EP0313348A2
Expired / Lapsed
EP
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Device and method for depletion of the leukocyte content of blood and blood components
Assignee: Pall Corp
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Filing: 1988-10-20
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Granted: —
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Expires: 2008-10-20
Abstract
Abstract Devices for the depletion of leukocytes in blood products, preferably comprising an upstream porous element including means for removal of gels, at least one intermediate porous element including means for removal of microaggregates, and a downstream element including means for removal of leukocytes by both adsorption and filtration, preferably with at least one of the elements having been modified to a CWST in excess of 53 dynes/cm.
Inventors
- 👤 David B. Pall
Bibliographic Details
Application Number
—
Jurisdiction
EP
Data Source
google_patents
Last Synchronized
2026-10-28 17:25
CPC Classifications
A; A61; A61M; A61M1/00; A61M1/36; A61M1/3621; A61M1/3627; A61M1/3633; B; B01; B01D; B01D35/00; B01D35/30; B01D39/00; B01D39/02; B01D39/04; B01D39/14; B01D39/16; B01D39/1607; B01D39/1623; A61M2202/00; A61M2202/04; A61M2202/0413; A61M2202/0439; A61M2205/00; A61M2205/75; B01D2239/00; B01D2239/12; B01D2239/1208; B01D2239/1216; B01D2239/1291
Claims Analysis
Total Claims: 71
Claim 1
Independent Claim
71 words
A device for the depletion of the leukocyte content of a blood product comprising at least first, second, and third preformed porous elements with the second element interposed between the first and third elements, each successive element having a smaller pore diameter than that preceding it, the first element including means for removing gels, the second element including means for removing microaggregates, and the third element including means for removing leukocytes.
Claim 2
Independent Claim
71 words
A device for the depletion of the leukocyte content of a blood product comprising at least first, second, and third preformed porous elements with the second element interposed between the first and third elements, each successive element having a smaller pore diameter than that preceding it, the first element including means for removing gels, the second element including means for removing microaggregates, and the third element including means for removing leukocytes.
Claim 3
Dependent Claim
44 words
The device of claim 1 in which the third element has a pore diameter in the range of from about 4 to about 5.5 micrometers, the device being well suited for processing a blood product of age 2 to about 5 to 10 days.
Claim 4
Dependent Claim
43 words
The device of claim 1 in which the third element has a pore diameter in the range of from about 6 to about 8 micrometers, the device being well suited for processing a blood product of age in excess of about 10 days.
Claim 5
Dependent Claim
18 words
The device of claim 1 in which the first element in the series comprises a needled fibrous structure.
Claim 6
Dependent Claim
17 words
The device of claim 4 in which the first element has been hot compressed to controlled thickness.
Claim 7
Dependent Claim
41 words
The device of claim 1 in which there are at least two interposed elements comprised of porous media which in at least three steps span in approximate geometric progression the pore diameter range of from about 25 to about 10 micrometers.
Claim 8
Dependent Claim
35 words
The device of claim 1 in which there are at least two interposed elements comprised of porous media having progressively stepwise decreasing pore diameters spanning the range of from about 25 to about 10 micrometers.
Claim 9
Dependent Claim
38 words
The device of claim 1 in which the pore diameter of a single interposed element varies progressively stepwise from about 25 micrometers down to a pore diameter in the range of from about 10 to about 15 micrometers.
Claim 10
Dependent Claim
19 words
The device of claim 1 in which a surfactant has been added to one or more of the elements.
Claim 11
Dependent Claim
34 words
The device of claim 9 in which the surfactant characteristics are such as to induce a surface tension in the range of about 55 to 45 dynes/cm in a blood product processed through it.
Claim 12
Dependent Claim
24 words
The device of claim 1 in which at least one of the elements has been modified to a CWST in excess of 53 dynes/cm.
Claim 13
Dependent Claim
25 words
The device of claim 11 in which at least one of the elements has been modified to a CWST in excess of about 59 dynes/cm.
Claim 14
Dependent Claim
24 words
The device of claim 12 in which at least one of the elements has been modified to a CWST in excess of 63 dynes/cm.
Claim 15
Dependent Claim
30 words
The device of claim 11 in which at least one of the elements has been modified to a CWST in the range of from about 55 to about 75 dynes/cm.
Claim 16
Dependent Claim
30 words
The device of claim 14 in which at least one of the elements has been modified to a CWST in the range of from about 55 to about 70 dynes/cm.
