JP2010518962A - Large volume body fluid filtration device - Google Patents

Abstract

Disclosed is a body fluid filtering device, system, and method with a small hold-up amount for filtering body fluid.
A body fluid filtering device includes an inlet, a first outlet, a second outlet, a first fluid flow path defined between the inlet and the first outlet, and an inlet and a second outlet. A housing having a second fluid flow path defined therebetween, and a first body fluid filtration medium disposed between the inlet and the first outlet and across the first fluid flow path; A second bodily fluid filtration medium disposed between the inlet and the second outlet and disposed across the second fluid flow path. The housing does not have a partition that substantially isolates the first body fluid filtration medium and the second body fluid filtration medium from each other. A first flow restriction unit may be added downstream of the first body fluid filtration medium, and a second flow restriction unit may be added downstream of the second body fluid filtration medium.
[Selection] Figure 8

Description

  The present invention relates to the field of filtration, and more particularly to an improved body fluid filtration system with a low hold-up amount. The bodily fluid filtration system includes a double-sided bodily fluid filter device that can filter bodily fluids and has a small hold-up amount and no partition wall. Filtration of bodily fluids includes the separation of certain components or chemicals from blood or blood products, including the separation of white blood cells from concentrated red blood cells and the separation of prions from blood or blood products.

  Patent Document 1 discloses a double-sided body fluid filtration device having a partition and having one inlet and one outlet. A double-sided body fluid filtration device having a partition is also disclosed in Patent Document 2. A double-sided body fluid filtration device having a partition is also disclosed in Patent Document 3. The double-sided body fluid filtration device disclosed in Patent Document 2 and Patent Document 3 includes two independent fluid flow paths separated by one partition, and each fluid flow path has a separate inlet and outlet. Thus, it is possible to separately filter two units of body fluid containing blood or blood products.

  Patent Document 4 discloses a double-sided body fluid filtering device without a partition, which includes one inlet, one outlet, and two fluid flow paths between the inlet and the outlet. The disadvantage of this type of device is that if two units of blood or blood products are filtered through this device and collected in two separate blood receiving bags, the first unit is a relatively This means that the second unit will be filtered by the relatively clogged filter element provided in the apparatus. For this reason, the flow rate of the first unit passing through the device is faster than the flow rate of the second unit. Therefore, the filtration efficiency may be different between the first unit and the second unit. Thus, when the device is used to remove leukocytes, the leukocyte removal rate may be different between the first unit and the second unit.

  Accordingly, the object of the present invention is to provide a single inlet that simultaneously filters two units of body fluid containing blood or blood products at approximately the same flow rate and operates automatically to minimize hold-up. It is to provide a bodily fluid filtration system including a bodily fluid filtration device without two septums with two outlets. Another object of the present invention is to provide a single vent filtration device that can vent the two fluid flow paths of a body fluid filtration device that includes two independent fluid flow paths. It is a further object of the present invention to provide means for limiting the flow rate through the bodily fluid filtration device by providing a flow restricting portion downstream of the bodily fluid filtration medium of the bodily fluid filtration device.

  (Definition)

  As used herein, the term “double-sided body fluid filtration device (hereinafter referred to as BFFD)” includes a housing including one inlet and two outlets, and a first of the inlet and the two outlets. A first fluid flow path defined between the outlet; a second fluid flow path defined between the inlet and a second outlet of the two outlets; the inlet and the first A first bodily fluid filtration medium disposed between the outlet and the first fluid flow path, wherein the bodily fluid is disposed between the housing and the first bodily fluid filtration medium. The first body fluid filtering medium, which is in close contact with the housing so as not to flow, is disposed between the inlet and the second outlet and across the second fluid flow path. A second bodily fluid filtration medium comprising the second bodily fluid filtration medium, which is in close contact with the housing so that no bodily fluid flows between the housing and the second bodily fluid filtration medium. means. The bodily fluid filtering device may filter the bodily fluid to separate leukocytes, prions, other blood components, cells, and chemicals that can be used to treat the bodily fluid from bodily fluids including blood or blood products. it can. BFFD may also be used as an abbreviation for other types of body fluid filtration devices.

  As used herein, the term “body fluid filtration medium (hereinafter referred to as BFFM)” is used to treat white blood cells, prions, other blood components, cells, and said body fluids from body fluids including blood or blood products. It refers to a porous filtration medium that can filter the bodily fluid to separate the resulting chemicals. The bodily fluid filtration medium (BFFM) may comprise at least one filter element comprising one or more layers of the same type of porous filter material. The body fluid filtration medium may comprise two or more filter elements, including different types of filter materials. Any of various types of bodily fluid filtration media including one or more filter elements of the same type or different types as disclosed in Patent Document 2 or Patent Document 3 is considered as the bodily fluid filtration medium of the present invention. good.

  As used herein, the term “vent filtration media” refers to filtration media used in vent filter devices. The vent filtration medium can be a fine pore filtration material made of a material such as Teflon (registered trademark) or PVDF, and preferably has a pore diameter of 0.2 μm or less. Alternatively, the vent filtration media can be depth media such as cotton, spunbond polyester, or molded depth media such as Porex.

  As used herein, the term “housing” refers to an enclosure within which the filtration medium is closely attached. The BFFD housing includes an inlet, two outlets, a first fluid flow path defined between the inlet and a first outlet of the two outlets, the inlet and the first A first BFFM disposed between the outlet and the first fluid flow path so as not to allow a body fluid to flow between the housing and the first BFFM. A first fluid flow path defined between the first BFFM, the inlet and a second outlet of the two outlets, in close contact with the housing; the inlet and the second outlet; And a second BFFM arranged so as to cross the second fluid flow path, wherein a body fluid flows between the housing and the second BFFM. In close contact with the housing odd, and a said 2 BFFM. The housing does not have a partition wall. The housing can be made of a rigid material such as stainless steel or aluminum, or any rigid molded plastic material such as acrylic, polycarbonate, polypropylene, polyethylene. A vent filtration device housing includes a vent port in fluid communication with the atmosphere, a system port in fluid communication with the bodily fluid filtration system, a fluid flow path defined between the vent port and the system port, and the vent port And a vent filtration medium disposed between the system port and across the fluid flow path. The vent filtration medium is in close contact with the housing so that no body fluid or gas flows between the vent filtration medium and the housing.

  The term “body fluid” as used herein means any type of biological fluid including blood or blood products, leukocyte-containing suspensions or prion-containing suspensions.

  The term “leukocyte-containing suspension” as used herein means a liquid in which leukocytes are suspended. Examples of leukocyte-containing suspensions include whole blood; concentrated red blood cells, washed red blood cells, leukocyte-separated cells, red blood cell preparations such as thawed red blood cell concentrates and thawed red blood cell suspensions; platelet-poor plasma, rich in platelets Plasma preparations such as plasma, fresh lyophilized plasma, fresh liquid plasma and cryoprecipitates; and other leukocyte-containing blood preparations such as concentrated platelet cells, buffy coat blood and sequestered blood. The leukocyte-containing suspension filtered by the device and system according to the present invention is not limited to the examples described above.

  The term “prion-containing suspension” as used herein means a liquid in which prions are suspended.

  As used herein, the term “diaphragm discharge device (hereinafter referred to as DDD)” includes an inlet in fluid communication with the atmosphere, an outlet in fluid communication with a second device to be discharged, the inlet and the It means a device having a housing with a diaphragm arranged between the outlets. In its normal state, the housing contains a certain amount of gas between the diaphragm and the outlet.

US Pat. No. 6,660,171 US patent application Ser. No. 10 / 934,881 PCT International Application No. PCT / US2004 / 029026 US Pat. No. 6,231,770 US patent application Ser. No. 10 / 693,757

  By using a body fluid filtration device (BFFD) and system constructed according to the principles of the present invention, the above-mentioned problems of the prior art are solved and the object of the present invention is achieved. The bodily fluid filtration system of the present invention filters the bodily fluid to separate leukocytes, prions, other blood components, cells, and chemicals that can be used to treat the bodily fluid from bodily fluids containing blood or blood products. can do.

