CA2478187A1 - Method and apparatus for the continuous fractionation of biological fluids into components - Google Patents

Method and apparatus for the continuous fractionation of biological fluids into components Download PDF

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Publication number
CA2478187A1
CA2478187A1 CA002478187A CA2478187A CA2478187A1 CA 2478187 A1 CA2478187 A1 CA 2478187A1 CA 002478187 A CA002478187 A CA 002478187A CA 2478187 A CA2478187 A CA 2478187A CA 2478187 A1 CA2478187 A1 CA 2478187A1
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Canada
Prior art keywords
channel
bowl
sleeve
core
conduit
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Granted
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CA002478187A
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French (fr)
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CA2478187C (en
Inventor
Dennis A. Briggs
Michael Hutchinson
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Mallinckrodt Hospital Products IP Unlimited Co
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Individual
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3681—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by irradiation
    • A61M1/3683—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by irradiation using photoactive agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging
    • A61M1/3696—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B5/00—Other centrifuges
    • B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
    • B04B5/0442—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3681—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits by irradiation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/05—General characteristics of the apparatus combined with other kinds of therapy
    • A61M2205/051—General characteristics of the apparatus combined with other kinds of therapy with radiation therapy
    • A61M2205/053—General characteristics of the apparatus combined with other kinds of therapy with radiation therapy ultraviolet
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B5/00—Other centrifuges
    • B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
    • B04B5/0442—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
    • B04B2005/0464—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation with hollow or massive core in centrifuge bowl
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B04—CENTRIFUGAL APPARATUS OR MACHINES FOR CARRYING-OUT PHYSICAL OR CHEMICAL PROCESSES
    • B04B—CENTRIFUGES
    • B04B5/00—Other centrifuges
    • B04B5/04—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers
    • B04B5/0442—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
    • B04B2005/0492—Radial chamber apparatus for separating predominantly liquid mixtures, e.g. butyrometers with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation with fluid conveying umbilicus between stationary and rotary centrifuge parts

Abstract

The present invention relates to systems, methods and apparatus for improvin g the yield for separating components of fluids, for example biological or sensitive fluids such as blood, and improving the component yield, for example, from donated whole blood by separating its components by density in a centrifuge bowl with a multi-axial lumen. The apparatus, system, and method eliminate the need to batch-type separate blood and can reduce the time need ed to treat patients suffering from T-cell or white blood cell mediated disease s or conditions to less than 70 minutes. In one aspect, the invention is a centrifuge bowl (10) comprising an outer housing (100); a core (200); a lowe r plate (300); a lumen (400); a first bowl channel (420) within said lumen (40 0) for inflowing said fluid (800); a second bowl channel (410) for removing a first separated fluid component (810); and a third bowl channel (740) for removing a second separated fluid component (820).

Claims (71)

