FILTER ASSEMBLY AND CONTAINER FOR COLLECTING BLOOD CONTAINING THE SAME

Abstract

A filter assembly comprising a prefiltering support layer (84) is disclosed, wherein the prefiltering support layer (84) comprises a non-woven fabric of fibers, the non-woven fabric having a pore size. A first mesh filter layer (85) is arranged downstream the prefiltering support layer (84), wherein the first mesh filter layer (85) has a first mesh size, wherein the pore size of the prefiltering support layer (84) is equal to or bigger than the first mesh size of the first mesh filter layer (85). A container for collecting a body fluid comprising such a filter assembly as well as a method for manufacturing such a filter assembly are also disclosed.

Claims

1. Filter assembly comprising a prefiltering support layer (84) and a first mesh filter layer (85) arranged downstream the prefiltering support layer (84), wherein the prefiltering support layer (84) comprises a non-woven fabric of fibers, the non-woven fabric having a pore size, wherein the first mesh filter layer (85) has a first mesh size, wherein the pore size of the prefiltering support layer (84) is equal to or bigger than the first mesh size of the first mesh filter (85), characterized in that the filter assembly (6) comprises a filter holder (7) arranged downstream the first mesh filter layer (85), wherein the filter holder (7) contacts and stabilizes both the prefiltering support layer (84) and the first mesh filter layer (85).

2. Filter assembly according to claim 1, characterized in that the filter holder is made from plastic and is overmolded over a part of the prefiltering support layer (84) and a part of the first mesh filter layer (85).

3. Filter assembly according to claim 1, characterized in that the filter assembly (6) comprises a second mesh filter layer (86) arranged upstream the prefiltering support layer (84), wherein the second mesh filter layer (86) has a second mesh size, wherein the second mesh size of the second mesh filter layer (86) is equal to or bigger than the pore size of the prefiltering support layer (84).

4. Filter assembly according to claim 1, characterized in that the prefiltering support layer (84) comprises a spunbond nonwoven fabric.

5. Filter assembly according to claim 1, characterized in that at least a part of the fibers of prefiltering support layer (84) each comprise at least one groove extending in the longitudinal direction of the respective fiber.

6. Filter assembly according to claim 1, characterized in that at least a part of the fibers have a lobate cross-section, in particular a trilobal cross-section.

7. Filter assembly according to claim 1, characterized in that the prefiltering support layer (84), first mesh filter layer (85) and second mesh filter layer (86) have at least two, preferably at least three areas of different pore or mesh sizes with different filtration capacities.

8. Filter assembly according to claim 1, characterized in that the prefiltering support layer (84), the first mesh filter layer (85) and optionally a second mesh filter layer (86) extend over a vertical extension direction and over a horizontal extension direction, wherein the vertical extension direction is vertically aligned during normal operation of the filter assembly and the horizontal extension direction is horizontally aligned during normal operation of the filter assembly, wherein at least one of the non-woven fabric of the prefiltering support layer (84), the first mesh filter layer (85) and the second mesh filter layer (86) has a first area (87) in a first height of the vertical extension direction and a second area (88) in a second height of the vertical extension direction, wherein the first area (87) and the second area (88) have different mesh sizes and exhibit different filtration capacities.

9. Filter assembly according to claim 8, characterized in that the first area (87) and/or the second area (88) extend along the whole horizontal extension direction.

10. Filter assembly according to, claim 1 characterized in that the filter assembly is free of anti-foam agents.

11. Filter assembly according to claim 1 for filtering a body fluid in vitro.

12. Filter assembly according to claim 11 wherein the body fluid is blood.

13. Method for manufacturing a filter assembly according to claim 1, the filter assembly (6) comprising a filter holder (7), a first mesh filter layer (85) and a prefiltering support layer (84), wherein the prefiltering support layer (84) comprises a non-woven fabric of fibers, the non-woven fabric having a first mesh size, wherein the filter holder (7) is arranged downstream the first mesh filter layer (85), wherein the first mesh filter layer (85) is arranged downstream the prefiltering and support layer (84), wherein the first mesh filter layer (85) has a second mesh size, wherein the first mesh size is equal to or bigger than the second mesh size, characterized in that the filter holder (7) is overmolded over a part of the prefiltering support layer (84) and a part of the first mesh filter layer (85) so that it contacts and stabilizes both the prefiltering support layer (84) and the first mesh filter layer (85).