  The body fluid filtration system includes one supply container (usually a collapsible blood bag), one or more receiving containers (usually one or more collapsible blood bags), A body fluid filtering device (BFFD) disposed between the supply container (blood supply bag) and the receiving container (blood receiving bag); The BFFD comprises a housing without a septum comprising one inlet and two outlets, a first fluid flow path defined between the inlet and a first outlet of the two outlets; A first body fluid filtration medium (BFFM) disposed between the inlet and the first outlet and across the first fluid flow path; a first of the inlet and the two outlets; A second fluid flow path defined between the second outlet and a second fluid flow path disposed between the inlet and the second outlet and across the second fluid flow path. A body fluid filtration medium (BFFM). Each BFFM may include one filtration element or a plurality of different types of filtration elements. The housing also includes a chamber formed between the inlet and the upstream surface of the two BFFMs. The first flow restriction unit may be disposed downstream of the first BFFM, and the second flow restriction unit may be disposed downstream of the second BFFM. The bodily fluid filtration system also includes means for the BFFD upstream chamber to automatically drain liquid when the filtration cycle is complete. The discharge means may include a diaphragm type discharge device (DDD) having an integrated flow restriction. Any of various types of inline-type automatic discharge means disclosed in Patent Document 2 or 3 can be used as the automatic discharge means of the present invention.

  In any embodiment, the BFFM is, in turn, a first filter element comprising one or more layers of a porous filter material having a first pore size, a second pore size having a pore size smaller than the first pore size. A second filter element comprising one or more layers comprising a plurality of porous filter materials, a first comprising one or more layers comprising a porous filter material having a third pore size larger than the second pore size. 3 filter elements, and a combination of a fourth filter element including one or a plurality of layers made of a porous filter material having a pore diameter smaller than that of the second filter element and having a fourth pore diameter. There is. While the third filter element serves as a flow distribution layer, the first filter element may include means for separating a gel from blood or blood products, the second filter element May include means for separating microaggregates from blood or blood products, and the fourth filter element may include means for separating white blood cells from blood or blood products. However, the BFFM is not limited to the types described above, and any suitable type of BFFM for a specific application can be used.

A blood supply bag, a first blood receiving bag, a second blood receiving bag, the BFFD of the first embodiment disposed between the blood supply bag and the blood receiving bag, and the blood supply bag and the BFFD Of a first embodiment of a bodily fluid filtration system that can be used to filter bodily fluids constructed in accordance with the principles of the present invention, including a diaphragm-type drainage device (DDD) with an integral flow restrictor disposed therebetween It is a side view. 1 is a cross-sectional view of a BFFD of a first embodiment that can be used to filter body fluids constructed in accordance with the principles of the present invention. FIG. 2 is an isometric view showing a DDD with a portion of the DDD shown in FIG. 1 removed. FIG. 3 is an isometric view of the housing inlet half with a portion of the BFFD illustrated in FIG. 2 removed. FIG. 3 is an isometric view showing a first housing outlet half with a portion of the BFFD illustrated in FIG. 2 removed. The second housing outlet half is the same as the first housing outlet half. FIG. 5 is an isometric view showing a housing inlet half with a baffle, partially removed, that can replace the housing inlet half shown in FIG. 4. A blood supply bag, a first blood receiving bag, a second blood receiving bag, a BFFD of the second embodiment disposed between the blood supply bag and the blood receiving bag, and the blood supply bag and the BFFD Of a second embodiment of a bodily fluid filtration system that can be used to filter bodily fluids constructed in accordance with the principles of the present invention, including a diaphragm-type drainage device (DDD) with an integral flow restrictor disposed therebetween It is a side view. It is sectional drawing of the single-sided BFFD which can be used for the filtration of the bodily fluid comprised according to the principle of this invention provided with a flow volume restriction part in an outlet.

  One embodiment of a bodily fluid filtration system constructed in accordance with the principles of the present invention is illustrated in FIGS. The body fluid filtration system 1000 illustrated in FIG. 1 includes a blood supply bag 98, a first blood receiving bag 99, and a second blood receiving bag 99a. A body fluid filtering device (BFFD) 100 is disposed between the blood supply bag 98 and the two blood receiving bags. A diaphragm drain (DDD) 50 can also be placed between the blood supply bag 98 and the BFFD 100. The outlet of the blood supply bag 98 and the inlet tube socket 51 of the DDD 50 are connected by a tube 81 having a first length. The outlet tube socket 52 of the DDD 50 and the inlet tube socket 6 of the BFFD 100 are connected by a tube 81a having a second length. The first outlet tube socket 28 of the BFFD 100 and the inlet of the first blood receiving bag 99 are connected by a tube 82 having a third length. The second outlet tube socket 28a of the BFFD 100 and the inlet of the second blood receiving bag 99a are connected by a tube 82a having a fourth length. Alternatively, the outlet end of the tube 82 is connected to the first port of the T-shaped tube or Y-shaped tube, and the outlet end of the tube 82a is connected to the second port of the T-shaped tube or Y-shaped tube; A third port of the T-shaped or Y-shaped tube can also be connected to the inlet of a common blood receiving bag. The tube 81 may include a tube clamp 95, the tube 82 may include a tube clamp 96, and the tube 82a may include a tube clamp 96a. The diaphragm discharge device 50 can be replaced with a vent filtration device or can be removed completely.

  2 to 5, the BFFD 100 includes a rigid housing including a housing inlet half 1, a first housing outlet half 20, and a second housing outlet half 20a. The housing seal surface 19 of the housing inlet half 1 is coupled to the housing seal surface 29 of the first housing outlet half 20. The housing seal surface 19a of the housing inlet half 1 is coupled to the housing seal surface 29a of the second housing outlet half 20a. The bond is preferably ultrasonic welding, but may be a heat bond, an adhesive bond, a solvent bond, or any other type of tight tight bond.

  With reference to FIGS. 2, 4, and 5, the housing inlet half 1 includes a first filter well 11 defined by an inner wall 8 and a plane through the filter sealing surface 7. The housing inlet half 1 also includes a second filter well 11a defined by an inner wall 8a and a plane passing through the filter seal surface 7a. The upstream chamber 13 is defined by the inner surface 10a of the inner wall 10 of the housing inlet half 1, the upstream surface 16b of the filtration element 16, and the upstream surface 16ab of the filtration element 16a. For this reason, the upstream chamber forms a space between the upstream surface of the first BFFM and the upstream surface of the second BFFM. However, the upstream surface of the first BFFM is opposed to the upstream surface of the second BFFM. Details of the first and second BFFMs will be described later. Inlet 5 is in fluid communication with upstream chamber 13. The outlet end portion of the tube 81a is inserted into the inlet tube socket 6 and coupled. Although the inlet 5 is illustrated as being disposed on the vertical center line of the housing inlet half 1 at the top of the upstream chamber 13, it may be disposed at any position between the top and bottom of the upstream chamber 13. It may be arranged on either the right side or the left side of the vertical center line.

  2 and 5, the BFFD 100 includes a first housing outlet half 20 and a second housing outlet half 20a. The housing outlet half 20 a is the same as the housing outlet half 20. The housing outlet half 20 includes an annular outlet channel 25 and an outlet 27. The outlet 27 may include a flow restriction as illustrated in FIGS. The annular outlet channel 25 is in direct fluid communication with the outlet 27, and the portion of the annular outlet channel 25 adjacent to the outlet 27 has a flow path cross-sectional area that is larger than the flow path cross-sectional area of the outlet 27. The housing outlet half 20 also includes a plurality of vertical channels 22, 22a that are open at the top and closed at the bottom. One end of each vertical channel 22, 22 a is in fluid communication with the annular outlet channel 25. The upper portion of the annular outlet channel 25 is widened to receive the body fluid flow from the vertical channels 22, 22a. The width of the remaining portion of the annular outlet channel 25 (ie, the lower portion of the annular outlet channel 25) is preferably equal to the width of the vertical channel. Two outermost vertical channels, shown as vertical channels 22 a, are adjacent to the annular outlet channel 25. However, the width of the annular outlet channel 25 is equal to the width of the vertical channel. By combining the outlet channel and the vertical channel, a filter underdrain structure cut into the wall 37 of the housing outlet half 20 is formed, and as shown in FIG. It is arranged inside the inner wall 21 of the housing outlet half 20. The cross-sectional area of the outlet channel and the vertical channel is defined by the inner surface of each channel and the downstream surface of the BFFM that contacts the wall. As shown in FIG. 5, the distance between the vertical channel 22 and the vertical channel 22a is larger than the width of each vertical channel 22, 22a, and the distance between the vertical channel 22 and the vertical channel 22a is It is larger than the depth of the vertical channels 22 and 22a. For example, the distance between the centerlines of two vertical channels is equal to 0.181 inches and the width of each vertical channel is equal to 0.032 inches. The depth of the vertical channel is equal to 0.063 inches (0.025 inches). The housing outlet half 20 also includes a filter seal surface 24. Since the housing outlet half 20 does not include an open chamber or space downstream of the BFFM, the amount of body fluid hold-up can be minimized. The housing outlet half 20 of the present invention is the same as the housing outlet half 220 disclosed in Patent Document 2 and Patent Document 3 except that the housing outlet half 20 includes a flow restriction portion in the outlet.

