WO1998017369A2 - Filtre a poche - Google Patents

Filtre a poche Download PDF

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Publication number
WO1998017369A2
WO1998017369A2 PCT/US1997/018616 US9718616W WO9817369A2 WO 1998017369 A2 WO1998017369 A2 WO 1998017369A2 US 9718616 W US9718616 W US 9718616W WO 9817369 A2 WO9817369 A2 WO 9817369A2
Authority
WO
WIPO (PCT)
Prior art keywords
filter
fluid
biological fluid
bag filter
bag
Prior art date
Application number
PCT/US1997/018616
Other languages
English (en)
Other versions
WO1998017369A3 (fr
Inventor
Frank R. Pascale
Leonard R. Castellano
Noel A. Evans
John B. Ronan
Original Assignee
Pall Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pall Corporation filed Critical Pall Corporation
Priority to AU49041/97A priority Critical patent/AU4904197A/en
Publication of WO1998017369A2 publication Critical patent/WO1998017369A2/fr
Publication of WO1998017369A3 publication Critical patent/WO1998017369A3/fr

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D19/00Degasification of liquids
    • B01D19/0031Degasification of liquids by filtration
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D29/00Filters with filtering elements stationary during filtration, e.g. pressure or suction filters, not covered by groups B01D24/00 - B01D27/00; Filtering elements therefor
    • B01D29/11Filters with filtering elements stationary during filtration, e.g. pressure or suction filters, not covered by groups B01D24/00 - B01D27/00; Filtering elements therefor with bag, cage, hose, tube, sleeve or like filtering elements
    • B01D29/13Supported filter elements
    • B01D29/23Supported filter elements arranged for outward flow filtration
    • B01D29/27Filter bags
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01DSEPARATION
    • B01D36/00Filter circuits or combinations of filters with other separating devices
    • B01D36/001Filters in combination with devices for the removal of gas, air purge systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3627Degassing devices; Buffer reservoirs; Drip chambers; Blood filters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/04Liquids
    • A61M2202/0413Blood
    • A61M2202/0439White blood cells; Leucocytes