1. An apparatus for separating components of a fluid (800) comprising:
an outer housing with an upper housing end and a lower housing end, wherein said outer housing increases in diameter from said upper housing end to said lower housing end, said lower housing end having a housing floor and said housing upper end having a housing outlet, said outer housing having an interior volume and adapted for rotation about a center axis;
a core connected with said outer housing for rotation therewith; having an outer wall having an upper core end and a lower core end, said lower core end having a core floor and said upper core end having a core outlet; occupying a coaxial volume of said interior volume of said outer housing, and providing a separation volume between said core and said outer housing;
a lower plate having a top surface, said lower plate positioned within said separation volume, beneath said core floor and above said housing floor;
a lumen positioned inside said core, said lumen extending axially through said core;
a first bowl channel within said lumen to said top surface of said lower plate for inflowing said fluid;
a second bowl channel from within said separation volume beneath said lower plate for removing a first separated fluid component, and a third bowl channel from said separation volume above said lower plate for removing a second separated fluid component.
2. The apparatus of claim 1 wherein said outer wall of said core increases in diameter from said upper end to said lower end.
3. The apparatus of claim 1 wherein said second bowl channel is within said lumen.
4. The apparatus of claim 1 wherein said third bowl channel is within said lumen.
5. The apparatus of claim 1, further comprising a connection sleeve adapted to be secured to said apparatus near said housing outlet of said outer housing for rotation therewith, said connection sleeve adapted to fluidly connect each of said first, second, and third bowl channels to a corresponding conduit channel of an external conduit.
6. The apparatus of claim 5 wherein said connection sleeve is secured to said lumen.
7. The apparatus of claim 5 wherein said core is adapted to secure said connection sleeve.
8. The apparatus of claim 5 wherein said connection sleeve comprises a sleeve flange and said housing outlet is adapted to retain said sleeve flange.
9. The apparatus of claim 1 wherein said lumen has an upper lumen end and a lower lumen end, and said lumen increases in outside diameter from said upper lumen end to said lower lumen end.
10. The apparatus of claim 1 wherein said core comprises a neck fitted around said lumen.
11. The apparatus of claim 1 wherein said core floor further comprises a floor flange that extends into said separation volume.
12. The apparatus of claim 11 wherein said floor flange is adapted to guide flow of said second separated fluid component upward.
13. The apparatus of claim 11 wherein said floor flange is adapted to allow flow of said first separated fluid component to said housing floor.
14. The apparatus of claim 1 wherein said outer housing comprises a locking mechanism adapted to secure said outer housing to a means for rotating said apparatus.
15. The apparatus of claim 14 wherein said locking mechanism comprises protrusions.
16. The apparatus of claim 14 wherein said locking mechanism comprises a key slot.
17. The apparatus of claim 1 wherein said lower plate is circular.
18. The apparatus of claim 1 wherein said apparatus is adapted for use without a rotatable seal.
19. The apparatus of claim 1 wherein said apparatus is closed to undesired contagions.
20. The apparatus of claim 1 wherein said apparatus is adapted to allow rotation of said core, said lower plate, and said outer housing about said lumen.
21. The apparatus of claim 1 wherein said lumen and said core floor are a single structure.
22. The apparatus of claim 1 further comprising means for rotating said outer housing about said axis.
23. The apparatus of claim 22 wherein said means for rotating comprises a bracket.
24. The apparatus of claim 23 wherein said bracket is adapted to engage and rotate an external conduit that is fluidly connected to said first bowl channel, said second bowl channel, and said third bowl channel.
25. The apparatus of claim 24 wherein said rotation means is adapted to rotate said outer housing and said external conduit using 1-omega/2-omega spin technology.
26 The apparatus of claim 22 further comprising:
means to remove said fluid from a source, said means to remove said fluid fluidly connected to said first bowl channel;
means to remove said first separated fluid component via said second bowl channel;
means to remove said second separated fluid component via said third bowl channel; and means to treat said second separated fluid component subsequent to being removed via said third bowl channel.
27. The apparatus of claim 26 further comprising means to reinfuse treated second separated fluid component and said first separated fluid component back into said source, wherein said apparatus is a closed-loop apparatus when connected to said source.
28. The apparatus of claim 27 wherein said reinfusion means comprises a needle or catheter.
29. The apparatus of claim 26 wherein said source is a patient and said fluid is blood.
30. The apparatus of claim 26 further comprising an anticoagulant source fluidly connected between said means to remove said fluid from said source and said first bowl channel.
31. The apparatus of claim 26 wherein said means to remove said fluid from said source comprises a needle or catheter.