  Referring to FIG. 2, a first body fluid filtration medium (BFFM) comprising at least one filter element is disposed between the inlet 5 and the first outlet 27 and the flow of unfiltered body fluid is between the housing and the It closely adheres to the housing so as not to flow between the first BFFM and prevents the unfiltered body fluid from bypassing the periphery of the first BFFM. A second body fluid filtration medium (BFFM) comprising at least one filter element is disposed between the inlet 5 and the second outlet 27a, and a flow of unfiltered body fluid is between the housing and the second BFFM. In close contact with the housing so as not to flow between them, the unfiltered body fluid is prevented from bypassing around the second BFFM. The first BFFM illustrated in FIG. 2 includes filter elements 16 and 18. The filter elements may all be the same type of filter elements or may be different types of filter elements. For example, the filter element 16 can be a microaggregate filter element and the filter element 18 can be a leukocyte separation filter element. Each filter element has an upstream surface (shown as an upstream surface 16b in the case of the filter element 16), a downstream surface (shown as a downstream surface 16c in the case of the filter element 16), and a peripheral surface (a peripheral surface 16d in the case of the filter element 16). As shown). The downstream surface of the BFFM, shown as the downstream surface 18 c of the filter element 18, contacts the inner wall 21 of the housing outlet half 20. Since the downstream surface of the BFFM contacts the inner wall 21 of the housing outlet half 20, the BFFD 100 does not include an open chamber or space downstream of the BFFM. Air or liquid exhausted through the BFFM must pass through the vertical channel and the annular outlet channel before entering the outlet 27 of the BFFD 100. As illustrated by the filter element 18, the at least one filter element can be brought into close contact with the housing by an interference fit between the peripheral surface of the at least one filter element and the inner wall 8 of the housing inlet half 1. Or, as illustrated by the filter element 16, the at least one filter element may be pressure contacted by pressing the outer edge of the at least one filter element with the filter sealing surface 7 of the housing inlet half 1, The at least one filter element can be in intimate contact with the housing or in close contact with the housing using heat seal, ultrasonic welding, glue seal, solvent seal, high frequency welding, or any other type of intimate seal Can be made. Also, a plurality of sealing methods can be used in combination in order to bring at least one filter element into close contact with the housing. The second BFFM is preferably the same as the first BFFM, and is preferably adhered to the housing by the same method as the first BFFM is adhered to the housing. Any of the combinations of filter elements disclosed in Patent Document 2 and Patent Document 3 can be used in the present invention. For example, in the present invention, a combination of a gel filter element, a microaggregate filter element, a flow distribution filter element, and a leukocyte separation filter element can be used.

  Referring to FIGS. 2 and 5, a first fluid flow path is defined between the inlet 5 of the BFFD 100 and the first outlet 27 of the BFFD 100, wherein at least one filter element of the first BFFM is: Between the inlet 5 and the 1st outlet 27, it arrange | positions so that the said 1st fluid flow path may be crossed. The first fluid flow path passes from the inlet 5 through the upstream chamber 13, through the vertical channels 22, 22 a through the at least one filter element of the first BFFM, through the annular outlet channel 25, And it passes the outlet 27 which may include a flow restriction part, and passes through the entire first housing outlet half 20. The second fluid flow path is defined between the inlet 5 of the BFFD 100 and the second outlet 27a of the BFFD 100, and at least one filter element of the second BFFM is connected to the inlet 5 and the second outlet 27a. Between the two and the second flow path. The second fluid flow path passes through the upstream chamber 13 from the inlet 5, passes through the vertical channels 22, 22a through the at least one filter element of the second BFFM, passes through the annular outlet channel 25a, And it passes the outlet 27a which may contain a flow restriction part, and passes through the second housing outlet half 20a.

  1 and 3 illustrate a diaphragm-type discharge device 50 (hereinafter referred to as DDD 50). The DDD 50 includes a rigid housing inlet half 58, a rigid housing outlet half 59, and a flexible diaphragm 53. The housing outlet half 59 includes an inlet tube socket 51, an outlet tube socket 52, a first channel 54, a second channel 55, a third channel 56, and a common node 60. Common node 60 (shown as a point) is placed in a position where each of the three channels is in fluid communication with the other two channels. The second channel 55 includes a flow restriction that is illustrated as a channel that is longer and smaller in diameter than the first and third channels. The first channel may be referred to as the inlet 54, the second channel may be referred to as the outlet 55, and the third channel may be referred to as the side port 56. The housing outlet half 59 is formed by combining the three-port tube connector 1650 and the housing outlet half 1820 disclosed in Patent Document 2 and Patent Document 3 into one component. The shape of the three-necked tube connector composed of the first channel 54, the second channel 55, and the third channel 56 is shown as a T-shape, but is not limited to this shape. For example, a Y-shaped shape may be used. FIG. 3 illustrates a normal state of the DDD 50 in which the housing inlet half 58 is in close contact with the housing outlet half 59. The adhesion is preferably an ultrasonic seal, but may be a heat seal, a solvent seal, an adhesive seal, a pressure seal between the housing inlet half 58 and the housing outlet half 59, or any other type of adhesive seal. There may be. The flexible diaphragm 53 can be molded from a soft rubber material such as silicone rubber, or can be molded or thermoformed from a material such as PVC, polyethylene, or polypropylene, but is limited to these materials. I don't mean. The flexible diaphragm 53 is preferably shaped such that, in its normal state, the outer surface 66 fits the inner surface 67 of the housing inlet half 58. The flexible diaphragm 53 includes a flange 68 that can be coupled to the housing inlet half 58 or the housing outlet half 59. The bond can be a heat bond, an ultrasonic bond, an adhesive bond, a solvent bond, or any other type of tight bond. Alternatively, the flange 68 can be brought into close contact with the housing inlet half 58 and the housing outlet half 59 by a pressure seal. FIG. 3 illustrates the DDD 50 in a normal state, where the outer surface 66 of the diaphragm 53 is in contact with the inner surface 67 of the housing inlet half 58. The DDD 50 includes a chamber 63 that is in fluid communication with the third channel 56 in its normal state. In the normal state, the chamber 63 is filled with atmospheric pressure gas (usually sterile air). When the diaphragm 53 is completely crushed, the inner surface 69 of the diaphragm 53 contacts the inner surface 70 of the housing outlet half 59.

  With reference to FIGS. 1-3, a third fluid flow path is defined between the blood supply bag 98 and the common node 60 of the housing outlet half 59 of the DDD 50. The flow of the third fluid flow path passes from the blood supply bag 98 through the tube 81 through the inlet 54 of the DDD 50 and reaches the common node 60. A fourth fluid flow path is defined between the common node 60 of the DDD 50 and the inlet 5 of the BFFD 100. The flow of the fourth fluid flow path passes from the common node 60 through the outlet 55 (including the flow restriction unit) of the DDD 50 and reaches the inlet 5 of the BFFD 100 via the tube 81a. A fifth fluid flow path is defined between the common node 60 and the chamber 63 of the DDD 50. The flow of the fifth fluid flow path passes from the chamber 63 through the third channel 56 to the common node 60.

  Referring to FIGS. 1 to 5, the body fluid filtration system 1000 operates as follows. The user purchases a system that includes all the components illustrated in FIG. The user connects the tube 81 to the outlet 92 of the blood supply bag 98 by methods well known in the art. The blood supply bag 98 can be hung from the hook of the blood bag pole so that the various components of the system can be placed as illustrated in FIG. 1, and the first blood receiving bag 99 and the second blood receiving bag. 99a can be placed on a table or the like. Alternatively, the blood supply bag 98 can be part of a set that includes all the components illustrated in FIG. In this case, blood or blood products collected from the donor will be collected in the blood supply bag 98. The tube clamp 95 is closed before the tube 81 is connected to the blood supply bag 98. The tube clamps 96 and 96a are opened before the tube clamp 95 is opened and body fluid (ie, liquid) begins to flow through the system.