14. Method according to claim 13, characterized in that the first mesh filter layer (85) and the prefiltering support layer (84) are manufactured in form of flat ribbon (80) which is then brought into the desired shape of the filter assembly (6), wherein the desired shaped is fixed by partially overmolding the prefiltering support layer (84) and the first mesh filter layer (85) with the filter holder (7).

15. Container for collecting a body fluid, comprising a container housing (2) with a body fluid inlet (4) though which body fluid can enter an inlet section (5) of the container housing (2), a body fluid collection section (9), a vacuum connector (10) for connecting a vacuum source to the container housing (2) for applying a low pressure to the inlet section (5) and the body fluid collection section (9), and a filter module (6) being arranged between the inlet section (5) and the body fluid collection section (9), wherein the filter module (6) has a raw side and a clean side, wherein the raw side faces the inlet section (5) and the clean side faces the body fluid collection section (9), characterized in that the filter module (6) is a filter assembly according to claim 1.

16. Container for collecting a body fluid according to claim 15, characterized in that the container housing (2) additionally comprises a hydrophobic filter (11) that is arranged between the body fluid collection section (9) and the vacuum connector (10) in flow direction of air drawn by a vacuum source from the body fluid collection section (9) during intended use of the container.

17. Container according to claim 15, characterized in that the filter holder (7) and a top cover (3) of the container housing (2) are integrally formed.

18. Container according to claim 15, characterized in that the filter holder (7) comprises bars that serve for stabilizing the mesh filter (8) that is arranged inside a space of the filter holder (7) that is surrounded by the bars.

19. Container according to claim 15, characterized in that an inlet area (15) of the filter assembly (6) is funnel-shaped.

20. Container according to claim 15, characterized in that a bottom (13) of the filter assembly (6) comprises an indention towards an interior space of the filter assembly (6).

21. Container according to claim 15, characterized in that the hydrophobic filter (11) is integrated into a top cover (3) of the container housing (2).

22. Container according to claim 15, characterized in that the hydrophobic filter (11) comprises a pleated filter material.

23. Container according to claim 22, characterized in that pleated filter material has a filter surface area that is at least three times as high as a surface area of a filter element housing the hydrophobic filter (11).

24. Method for manufacturing a container according to claim 15, characterized in that a top cover (3) of a container housing (2) of the container (1) and a filter holder (7) of the container (1) are co-molded so as to be produced as one piece.

Description

[0089] Further details of aspects of the present invention will be explained in the following with respect to exemplary embodiments and accompanying Figures. In the Figures:

[0090] FIG. 1 is a perspective view of an embodiment of a blood-collecting canister;

[0091] FIG. 2 is a side view onto the broad side of the canister of FIG. 1;

[0092] FIG. 3 is a detailed view of an upper part of the canister of FIG. 1 seen from the narrow side of the canister;

[0093] FIG. 4A is a schematic depiction of a manufacturing process of an embodiment of a filter assembly;

[0094] FIG. 4B is an enlarged detailed view of the area in FIG. 4A that is encircled and marked with the letters AA;

[0095] FIG. 5A is a partially cut depiction of another embodiment of a filter assembly;

[0096] FIG. 5B is an enlarged detailed view of the area FIG. 5A that is encircled and marked with the letter T;

[0097] FIG. 6 is a schematic depiction of the microstructure of a prefiltering support layer and an mesh filter layer of an embodiment a filter assembly; and

[0098] FIG. 7 is a schematic depiction of another embodiment of a filter assembly.

[0099] FIG. 1 is perspective view of a blood-collecting canister 1 that serves as container for collecting a body fluid. The blood-collecting canister 1 comprises a canister housing 2 having a top cover 3. Three different blood inlets 4 are arranged in the top cover 3. Typically, only one of these blood inlets 4 is used for connecting a blood suction line with the blood-collecting canister 1 in order to draw blood from a patient into the interior of the canister housing 2. The most right blood inlet 4 is designed as a ⅜ inch connection. The middle blood inlet 4 is designed as Luer inlet, wherein the most left blood inlet 4 is designed as suction line connector sized for accommodating typical blood suction lines.

[0100] Each of the blood inlets 4 is fluidly connected with a blood receiving section 5 that is arranged on an inner side of the top cover 3. This blood receiving section 5 is in fluid communication with an interior of a filter module 6 (serving as filter assembly) that comprises a skeletal structure 7 that serves as filter holder. Inside the skeletal structure 7, two layers of filter material 8 are arranged. The filter material 8 comprises a prefiltering support layer as well as a mesh filter layer made of a medical grade mesh. If blood enters through the blood inlet 4 into the receiving section 5 of the blood-collecting canister 1, it flows or it is drawn into the interior of the filter module 6. Afterwards, it passes the filter material 8 and reaches a blood collection section 9 of the canister housing 2.

