WO2001056679A1 - Blood collection systems including an integral, flexible filter - Google Patents
Blood collection systems including an integral, flexible filter Download PDFInfo
- Publication number
- WO2001056679A1 WO2001056679A1 PCT/US2001/003329 US0103329W WO0156679A1 WO 2001056679 A1 WO2001056679 A1 WO 2001056679A1 US 0103329 W US0103329 W US 0103329W WO 0156679 A1 WO0156679 A1 WO 0156679A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- filter
- sheets
- bag
- flexible
- integral
- Prior art date
Links
- 210000004369 blood Anatomy 0.000 title claims abstract description 32
- 239000008280 blood Substances 0.000 title claims abstract description 32
- 239000000463 material Substances 0.000 claims abstract description 39
- 210000000265 leukocyte Anatomy 0.000 claims abstract description 28
- 230000002093 peripheral effect Effects 0.000 claims abstract description 13
- 239000011159 matrix material Substances 0.000 claims abstract description 6
- 239000012503 blood component Substances 0.000 abstract description 4
- 238000012546 transfer Methods 0.000 description 32
- 238000001914 filtration Methods 0.000 description 29
- 238000003860 storage Methods 0.000 description 23
- 210000003743 erythrocyte Anatomy 0.000 description 19
- 210000004623 platelet-rich plasma Anatomy 0.000 description 11
- 210000002381 plasma Anatomy 0.000 description 8
- 239000012530 fluid Substances 0.000 description 7
- 238000000034 method Methods 0.000 description 7
- 229920003023 plastic Polymers 0.000 description 7
- 239000004033 plastic Substances 0.000 description 7
- 238000012545 processing Methods 0.000 description 7
- 239000003634 thrombocyte concentrate Substances 0.000 description 6
- 239000002657 fibrous material Substances 0.000 description 5
- 210000001772 blood platelet Anatomy 0.000 description 4
- 239000011148 porous material Substances 0.000 description 4
- 238000011045 prefiltration Methods 0.000 description 4
- 238000007789 sealing Methods 0.000 description 4
- 230000001954 sterilising effect Effects 0.000 description 4
- 238000004659 sterilization and disinfection Methods 0.000 description 4
- 238000011144 upstream manufacturing Methods 0.000 description 4
- 230000000712 assembly Effects 0.000 description 3
- 238000000429 assembly Methods 0.000 description 3
- 239000000306 component Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
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- 229920000915 polyvinyl chloride Polymers 0.000 description 3
- 239000004800 polyvinyl chloride Substances 0.000 description 3
- 239000004698 Polyethylene Substances 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 238000001816 cooling Methods 0.000 description 2
- 238000011118 depth filtration Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 230000007774 longterm Effects 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 239000002985 plastic film Substances 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 230000037452 priming Effects 0.000 description 2
- 239000012209 synthetic fiber Substances 0.000 description 2
- 229920002994 synthetic fiber Polymers 0.000 description 2
- 238000013022 venting Methods 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- 239000004803 Di-2ethylhexylphthalate Substances 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 229920012485 Plasticized Polyvinyl chloride Polymers 0.000 description 1
- 239000004743 Polypropylene Substances 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- KRADHMIOFJQKEZ-UHFFFAOYSA-N Tri-2-ethylhexyl trimellitate Chemical compound CCCCC(CC)COC(=O)C1=CC=C(C(=O)OCC(CC)CCCC)C(C(=O)OCC(CC)CCCC)=C1 KRADHMIOFJQKEZ-UHFFFAOYSA-N 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- BJQHLKABXJIVAM-UHFFFAOYSA-N bis(2-ethylhexyl) phthalate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 230000012953 feeding on blood of other organism Effects 0.000 description 1
- 229920002457 flexible plastic Polymers 0.000 description 1
- 230000005484 gravity Effects 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
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- 238000004519 manufacturing process Methods 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
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- 229920001778 nylon Polymers 0.000 description 1
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- 229920000728 polyester Polymers 0.000 description 1
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- 238000012552 review Methods 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
Classifications
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- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
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- B29C65/00—Joining or sealing of preformed parts, e.g. welding of plastics materials; Apparatus therefor
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- B29C66/05—Particular design of joint configurations
- B29C66/10—Particular design of joint configurations particular design of the joint cross-sections
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- B29C66/53—Joining single elements to tubular articles, hollow articles or bars
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- B29C66/9261—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools by controlling or regulating the pressure, the force, the mechanical power or the displacement of the joining tools by controlling or regulating the displacement of the joining tools