  When the tube clamp 95 is opened, body fluid (ie, fluid) passes from the blood supply bag 98 through the tube 81, flows into the inlet 54 of the DDD 50, passes through the outlet 55 of the DDD 50, passes through the tube 81a, It flows into the inlet 5 of the BFFD 100 and flows into the upstream chamber 13 of the BFFD 100. Since the outlet 55 of the DDD 50 includes a flow restriction unit, the flow downstream of the DDD inlet and the downstream side port of the DDD is automatically restricted, and a positive pressure can be generated at the common node 60 of the DDD 50. Further, since the flexible diaphragm 53 is in close contact with the DDD 50 by a liquid-tight / air-tight seal, air does not leak from the inlet 57 of the DDD 50. Therefore, even if any, the air in the chamber 63 of the DDD 50 is pressurized so that only a small amount of body fluid flows into the side port 56 of the DDD 50.

  When the tube clamp 95 is opened, one of the following four states occurs. In the first state, if the capacity of the upstream chamber 13 is sufficiently small and the combined amount of the initial flow rates of the first and second BFFMs does not exceed the flow rate of the body fluid flowing into the inlet 5, the upstream chamber of the BFFD 100 13 will be quickly filled with body fluid from the bottom to the top. As the upstream chamber 13 is filled from the bottom toward the top, the initial air in the upstream chamber 13 is discharged by the body fluid filling the upstream chamber 13. A portion of the exhausted air is forced through the first BFFM, delivered to the vertical channels 22, 22a, delivered to the annular outlet channel 25, and delivered to the first outlet 27, the first Will pass through the entire housing outlet half 20. The remainder of the exhausted air is forced through the second BFFM, delivered to the vertical channels 22, 22a, delivered to the annular outlet channel 25a, and delivered to the second outlet 27a, the second Will pass through the entire housing outlet half 20a. Body fluid in the upstream chamber 13 can be pressurized. The pressure at the bottom of the upstream chamber 13 is proportional to the distance from the body fluid level in the blood supply bag 98 to the bottom of the upstream chamber 13, and the pressure at the top of the upstream chamber 13 is that of body fluid in the blood supply bag 98. It is proportional to the distance from the liquid level to the top of the upstream chamber 13. For this reason, the pressure at the top of the upstream chamber 13 is smaller than the pressure at the bottom of the upstream chamber 13. Due to the positive pressure in the upstream chamber 13, the body fluid passes through the first and second BFFM over the entire surface area of the first and second BFFM, and the body fluid causes the air in the pores of the first and second BFFM to flow. The first and second BFFMs are pushed away from the upstream side of the first and second BFFMs to the downstream side of the first and second BFFMs. As each BFFM gets wet, the air initially in the pores of each BFFM is pushed away by body fluid and flows into the vertical channels 22, 22a of each housing outlet half, into the annular outlet channel 25, and then into the housing. It flows into the outlet 27 of the outlet half 20 and the outlet 27a of the housing outlet half 20a, then flows into the tube 82, flows into the first blood receiving bag 99, and flows into the tube 82a to enter the second blood receiving bag. It flows into 99a. Since the pressure at the bottom of the upstream chamber 13 is greater than the pressure at the top of the upstream chamber 13, the initial flow rate of body fluid passing through the BFFM is greater at the bottom of the BFFM than at the top of the BFFM. Therefore, the BFFM is first completely wetted from the upstream surface of the BFFM to the downstream surface of the BFFM at the bottom of the BFFM. When the width of the vertical channels 22 and 22a of each housing outlet half is sufficiently small and the depth of the vertical channels 22 and 22a is sufficiently shallow, the flow channel cross-sectional area of the vertical channels 22 and 22a is sufficiently small, and the vertical channels When the distance between 22 is sufficiently large, for body fluids that pass through the BFFM continuously, the minimum resistance path is the BFFM capillary in both the horizontal and vertical directions, not the vertical channel. This is because, when the flow channel cross-sectional area of the vertical channel is sufficiently small, a sufficiently high positive pressure is generated in the vertical channel by the air discharged from the BFFM flowing into and passing through the vertical channel, Is not allowed to flow into the vertical channel. The downstream surface of the BFFM is therefore wetted from bottom to top, and the exhausted air that was in the BFFM flows continuously into the vertical channel, into the annular outlet channel, and It will continue to flow into the outlet. When the downstream surface of each BFFM is wetted to the level of the top of the vertical channel 22a, the downstream surfaces of the BFFM below the top of the two outermost vertical channels 22a are wetted so that the two outermost vertical channels The flow of air passing through 22a stops. Thus, the pressure in the two outermost vertical channels is reduced to allow body fluid to flow into the two outermost vertical channels from the bottom to the top, thereby providing the two outermost vertical channels. Exhaust air that was in the channel. At the same time, the wetting level of the downstream surface of each BFFM continues to wet in the vertical direction and wets the downstream surface of each BFFM in the vicinity adjacent to each annular outlet channel 25. Due to the air flowing through the annular outlet channel 25, the uppermost channel cross-sectional area of the annular outlet channel 25 is not small enough to generate a positive pressure in the annular outlet channel 25, so that each BFFM is vertically oriented. As wetting continues, body fluid will begin to flow into the top of the vertical channel 22 and the annular outlet channel 25. The body fluid that flows into the vertical channels 22 and 22a and the annular outlet channel 25 flows into the outlets 27 and 27a of the BFFD 100, then flows into the tube 82, flows toward the blood receiving bag 99, and flows into the tube 82a. It flows toward the blood receiving bag 99a. Since the body fluid starts to flow into the outlets 27 and 27a, the first and second BFFMs continue to get wet in the vertical direction. Thus, the initial flow through the annular outlet channel 25 and outlets 27, 27a is initially air, then a mixture of air and body fluid, and finally only body fluid, and the initial flow into the tubes 82 and 82a. The flow is initially air, then the body fluid and air portions alternate, and finally the body fluid only. Once the BFFM is wet, the flow of body fluid through the BFFM is uniform over the entire surface area of the BFFM, and the body fluid is filtered over the entire surface area of the BFFM, thereby allowing the BFFM to flow most. It can be used efficiently. The present invention is not limited to the underdrain filter illustrated in FIG. For example, any of the underdrain filters disclosed in Patent Document 2, Patent Document 3, or Patent Document 1 can be used in the present invention. Also, any other type of underdrain filter that provides sufficient support for the BFFM and provides fluid flow means downstream of the BFFM and between each outlet can be used.

  In a second state that can occur after the tube clamp 95 is opened, the BFFD 100 is wetted as described in the first state above, so that the initial flow rate (ie, before each BFFM is in a wet state). (Flow rate) is a flow rate as described in the first state. However, once each BFFM becomes wet with body fluid, the combined amount of flow through the first and second BFFMs exceeds the amount of body fluid flowing into the chamber 13 via the inlet 5. The flow rate through each BFFM may increase. In this case, the body fluid is first filled from the bottom of the chamber 13 toward the top, and after the BFFM is wetted, the liquid level in the chamber 13 falls to a level below the top of the chamber 13. For this reason, once the BFFM is in a wet state, the flow rate of the body fluid passing through the portion below the uppermost liquid level in the chamber 13 of the BFFM is higher than the uppermost liquid level in the chamber 13 of the BFFM. Since the flow rate is higher than the body fluid flow rate, the portion above the liquid level of the BFFM is not properly used. When BFFD 100 is used to separate leukocytes from blood or blood products, the BFFM's ability to remove leukocytes may be reduced in the second state as compared to the first state described above. Thus, in the second state, the filtered blood or blood product in the blood receiving bag is more than the filtered blood or blood product in the blood receiving bag filtered under the first state. Of white blood cells. The second state can be adjusted by adding a flow restriction unit to the first outlet 27 and the second outlet 27a as illustrated in FIG. In FIG. 2, the flow restrictor is illustrated as a long and small diameter outlet. The flow restrictor is sized so that the combined amount of body fluids passing through the first and second BFFMs, and hence the outlets 27 and 27a, is less than or equal to the amount of body fluid flowing into the chamber 13 via the inlet 5. It is determined. The flow restriction unit can be arranged at any position downstream of each BFFM. For example, the first flow restriction can be placed in the tube 82 between the outlet 27 and the first blood receiving bag 99, and the second flow restriction can be the outlet 27a and the second blood receiving. It can arrange | position in the tube 82a between the bags 99a. Alternatively, all or part of the tube 82 and the tube 82a may have an inner diameter smaller than that of the tube 81 and the tube 81a, and the limiting portion may be formed downstream of the first and second BFFMs. The flow restricting unit can also be used downstream of the BFFM in the single-sided BFFD for the same reason as described above. In either of the single-sided devices disclosed in Patent Document 2 or Patent Document 3, a flow rate limiting unit can be added downstream of the BFFM.

