the filter element includes the inlet-side filter layer, the intermediate filter layer, and the outlet-side filter layer, the present invention is not limited thereto, and the filter element may include more filter layers.
(2) In the above embodiment, the first composite material layer and the second composite material layer do not necessarily exist at the same time, and the peeling resistance and the centrifugation resistance of the blood treatment filter can be improved by forming one of the two composite material layers. In addition, the first composite layer may be formed by melt-mixing only the inlet-side filter layer and the inlet-side flexible container, and the second composite layer may be formed by melt-mixing only the outlet-side filter layer and the outlet-side flexible container.
(3) Although it is described in the above embodiment that the fiber diameters or pore diameters of the respective layers in the filter element may be different, the present invention is not limited thereto, and the fiber diameters or pore diameters of the respective layers in the filter element may be the same.
Claims (10)
1. A blood treatment filter, characterized in that it comprises a flexible container (1) and a filter element (2),
the flexible container (1) clamps the filter element (2) and is sealed,
the filter element (2) comprises at least an inlet-side filter layer (21), an intermediate filter layer (22), and an outlet-side filter layer (23) that are arranged in layers, the inlet-side filter layer (21) and the outlet-side filter layer (23) being made of polyethylene terephthalate, the intermediate filter layer (22) being made of polybutylene terephthalate,
the flexible container (1) is melt mixed with the filter element (2) to form a composite layer.
2. A blood treatment filter according to claim 1, wherein the blood treatment filter comprises a first sealing portion (13), the first sealing portion (13) being formed into an annular band shape by welding the flexible container (1) and the filter element (2).
3. A blood treatment filter according to claim 2, wherein the blood treatment filter comprises a second sealing portion (14), the second sealing portion (14) being formed on the outside thereof in such a manner as to surround the first sealing portion (13), by welding the flexible container (1).
4. A blood treatment filter according to claim 1, wherein the flexible container (1) comprises an inlet side flexible container (11) and an outlet side flexible container (12), the inlet side flexible container (11), the inlet side filter layer (21) and the intermediate filter layer (22) being melt-mixed to form a first composite material layer.
5. A blood treatment filter according to claim 1, wherein the flexible container (1) comprises an inlet side flexible container (11) and an outlet side flexible container (12), the intermediate filter layer (22), the outlet side filter layer (23) and the outlet side flexible container (12) being melt-mixed to form a second composite material layer.
6. A blood treatment filter according to claim 1, wherein the fiber diameter or pore size of the filter element (2) decreases stepwise or continuously from a portion of the filter element (2) contacting the flexible container (1) in the thickness direction of the filter element (2).
7. A blood treatment filter according to claim 6, wherein the fiber diameter or pore size of the inlet-side filtration layer (21) is larger than that of the intermediate filtration layer (22), and the fiber diameter or pore size of the outlet-side filtration layer (23) is larger than that of the intermediate filtration layer (22).
8. A blood treatment filter according to claim 1, wherein the flexible container (1) is made of a soft polyvinyl chloride, vinylidene chloride, nylon or polyurethane material.
9. A blood treatment filter according to claim 1, wherein the flexible container (1) comprises an inlet side flexible container (11) and an outlet side flexible container (12), the inlet side flexible container (11) having a blood inlet (111) formed thereon, the blood inlet (111) being for introducing blood to be filtered.
10. A blood treatment filter according to claim 9, wherein the outlet side flexible container (12) is formed with a blood outlet for discharging blood filtered by the filter element (2).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202020245930.4U CN211885768U (en) | 2020-03-03 | 2020-03-03 | Blood treatment filter |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202020245930.4U CN211885768U (en) | 2020-03-03 | 2020-03-03 | Blood treatment filter |
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| Publication Number | Publication Date |
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| CN211885768U true CN211885768U (en) | 2020-11-10 |
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| CN202020245930.4U Active CN211885768U (en) | 2020-03-03 | 2020-03-03 | Blood treatment filter |
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- 2020-03-03 CN CN202020245930.4U patent/CN211885768U/en active Active
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