[0101] The blood-collecting canister 1 comprises in the top section 3 of the canister housing 2 a vacuum connector 10 that is intended to be connected to a vacuum line and, via the vacuum line, with a vacuum pump that serves as vacuum source. Air or any other gases being present in the blood-collecting section 9 that are drawn through the vacuum connector 10 into a connected vacuum line need to pass a hydrophobic filter 11 that is arranged between the blood-collecting section 9 and the vacuum connector 10.

[0102] The blood-collecting canister 1 further comprises a safety valve 12 that limits the amount of negative pressure that can be achieved within the interior of the canister housing 2. Thus, the safety valve 12 serves for reducing the risk of the blood-collecting canister 1 to implode due to an undesired low negative pressure in the interior of the canister housing 2.

[0103] When seen from the outside, a bottom 13 of the filter module 6 has a concave shape, i.e., it comprises an indention towards the interior of the filter module 6.

[0104] Blood that has entered the canister housing 2 through the blood inlet 4 and has passed the filter material 8 collects in the blood-collecting section 9. It can then be drawn through a blood outlet 14 out of the blood-collecting canister 1 in order to be further processed and/or auto-transfused to the patient.

[0105] FIG. 2 shows the blood-collecting canister 1 from FIG. 1 in a side view onto the broad side of the blood-collecting canister 1. Thereby, the same numeral references for the same elements are used. Reference is made to the explanations given with respect to FIG. 1. In FIG. 2, a connection between the filter module 6 and the blood receiving section 5 of the canister housing 2 can be seen. It is apparent from FIG. 2 that blood can enter from the blood receiving section 5 only the interior of the filter module 6 and then needs to pass the filter material 8 in order to reach the blood-collecting section 9 of the canister housing 2. Thus, the filter module 6 separates the blood receiving section 5 from the blood-collecting section 9.

[0106] FIG. 3 shows a partially cut view from the narrow side onto the blood-collecting canister 1 of FIG. 1. Thereby, once again the same numeral references are used for the same elements. Reference is made once again to the explanations given above.

[0107] In the depiction of FIG. 3, a funnel-shaped inlet 15 is arranged in an inlet area of the filter element can be seen. Blood entering the filter module 6 from the blood receiving section 5 needs to pass needs to pass this funnel-shaped inlet 15. The funnel-shaped inlet 15 serves—together with the filter material 8 and the concavely shaped bottom 13 of the filter module 6 for a reduced foam formation in the blood that passes through the filter module 6. Such a reduced formation of foam leads to blood having better quality than foamed blood and to a higher collection yield due to a lower hemolysis rate.

[0108] can be furthermore seen in the depiction of FIG. 3 that the hydrophobic filter 11 comprises a pleated filter material. Due to this folding of the filter material, the effective filter surface area is significantly increased. To give an example, the filter material of the hydrophobic filter 11 has an overall filter surface area of approximately 60 cm.sup.2. Thereby, the hydrophobic filter itself takes only approximately 10 cm.sup.2 space in the top cover 3 of the canister housing 2. Thus, by folding the filter material, the effective filter surface area is made six times as big as the surface area needed by the hydrophobic filter element 11.

[0109] FIG. 4A shows an exemplary manufacturing process of a filter module 6 that can be used as filter module for the blood-collecting canister shown in FIG. 1. First, a flat ribbon 80 of a co-molded spunbond prefilter (serving as prefiltering support layer) and a mesh filter (serving as mesh filter layer) is provided. This flat ribbon 80 is shaped into the desired shape in subsequent manufacturing steps 100, 101, 102 and 103. Thereby, the flat ribbon 80 becomes shaped filter material 8 that has, in this embodiment, the shape of a cylinder jacket with an elliptical ground area. Thereby, free ends 81 and 82 of the ribbon that are not yet connected in manufacturing step 102 are connected to each other to form a connection line 83 in manufacturing step 103. The connection line 83 can be realized in form of seam like a welded seam or in form of a seamless joint, i.e., a non-welded joint.