Definitions

  • This invention relates to a bag filter, preferably a bag filter for filtering biological fluids such as blood or blood components.
  • Bag filters can be used in variety of filtering applications.
  • a bag filter is formed from one or more sheets of fibrous nonwoven webs that are folded into a tubular form, and then the adjoining portions and one end of the tube are sewn together. The resulting bag is turned inside-out, and then the seams are heat-sealed with thermoplastic tape.
  • the bag filter thus produced has two seams, namely a side seam and an end seam. Bag filters produced by sewing and heat-sealing have certain deficiencies. Since the filter medium and/or the seams have been punctured by the sewing needle and are held together by the thread, the structural integrity of the seam and/or the medium, and hence that of the bag filter itself, is weakened.
  • sewn seams can provide fluid leakage pathways during use, thereby allowing unfiltered fluid to bypass the filter medium.
  • the method of producing such bag filters is time-consuming and costly because of the number of steps involved when the seams are sewn and heat-sealed with thermoplastic tape.
  • Some bag filters are formed by merely gluing or thermally sealing the seams, i.e., bonding the fibrous web to itself without any sewing.
  • gluing and thermal sealing techniques avoid the need to puncture the fibrous nonwoven web with a sewing needle
  • the thermal sealing technique also result in two seams, and suffer from other drawbacks.
  • the thermal sealing technique requires the partial melting of the fibrous nonwoven web, thereby adversely affecting the structural integrity and filtering characteristics of the bag filter.
  • gluing or heat-sealing may fail to provide a strong mechamcal bond, and the filter thus produced may be unsuitable for use in rugged environments.
  • Felt bag filters have been used in cardiotomy reservoirs during surgery to remove surgical debris such as bone chips, fat, and clots from blood before returning the blood to the patient.
  • these devices which are used in an extracorporeal circuit, have suffered from a number of deficiencies.
  • the bag filter may leak and/or lack sufficient structural integrity for the reasons set forth above.
  • the device including the bag filter may require additional elements, e.g., for support.
  • the filter may lack sufficient dirt capacity to remove all of the surgical debris without clogging over the course of the surgical procedure. This can be a particular problem, since replacing a cardiotomy reservoir during a surgical protocol can be a labor intensive effort. For example, replacing the device requires disconnecting a number of conduits from the device, and then priming the replacement device before use.
  • blood includes varying amounts of leukocytes
  • the contact of the blood with the various components of the extracorporeal circuit may cause the leukocytes in the blood to become activated.
  • the activated leukocytes may inflict damage to internal organs.
  • the activated leukocytes may release agents that can disrupt and destroy normal cellular functions, and cause other injuries.
  • the most common leukocyte, the granulocytic neutrophil has been implicated as the mediator of tissue destructive events in a variety of disorders, including reperfusion injury, respiratory distress syndromes, and pulmonary edema.
  • conventional cardiotomy reservoirs are not designed to remove leukocytes from blood before the blood is returned to the patient.
  • a bag filter having an open end and a closed end, wherein the closed end is formed without an end seam.
  • the bag filter comprises a filter element comprising a polymeric porous medium including a continuum of polymeric material extending from the open end through the closed end, wherein the filter is formed without a side seam or an end seam.
  • the filter can be used to process a variety of fluids, and is especially useful for filtering a biological fluid such as blood or a blood component.
  • the bag filter is placed in a device such as a cardiotomy reservoir or a drip chamber, and can be used to deplete leukocytes from a biological fluid.
  • Figure 1 is a cross-sectional view of embodiment of the present invention, illustrating a cardiotomy reservoir including a bag filter.
  • FIG. 2 is a schematic illustration of an embodiment of a system according to the present invention, including a cardiotomy reservoir including a bag filter.
  • Figure 3 is a side view of a melt-blowing apparatus showing the translation of a collector having a cap at one end.
  • Figure 4 is an end view of a melt-blowing apparatus with two rows of angled and offset fiberizing nozzles.
  • Figure 5 is a top view of the apparatus illustrated in Figure 4 as seen along line
  • Figure 6 is a cross-sectional view of another embodiment of the present invention, illustrating a drip chamber including a bag filter.
  • Figure 7 illustrates a collector and a variety of different collector caps that can be used to produce bag filters in accordance with the invention.
  • Figure 7A illustrates a collector and one cap.
  • Figures 7B - 7F illustrate other collector caps.
  • FIG. 8 is a cross-sectional view of another embodiment of the present invention, illustrating a cardiotomy reservoir including a bag filter, and further comprising a vent including a porous medium for passing gas therethrough.
  • a filter comprising a filter medium formed into a bag configuration with an opening, an inside surface, and an outside surface, said filter being free of an end seam on at least one end.
  • An embodiment of the present invention also provides a filter comprising a cylindrical filter element comprising a porous medium, the element having a first end, a second end, and a hollow interior, wherein the second end is closed without an end seam.
  • the instant invention also provides a filter comprising a cylindrical filter element comprising a polymeric porous medium, said element having an open end, a closed end, and a hollow interior, wherein the element comprises a continuum of polymeric material at the closed end.
  • the filter comprises a continuum of polymeric material extending from the open end through the closed end.
  • the filter which can be used to filter a variety of fluids, especially biological fluids such as blood and blood components, is typically placed in a housing.
  • An embodiment of the filter device comprises a housing having an inlet and an outlet, and defining a fluid flow path between the inlet and the outlet; a filter disposed in the housing across the fluid flow path, the filter comprising a cylindrical filter element comprising a porous medium, the element having a first end, a second end, and a hollow interior, wherein the second end is closed without an end seam.
  • the present invention also provides a filter device comprising a housing having an inlet and an outlet, and defining a fluid flow path between the inlet and the outlet; a filter disposed in the housing across the fluid flow path, the filter comprising a cylindrical filter element comprising a porous medium, the element having an open end, a closed end, and a hollow interior, wherein the element comprises a continuum of material at the closed end.
  • a method for filtering a fluid comprising passing the fluid through a bag filter comprising a cylindrical filter element comprising a porous medium, the element having a first end, a second end, and a hollow interior, wherein the second end is closed without an end seam.