- B29C66/92651—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools by controlling or regulating the pressure, the force, the mechanical power or the displacement of the joining tools by controlling or regulating the displacement of the joining tools by using stops
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- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/92—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools
- B29C66/929—Measuring or controlling the joining process by measuring or controlling the pressure, the force, the mechanical power or the displacement of the joining tools characterized by specific pressure, force, mechanical power or displacement values or ranges
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C66/00—General aspects of processes or apparatus for joining preformed parts
- B29C66/90—Measuring or controlling the joining process
- B29C66/94—Measuring or controlling the joining process by measuring or controlling the time
- B29C66/949—Measuring or controlling the joining process by measuring or controlling the time characterised by specific time values or ranges
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
- B29K2023/04—Polymers of ethylene
- B29K2023/06—PE, i.e. polyethylene
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2027/00—Use of polyvinylhalogenides or derivatives thereof as moulding material
- B29K2027/06—PVC, i.e. polyvinylchloride
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2009/00—Layered products
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/14—Filters
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/712—Containers; Packaging elements or accessories, Packages
- B29L2031/7148—Blood bags, medical bags
Definitions
- the invention generally relates to blood col- lection and processing systems and methods .
- the invention provides a blood collection system comprising a container for holding blood and a filter communicating with the container.
- the filter includes first and second flexible sheets comprising a meltable material and a depth filter medium comprising a meltable material.
- a peripheral seal joins the sheets directly to the filter medium to encapsulate the filter medium between the first and second sheets .
- the seal comprises a commingled melted matrix comprising material of the sheets and material of the filter medium.
- the filter medium removes leukocytes from blood.
- Fig. 1 is a schematic view of a blood collection and storage system that includes an integral flexible filter that removes leukocytes from red blood cells;
- Fig. 2 is an exploded perspective view of the integral flexible filter that forms a part of the system shown in Fig. 1, showing inlet and outlet ports that pass through the unitary peripheral seal;
- Fig. 3 is an assembled perspective view of the integral flexible filter shown in Fig. 2;
- Fig. 4 is an assembled perspective view of an alternative embodiment of an integral flexible filter that can form a part of the system shown in Fig. 1, showing inlet and outlet ports that do not pass through the unitary peripheral seal;
- Fig. 5 is a perspective diagrammatic view showing a pre-assembled form of the integral flexible filter shown in Fig. 2, being assembled from continuous roll stock;
- Fig. 6 is a side section view of the pre- assembled form of the integral flexible filter shown in Fig. 5, as it passes between two spaced apart radio frequency energy dies;
- Fig. 7 is a side section view of the pre- assembled form of the integral flexible filter shown in Fig. 6, engaged by the dies, which apply radio frequency energy to form a unitary peripheral seal;
- Fig. 8 is a top view of multiple sealed filter assemblies that are sequentially formed and die cut into individual filters 20 that can be integrated into the system shown in Fig. 1;
- Fig. 9 is a schematic view of a blood collection and storage system that includes an integral flexible filter that removes leukocytes from red blood cells, with a by pass channel for venting air around the filter;
- Fig. 10 is a schematic view of a blood collection and storage system that includes an integral flexible filter that removes leukocytes from red blood cells, with an integral air venting bag;
- Fig. 11 is a schematic view of a blood collection and storage system that includes two integral flexible filters, one to remove leukocytes from red blood cells and the other to remove leukocytes from platelet- rich plasma; and
- Fig. 12 is a schematic view of a blood collection and storage system that includes an integral flexible filter that removes leukocytes from whole blood prior to centrifugal processing.
- Fig. 1 shows a manual blood collection and storage system 10 having an integral flexible filter 20.
- the system 10 provides red blood cells for long term storage that are substantially free of leukocytes .
- the system 10 also provides platelet concentrate and the platelet -poor plasma for long term storage.
- the blood collection and storage assembly 10 once sterilized, constitutes a sterile, "closed" system, as judged by the applicable standards in the United States.
- the system 10 is a disposable, single use item.
- the system 10 includes a primary bag 12 and three transfer bags or containers 14, 16, and 18. Like the flexible filter 20, the transfer bags 14, 16, and 18 are integrally attached to the system 10. In use, the system 10 is manipulated in conventional ways.