[0110] Speaking generally, this filter material 8 can then be inserted into a skeletal structure 7 of the bare filter module 6 so as to form a complete filter module 6 including the filter material 8. However, in an embodiment, the skeletal structure 7 is overmolded over the shaped filter material, e.g., by injection molding. Thereby, it partly embeds the individual layers of the shaped filter material (in particular at their bottom portion that is oriented towards the elliptical ground area) and serves for connecting them tightly together. Thereby, the skeletal structure can also overmold a seamless joint between the free ends of the shaped filter material 8 to also serve for a tight connection of the shaped filter material 8 between its free ends (i.e., along a vertical extension direction that is vertically aligned during normal operation of the assembled filter module 6).

[0111] FIG. 4B shows an enlarged detailed view of the area of the ribbon 80 that is encircled and marked with the letters AA in step 101 of FIG. 4A. This enlarged view shows that the ribbon 80 is made up of a prefiltering support layer 84 and a mesh filter layer 85. The structure of these two layers 84, 85 is also schematically depicted in FIG. 4B. Whereas the prefiltering support layer 84 consists of non-woven fibers with a trilobal cross-section, the mesh filter layer 85 consists of a regularly formed medical grade mesh.

[0112] FIG. 5A shows another embodiment of the filter module 6 that can be used in connection with the blood-collecting canister shown in FIG. 1. For illustration purposes only, the filter material 8 of this embodiment of the filter module 6 is partially cut. The area that is encircled and marked with the letter T is depicted in an enlarged detailed view in FIG. 5B. In this detailed view, it can be seen that the filter material 8 comprises a prefiltering support layer 84 made up of non-woven fibers having a trilobal cross-section and a first mesh filter layer 85 that is arranged on the side of the prefiltering support layer 84 that faces the skeletal structure 7 of the filter module 6. Furthermore, the filter material 8 of this embodiment comprises a second mesh filter layer 86 that is arranged on the opposite side of the prefiltering support layer 84 than the first mesh filter layer 85. Thus, the prefiltering support layer 84 is encompassed between the first mesh filter layer 85 and the second mesh filter layer 86 and thus forms a sandwich-like structure together with the first mesh filter layer 85 and the second mesh filter layer 86.

[0113] FIG. 6 shows a depiction of the microstructure of the filter material 8 based on an electron microscopic picture of individual fibers that make up the prefiltering support layer 84. In contrast to a non-woven and typically unordered structure of the individual fibers making up the prefiltering support layer 84, the individual grid elements that make up the mesh filter layer 85 are highly ordered and are arranged horizontally and vertically so as to form an ordered grid. In doing so, a highly repetitive and reproducible structure of the mesh filter layer 85 results.

[0114] FIG. 7 shows another embodiment of a filter module 6 that can be used as filter module for the blood collection canister shown in FIG. 1. As the other embodiments of filter modules shown in the Figures discussed above, the filter module 6 of FIG. 7 comprises a skeletal structure 7 and a filter material 8. This filter material 8 comprises three zones of differing filtration capacity that are arranged one above another in a vertical extension direction of the filter module in which the filter module 6 is vertically aligned during normal operation. The lowest zone 87 has a mesh size of 40 μm so as to allow only particles having a size smaller than 40 μm to pass. An intermediate zone 88 has a mesh size of 80 μm and has a somewhat lower filtration capacity then the lowest zone 87 but and enables a higher volume to pass in the same time then the first zone 87. All three zones extend along the whole circumference of the filter module 6, i.e., along the whole circumference in a horizontal extension direction which is horizontally aligned during normal operation of the filter module 6.

[0115] The topmost zone 89 has a mesh size of 120 μm and allows an even higher blood flow through the filter material 8 than the intermediate zone 88 if the blood level in the filter material 8 is so high that blood can flow through the topmost zone 89. Thus, the filter material 8 has, in this embodiment, a vertical gradient of mesh size that efficiently prevents an overflow of the filter module 6 since it allows higher volumes of blood to pass the filter material 8 in dependence on the level or the amount of blood being present in the interior of the filter module 6. The topmost zone 89 can also be seen as a safety zone that allows proper functioning of the filter module 6 even in cases of a high blood inflow. As a side effect, the filtration effect is reduced in cases of such high blood inflow into the filter module 6, since the filtration capacity of the topmost zone 89 is significantly lower than the filtration capacity of the lowest zone 87.

[0116] The differing filtration capacities of the individual zones 87, 88 and 89 of the filter material 8 are achieved, in the embodiment of FIG. 7, by combining meshes having different mesh sizes onto one and the same prefiltering support layer. This significantly facilitates the manufacturing of the filter material 8 and does not necessitate an adjustment of the structure of the non-woven fibers making up the prefiltering support layer (which is not visible in the drawing of FIG. 7).