  • the present invention also provides a method for processing a biological fluid comprising passing a biological fluid containing undesirable material through a bag filter comprising a cylindrical filter element comprising a porous medium, the element having a first end, a second end, and a hollow interior, wherein the second end is closed without an end seam, wherein passing the biological fluid through the filter depletes undesirable material from the biological fluid.
  • filters, devices, methods and systems according to the present invention provide for depleting leukocytes from a biological fluid.
  • a biological fluid includes any treated or untreated fluid (including a suspension) associated with living organisms, particularly blood, including whole blood, warm or cold blood, and stored or fresh blood; treated blood, such as blood diluted with at least one physiological solution, including but not limited to saline, nutrient, and/or anticoagulant solutions; blood components, such as platelet concentrate (PC), platelet-rich plasma (PRP), platelet-poor plasma (PPP), platelet-free plasma, plasma, serum, fresh frozen plasma (FFP), components obtained from plasma, packed red cells (PRC), transition zone material or buffy coat (BC); blood products derived from blood or a blood component or derived from bone marrow; red cells separated from plasma and resuspended in physiological fluid; and platelets separated from plasma and resuspended in physiological fluid.
  • the biological fluid may have been treated to remove some of the leukocytes before being processed according to the invention.
  • blood product or biological fluid refers to the components described above, and to similar blood products or biological
  • a “unit” is the quantity of biological fluid from a donor or derived from one unit of whole blood. It may also refer to the quantity drawn during a single donation. Typically, the volume of a unit varies, the amount differing from patient to patient and from donation to donation. Multiple units of some blood components, particularly platelets and buffy coat, may be pooled or combined, typically by combining four or more units.
  • the porous medium of the bag filter is a medium through which a fluid, typically a biological fluid (e.g., blood or at least one blood component) passes.
  • the porous medium has two opposing sides (e.g., an upstream side and an opposing downstream side, in relation to a biological fluid to be treated by being passed through the porous medium), with a central portion therebetween.
  • the pores in the porous medium generally enable fluid communication between the two opposing sides (e.g., between the upstream and downstream sides) of the porous medium.
  • the porous medium typically removes one or more undesirable substances from the fluid.
  • the porous medium can remove at least one complement component, protein and/or fragment (including biologically active fragments such as C3a); lipids (including lipid globules, lipid droplets, and lipid particulates); coalesced particles; clots; bone fragments; gels; aggregates; microaggregates; and/or leukocytes from a biological fluid.
  • the porous medium of the bag filter comprises a fibrous medium.
  • the porous medium comprises a fibrous nonwoven web, more preferably a melt-blown fibrous nonwoven web wherein material is fiberized by extrusion into a high velocity gas stream and collected as a mass of mechanically entangled or intertwined fibers.
  • the porous medium can be multilayered and/or a composite of different materials and/or media.
  • the porous medium may also include one or more structures having different characteristics and/or functions.
  • the porous medium can comprise a filter providing for leukocyte depletion, as well as prefiltration and/or microaggregate removal.
  • the porous medium can also provide for defoaming and/or venting.
  • the porous medium is configured as a bag filter.
  • the bag filter lacks an end seam at the closed end, i.e., the end is formed as a continuum of material without joining the material by sewing and/or melting the formed material.
  • the bag filter is formed without a side seam and without an end seam, i.e., the continuum of material extends from the closed end of the filter to include the sides of the filter.
  • the continuum extends from the closed end of the filter to include the cylindrical side walls defining the body of the filter.
  • the filter may include portions or areas wherein fiber-to-fiber bonding is increased.
  • the filter can include self-bonded fibers, e.g., on the upstream and/or downstream surface of the filter, so that the fiber-to-fiber bonding provides support and/or drainage.
  • the bag filter may comprise other structures or layers in addition to the filter material, such as an inner liner and outer wrap of a non- woven material such as of polypropylene.
  • the bag filter may include an end cap.
  • the bag filter may also comprise a mesh, screen, and/or membrane.
  • the additional structures can provide, for example, support, drainage, venting and/or defoaming.
  • a variety of materials can be used to produce the porous medium of the bag filter, which typically comprises a polymeric structure.
  • the porous medium comprises a leukocyte depletion medium.
  • Suitable materials include, but are not limited to, synthetic polymeric material, such as, for example, polybutylene terephthalate (PBT), polyethylene, polyethylene terephthalate (PET), polypropylene, polymethylpentene, polyvinylidene fluoride, nylon 6, nylon 66, nylon 612, nylon 11, and nylon 6 copolymers.
  • PBT polybutylene terephthalate
  • PET polyethylene
  • PET polypropylene
  • polymethylpentene polyvinylidene fluoride
  • nylon 6, nylon 66 nylon 612
  • nylon 11 nylon 6 copolymers
  • the leukocyte depletion medium comprises a medium prepared from melt-blown fibers.
  • a medium prepared from melt-blown fibers Illustratively, U.S. Patent Nos. 4,880,548; 4,925,572; 5,152,905; 5,258,127, and 5,443,743; and International Publication No. WO 96/03194, disclose leukocyte adsorption media comprising melt-blown fibers.
  • the leukocyte depletion medium can include a plurality of layers.
  • the porous medium of the bag filter is preferably treated for increased efficiency in processing a biological fluid.
  • the medium may be surface modified to affect the critical wetting surface tension (CWST) of the medium, as described in, for example, U.S. Patent Nos. 4,880,548; 4,925,572; 5,152,905; 5,258,127, and
  • the porous medium of the bag filter according to the invention which is, more preferably, a porous synthetic polymeric medium, has a CWST of greater than about 58 dynes/cm.
  • the medium may have a CWST in the range from about 60 dynes/cm to about 115 dynes/cm, e.g. , in the range of about 61 to about 100 dynes/cm.
  • the medium has a CWST of about 62 dynes/cm, or greater, e.g., in the range from about 63 to about 70 dynes/cm, or in the range from about 85 dynes/cm to about 98 dynes/cm.
  • Surface characteristics of the medium can be modified by chemical reaction including wet or dry oxidation, by coating or depositing a polymer on the surface, or by a grafting reaction. Grafting reactions may be activated by exposure to an energy source such as gas plasma, heat, a Van der Graff generator, ultraviolet light, electron beam, or to various other forms of radiation, or by surface etching or deposition using a plasma treatment.
  • an energy source such as gas plasma, heat, a Van der Graff generator, ultraviolet light, electron beam, or to various other forms of radiation, or by surface etching or deposition using a plasma treatment.
  • a bag filter comprises a filter element comprising a porous medium formed into a bag configuration with an open end, an inside surface, an outside surface, and a closed end, wherein the filter is free of an end seam at the closed end.