- the primary bag 12 (which is also called a donor bag) receives whole blood from a donor through integrally attached donor tube 22 that carries an phlebotomy needle 24.
- a suitable anticoagulant A is contained in the primary bag 12.
- the whole blood is centrifugally separated by convention means inside the primary bag 12 into red blood cells and platelet-rich plasma. Leukocytes dwell in the interface between the red blood cells and platelet-rich plasma.
- the transfer bag 14 is intended to receive platelet-rich plasma separated from the whole blood collected in the primary bag 12. Attempts are made when transferring the platelet -rich plasma out of the primary bag 12 to keep as many leukocytes in the primary bag 12 as possible.
- the transfer of platelet-rich plasma into the transfer bag 14 leaves the red blood cells and the leukocytes behind in the primary bag 12.
- the transfer bag 16 contains a suitable storage solution S for red blood cells.
- One such solution is disclosed m Grode et al U.S. Patent 4,267,269, which is sold by Baxter Healthcare Corporation under the brand name ADSOL ® Solution.
- the storage solution S is transferred into the primary bag 12 after transfer of the platelet-rich plasma into the transfer bag 14.
- the platelet-rich plasma is centrifugally separated by conventional means m the transfer bag 14 into platelet concentrate and platelet-poor plasma
- the platelet-poor plasma is transferred into the transfer bag 16, which is now emptied of storage solution S.
- the transfer bag 16 serves as the storage container for the platelet-poor plasma.
- the transfer bag 14 serves as its storage container for the platelet concentrate.
- the storage solution S is mixed with the red blood cells and leukocytes remaining m the primary bag 12.
- the mixture of storage solution S, red blood cells, and leukocytes is transferred from the primary bag 12 through tubing 26.
- the tubing 26 carries m-line the integral, flexible filter 20.
- the flexible filter 20 includes a filtration medium 28 contained within a housing 30. The filtration medium is selected to remove leukocytes from red blood cells.
- the leukocyte-reduced red blood cells enter the transfer bag 18.
- the transfer bag 18 serves as the storage container for the leukocyte-reduced red blood cells .
- the bags and tubing associated with the processing system 10 can all be made from conventional approved medical grade plastic materials, such as polyvmyl chloride plasticized with d ⁇ -2-ethylhexyl- phthalate (PVC-DEHP) .
- the bags are formed using conventional heat sealing technologies, e.g., radio frequency (RF) heat sealing.
- RF radio frequency
- the transfer bag 14 since the transfer bag 14 is intended to store the platelet concentrate, it can be made of polyolefin material (as disclosed in Gajewski et al U.S. Patent 4,140,162) or a polyvinyl chloride material plasticized with tri-2-ethylhexyl trimellitate
- TEZTM TEZTM
- DEHP- plasticized polyvinyl chloride materials have greater gas permeability that is beneficial for platelet storage.
- the flexible filter 20, like the rest of the system 10, is a disposable, single use item.
- the filter housing 30 is made using conventional approved medical grade plastic materials.
- the filter housing 30 is formed using conventional radio frequency heat sealing technology. The filter 20, being flexible, facilitates handling and reduces the incidence of damage to other components of the system 10 during centrifugal processing.
- the filter housing 30 comprising first and second sheets 32 and 34 of medical grade plastic material, such as polyvinyl chloride plasticized with di-2-ethylhexyl- phthalate (PVC-DEHP) .
- medical grade plastic materials can be used that are not PVC and/or are DEHP- free, provided that the material heats and flows when exposed to radio frequency energy.
- the filtration medium 28 is made from a fibrous material, which is sandwiched between the sheets 32 and 34.
- the filtration medium 28 can be arranged in a single layer or in a multiple layer stack.
- the medium 28 can include melt blown or spun bonded synthetic fibers (e.g., nylon or polyester or polypropylene), semi- synthetic fibers, regenerated fibers, or inorganic fibers.
- the medium 28 removes leukocytes by depth filtration.
- the filtration medium 28 comprises, in the blood flow direction, a prefilter region, a main filter region, and a postfilter region.
- the prefilter and postfilter are made of fibrous material (e.g., polyethylene) having a pore size and fiber diameter not suited for leukocyte removal .
- the fibrous material of the prefilter is sized to remove gross clots and aggregations present in the blood.
- the fibrous material of the postfilter is sized to provide a fluid manifold effect at the outlet of the filter.