  In a third state that can occur after the tube clamp 95 is opened, if the volume of the upstream chamber 13 is sufficiently large, before the liquid level in the upstream chamber 13 reaches the top of the upstream chamber 13, the upstream chamber The BFFM is wetted by the combination of the liquid passing through the BFFM below the liquid level in the inside 13 and the wetting by the capillary above the liquid level, thereby purging air from the BFFM. Once the BFFM is in a wet state, the air above the liquid level in the upstream chamber 13 is trapped in the upstream chamber 13. This is because this air cannot be purged from the upstream chamber 13 because the BFFM is wet. Once the BFFM is in a wet state, the flow rate of the bodily fluid that passes through the portion below the uppermost liquid level in the chamber 13 of the BFFM is such that the body fluid that passes through the upper portion of the liquid level in the chamber 13 of the BFFM. Therefore, the portion of the BFFM above the liquid level is not properly used. When BFFD100 is used to separate leukocytes from blood or blood products, the BFFM's ability to remove leukocytes may be reduced in the third state compared to the first state described above. Thus, in the third state, the filtered blood or blood product in the blood receiving bag is more than the filtered blood or blood product in the blood receiving bag filtered under the first state. Of white blood cells. The third state can be adjusted by reducing the capacity of the upstream chamber 13. Referring to FIG. 4, when the cross-sectional area of the inlet 5 is made sufficiently large so as not to restrict the flow of body fluid through the inlet 5, the width of the inner surface 10a of the housing inlet half 1 (ie, the filter seal surface 7 and the filter The distance between the seal surface 7a and the seal surface 7a must be sufficiently wide. In this case, the capacity of the upstream chamber 13 can be minimized by adding a baffle 12 to the inner wall 10 of the housing inlet half 1a, as illustrated in FIG. The baffle 12 extends from one side of the inner wall 10 to the other side of the inner wall 10. The baffle 12 may include a filter support rib 15 disposed on the first surface 9 and a filter support rib 15a disposed on the second surface 9a as illustrated in FIG. The housing inlet half 1a is formed by adding a baffle 12 to the housing inlet half 1a and increasing the sectional area of the inlet 5a so that the sectional area of the inlet 5a is equal to or larger than the sectional area inside the tube 81a shown in FIG. It is the same as the housing inlet half 1 except that the width of 10a is increased. However, since a certain volume is occupied by the baffle 12 and the filter support ribs 15, 15 a, the capacity of the upstream chamber 13 of the housing inlet half 1 a is smaller than the capacity of the upstream chamber 13 of the housing inlet half 1. Because of the gaps 14, 14 a above the top and below the bottom of the baffle 12, the baffle 12 does not function as a septum that isolates the upstream chamber 13 into two separate chambers. The combined size of the two gaps is large enough not to isolate the upstream chamber 13 into two separate chambers. The cross-sectional area of each gap is defined as the cross-sectional area of the gap measured in a plane passing through the center of the baffle and parallel to the filter seal surface 7 and the filter seal surface 7a. The only purpose of adding the baffle 12 to the housing inlet half is to add filter support ribs 15, 15a that provide a means to reduce the capacity of the upstream chamber 13 and keep the two BFFMs properly separated. is there. The filter support ribs can be replaced with an array of filter support pins, or other means. The baffle illustrated in FIG. 6 has a first gap above it and a second gap below it, but the baffle isolates the upstream chamber 13 into two separate chambers. One gap may be placed above or below the baffle or somewhere between the two so that it does not function as such a septum. The gap may also be called an opening.

  In the fourth state that may occur after the tube clamp 95 is opened, if the combined amount of the initial flow rates of the first and second BFFMs exceeds the flow rate of the body fluid flowing into the inlet 5, the liquid in the upstream chamber 13 Before the surface reaches the top of the upstream chamber 13, the BFFM is wetted by the combination of the liquid passing through the BFFM below the liquid surface in the upstream chamber 13 and the wetting by the capillary above the liquid surface. To purge air from the BFFM. Once the BFFM is in a wet state, the air above the liquid level in the upstream chamber 13 is trapped in the upstream chamber 13. This is because this air cannot be purged from the upstream chamber 13 because the BFFM is wet. Once the BFFM is in a wet state, the flow rate of the bodily fluid that passes through the portion below the uppermost liquid level in the chamber 13 of the BFFM is such that the body fluid that passes through the upper portion of the liquid level in the chamber 13 of the BFFM. Therefore, the portion of the BFFM above the liquid level is not properly used. When BFFM100 is used to separate leukocytes from blood or blood products, the BFFM's ability to remove leukocytes may be reduced in the fourth state as compared to the first state described above. Thus, in the fourth state, the filtered blood or blood product in the blood receiving bag is more than the filtered blood or blood product in the blood receiving bag filtered under the first state. Of white blood cells. The fourth state is implemented by reducing the initial flow rate through the BFFM, decreasing the surface area of the BFFM, or increasing the resistance to pass through the BFFM, or a combination thereof. It can be adjusted by doing. Alternatively, the fourth state can be adjusted by adding a flow restriction unit (for example, a flow restriction unit in the outlets 27 and 27a illustrated in FIG. 2) downstream of the BFFM. The addition of a flow restrictor eliminates the need to reduce the surface area of the BFFM, thereby increasing the total throughput of filtered blood or filtered blood product without adversely affecting leukocyte removal of the filtered product. it can.

  Referring to FIGS. 1-5, when all the air is purged from the first and second fluid flow paths in the BFFD 100, the body fluid is stored in the BFFD 100 until the blood supply bag 98 containing the body fluid is emptied. It passes through the first fluid flow path from the inlet 5 to the first outlet 27 of the BFFD 100 and continues to flow into the first blood receiving bag 99 via the tube 82, and the second of the BFFD 100 from the inlet 5 of the BFFD 100. It passes through the second fluid flow path leading to the outlet 27a and continues to flow into the second blood receiving bag 99a via the tube 82a. By adding a flow restriction to the outlets 27, 27a as illustrated in FIG. 2, the flow of body fluid through the first and second BFFMs is balanced, so both BFFMs are properly utilized, The filter fluid in the blood receiving bag 99 and the blood receiving bag 99a can be of the same quality. When the blood supply bag 98 is emptied, the blood supply bag 98 collapses, so that the tip of the tube 81 is effectively sealed, thereby preventing the flow of body fluid from flowing into the tube. When the first blood receiving bag 99 and the second blood receiving bag 99a are disposed at a position sufficiently lower than the BFFD 100, the pressure downstream of the first and second BFFM may be a negative pressure. When the blood supply bag 98 collapses and the flow of body fluid through the first and second fluid flow paths stops, the differential pressure between the first BFFM and the second BFFM becomes zero, so upstream The pressure in the chamber 13, the pressure in the tube 81a, and the pressure in the outlet 55, the side port 56, and the chamber 63 of the DDD 50 are negative pressures. Since the outer surface 66 of the flexible diaphragm 53 is at atmospheric pressure via the inlet 57 of the DDD 50, body fluid is drawn by the suction force (ie, negative pressure), the side port 56 of the DDD 50, the outlet 55 of the DDD 50, the tube 81a, and the upstream. It is automatically discharged from the chamber 13 and flows into the blood receiving bags 99 and 99a through the outlets 27 and 27a and the tubes 82 and 82a of the BFFM and BFFD100. The flexible diaphragm 53 is automatically crushed by the suction force, and the body fluid discharged from the upstream side of the BFFM is discharged by the air in the chamber 63 of the DDD 50. If the volume of the chamber 63 of the DDD 50 is equal to or greater than the amount of body fluid to be discharged, all body fluid is automatically discharged as described above. When the volume of the chamber 63 of the DDD 50 exceeds the amount of body fluid to be discharged, the flexible diaphragm 53 is only partially collapsed. When the filtration cycle is complete, body fluid remains in the BFFM, in the culvert filter structures of the first and second housing outlet halves, and in the tubes 82, 82a. Although the DDD 50 is used as an automatic discharge means of the body fluid filtration system 1000, any other automatic discharge means including any of the automatic discharge means disclosed in Patent Document 2 or Patent Document 3 may be used. it can. Alternatively, automatic draining means may not be used, in which case the upstream chamber is not drained after the blood supply bag 98 is emptied.