32. The apparatus of claim 26 wherein said means to remove said first separated fluid component comprises a pump.
33. The apparatus of claim 26 wherein said treatment means comprises a chamber and a source of ultraviolet radiation.
34. A connection sleeve for fluidly connecting an external conduit having a first conduit channel to a lumen of a centrifuge bowl having a first bowl channel, said connection sleeve comprising;
a body having an upper sleeve end and a lower sleeve end, said lower sleeve end adapted to be secured to said centrifuge bowl;
a stub having a first stub channel extending therethrough, wherein said first stub channel is adapted to form a first passageway from said first conduit channel to said first bowl channel;
a wall surrounding said stub near said upper sleeve end; and a trench between said wall and said stub, said trench adapted to receive and hold said external conduit.
35. The connection sleeve of claim 34 further comprising a sleeve flange on said lower sleeve end of said body, said sleeve flange adapted to engage said centrifuge bowl.
36. The connection sleeve of claim 34 wherein said trench is tapered.
37. The connection sleeve of claim 34 wherein said body increases in diameter from said upper sleeve end to said lower sleeve end.
38. The connection sleeve of claim 34 wherein said wall is raised above said stub.
39. The connection sleeve of claim 34 wherein said stub further comprises a second stub channel extending therethrough, said second stub channel adapted to form a second passageway from a second conduit channel to a second bowl channel.
40. The connection sleeve of claim 34 wherein said stub further comprises a third stub channel extending therethrough, said third stub channel adapted to form a third passageway from a third conduit channel to a third bowl channel.
41. The connection sleeve of claim 34 wherein said connection sleeve is adapted to be overmolded to said external conduit.
42. A method for separating components of a fluid comprising a higher density component and a lower density component, the method comprising:
providing a centrifuge bowl comprising a first bowl channel, a second bowl channel, and a third bowl channel;
flowing said fluid from a source into said centrifuge bowl through said first bowl channel;
rotating said centrifuge bowl about an axis;
removing said higher density component from said bowl via said second bowl channel; and removing said lower density component from said bowl via said third bowl channel concurrently with said removing of said higher density component.
43. The method of claim 42 wherein said centrifuge bowl further comprises:
an outer housing with an upper housing end and a lower housing end, wherein said outer housing increases in diameter from said upper housing end to said lower housing end, said lower housing end having a housing floor and said housing upper end having a housing outlet, said outer housing having an interior volume and adapted for rotation about a center axis;
a core connected with said outer housing for rotation therewith; having an outer wall having an upper core end and a lower core end, said lower core end having a core floor and said upper core end having a core outlet; occupying a coaxial volume of said interior volume of said outer housing, and providing a separation volume between said core and said outer housing;
a lower plate having a top surface, said lower plate positioned within said separation volume, beneath said core floor and above said housing floor;
a lumen positioned inside said core, said lumen extending axially through said core;
wherein said first bowl channel is within said lumen and provides a passageway to said top surface of said lower plate;
wherein said second bowl channel provides a passageway from within said separation volume beneath said lower plate; and wherein said third bowl channel provides a passageway from said separation volume above said lower plate.
44. The method of claim 42 wherein said step of removing said first separated fluid component comprises applying negative pressure to said second bowl channel.
45. The method of claim 42 wherein said negative pressure is applied by a pump.
46. The method of claim 45 wherein said pump provides substantially stable flow.
47. The method of claim 42 wherein said step of removing said first separated fluid component comprises applying positive pressure to said centrifuge bowl.
48. The method of claim 42 wherein said fluid (800) comprises a biological fluid.
49. The method of claim 48 wherein said biological fluid comprises blood.
50. The method of claim 49 wherein said higher density component comprises red blood cells and said lower density component comprises a buffy coat.
51. The method of claim 50 further comprising the step of collecting platelets from said lower density component.
52. The method of claim 50 further comprising the step of reinfusing said higher density component into said source.
53. The method of claim 50 further comprising:
treating said lower density component; and reinfusing said treated lower density component into said source to treat, ameliorate, prevent, or delay the onset of white blood cell or T-cell mediated diseases.
54. The method of claim 53 wherein said method is completed in less than 70 minutes.