- the prefilter material has a pore size of between about 15 ⁇ m to about 20 ⁇ m
- the postfilter material has a pore size of about 20 ⁇ m.
- the main filter region is made of a fibrous material (e.g., polyethylene) having a pore size and diameter sized to remove leukocytes by depth filtration.
- the material of the main filter region can have the characteristics described in atanabe et al . United States Patent No. 4,701,267 or Nishimura et al . United States Patent No. 4,936,998, which are incorporated herein by reference .
- the filtration medium 28 can be made symmetric, meaning that the material layers of filtration medium encountered during flow through the medium 28 are the same regardless of the direction of flow. Thus, either side of the medium 28 can serve as an inlet or an outlet.
- the symmetric nature of the filtration medium 28 further simplifies manufacture, as it is not necessary to differentiate between "inlet” and “outlet” side of the filtration medium 28 or "inlet” or “outlet” orientation of the sheets 32 and 34.
- a unitary, continuous peripheral seal 36 is formed by the application of pressure and radio frequency heating in a single process to the two sheets 32 and 34 and filtration medium 28.
- the seal 36 joins the two sheets 32 and 34 to each other, as well as joins the filtration medium 28 to the two sheets 32 and 34.
- the seal 36 integrates the material of the filtration medium 28 and the material of the plastic sheets 32 and 34, for a reliable, robust, leak-proof boundary. Since the seal 36 is unitary and continuous, the possibility of blood shunting around the periphery of the filtration medium 30 is eliminated.
- the filter 20 also includes inlet and outlet ports 38 and 40.
- the ports 38 and 40 comprise tubes made of medical grade plastic material, like PVC-DEHP.
- the ports 38 and 40 can be located in the integrated peripheral seal 36, and be sealed in place at the same time that the unitary peripheral seal 36 is formed.
- the ports 38 and 40 can be inserted and sealed to each sheet 32 and 34 in a separate assembly process before the unitary peripheral seal is formed, in the manner shown in Fischer et al .
- the ports 38 and 40 can comprise separately molded parts that are heat sealed by radio frequency energy over a hole formed in the sheets.
- the symmetric orientation of filtration medium 28, described above, makes the filter 30 "non- directional."
- the port 38 can be oriented to serve either as an inlet port or an outlet port, with the other port 40 serving, respectively, as the corresponding outlet port or inlet port, and vice versa.
- the filter 20 (see Fig. 5) is formed from roll stock 42 and 44 of the first and second plastic sheets 32.
- the layer or layers of filtration medium 28 are also supplied from roll stock 46.
- the roll stock 42, 44, and 46 supply a continuous, layered filter pre-assembly 48.
- the pre-assembly 48 is advanced in measured steps between a pair of opposed dies 50 and 52 (see Fig. 6) . Between each step, the opposed dies 50 and 52 are moved together (see Fig. 7) , to apply pressure to press the peripheral edge of the pre-assembly 48 together.
- a stop 54 is provided to accurately space the dies 50 and 52 apart from each other.
- RF energy is applied through the dies 50 and 52, The combination of RF energy and pressure softens the plastic material of the sheets 32 and 34.
- the applied pressure causes the heat softened material of the sheets 32, 34 to penetrate the interstices of the filtration medium 28, creating an interior matrix of sheet material commingled with filtration medium material. Within the matrix, the filtration medium melts , creating a composite seal 36.
- the seal 36 comprises mostly the material of the sheets 32 and 34. With increasing distance from the surface, the seal 36 comprises a commingled melted matrix of the material of the sheets 32 and 34 and the material of the filtration medium 28. This is believed to occur because the sheet material, which is electrically heated and caused to flow by the applied radio frequency energy, is further caused by the applied pressure to flow into and penetrate the interstices of the medium 28. The heated sheet material that flows under pressure into the interstices of the medium 28 causes the medium 28 itself to melt about it.
- the seal 36 sets and the dies 50 and 52 are withdrawn.
- the dies 50 and 52 are coupled to a 4 KW radio frequency energy generator. Pressure of 60 PSI is applied, maintaining a die gap of 1.2 mm. A sealing time of about 5.5 seconds is realized, followed by a cooling time of about 5 seconds.
- multiple sealed filter assemblies 56 can be sequentially formed along the pre- assembly 48.
- the filter assemblies are die cut into individual filters 20 (as shown by phantom lines 84 in Fig. 8) .
- the filter 20 is then integrated into a blood processing and collection system 10, as shown in Fig. 1. As Figs.