  • the bag filter is placed in a housing.
  • device 100 comprises a housing 7, having a plurality of inlets 1, and at least one outlet 3, and a bag filter 4 disposed across the fluid flow path between the inlet(s) and the outlet.
  • the bag filter 4 which is free of an end seam, has an inner surface 11, an outer surface 12, an open end 9, and a closed end 10.
  • device 100 includes a collar or sleeve 8 that engages the open end 9 of bag filter 4, and also includes a retainer 6 to further secure the bag filter in the housing.
  • the illustrated device also includes a vent port 2, as well as a defoaming element 5 upstream of the bag filter 4.
  • the device includes a delivery port 13 (in dotted lines).
  • the device also includes a vent 19, in fluid communication with an inlet 1, the vent 19 having a porous structure 21 that allows gas to pass therethrough.
  • the ports are capped or covered until the device is connected to other components of a processing system such as a pump and/or another component of a biological fluid processing system.
  • the device 100 comprises a cardiotomy reservoir for use in a biological fluid processing system, more preferably, an extracorporeal blood treatment system.
  • a biological fluid processing system more preferably, an extracorporeal blood treatment system.
  • device 100 is interposed between a source of biological fluid such as a patient, and a container 30 for biological fluid such as a venous reservoir for blood.
  • One or more pressure differential generators 70 such as peristaltic pumps pass blood from the patient to the device 100 along conduits 61 (e.g., a cardiotomy sucker line) and 62 (e.g., a ventricular vent line).
  • the bag filter 4 filters the blood, e.g., to remove surgical debris and, more preferably, to deplete the blood of leukocytes, and the filtered blood is passed along conduit 63 and collected in container 30. Typically, at least a portion of the blood is subsequently passed along through an oxygenator 50 and an arterial filter 40 and returned to the patient via conduits 64, 65, and 66, respectively. In the illustrated system, blood may also be passed from the patient to the container 30 along conduit 67 (e.g., a venous line).
  • conduit 67 e.g., a venous line
  • device 100 comprises a drip chamber, comprising a housing 7, having an inlet 1 and an outlet 3, and a bag filter 4 disposed across the fluid flow path between the inlet and the outlet.
  • the bag filter 4 has an inner surface 11, an outer surface 12, an open end 9, and a closed end 10.
  • the filter is free of an end seam, and is preferably also free of a side seam.
  • the filter may be of any suitable configuration and size. Typically, it is generally cylindrical in shape. In one embodiment, the cylindrical shape includes a taper along at least a portion of the length of the filter.
  • the filter can be any suitable size.
  • the filter can have a length of about 1 cm or more. In some embodiments, the length is in the range of about 2.5 cm, to about 2 meters, or more. Typically, the length of the filter is in the range of about 1.3 cm to about 75 cm. In one embodiment, the length of the filter is in the range of about 10 cm to about 36 cm.
  • Illustrative diameters can be about 1 cm or more, more preferably, about 3 cm or more. In some embodiments, the diameter is in the range of about 5 cm to about 200 cm. In other embodiments, the diameter is greater than about 200 cm. Typically, the diameter of the filter is in the range of about 4 cm to about 30 cm.
  • the diameter of the filter can be substantially uniform along its length. Alternatively, portions of the filter may have different diameters. For example, as noted above, the filter can be tapered along at least a portion of its length.
  • the fibers can have any suitable average fiber diameter, or a range of suitable fiber diameters.
  • Illustrative average fiber diameters are about 1 ⁇ m, or less, to about 50 ⁇ m, or more. Typically, the average fiber diameters are about 1.5 ⁇ m to about 40 ⁇ m.
  • Illustrative fiber densities are about .05 g/cc to about .4 g/cc, typically about .10 g/cc to about .25 g/cc.
  • Illustrative voids volumes are about 95% to about 50%, typically about 90% to about 75%.
  • the porosity of the filter medium of the bag filter may be any desired value.
  • the bag filter has a tapered or graded pore structure, with decreasing pore size from the inside surface of the bag filter to the outside surface of the bag filter, which will be in the usual direction of filtration flow.
  • the pore size decreases from the inside surface and approaching the outside surface, and then increases at the outside surface.
  • the filter has a different density and/ or a different fiber diameter along the fluid flow path through the medium.
  • the fiber diameter can be greater at the inside surface than at the outside surface.
  • the fiber density can be lesser at the inside surface than at the outside surface.
  • the bag filter has two or more elements having different pore structures, or the filter comprises a single element providing the different pore structures.
  • the tapered or grade pore structure is capable of providing for the progressive removal of clots and/or bone fragments, microaggregates, and leukocytes, if these materials are present in the biological fluid.
  • clots, gels and/or larger debris such as bone chips can be removed in the portion or the section of the filter having the larger pores, and microaggregates can be removed in the portion or section of the filter having the intermediate size pores.
  • the majority of the leucocytes that are removed by the bag filter are typically removed in the portion or the section of the filter having the smaller pores.
  • the pore structure is initially tapered or graded as described above, and the pores increase in size at the downstream surface. Such a configuration may provide support and/or assist in coalescing bubbles, for example.
  • the filter medium has a more "open" pore structure, e.g., a larger pore size, toward the open end of the filter than at the closed end of the filter.
  • the filter provides a type of automatic bypass system, while providing some level of filtration efficiency.
  • the accumulation of surgical debris such as bone chips and clots near the closed end of the filter can prevent fluid flow through the smaller pores, and the level of fluid in the filter can rise.
  • the larger pores near the open end may offer less resistance to fluid flow.
  • the fluid can pass through the upper portions of the filter, and some undesirable material will still be removed from the fluid.
  • Embodiments of the bag filter can be used with or without a housing.
  • the bag filter is disposed in a housing having an inlet and an outlet and defining a fluid flow path between the inlet and the outlet, wherein the bag filter is disposed across the fluid flow path.
  • the bag filter is disposed in a housing to provide "inside/out” fluid flow, i.e., fluid flow from the inside surface of the bag filter to the outside surface of the filter.
  • “outside/in” to provide fluid flow from the outside surface of the bag filter to the inside surface may also be suitable.
  • Figures 1 and 8 illustrate exemplary embodiments of a device 100 comprising a housing 7, having at least one inlet 1, and at least one outlet 3, and defining a fluid flow path between the inlets and the outlet.
  • the device 100 also includes a bag filter 4 disposed across the fluid flow path between the inlets and the outlet.