55. The method of claim 53 wherein said white blood cell and T-cell mediated diseases are selected from the group consisting of cancer, T-cell lymphoma, Graft-versus-Host disease, Rheumatoid Arthritis, Progressive Systematic Sclerosis, Juvenile Onset Diabetes, Inflamatory Bowel Disease, Alopecia Areata, Ankylosing Spondylitis, Antiphospholipid Syndrome, Autoimmune Addison's Disease, Autoimmune Hemolytic Anemia, Autoimmune Hepatitis, Behcet's Disease, Bullous Pemphigoid, Cardiomyopathy, Celiac Sprue-Dermatitis, Chronic Fatigue Immune Dysfunction Syndrome, Chronic Inflammatory Demyelinating Polyneuropathy, Churg-Strauss Syndrome, Cicatricial Pemphigoid, CREST Syndrome, Cold Agglutinin Disease, Crohn's Disease, Discoid Lupus, Essential Mixed Cryoglobulinemia, Fibromyalgia-Fibromyositis, Graves' Disease, Guillain-Barre Syndrome, Hashimoto's Thyroiditis, Idiopathic Pulmonary Fibrosis, Idiopathic Thrombocytopenia Purpura, IgA Nephropathy, Insulin Dependent Diabetes, Juvenile Arthritis, Lichen Planus, Ménière's Disease, Mixed Connective Tissue Disease, Multiple Sclerosis, Myasthenia Gravis, Pemphigus Vulgaris, Pernicious Anemia, Polyarteritis Nodosa, Polychondritis, Polyglandular Syndromes, Polymyalgia Rheumatica, Polymyositis and Dermatomyositis, Primary Agammaglobulinemia, Primary Biliary Cirrhosis, Psoriasis, Raynaud's Phenomenon, Reiter's Syndrome, Rheumatic Fever, Rheumatoid Arthritis, Sarcoidosis, Scleroderma, Sjögren's Syndrome, Stiff-Man Syndrome, Systematic Lupus Erythematosus, Takayasu Arteritis, Temporal Arteritis/Giant Cell Arteritis, Ulcerative Colitis, Uveitis, Vasculitis, Vitiligo, and Wegener's Granulomatosis.
56. The method of claim 53 further comprising ameliorating or preventing organ or tissue transplant rejection.
57. The system of claim 53 wherein said treatment step comprises irradiating said lower density component.
58. The method of claim 53 wherein said treatment step is performed so as to induce apoptosis within said lower density component.
59. The method of claim 53 wherein said method is performed continuously without the need to batch process said fluid.
60. A conduit assembly for fluidly connecting a source of fluid to a centrifuge bowl comprising:
an external conduit of approximately constant diameter having a first conduit end and a second conduit end;
a connection sleeve secured to said first conduit end, said connection sleeve adapted to fluidly connect to said centrifuge bowl;
an anchor sleeve secured to said second conduit end;
a first bearing ring surrounding said external conduit and positioned between said connection sleeve and said anchor sleeve, said first bearing ring adapted to engage a means for rotating said centrifuge bowl; and a first assembly channel extending through said conduit assembly.
61. The conduit assembly of claim 60 wherein said connection sleeve and said anchor sleeve are overmolded to said external conduit.
62. The conduit assembly of claim 60 wherein said anchor sleeve has a first anchor end and a second anchor end, said first anchor end being secured to said external conduit, said anchor sleeve increasing in diameter from said first anchor end to said second anchor end.
63. The conduit assembly of claim 60 wherein said connection sleeve has an upper sleeve end and a lower sleeve end, said upper sleeve end being secured to said external conduit, said connection sleeve increasing in diameter from said upper sleeve end to said lower sleeve end.
64. The conduit assembly of claim 60 wherein said connection sleeve has a wall surrounding a stub near said upper sleeve end, said connection sleeve further having a trench between said wall and said stub, said trench adapted to receive and secure said external conduit.
65. The conduit assembly of claim 64 wherein said trench is tapered.
66. The conduit assembly of claim 64 wherein said wall is raised above said stub.
67. The conduit assembly of claim 60 wherein said connection sleeve comprises a sleeve flange.
68. The conduit assembly of claim 60 further comprising a second assembly channel and a third assembly channel through said conduit assembly.
69. The conduit assembly of claim 60 further comprising a second bearing ring surrounding said conduit and positioned between said first bearing ring and said anchor sleeve, said second bearing ring adapted to engage a means for rotating said centrifuge bowl.
70. The conduit assembly of claim 60 wherein said first and second bearing rings are 7.5 to 9.5 inches apart.
71. The conduit assembly of claim 70 wherein said first bearing ring is 5.0 to 5.5 inches from a lower end of said connection sleeve.
CA2478187A 2002-03-04 2003-02-28 Method and apparatus for the continuous fractionation of biological fluids into components Expired - Lifetime CA2478187C (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US36128702P 2002-03-04 2002-03-04
US60/361,287 2002-03-04
US10/375,629 2003-02-27
US10/375,629 US7186230B2 (en) 2002-03-04 2003-02-27 Method and apparatus for the continuous separation of biological fluids into components
PCT/US2003/006032 WO2003075983A2 (en) 2002-03-04 2003-02-28 Method and apparatus for the continuous fractionation of biological fluids

Publications (2)

Publication Number Publication Date
CA2478187A1 true CA2478187A1 (en) 2003-09-18
CA2478187C CA2478187C (en) 2011-07-19

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CA2478187A Expired - Lifetime CA2478187C (en) 2002-03-04 2003-02-28 Method and apparatus for the continuous fractionation of biological fluids into components

Country Status (10)

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US (1) US7186230B2 (en)
EP (1) EP1483000B1 (en)
JP (1) JP4519467B2 (en)
AU (1) AU2003219935B2 (en)
BR (1) BR0308164B1 (en)
CA (1) CA2478187C (en)
ES (1) ES2483169T3 (en)
MX (1) MXPA04008548A (en)
NZ (3) NZ534867A (en)
WO (1) WO2003075983A2 (en)

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