- the dies 50 and 52 can be provided with aligned concave recesses 58.
- the recesses 58 register to receive the port tubes 38 and 40.
- the dies 50 and 52 are brought together about the port tubes 38 and 40 and along the remaining periphery of the pre-assembly 48.
- Mandrels (not shown) are inserted into the tubes 38 and 40 to prevent deformation of the tubes 38 and 40 while the seal 36 forms. The mandrels are removed after the seal 36 cools .
- the flexible filter housing 30 comprises a variable volume reservoir that can be used, after filtration, to receive residual air trapped in the transfer bag 18.
- a variable volume reservoir that can be used, after filtration, to receive residual air trapped in the transfer bag 18.
- leukocyte-depleted red blood cells have been transferred from the filter 20 into the bag 18, residual air is expressed from the transfer bag 18 back into the filter housing 30.
- Tubing upstream of the filter 20 can be clamped closed to trap air in the filter housing 30.
- the housing 30 expands to accommodate the residual air volume.
- the residual air in the transfer bag 18 can be transferred back into the primary bag 12 through an air vent path that bypasses the filter 20.
- a tubing path 60 leads from the transfer bag 18 to the primary bag 12, through which residual air can be vented out of the transfer bag 18.
- an air bypass channel 62 can be provided around the filter 20.
- An in-line one-way valve 64 can be placed in the bypass channel 62, to prevent blood flow through the channel in the direction toward the transfer bag 18.
- residual air in the transfer bag 18 can be transferred into an air vent bag 66 through an integral air vent tube 68.
- a flexible filter can be integrated in different ways into multiple blood bag systems.
- a system 10' like that shown in Fig. 1 can include a second integral flexible filter 20' in-line between the primary bag 12 and the transfer bag 14.
- the filtration medium 28' is selected to remove leukocytes from platelet-poor plasma prior to entering the transfer bag 14.
- Fig. 12 shows a system 70 that includes a primary bag 72 and transfer bags 74, 76, 78.
- the primary bag 72 receives whole blood from a donor.
- the whole blood is transferred from the primary bag 72 through tubing 80 into the transfer bag 74.
- the tubing 80 carries in-line an integral, flexible filter 82 of the type previously described.
- the filtration medium 84 is selected to remove leukocytes from the whole blood, without also removing platelets or red blood cells.
- the leukocyte-depleted whole blood is centrifugally processed in the transfer bag 74 into red blood cells and platelet- rich plasma, both of which are in a leukocyte-depleted condition.
- the transfer bag 76 receives the leukocyte- depleted platelet-rich plasma, leaving the leukocyte- depleted red blood cells in the transfer bag 74 for storage.
- the platelet-rich plasma is centrifugally separated by conventional means in the transfer bag 76 into platelet concentrate and platelet-poor plasma.
- the platelet-poor plasma is transferred into the transfer bag 78 for storage. This leaves the platelet concentrate in the transfer bag 76, which serves as its storage container .
- the flexible filter that embodies the invention avoids the handling and processing problems rigid filter housings have presented in the past. Unlike a rigid housing, the flexible housing 30 will not puncture associated bags, which are also made of flexible plastic materials. Unlike a rigid housing, the flexible housing 30 conforms and is compliant to stress and pressures induced during use .
- the close proximity of the flexible sheet 32 and the filtration medium 28 on the inlet side of the filter 20 creates a capillary effect, which promotes displacement of air and automatic priming of the filter 30 under the fluid head pressure of gravity flow from a source container.
- the fluid head pressure causes the flexible sheet 32 to distend or expand after priming. It thus creates a natural pressure manifold, which evenly distributes the fluid across the inlet face of the filtration medium 28. This assures that entrapped air is vented and that the fluid flows through the filtration medium 28 under uniform pressure and distribution.
- the flexible filter 30 provides a visual indication of an upstream occlusion or blockage during use. If an occlusion occurs in the inlet tubing upstream of the filter 30 during use (e.g., by formation of a kink in the tubing or by formation of an in-line blood clot) , the inlet and outlet sheets 32 and 34 of the housing 30 will respond by collapsing, in the same fashion occasioned by an empty source container. Thus, an unexpected collapse of the filter 30 during use visually signifies the presence of an occlusion upstream of the filter 30.
- the flexible housing 30 will not crack during heat sterilization.