Claim 17
Dependent Claim
65 words
The device of claim 11 in which at least one of the elements has been surface modified by exposure to an energy source while in contact with a monomer containing at least one hydroxyl moiety and one moiety capable of activation by an energy source, together with a monomer containing at least one hydrophobic moiety and one moiety capable of activation by an energy source.
Claim 18
Dependent Claim
24 words
The device of claim 1 in which the effective cross sectional area of each of the elements is in excess of 54 square centimeters.
Claim 19
Dependent Claim
18 words
The device of claim 1 wherein the means for removing leukocytes in the third element includes filtration means.
Claim 20
Independent Claim
88 words
A device for the depletion of the leukocyte content of a blood product comprising at least first, second, and third porous elements with the second element interposed between the first and third elements, each successive element having a smaller pore diameter than that preceding it, the first element including means for removing gels, the second element including means for removing microaggregates, and the thirds element including means for removing leukocytes, and at least one of the elements has been modified to a CWST in excess of 53 dynes/cm.
Claim 21
Independent Claim
88 words
A device for the depletion of the leukocyte content of a blood product comprising at least first, second, and third porous elements with the second element interposed between the first and third elements, each successive element having a smaller pore diameter than that preceding it, the first element including means for removing gels, the second element including means for removing microaggregates, and the thirds element including means for removing leukocytes, and at least one of the elements has been modified to a CWST in excess of 53 dynes/cm.
Claim 22
Dependent Claim
35 words
The device of claim 19, said device consistently providing prior to clogging a capacity of at least two units of blood product of any age up to and including its permissible limit for human use.
Claim 23
Dependent Claim
49 words
The device of claim 20 in which the total voids volume of all the elements is less than 28 milliliters, in which the total internal voids volume of the device is less than 37 milliliters, and in which the total volume of the device is less than 60 milliliters.
Claim 24
Dependent Claim
26 words
The device of claim 20 in which the porous elements are fibrous and total surface area of all the fibers is less than 4 square meters.
Claim 25
Dependent Claim
21 words
The device of claim 20 in which the total surface area of all the fibers is less than 3.5 square meters.
Claim 26
Dependent Claim
28 words
The device of claim 1, 22, or 23 in which the pore diameter of the third element is in the range of about 4 to about 8 micrometers.
Claim 27
Dependent Claim
17 words
The device of claim 19 wherein the first element includes two or more means for removing gels.
Claim 28
Independent Claim
37 words
A device for the depletion of the leukocyte content of a blood product comprising at least one integral element preformed of synthetic fibers, the surfaces of said fibers having a modified CWST in excess of 53 dynes/cm.
Claim 29
Independent Claim
37 words
A device for the depletion of the leukocyte content of a blood product comprising at least one integral element preformed of synthetic fibers, the surfaces of said fibers having a modified CWST in excess of 53 dynes/cm.
Claim 30
Dependent Claim
22 words
The device of claim 26 in which the fibers have been surface modified to increase their CWST by 2 or more dynes/cm.
Claim 31
Dependent Claim
15 words
The device of claim 26 in which the CWST is in excess of 59 dynes/cm.
Claim 32
Dependent Claim
15 words
The device of claim 28 in which the CWST is in excess of 63 dynes/cm.
Claim 33
Independent Claim
48 words
A device for the depletion of leukocytes from a blood product comprising at least one element in which a fibrous medium has been radiation-grafted to obtain a critical wetting surface tension in excess of 53 dynes per centimeter, and thereafter hot compressed to form a non-friable, coherent body.
Claim 34
Independent Claim
48 words
A device for the depletion of leukocytes from a blood product comprising at least one element in which a fibrous medium has been radiation-grafted to obtain a critical wetting surface tension in excess of 53 dynes per centimeter, and thereafter hot compressed to form a non-friable, coherent body.
Claim 35
Dependent Claim
24 words
The device of claim 30 in which the element has been modified to a CWST in the range of about 55 to 75 dynes/cm.
Claim 36
Independent Claim
29 words
A device for the depletion of the leukocyte content of a blood product comprising at least one integral element, preformed element of synthetic fibers including means for removing leukocytes.
Claim 37
Independent Claim
29 words
A device for the depletion of the leukocyte content of a blood product comprising at least one integral element, preformed element of synthetic fibers including means for removing leukocytes.
Claim 38
Dependent Claim
25 words
The device of claim 32 in which the synthetic fibers have been modified to a CWST in the range of about 55 to 75 dynes/cm.
Claim 39
Dependent Claim
63 words
The device of claim 26, 30, or 32 in which the fibers have been surface-modified by exposure to an energy source while in contact with a monomer containing at least one hydroxyl moiety and one moiety capable of activation by an energy source, together with a monomer containing at least one hydrophobic moiety and one moiety capable of activation by an energy source.