  • the bag filter 4 has an inner surface 11, an outer surface 12, an open end 9 and a closed end 10, and is disposed in the housing to provide "inside/out" fluid flow.
  • the device 100 includes a structure arranged to engage the filter.
  • device 100 can include a collar or sleeve 8 that allows engagement with the open end 9 of bag filter 4.
  • the collar or sleeve can slidably or frictionally engage the open end of the filter.
  • the illustrated device further includes a retainer or tie 6 (e.g., a retainer strip or an O ring) to further secure the bag filter in the housing.
  • the bag filter includes a collar attached thereto, and the collar engages with the housing.
  • the device may also provide for separating the air or gas from the fluid to be filtered.
  • the device may also include a vent and/or a defoaming element.
  • the bag filter can provide for venting and/or defoaming.
  • the efficiency of defoaming is further improved by treating the bag filter with an antifoaming agent, or including an antifoaming agent while forming the bag filter.
  • the device in an embodiment, particularly in an embodiment wherein device 100 comprises a cardiotomy reservoir, the device includes a vent and provides for defoaming.
  • the bag filter 4 provides for defoaming by coalescing bubbles of air, and the larger bubbles are vented.
  • the device can include a separate structure, e.g., a defoaming element, that coalesces bubbles of air.
  • device 100 includes a vent port 2 and a defoaming element 5 located upstream of the bag filter 4.
  • device 100 includes a vent 19 including a porous structure 21 that allows gas to pass therethrough.
  • the device can include, for example, a vent including a porous structure, and a defoaming element downstream of the bag filter.
  • the device can include a vent including a porous medium, wherein the device either lacks a defoaming element, or has defoaming elements upstream and downstream of the bag filter.
  • defoaming elements 5 are suitable for carrying out the invention, and the element can be disposed upstream and/or downstream of the bag filter. Additionally, the defoaming element can be treated with antifoaming agents as is known in the art. Moreover, as noted earlier, the bag filter can be treated with, or formed while including at least one defoaming agent. Suitable defoaming elements include, but are not limited to, those disclosed in U.S. Patent Nos. 4,572,724 and 5,362,406, and open cell foams, e.g., polyurethane foams.
  • the embodiment illustrated in Figure 1 includes a plurality of ports, i.e., three inlets 1, an outlet 3, a vent 2, as well as an optional delivery port 13 (dotted lines).
  • delivery port 13 and/ or one or more inlets 1 are sealed (e.g. , with a cap and/or needleless connector) when not in use and/or when the device is not attached to another element of a fluid processing system.
  • the device can have fewer ports, or additional ports, or other combinations of port types.
  • ports can have a plurality of functions.
  • one of the inlet ports can be used as a delivery port, particularly if it is desirable for the material to be delivered, e.g. , a therapeutic agent, to be filtered by the bag filter.
  • a delivery port can be utilized as a vent.
  • an inlet port can be used as a vent port.
  • an inlet port 1 can be in fluid communication with vent 19.
  • the device has an additional outlet port, e.g., to provide for collecting filtered blood in a container other than a venous reservoir.
  • the system including the device can have additional ports upstream and/or downstream of the device as desired.
  • the system can include an additional port downstream of the device 100 to allow filtered blood to be collected in a container other than the venous reservoir 30.
  • the system (and/or the device) can include one or more additional vent ports.
  • the device includes a vent 19 including a porous strucmre 21 for passing gas therethrough.
  • a vent port also includes a pressure relief valve for relieving pressure upstream of the bag filter.
  • the device can have two ports.
  • device 100 can comprise a drip chamber, the housing 7 including an inlet port 1 and an outlet port 3, with bag filter 4 disposed across the fluid flow path from the inlet to the outlet.
  • the device 100 can be any suitable configuration and size.
  • the device has a total capacity of several liters or less, typically about 3 liters or less.
  • the drip chamber has a total capacity of, for example, about 50 cc or less, more preferably about 20 cc or less.
  • about two-thirds of the total capacity of the drip chamber is used for containing the biological fluid, and the rest of the capacity is used to contain air or gas.
  • the housing 7, that can comprise a plurality of portions or sections, can be fabricated from any suitable impervious material, including any impervious thermoplastic material, which is compatible with the fluid being processed.
  • the housing can be fabricated from a metal, or from a polymer.
  • the housing is a transparent or translucent polymer, such as an acrylic, polypropylene, polystyrene, or a polycarbonate resin. Such a housing is easily and economically fabricated, and allows observation of the passage of the biological fluid through the housing.
  • the device can include additional structures such as a screen, core and/or cage, e.g. , for support and/or drainage.
  • the device includes an end cap for the open end of the bag filter.
  • the device includes a porous structure such as a membrane that allows gas to pass therethrough, e.g. , from the interior of the housing through the membrane and the vent.
  • the porous strucmre can comprise a hydrophobic membrane that allows gas, but not biological fluid, to pass therethrough.
  • the bag filter can include the membrane (e.g., as part of a composite).
  • the device includes a vent 19 including a porous structure 21 that allows gas to pass therethrough.
  • the porous strucmre 21 prevents the passage of bacteria therethrough.
  • the porous strucmre can have a pore rating of about 2 ⁇ m or less. In an embodiment, the pore rating can be about .02 ⁇ m.
  • Suitable vents and porous structures include, but are not limited to, those disclosed in U.S. Patent Nos. 5,126,054, 5,451,321, and 5,362,406.
  • At least a portion of the bag filter 4 itself passes gas without passing biological fluid therethrough.
  • at least a portion of the bag filter 4 e.g., a band nearer the open end of the filter than the closed end, or any desired area of the filter
  • CWST Critical Wetting Surface Tension
  • gas, but little or no biological fluid passes through the portions that have the lower CWST.
  • the bag filter can be treated to provide portions having different CWSTs.
  • portions of the bag filter can be surface modified to change the CWST of one or more desired portions, without modifying (or providing less modification to) the CWST of other desired portions.
  • a filter medium having a closed end is produced by forming the medium in a tubular configuration onto a rotating mandrel or collector.
  • fibers can be melt-blown onto a collector 200 (which is preferably generally cylindrical in shape) while the collector is rotating and translating, with the fibers being deposited on the surface of the collector and on one end of the collector.
  • Figure 3 illustrates the translation of the collector 200 with respect to a fiberizer assembly 302.
  • One method of preparing a melt-blown fibrous nonwoven web comprises extruding molten resin from two parallel rows of linearly arranged, substantially equally spaced nozzles to form fibers onto the surface of a collector having a longitudinal axis arranged parallel to the rows of nozzles, wherein the rows of nozzles are offset from each other and are angled toward each other.