  A single-sided BFFD, wherein one inlet, one outlet, a fluid flow path defined between the inlet and the outlet, and between the inlet and the outlet and the fluid flow path A single-sided BFFD with a BFFM arranged to traverse can benefit by adding a flow restrictor downstream of the BFFM. For example, when single-sided BFFD is used to separate white blood cells from bodily fluids, the initial flow rate of bodily fluid passing through the BFFM is initially high and decreases as the BFFM becomes clogged. If the initial flow rate is too high, the BFFM's ability to remove leukocytes may be reduced, and as a result, the white blood cells per unit volume of the filtered body fluid may be lower than after the flow rate is reduced due to clogging of the BFFM. The number removed from the body fluid is less. In this case, the flow rate through the BFFM is made more uniform throughout the filtration cycle by restricting the flow of bodily fluid through the BFFD using a restriction unit downstream of the BFFM, thereby removing leukocytes. Improve the rate. In this case, the single-sided BFFD includes one inlet, one outlet, a fluid flow path defined between the inlet and the outlet, and between the inlet and the outlet, and the fluid flow path. The BFFM is disposed so as to cross the BFFM, and a flow restricting portion is disposed downstream of the BFFM, and the fluid flow path passes through the flow restricting portion.

  Single-sided BFFD, with one inlet 105, one outlet 127, fluid flow path defined between the inlet and the outlet, between the inlet and the outlet, and upstream chamber 113 A single-sided BFFD, such as the BFFD 300 illustrated in FIG. 8, can be benefited by adding a flow restrictor downstream of the BFFM 118. The BFFD 300 can be replaced with the BFFD 100 of the body fluid filtration system 1000 illustrated in FIG. In that case, one blood receiving bag is connected to the outlet 127. When the tube clamp 95 is opened, if the capacity of the upstream chamber 113 is sufficiently small and the initial flow rate of the BFFM 118 does not exceed the flow rate of the body fluid flowing into the inlet 105, the upstream chamber 113 of the BFFD 200 moves from the bottom to the top. Quickly filled with body fluids. As the upstream chamber 113 is filled from the bottom toward the top, the initial air in the upstream chamber 113 is discharged by the body fluid filling the upstream chamber 113. The exhausted air is forced to pass through the BFFM 118 and sent to the outlet 127. However, once the BFFM 118 is wetted with body fluid, the flow rate passing through the BFFM 118 may increase, so the flow rate passing through the BFFM 118 exceeds the flow rate of the body fluid flowing into the chamber 113 via the inlet 105. In this case, the body fluid initially fills the chamber 113 from the bottom to the top, and then the BFFM gets wet, and then the liquid level in the chamber 113 falls to a level below the top of the chamber 113. Therefore, once the BFFM is in a wet state, the flow rate of bodily fluid passing through the portion below the top of the liquid level in the chamber 113 of the BFFM is the portion above the top of the liquid level in the chamber 113 of the BFFM. Since the flow rate is higher than the body fluid flow rate, the portion above the liquid level of the BFFM is not properly used. When BFFD 300 is used to separate leukocytes from blood or blood products, the BFFM's ability to remove leukocytes may be reduced compared to when the upstream chamber is filled through the filtration cycle. Thus, the filtered blood or blood product in the blood receiving bag may contain more white blood cells than the white blood cells that the filtered blood or blood product would contain. The problem can be adjusted by adding a flow restriction to the outlet 127 as illustrated in FIG. In FIG. 8, the flow restricting portion is illustrated as an outlet having a long diameter and a small diameter. The flow restricting unit is sized so that the flow rate of the body fluid passing through the BFFM and hence the outlet 127 is equal to or less than the flow rate of the body fluid flowing into the chamber 113 through the inlet 105. The flow rate limiting unit can be arranged at any position downstream of the BFFM. For example, the flow restriction can be placed in a tube 82 between the outlet 127 and the blood receiving bag. Alternatively, all or part of the tube 82 may have an inner diameter smaller than that of the tube 81 and the tube 81a, and the limiting portion may be formed downstream of the BFFM.

  In a second state that can occur after the tube clamp 95 of the single-sided BFFD is opened, if the initial flow rate of the BFFM 118 exceeds the flow rate of the body fluid flowing into the inlet 105, the liquid level in the upstream chamber 113 becomes higher in the upstream chamber 113. Before reaching the top, the combination of the liquid passing through the BFFM below the liquid level in the upstream chamber 113 and the wetting by the capillary above the liquid level wets the BFFM, thereby purging air from the BFFM. . Once the BFFM is wet, air above the liquid level in the upstream chamber 113 is trapped in the upstream chamber. This is because this air cannot be purged from the upstream chamber 113 because the BFFM is wet. Once the BFFM is in a wet state, the flow rate of the bodily fluid that passes through the portion below the uppermost liquid level in the chamber 113 of the BFFM is the body fluid that passes through the portion above the uppermost liquid level in the BFFM chamber 113 Therefore, the portion of the BFFM above the liquid level is not properly used. If BFFD 300 is used to separate leukocytes from blood or blood products, the BFFM's leukocyte removal capability in this second state may be reduced. Thus, in this second state, the filtered blood or blood product in the blood receiving bag may contain more white blood cells than desired. This second state can be achieved by reducing the initial flow rate through the BFFM, by reducing the surface area of the BFFM, or by increasing the resistance to pass through the BFFM, or a combination thereof. It can be adjusted by carrying out. Alternatively, the second state can be adjusted by adding a flow restriction unit (for example, a flow restriction unit in the outlet 127 shown in FIG. 8) downstream of the BFFM. The addition of a flow restriction eliminates the need to reduce the surface area of the BFFM, thereby increasing the total throughput of filtered blood or blood products without reducing the leukocyte removal rate of the filtered product. it can.

  A double-sided BFFD, wherein one inlet, one outlet, a first fluid flow path defined between the inlet and the outlet, between the inlet and the outlet, and the first A first BFFM arranged to traverse one fluid flow path, a second fluid flow path defined between the inlet and the outlet, between the inlet and the outlet, and A double-sided BFFD without a partition, comprising a second BFFM arranged so as to cross the second fluid flow path, is obtained by adding a flow restrictor downstream of the first and second BFFMs. Profit. For example, when such a double-sided BFFD is used to separate white blood cells from bodily fluids, the initial flow rate of bodily fluid passing through the BFFM is initially high and decreases as the BFFM becomes clogged. If the initial flow rate is too high, the BFFM's ability to remove leukocytes may decrease, and as a result, the flow rate of leukocytes per unit volume of the filtered body fluid passes through the BFFM due to clogging of the BFFM. The initial number is removed from the body fluid less than later. In this case, by restricting the flow of bodily fluid passing through the BFFD using a restriction unit downstream of both BFFMs, the flow rate passing through the BFFM is made more uniform throughout the filtration cycle, whereby the leukocytes Improve the removal rate. In this case, the double-sided BFFD without a partition wall is provided between one inlet, one outlet, a first fluid flow path defined between the inlet and the outlet, and the inlet and the outlet. And a first BFFM arranged to traverse the first fluid flow path, a second fluid flow path defined between the inlet and the outlet, and the inlet and the outlet A second BFFM disposed between and across the second fluid flow path, and a flow restrictor disposed downstream of both the first and second BFFM, The first and second fluid flow paths pass through the flow rate limiting unit.

  A double-sided BFFD, wherein one inlet, one outlet, a first fluid flow path defined between the inlet and the outlet, between the inlet and the outlet, and the first A first BFFM arranged to traverse one fluid flow path, a second fluid flow path defined between the inlet and the outlet, between the inlet and the outlet, and A double-sided BFFD (e.g., disclosed in Patent Document 1 and Patent Document 2) having a partition wall and having a second BFFM arranged to cross the second fluid flow path is a first type. And by adding a flow restrictor downstream of the second BFFM. For example, when such a double-sided BFFD is used to separate white blood cells from bodily fluids, the initial fluid flow rate through the BFFM is initially high and decreases as the BFFM becomes clogged. If the initial flow rate is too high, the BFFM's ability to remove leukocytes may decrease, and as a result, the flow rate of leukocytes per unit volume of the filtered body fluid passes through the BFFM due to clogging of the BFFM. The initial number is removed from the body fluid less than later. In this case, by restricting the flow of bodily fluid passing through the BFFD using a restriction unit downstream of both BFFMs, the flow rate passing through the BFFM is made more uniform throughout the filtration cycle, whereby the leukocytes Improve the removal rate. In this case, the double-sided BFFD including a partition wall is provided between one inlet, one outlet, a first fluid flow path defined between the inlet and the outlet, and the inlet and the outlet. And a first BFFM arranged to traverse the first fluid flow path, a second fluid flow path defined between the inlet and the outlet, and the inlet and the outlet A second BFFM disposed between and across the second fluid flow path, and a flow restrictor disposed downstream of both the first and second BFFM, The first and second fluid flow paths pass through the flow rate limiting unit.