- the flexible housing 30 also does not impede heat penetration during heat sterilization processes. Instead, the housing 30 accommodates uniform heat penetration into the filtration medium 28.
- the filter 20 can undergo sterilization at the same time the entire system 10 is sterilized, making a one-step sterilization process possible.
Abstract
Description
Claims
Priority Applications (8)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2001556567A JP4186096B2 (en) | 2000-02-04 | 2001-02-01 | Blood collection system including an integrated flexible filter |
CA2368645A CA2368645C (en) | 2000-02-04 | 2001-02-01 | Blood collection systems including an integral, flexible filter |
EP01908785A EP1204447A4 (en) | 2000-02-04 | 2001-02-01 | Blood collection systems including an integral, flexible filter |
MXPA01010043A MXPA01010043A (en) | 2000-02-04 | 2001-02-01 | Blood collection systems including an integral, flexible filter. |
AU36618/01A AU780793B2 (en) | 2000-02-04 | 2001-02-01 | Blood collection systems including an integral, flexible filter |
BR0104379-0A BR0104379A (en) | 2000-02-04 | 2001-02-01 | Blood collection systems that include a flexible, integral filter |
IL14530601A IL145306A (en) | 2000-02-04 | 2001-02-01 | Blood collection systems including an integra., flexible filter |
NO20014800A NO20014800L (en) | 2000-02-04 | 2001-10-03 | Blood collection systems with an integrated flexible filter |
Applications Claiming Priority (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/498,085 | 2000-02-04 | ||
US09/498,085 US6367634B1 (en) | 1993-12-22 | 2000-02-04 | Blood collection systems including an integral, flexible filter |
US09/593,782 | 2000-06-14 | ||
US09/593,782 US6422397B1 (en) | 1993-12-22 | 2000-06-14 | Blood collection systems including an integral, flexible filter |
Publications (1)
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WO2001056679A1 true WO2001056679A1 (en) | 2001-08-09 |
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PCT/US2001/003329 WO2001056679A1 (en) | 2000-02-04 | 2001-02-01 | Blood collection systems including an integral, flexible filter |
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US (3) | US6422397B1 (en) |
EP (1) | EP1204447A4 (en) |
JP (1) | JP4186096B2 (en) |
KR (1) | KR100808691B1 (en) |
CN (1) | CN1207078C (en) |
AU (1) | AU780793B2 (en) |
BR (1) | BR0104379A (en) |
CA (1) | CA2368645C (en) |
IL (1) | IL145306A (en) |
MX (1) | MXPA01010043A (en) |
NO (1) | NO20014800L (en) |
WO (1) | WO2001056679A1 (en) |
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WO2008145847A2 (en) * | 2007-04-25 | 2008-12-04 | Maco Pharma | Filtration unit for a biological fluid equipped with an offset inlet and/or outlet element |
WO2008145847A3 (en) * | 2007-04-25 | 2009-06-25 | Maco Pharma Sa | Filtration unit for a biological fluid equipped with an offset inlet and/or outlet element |
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US20100084332A1 (en) * | 2008-09-29 | 2010-04-08 | Fenwal, Inc. | Flexible housing filter and methods for making such filter |
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Also Published As
Publication number | Publication date |
---|---|
EP1204447A4 (en) | 2009-07-22 |
IL145306A0 (en) | 2002-06-30 |
US7353956B2 (en) | 2008-04-08 |
KR20010108436A (en) | 2001-12-07 |
JP4186096B2 (en) | 2008-11-26 |
US20020148764A1 (en) | 2002-10-17 |
KR100808691B1 (en) | 2008-02-29 |
US6745902B2 (en) | 2004-06-08 |
IL145306A (en) | 2005-11-20 |
AU3661801A (en) | 2001-08-14 |
US20040149646A1 (en) | 2004-08-05 |
AU780793B2 (en) | 2005-04-14 |
CN1207078C (en) | 2005-06-22 |
CA2368645C (en) | 2010-01-26 |
BR0104379A (en) | 2002-01-02 |
CN1362891A (en) | 2002-08-07 |
MXPA01010043A (en) | 2002-06-21 |
JP2003521358A (en) | 2003-07-15 |
EP1204447A1 (en) | 2002-05-15 |
US6422397B1 (en) | 2002-07-23 |
CA2368645A1 (en) | 2001-08-09 |
NO20014800L (en) | 2001-12-03 |
NO20014800D0 (en) | 2001-10-03 |
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