  • Figures 4 and 5 illustrate one exemplary arrangement of nozzles 300 on a manifold 301.
  • the rows of nozzles can be offset from each other by, for example, about one-half the spacing between the nozzles within each row and the rows of nozzles are preferably angled toward each other by substantially equal but opposite angles, e.g., each of the rows of nozzles is angled by about 40° or less, more preferably, about 25° or less, from a vertical plumb line originating at the center of the collector.
  • melt-blown fibrous nonwoven webs include using a single row of nozzles, and/or asymmetrically arranged nozzles.
  • the nozzles may be arranged to provide crossed stream fibers or non-crossed stream fibers.
  • Exemplary methods for preparing melt-blown nonwoven webs include but are not limited to those disclosed in U.S. Patent Nos. 4,726,901 and 4,594,202, and International Publication WO 96/03194.
  • the collector 200 can have any suitable diameter, and the diameter can be substantially constant along the length of the collector. Typically, the diameter is about 2 cm or more, more preferably about 4 cm or more. In some embodiments, the diameter is about 5 cm to about 200 cm, e.g. , about 10 cm to 150 cm. In other embodiments, the diameter may be greater than about 200 cm, or about 1 cm, for example.
  • the collector can have, for example, a changing diameter along at least a portion of its length.
  • the collector can include a diameter that generally decreases along a portion of the length, or generally decreases from one end of the collector to the other.
  • Figure 7 A illustrates an embodiment of a collector that can be used in accordance with the invention, having a tapered diameter over a portion of its length.
  • One end of the collector 200 can be configured to produce a desired characteristic or feature for a closed end of the bag filter.
  • the end of the collector can be tapered to produce a less rounded end for the filter.
  • the end of the collector can be inverted to produce, for example, a filter end having a desired density.
  • the collector 200 has a cap 201 to provide the desired filter end characteristic or feature.
  • Figures 7A - 7F illustrate a few of the exemplary shapes of caps 201 that can be used in accordance with the invention.
  • Figures 7A - 7D illustrate caps having angles of 90°, 60°, 60°, and 30°, respectively.
  • Figure 7B illustrates a cap having a stepped shape
  • Figure 7E illustrates a cap having a dimpled shape
  • Figure 7F illustrates a cap having a compound angle, i.e., 60° and 30°.
  • a cap 201 having any angle (including any compound angle) and/or shape can be used in accordance with the invention, one preferred angle is in the range of from about 45° to about 90°. In some embodiments, using a lesser angle than about 90° (e.g. , about 65° or less) provides a medium having a more uniform weight along the cross-section of the medium.
  • the collector 200 can be hollow, with one or more holes in the end and/or sides.
  • the cap 201 can also have one or more holes therethrough. Such configurations may be useful during various stages of producing and handling the filter medium.
  • a positive pressure can be created within the interior of the collector for ease in removing the formed bag filter from the collector.
  • a negative pressure can be created within the interior of the collector while forming the bag filter to more efficiently control the density of the bag medium.
  • the collector (which can be hollow or solid) may be surfaced with a suitable release coating.
  • the collector can be rotated at any suitable surface velocity, generally at least about 20 m/min, and preferably not exceeding about 1000 m min. In an embodiment, the surface velocity is in the range from about 150 m/min to about 250 m/min.
  • the collector 200 is preferably translated at a rate not exceeding about 2 cm/revolution. In one illustrative embodiment, the translation rate does not exceed about 1 cm/revolution.
  • bag filters can be produced having a desired fiber density.
  • the fiber density can be substantially uniform over the entire bag.
  • different portions, sections or areas of the bag can have different densities.
  • the fiber density at the closed end of the bag can be higher or lower than that of the more cylindrical portion of the bag.
  • the nozzles can be spaced any suitable distance from the collector, preferably about 2 cm to about 50 cm, more preferably about 2 cm to about 25 cm.
  • the die-to-collector distance (DCD) which is the distance from the nozzle tip to the surface of the collector, is smaller when a filter medium of higher density with lower voids volume and higher tensile strength is desired.
  • the nozzles can be spaced apart any suitable distance, generally about 2 cm or less. In an illustrative embodiment, the space between the nozzles is about 1 cm or less.
  • the parallel rows can be spaced apart any suitable distance, preferably such that the nozzle tip to nozzle tip separation between rows is about 1 to 2 cm.
  • the web is prepared while a negative pressure is maintained between the rows of the nozzles. Illustratively, a negative pressure in the range from zero to about 4" of water column can be generated within the nozzle manifold 301 to produce a more uniform product. If desired, multiple passes can be made, typically while adjusting the DCD and/or the fiber diameter, to produce a bag filter with the desired characteristics.
  • the rotation and/or translation of the collector can be adjusted or arranged to produce a bag filter with the desired characteristics. For example, as the end of the collector remains in the melt-blown fiber stream, the translation of the collector can be briefly stopped while rotation continues. If desired, the translation of the collector can be adjusted or arranged such that the end of the collector remains in the melt-blown fiber stream for a longer period of time. In general, these arrangements increase the fiber density at the closed end of the filter.
  • bag filters having a decreased fiber density at the closed end of the filter can also be produced in accordance with the invention. This can be especially suitable for some embodiments, e.g., in some embodiments wherein the bag filter is a cardiotomy filter and the closed end of the filter contacts a projection on the inner surface of the cardiotomy housing.
  • the bag filter is a cardiotomy filter and the closed end of the filter contacts a projection on the inner surface of the cardiotomy housing.
  • Such a bag configuration can be easier to fit and seal in conventional cardiotomy housings.
  • the bag filter according to the present invention can be used in any filtering protocol, especially those involving conventional bag filters.
  • the bag filter can be used to filter paints and coatings, especially water-based paints and primers, chemicals, petrochemical products, water, and aqueous suspensions.
  • the inventive bag filter is used to filter a biological fluid.
  • the bag filter can be used in a drip chamber to remove at least one complement protein, component and/or fragment (e.g., C3a).
  • the bag filter can be used in a drip chamber to remove clots, microaggregates and leukocytes from a biological fluid.
  • the bag filter is used to deplete surgical debris and leukocytes from a biological fluid.
  • Figures 1 and 8 illustrate exemplary embodiments of device 100 including a bag filter 4 according to the invention.
  • Figure 2 illustrates a system for filtering a biological fluid in an extracorporeal circuit using the device 100.