  A double-sided BFFD comprising: one inlet; two outlets; a first fluid flow path defined between the inlet and a first outlet of the two outlets; the inlet and the Defined between a first outlet and a first BFFM arranged to traverse the first fluid flow path and between the inlet and a second outlet of the two outlets. And a second BFFM disposed between the inlet and the second outlet and across the second fluid flow path. The double-sided BFFD (for example, disclosed in Patent Document 5) can benefit from the addition of a flow restriction unit downstream of the first and second BFFMs. For example, when such a double-sided BFFD is used to separate white blood cells from bodily fluids, the initial flow rate of bodily fluid passing through the BFFM is initially high and decreases as the BFFM becomes clogged. If the initial flow rate is too high, the BFFM's ability to remove leukocytes may decrease, and as a result, the flow rate of leukocytes per unit volume of the filtered body fluid passes through the BFFM due to clogging of the BFFM. The initial number is removed from the body fluid less than later. In this case, by restricting the flow of bodily fluid passing through the BFFD using a restriction unit downstream of both BFFMs, the flow rate passing through the BFFM is made more uniform throughout the filtration cycle, whereby the leukocytes Improve the removal rate. In this case, the double-sided BFFD including the partition wall includes one inlet, first and second outlets, a first fluid flow path defined between the inlet and the first outlet, and the inlet. And a first BFFM disposed between the first outlet and the first fluid flow path, and a second BFFM defined between the inlet and the second outlet. A second BFFM disposed between the inlet and the second outlet and across the second fluid channel, and both the first and second BFFMs. The first fluid flow path passes through the first flow restriction part, and the second fluid flow path passes through the second flow restriction part. Pass through.

  A double-sided BFFD comprising: two inlets; one outlet; a first fluid flow path defined between the first inlet and the outlet of the two inlets; Defined between a first BFFM arranged between the inlet and the outlet and across the first fluid flow path, and a second inlet of the two inlets and the outlet And a second BFFM disposed between the second inlet and the outlet and across the second fluid flow path. A double-sided BFFD (for example, one disclosed in Patent Document 5) can benefit from the addition of a flow restrictor downstream of the first and second BFFMs. For example, when such a double-sided BFFD is used to separate white blood cells from bodily fluids, the initial flow rate of bodily fluid passing through the BFFM is initially high and decreases as the BFFM becomes clogged. If the initial flow rate is too high, the BFFM's ability to remove leukocytes may decrease, and as a result, the flow rate of leukocytes per unit volume of the filtered body fluid passes through the BFFM due to clogging of the BFFM. The initial number is removed from the body fluid less than later. In this case, by restricting the flow of bodily fluid passing through the BFFD using a restriction unit downstream of the BFFM, the flow rate passing through the BFFM is made more uniform throughout the filtration cycle, thereby removing leukocytes. Improve the rate. In this case, the double-sided BFFD including a partition wall includes two inlets, one outlet, a first fluid flow path defined between the first inlet and the outlet of the two inlets, A first BFFM disposed between the first inlet and the outlet and across the first fluid flow path; a second inlet of the two inlets; and the outlet A second fluid flow path defined between, a second BFFM disposed between the second inlet and the outlet and across the second fluid flow path; and A flow restriction unit disposed downstream of both the first and second BFFMs, and the first and second fluid flow paths pass through the flow restriction unit. Alternatively, the BFFD is disposed between the first flow restricting unit disposed between the downstream side of the first BFFM and the outlet, and the downstream side of the second BFFM and the outlet. And a second flow restriction unit.

  A double-sided BFFD, wherein a first defined between two inlets, two outlets, a first inlet of the two inlets, and a first outlet of the two outlets. A fluid flow path, a first BFFM disposed between the first inlet and the first outlet and across the first fluid flow path, and of the two inlets A second fluid flow path defined between a second inlet and a second outlet of the two outlets; between the second inlet and the second outlet; and And a second BFFM arranged so as to cross two fluid flow paths, and having a partition wall that separates the first fluid flow path and the second fluid flow path from each other BFFD (e.g., (Disclosed in Permitted Document 2 and Patent Document 3) adds a first flow restriction unit downstream of the first BFFM and adds a second flow restriction unit downstream of the second BFFM. Profits can be obtained. For example, if such a double-sided BFFD is used to separate white blood cells from body fluids from one or two independent body fluid sources, one or more body fluids passing through the first and second BFFMs The initial flow rate is initially high and decreases as the BFFM becomes clogged. If there is too much initial flow through either of the BFFMs, the BFFM's ability to remove leukocytes may be reduced, resulting in one or more filtered body fluids passing through either fluid flow path. The number of leukocytes per unit volume is removed from the body fluid in the initial stage is smaller than after the flow rate passing through the BFFM is decreased due to the clogging of the BFFM. In this case, the first flow rate restriction unit is used downstream of the first BFFM, and the second flow rate restriction unit is used downstream of the second BFFM. By limiting the flow of one or more body fluids through, the flow rate through the BFFMs is made more uniform throughout the filtration cycle, thereby improving the leukocyte removal rate of the BFFMs. In this case, the double-sided BFFD having a partition wall that separates the first fluid channel and the second fluid channel from each other includes a first inlet, a first outlet, the first inlet, and the A first fluid flow path defined between the first outlet; and between the first inlet and the first outlet and across the first fluid flow path. The first BFFM, a second fluid flow path defined between the second inlet and the second outlet, between the second inlet and the second outlet, and the second A second BFFM arranged to cross the two fluid flow paths, a first flow restricting unit arranged downstream of the first BFFM, and a first BFFM arranged downstream of the second BFFM. 2 flow restriction parts, and the first fluid flow path is Passing through said first flow restriction, said second fluid flow path passes through said second flow restriction.

  A double-sided BFFD, wherein one inlet, one outlet, a first fluid flow path defined between the inlet and the outlet, between the inlet and the outlet, and the first A first BFFM arranged to traverse one fluid flow path, a second fluid flow path defined between the inlet and the outlet, between the inlet and the outlet, and A double-sided BFFD having a second BFFM arranged so as to cross the second fluid flow path, regardless of whether it has a partition wall, as shown in FIG. Benefits can be gained by adding two flow restrictors downstream. Referring to FIG. 7, double-sided BFFD 200 may or may not include a partition wall. The outlet of BFFD 200 is in fluid communication with the inlet of T-tube 70 via tube 82b. The side arm 70a of the T-shaped tube 70 is in fluid communication with the inlet of the blood receiving bag 99 via the tube 82c, and the side arm 70b of the T-shaped tube 70 is in fluid communication with the inlet of the blood receiving bag 99a via the tube 82d. is doing. The first restricting portion can be provided in the side arm 70a or the tube 82c, and the second restricting portion can be provided in the side arm 70b or the tube 82d. When the first and second restrictors apply equal back pressure to the body fluid flowing from the tube 82b, the amount of filtered body fluid flowing into the two blood receiving bags is equal. Furthermore, in the above example, the two restrictors restrict the flow of bodily fluids through the BFFD, thereby making the flow rate through the BFFM more uniform throughout the filtration cycle and thereby the leukocyte removal rate. To improve.

  Although the underdrain filter structure illustrated in FIG. 5 is used in the BFFD 100 illustrated in FIGS. 1 and 2, any other type of underdrain filter structure that provides adequate support for the BFFM can be used.

  While the invention has been illustrated and described with specific preferred embodiments, those skilled in the art will make various modifications or variations without departing from the inventive concepts disclosed and taught herein. It will be clear that it can. Such modifications and variations are intended to be included within the scope of the inventive concept. Any combination of the various structures of the embodiments described above is intended to be within the scope of the inventive concept.