Claim 40
Independent Claim
58 words
A device for the depletion of the gel content of a liquid phase prior to filtration and thereby extending the capacity of a filter assembly, comprising at least first and second porous elements, the first element composed at least in part of a needled fibrous web, and the second element having a smaller pore size than the first.
Claim 41
Independent Claim
58 words
A device for the depletion of the gel content of a liquid phase prior to filtration and thereby extending the capacity of a filter assembly, comprising at least first and second porous elements, the first element composed at least in part of a needled fibrous web, and the second element having a smaller pore size than the first.
Claim 42
Dependent Claim
14 words
The device of claim 35 in which the liquid phase is a blood product.
Claim 43
Dependent Claim
54 words
The device of claim 5 or 36 in which the pore diameter of the first element is such as to require, when prewetted by isopropyl alcohol, a differential pressure of 4 to 7 cm of water column to induce flow of air through it at a rate of 0.5 cms/second through the first element.
Claim 44
Dependent Claim
33 words
The device of claim 36 in which the effective flow path comprises, in part, three or more elements preformed prior to assembly, each with cross-sectional flow area in excess of 54 square centimeters.
Claim 45
Dependent Claim
18 words
The device of claim 35 in which the second element comprises at least one planar parallel non-woven component.
Claim 46
Dependent Claim
54 words
The device of claim 39 further comprising a third element with the second element disposed between the first and the third elements and in which at least one of the second and third elements has been modified to a CWST within about 2 to 20 dynes/cm of the surface tension of the liquid phase.
Claim 47
Dependent Claim
36 words
The device of claim 40, said device consistently providing prior to clogging a capacity of at least two units of a blood product of any age up to and including its permissible limit for human use.
Claim 48
Dependent Claim
22 words
The device of claim 17,20,38, or 41 in which the total voids volume of all the elements is less than 28 milliliters.
Claim 49
Dependent Claim
24 words
The device of claim 17, 20, 38, or 42 in which the total internal voids volume of the device is less than 37 milliliters.
Claim 50
Dependent Claim
32 words
The device of claim 40 in which at least one of the second and third elements has been modified to a CWST in the range from about 55 to about 75 dynes/cm.
Claim 51
Dependent Claim
26 words
The device of claim 19, 20, or 35 in which at least one of the component elements has prior to assembly been compressed to controlled thickness.
Claim 52
Dependent Claim
23 words
The device of claim 19 or 45 in which all of the component elements have prior to assembly been compressed to controlled thickness.
Claim 53
Dependent Claim
62 words
The device of claim 35 in which the second element has been surface modified by exposure to an energy source while in contact with a monomer containing at least one hydroxyl moiety and one moiety capable of activation by an energy source, together with a monomer containing at least one hydrophobic moiety and a moiety capable of activation by an energy source.
Claim 54
Independent Claim
95 words
A device for the depletion of the leukocyte content of a blood product comprising a housing including an inlet and an outlet and defining a fluid flow path between the inlet and the outlet, an upstream porous element, at least one intermediate porous element, at least one intermediate porous element and a downstream porous element, the upstream element including means for removing gels, the intermediate element including means for removing microaggregates, and the downstream element including means for removing leukocytes, the upstream, intermediate, and downstream elements being secured within the housing by an interference fit.
Claim 55
Independent Claim
95 words
A device for the depletion of the leukocyte content of a blood product comprising a housing including an inlet and an outlet and defining a fluid flow path between the inlet and the outlet, an upstream porous element, at least one intermediate porous element, at least one intermediate porous element and a downstream porous element, the upstream element including means for removing gels, the intermediate element including means for removing microaggregates, and the downstream element including means for removing leukocytes, the upstream, intermediate, and downstream elements being secured within the housing by an interference fit.
Claim 56
Independent Claim
117 words
A device for separating one or more substances from a fluid to be administered to a patient, the device comprising a housing including an inlet and an outlet and defining a fluid flow path between the inlet and the outlet and a separating element disposed within the housing across the fluid flow path and including a downstream surface, wherein the inlet communicates with the housing near the bottom of the housing and upstream from the separating element and wherein the housing further includes passage means for allowing air in the fluid to separate from the fluid, the passage means being disposed downstream from the separating element and communicating with the outlet near the top of the housing.