  • a biological fluid such as blood is removed from the cavity of the patient and delivered to the device 100 (sometimes referred to below as the "cardiotomy reservoir") via the ventricular vent line and the cardiotomy sucker line(s).
  • the device 100 sometimes referred to below as the "cardiotomy reservoir"
  • cardiotomy sucker line(s) In some embodiments, at least two cardiotomy sucker lines are utilized.
  • Blood passes through inlets 1, defoaming element 5, and bag filter 4.
  • the fluid is depleted of undesirable material such as lipids (e.g., lipid globules) and/ or surgical debris (e.g., aggregates, bone chips and/or clots).
  • the fluid is also depleted of leukocytes.
  • the biological fluid is depleted of about 90% of the leukocytes or more. In some embodiments, the biological fluid is depleted of about 99% of the leukocytes or more, even about 99.9% of the leukocytes or more.
  • defoaming element 5 acts to coalesce bubbles of air, and the coalesced bubbles are vented through vent port 2.
  • defoaming elements can be disposed upstream and/or downstream of the bag filter 4.
  • the bag filter 4 coalesces bubbles.
  • cardiotomy reservoir 100 lacks at least one defoaming element 5
  • the bag filter 4 provides for coalescing the bubbles, which are vented through vent port 2.
  • the bag filter 4 also includes a hydrophobic membrane and/or one or more portions with lower CWSTs
  • the air passes through the membrane and/or the lower CWST portion(s).
  • some of the air can be vented without passing it through the bag filter 4.
  • some of the air entering the device 100 passes out of the device through porous structure 21 and vent 19, without passing through the bag filter 4.
  • the differential pressure across the device preferably is about 15 p.s.i or less. In more preferred embodiments involving a cardiotomy reservoir, the differential pressure is about 10 p.s.i. or less, even more preferably, about 6 p.s.i. or less.
  • the filtered blood passing through cardiotomy reservoir 100 is collected in a container 30 such as a venous reservoir.
  • a container 30 such as a venous reservoir.
  • this blood is returned to the patient via the arterial line (e.g., after passing through an oxygenator 50 and an arterial filter 40).
  • At least a portion of filtered blood is passed from the cardiotomy reservoir 100 to a container other than container 30, or the fluid is passed to another container downstream of container 30.
  • the biological fluid is a red blood cell containing fluid
  • the red blood cells can be saline washed, and the washed cells can be returned to the patient at the patient's bedside, e.g. , after the patient has been disconnected from the extracorporeal circuit illustrated in Figure 2.
  • device 100 comprises a drip chamber.
  • the biological fluid passing through the bag filter 4 can be depleted of undesirable material, if the material is present in the fluid.
  • the biological fluid passing through the bag filter is depleted of lipids, clots, microaggregates and/or at least one complement protein, component and/or fragment.
  • the biological fluid passing through the filter is depleted of leukocytes.
  • the bag filter produced as described above is subsequently modified, for example, by sewing and/or heat sealing.
  • the open end of the bag filter can be closed, or a filter can be produced that is closed at both ends without an end seam at either end.
  • the bag filter can be produced as described above and subsequently pleated along at least a portion of its length, or the fibers can be melt-blown onto a collector shaped to provide a bag filter that is pleated along at least part of its length.
  • the bag filter used in this Example is prepared as follows. Two fiberizers, each with a row of nozzles, are offset axially of each other by 0.38 cm, and are angled toward each other at an inclination of 13° from the vertical.
  • the two sets of intersecting fiber streams deliver polybutylene terephthalate (hereinafter PBT) resin on a cylindrical collector.
  • PBT polybutylene terephthalate
  • the collector is 17.8 cm in length (including the cap), and has a tapered diameter over a portion of its length. The diameter ranges from 6.4 cm near the cap, to 8.4 cm at the other end of the collector. A cap with a 90° angle is used. Release paper is placed over the length of the collector.
  • the collector is rotated at 880 rpm while it is simultaneously translated axially at the rate of .5 cm per revolution for the length of each pass or stroke.
  • the stroke which is 114 cm, is longer than the length of the collector. Fibers are deposited on the surface of the collector, including the capped end of the collector.
  • the collector is operated for 6 passes, and the PBT resin throughput through the nozzles is kept essentially constant.
  • the resin temperature, and the air temperature are each about 650°F (about 346°C).
  • the resin is delivered at the rate of 1.36 grams per minute per nozzle.
  • the air pressure through the fiberizing nozzles is changed before each of the first 5 passes to provide a different fiber diameter for each of the first 5 layers of the filter.
  • the air pressure is essentially the same for passes 5 and 6, and thus, the fiber diameter provided during passes 5 and 6 is essentially the same.
  • the air pressure for the successive passes is 15 p.s.i. , 18 p.s.i. , 25 p.s.i., 32 p.s.i. , 39 p.s.i. , and 39 p.s.i.
  • the average fiber diameter for the successive passes is 10 ⁇ m, 5 ⁇ m, 4 ⁇ m, 2.5 ⁇ m, 2 ⁇ m, and 2 ⁇ m.
  • the die-to-collector distance (DCD) is varied from 2.4 cm for the first pass to 1 cm for the last pass while maintaining an essentially uniform density of .13 g/cc for each layer.
  • the bag filter thus produced is removed from the collector.
  • the filter which is formed without an end seam and without a side seam, is gas plasma treated to provide a critical wetting surface tension (CWST) of about 67 dynes/cm.
  • CWST critical wetting surface tension
  • the bag filter is flexible, and the closed end of the filter is inverted slightly, e.g. , by pushing against the downstream surface of the end of the filter to form a flattened end, before placing the filter in a housing.
  • the treated bag filter is placed in a commercially available cardiotomy reservoir housing after the commercially available cardiotomy filter (and defoamer) is removed.
  • the housing includes an open vent port, a vent port with a pressure relief valve, three inlet ports, and an outlet port. Upon assembly of the housing, the flattened end of the filter contacts a small projection on the inner surface of the housing.
  • a bag filter is produced as described in Example 1. The closed end of the filter is inverted as described above.
  • the treated bag filter is placed in a commercially available cardiotomy reservoir housing after the commercially available cardiotomy filter (and defoamer) is removed.
  • the flattened end of the filter contacts a small projection on the inner surface of the housing.
  • the housing includes an open vent port, a vent port with a pressure relief valve, three inlet ports, and an outlet port.
  • a venting device comprising a housing having an inlet and an outlet and a liquophobic membrane having a diameter of 25 mm disposed across the fluid flow path between the vent housing inlet and outlet is provided.
  • the membrane which is produced in accordance with U.S. Patent No. 5,451,321, has a pore rating of about 2 ⁇ m or less.
  • the venting device is placed in fluid communication with one of the cardiotomy reservoir inlet ports as generally illustrated in Figure 8.