Claims (26)

A body fluid filtering device,
An inlet, a first outlet, a second outlet, a first fluid flow path defined between the inlet and the first outlet, and defined between the inlet and the second outlet A housing having a second fluid flow path and wherein the first fluid flow path and the second fluid flow path are not substantially isolated from each other by a partition;
A first body fluid filtration medium having an upstream surface and a downstream surface, disposed between the inlet and the first outlet and across the first fluid flow path;
A second body fluid filtration medium having an upstream surface and a downstream surface, disposed between the inlet and the second outlet and across the second fluid flow path;
A space is formed between the first body fluid filtration medium and the second body fluid filtration medium, and the upstream surface of the first body fluid filtration medium and the upstream surface of the second body fluid filtration medium are A bodily fluid filtration device comprising: an upstream chamber defined to face each other.   The body fluid filtration device according to claim 1, wherein the first body fluid filtration medium and the second body fluid filtration medium are capable of separating white blood cells from the body fluid.   The first flow restriction unit is disposed downstream of the first body fluid filtration medium, and the second flow restriction unit is disposed downstream of the second body fluid filtration medium. The body fluid filtering device described.   The body fluid filtration according to claim 3, wherein the first flow restriction unit is disposed in the first outlet, and the second flow restriction unit is disposed in the second outlet. apparatus. The housing includes a baffle disposed in the upstream chamber and between the first body fluid filtration medium and the second body fluid filtration medium;
The baffle includes at least one opening, and the cross-sectional area of the opening is sized so as not to isolate the upstream chamber into two separate chambers, and the baffle reduces the capacity of the upstream chamber. The body fluid filtering device according to claim 1, wherein: A method for treating bodily fluids, comprising:
Flowing bodily fluid into a filtration device comprising a housing, the housing comprising an inlet, a first outlet, a second outlet, a first fluid defined between the inlet and the first outlet; A flow path and a second fluid flow path defined between the inlet and the second outlet, and the housing includes the first fluid flow path and the second fluid flow path. The steps are not substantially isolated from one another by a septum;
Flowing a portion of the body fluid along the first fluid flow path through a first body fluid filtration medium having an upstream surface and a downstream surface, wherein the first body fluid filtration medium comprises Disposed between an inlet and the first outlet and across the first fluid flow path;
Allowing another part of the body fluid to flow along the second fluid flow path via a second body fluid filtering medium having an upstream surface and a downstream surface, wherein the second body fluid filtering medium comprises: And a step disposed between the inlet and the second outlet and across the second fluid flow path.   7. The method of claim 6, wherein the first body fluid filtration medium and the second body fluid filtration medium are capable of separating white blood cells from the body fluid.   The first flow restriction unit is disposed downstream of the first body fluid filtration medium, and the second flow restriction unit is disposed downstream of the second body fluid filtration medium. The method described. The housing includes a baffle disposed in the upstream chamber and between the first body fluid filtration medium and the second body fluid filtration medium;
The baffle includes at least one opening, and the cross-sectional area of the opening is sized so as not to isolate the upstream chamber into two separate chambers, and the baffle reduces the capacity of the upstream chamber. The method according to claim 6, wherein:   The method of claim 9, wherein the baffle comprises at least one filter support rib on a first side thereof and at least one filter support rib on a second side thereof. An automatic discharge device is arranged upstream of the inlet,
The automatic discharge device automatically discharges the bodily fluid upstream of the first and second bodily fluid filtration media after the flow through the first and second fluid flow paths stops. The method according to claim 6. A body fluid filtration system comprising:
A blood supply bag;
A bodily fluid filtering device disposed downstream of the blood supply bag, wherein the bodily fluid filtering device includes an inlet, an outlet, a fluid flow path defined between the inlet and the outlet, and the inlet and the outlet. A bodily fluid filtration device comprising a bodily fluid filtration medium having an upstream surface and a downstream surface, disposed between and across the fluid flow path,
A blood receiving bag;
A length of tubing in fluid communication with the outlet of the bodily fluid filtration device and in fluid communication with the blood receiving bag;
A bodily fluid filtration system comprising: a flow restriction unit disposed downstream of the bodily fluid filtration medium.   The bodily fluid filtration system according to claim 12, wherein the flow restriction unit is disposed in the bodily fluid filtration device.   The body fluid filtration system according to claim 12, wherein the flow restriction unit is disposed downstream of the outlet of the body fluid filtration device and upstream of the blood receiving bag. The body fluid filtering device is:
A second outlet;
A second fluid flow path defined between the inlet and the second outlet;
A second bodily fluid filtration medium having an upstream surface and a downstream surface, disposed between the inlet and the second outlet and across the second fluid flow path;
The body fluid filtration system includes:
A second blood receiving bag;
A second length of tubing in fluid communication with the second outlet of the bodily fluid filtration device and in fluid communication with the second blood receiving bag;
The bodily fluid filtration system according to claim 12, further comprising a second flow restriction unit disposed downstream of the second bodily fluid filtration medium. The body fluid filtering device further includes a partition wall,
The said partition is provided with the 1st outlet arrange | positioned at the 1st side of the said partition, and the 2nd outlet arrange | positioned at the 2nd side of the said partition. The body fluid filtration system described.   16. The bodily fluid filtration according to claim 15, wherein the bodily fluid filtering device does not have a partition wall that substantially isolates the first fluid channel and the second fluid channel from each other. system. The body fluid filtering device is:
A second inlet;
A second outlet;
A second fluid flow path defined between the second inlet and the second outlet;
A second bodily fluid filtration medium having an upstream surface and a downstream surface disposed between the second inlet and the second outlet and across the second fluid flow path; ,
The body fluid filtration system includes:
A second blood receiving bag;
A second length of tubing in fluid communication with the second outlet of the bodily fluid filtration device and in fluid communication with the second blood receiving bag;
The bodily fluid filtration system according to claim 12, further comprising a second flow restriction unit disposed downstream of the second bodily fluid filtration medium.   The bodily fluid filtering device further includes a partition that isolates the first fluid channel and the second fluid channel from each other, whereby the first fluid channel and the second fluid channel are provided. The body fluid filtration system according to claim 18, wherein the body fluid filtration system is independent. The body fluid filtering device is:
A second outlet;
A second fluid flow path defined between the inlet and the second outlet;
A second body fluid filtration medium having an upstream surface and a downstream surface, disposed between the inlet and the second outlet and across the second fluid flow path;
A second length of tubing in fluid communication with the second outlet of the bodily fluid filtration device and in fluid communication with the blood receiving bag;
The bodily fluid filtration system according to claim 12, further comprising a second flow restriction unit disposed downstream of the second bodily fluid filtration medium. The body fluid filtering device further includes a partition wall,
21. The partition includes a first outlet disposed on a first side of the partition and a second outlet disposed on a second side of the partition. The body fluid filtration system described.   21. The bodily fluid filtration according to claim 20, wherein the bodily fluid filtration device does not have a partition wall that substantially isolates the first fluid channel and the second fluid channel from each other. system. The body fluid filtering device is:
A second inlet;
A second outlet;
A second fluid flow path defined between the second inlet and the second outlet;
A second bodily fluid filtration medium having an upstream surface and a downstream surface, disposed between the second inlet and the second outlet, and across the second fluid flow path;
A second length of tubing in fluid communication with the second outlet of the bodily fluid filtration device and in fluid communication with the blood receiving bag;
The bodily fluid filtration system according to claim 12, further comprising a second flow restriction unit disposed downstream of the second bodily fluid filtration medium.   The bodily fluid filtering device further includes a partition that isolates the first fluid channel and the second fluid channel from each other, whereby the first fluid channel and the second fluid channel are provided. 24. The body fluid filtration system according to claim 23, wherein the body fluid filtration system is independent. The body fluid filtering device is:
A second inlet;
A second fluid flow path defined between the second inlet and the outlet;
A second bodily fluid filtration medium having an upstream surface and a downstream surface disposed between the second inlet and the outlet and across the second fluid flow path;
The body fluid filtration system according to claim 12, wherein the flow restriction unit is disposed downstream of both the first and second body fluid filtration media. The body fluid filtering device is:
A second inlet;
A second fluid flow path defined between the second inlet and the outlet;
A second bodily fluid filtration medium having an upstream surface and a downstream surface disposed between the second inlet and the outlet and across the second fluid flow path;
The first flow restriction unit is disposed between the downstream side of the first body fluid filtration medium and the outlet, and the second flow restriction unit is disposed downstream of the second body fluid filtration medium and the outlet. The body fluid filtration system according to claim 12, wherein the body fluid filtration system is disposed between the two.

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