Claim 57
Independent Claim
117 words
A device for separating one or more substances from a fluid to be administered to a patient, the device comprising a housing including an inlet and an outlet and defining a fluid flow path between the inlet and the outlet and a separating element disposed within the housing across the fluid flow path and including a downstream surface, wherein the inlet communicates with the housing near the bottom of the housing and upstream from the separating element and wherein the housing further includes passage means for allowing air in the fluid to separate from the fluid, the passage means being disposed downstream from the separating element and communicating with the outlet near the top of the housing.
Claim 58
Dependent Claim
50 words
The device of claim 49 wherein the housing includes a wall facing the downstream surface of the separating element and defining a plenum and wherein the passage means includes a slot disposed in the wall and communicating between the plenum and the outlet, the slot being deeper than the plenum.
Claim 59
Dependent Claim
20 words
The device of claim 50 wherein the wall includes a plurality of concentric circular grooves which communicate with the slot.
Claim 60
Dependent Claim
18 words
The device of claim 50 wherein the slot extends from the bottom to the top of the housing.
Claim 61
Dependent Claim
30 words
The device of claim 50 wherein the slot length is 50 to 800/0 of an inner diameter of the housing, and the slot extends to the top of the housing.
Claim 62
Dependent Claim
16 words
The device of claim 53 wherein the slot depth increases towards the top of the housing.
Claim 63
Dependent Claim
36 words
The device of claim 50 wherein the housing has a generally circular configuration and the slot extends from the top of the housing along at least a portion of the vertical inner diameter of the housing.
Claim 64
Independent Claim
202 words
A device for separating one or more substances from a fluid to be administered to a patient, the device comprising a generally cylindrical housing including an inlet and an outlet and defining a fluid flow path between the inlet and the outlet and a disc shaped separation element disposed within the housing and having upstream and downstream surfaces, wherein the housing further includes an inlet section facing the upstream surface of the separating element and defining an inlet plenum, the inlet including a ridge extending vertically along the exterior of the inlet section and a passageway which opens at the top of the inlet ridge, extends through the inlet ridge, and communicates with the inlet plenum at the bottom of the housing, and an outlet section facing the downstream surface of the separating element and defining an outlet plenum and including a slot which is deeper than the outlet plenum and which communicates between the outlet plenum and the outlet, the outlet including a ridge extending vertically along the exterior of the outlet section and a passageway which opens at the bottom of the outlet ridge, extends through the outlet ridge, and communicates with the slot near the top of the housing.
Claim 65
Independent Claim
202 words
A device for separating one or more substances from a fluid to be administered to a patient, the device comprising a generally cylindrical housing including an inlet and an outlet and defining a fluid flow path between the inlet and the outlet and a disc shaped separation element disposed within the housing and having upstream and downstream surfaces, wherein the housing further includes an inlet section facing the upstream surface of the separating element and defining an inlet plenum, the inlet including a ridge extending vertically along the exterior of the inlet section and a passageway which opens at the top of the inlet ridge, extends through the inlet ridge, and communicates with the inlet plenum at the bottom of the housing, and an outlet section facing the downstream surface of the separating element and defining an outlet plenum and including a slot which is deeper than the outlet plenum and which communicates between the outlet plenum and the outlet, the outlet including a ridge extending vertically along the exterior of the outlet section and a passageway which opens at the bottom of the outlet ridge, extends through the outlet ridge, and communicates with the slot near the top of the housing.
Claim 66
Dependent Claim
59 words
The device of claim 56 wherein the inlet section includes a plurality of concentric circular grooves and an access extending between the inlet passageway and each circular groove, the circular grooves and the access collectively defining the inlet plenum and the inlet plenum having a depth which is greatest at the bottom of the housing near the inlet passageway.
Claim 67
Dependent Claim
54 words
The device of claim 56 wherein the outlet section includes a plurality of concentric circular grooves which communicate with the slot and wherein the slot extends from near the bottom of the housing to the top of the housing and has a greater depth at the top of the housing than at the bottom.
Claim 68
Dependent Claim
40 words
The device of claim 56 wherein the housing further includes a cylindrical collar disposed about the periphery of the disc shaped separation element, the disc shaped separation element being sealed to the cylindrical collar by an interference fit between them.
Claim 69
Independent Claim
28 words
A method for the depletion of the leukocyte content of a blood product comprising passing the blood product through the device of any of claims 1 to 59.
Claim 70
Independent Claim
21 words
A method for the depletion of the gel content of a liquid comprising passing the liquid through a needled fibrous web.
Claim 71
Independent Claim
21 words
A method for the depletion of the gel content of a liquid comprising passing the liquid through a needled fibrous web.
References Cited (Backward Citations)
No citation records indexed.
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