Abstract

L'invention concerne un filtre à poche (4) ayant une extrémité (10) fermée sans couture d'extrémité.
PCT/US1997/018616 1996-10-21 1997-10-15 Filtre a poche WO1998017369A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU49041/97A AU4904197A (en) 1996-10-21 1997-10-15 Bag filter

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US2977196P 1996-10-21 1996-10-21
US60/029,771 1996-10-21
US3300696P 1996-12-16 1996-12-16
US60/033,006 1996-12-16

Publications (2)

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WO1998017369A2 true WO1998017369A2 (fr) 1998-04-30
WO1998017369A3 WO1998017369A3 (fr) 1998-06-04

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AU (1) AU4904197A (fr)
CA (1) CA2198654A1 (fr)
WO (1) WO1998017369A2 (fr)

Cited By (7)

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EP1059094A1 (fr) * 1998-01-22 2000-12-13 Fresenius AG Dispositif de récupération du sang
WO2002011855A1 (fr) * 2000-08-04 2002-02-14 Pheresis Research Limited Filtre
WO2006094752A1 (fr) * 2005-03-11 2006-09-14 Maquet Cardiopulmonary Ag Dispositif de piegeage de bulles d'air veineux
US9805544B2 (en) 2000-11-22 2017-10-31 Intel Corporation Method and system for mediating interactive services over a wireless communications network
US10245508B2 (en) 2000-11-22 2019-04-02 Intel Corporation Method and system for providing interactive services over a wireless communications network
CN113692310A (zh) * 2019-01-29 2021-11-23 唐纳森公司 用于除气的系统和方法
WO2022015714A1 (fr) * 2020-07-14 2022-01-20 Donaldson Company, Inc. Système et procédé de désaération

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EP0146708A2 (fr) * 1983-11-11 1985-07-03 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Dispositif pour prélever et traiter du sang
EP0188104A2 (fr) * 1984-12-18 1986-07-23 BAXTER INTERNATIONAL INC. (a Delaware corporation) Matière filtrante hydrophobique et procédé de traitement avec un agent humidificateur
US4983292A (en) * 1988-06-27 1991-01-08 Morgan Jr H William Seamless filter bag and method of its manufacture
EP0437957A1 (fr) * 1989-12-19 1991-07-24 Medtronic, Inc. Réservoir de cardiotomie
US5586997A (en) * 1994-07-28 1996-12-24 Pall Corporation Bag filter

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EP0772484B1 (fr) * 1994-07-28 2008-02-27 Pall Corporation Bande fibreuse pour traiter un fluide

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Publication number Priority date Publication date Assignee Title
EP0146708A2 (fr) * 1983-11-11 1985-07-03 TERUMO KABUSHIKI KAISHA trading as TERUMO CORPORATION Dispositif pour prélever et traiter du sang
EP0188104A2 (fr) * 1984-12-18 1986-07-23 BAXTER INTERNATIONAL INC. (a Delaware corporation) Matière filtrante hydrophobique et procédé de traitement avec un agent humidificateur
US4983292A (en) * 1988-06-27 1991-01-08 Morgan Jr H William Seamless filter bag and method of its manufacture
EP0437957A1 (fr) * 1989-12-19 1991-07-24 Medtronic, Inc. Réservoir de cardiotomie
US5586997A (en) * 1994-07-28 1996-12-24 Pall Corporation Bag filter

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1059094A1 (fr) * 1998-01-22 2000-12-13 Fresenius AG Dispositif de récupération du sang
US6200276B1 (en) 1998-01-22 2001-03-13 Fresenius Ag Blood collecting device
WO2002011855A1 (fr) * 2000-08-04 2002-02-14 Pheresis Research Limited Filtre
US9805544B2 (en) 2000-11-22 2017-10-31 Intel Corporation Method and system for mediating interactive services over a wireless communications network
US10245508B2 (en) 2000-11-22 2019-04-02 Intel Corporation Method and system for providing interactive services over a wireless communications network
WO2006094752A1 (fr) * 2005-03-11 2006-09-14 Maquet Cardiopulmonary Ag Dispositif de piegeage de bulles d'air veineux
US7798985B2 (en) 2005-03-11 2010-09-21 Maquet Cardiopulmonary Ag Vensous bubble trap
CN113692310A (zh) * 2019-01-29 2021-11-23 唐纳森公司 用于除气的系统和方法
CN113692310B (zh) * 2019-01-29 2024-03-08 唐纳森公司 用于除气的系统和方法
WO2022015714A1 (fr) * 2020-07-14 2022-01-20 Donaldson Company, Inc. Système et procédé de désaération

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AU4904197A (en) 1998-05-15
WO1998017369A3 (fr) 1998-06-04
CA2198654A1 (fr) 1998-04-21

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