Apparatus for the continuous separation of biological fluids into components and method of using same

{
  "publication_number": "US2006186061A1",
  "country": "US",
  "kind": "A1",
  "title": "Apparatus for the continuous separation of biological fluids into components and method of using same",
  "abstract": "The present invention provides an apparatus for separating components of a fluid having an outer housing containing a core wherein three separate fluid pathways are provided to allow continuous separation of biological fluids.",
  "claims": [
    "1. A method for separating components of a fluid (800) comprising a higher density component (810) and a lower density component (820), the method comprising: providing a centrifuge bowl (10 A) comprising a first bowl channel (420 A), a second bowl channel (410 A), and a bowl chamber (740 A); flowing said fluid (800) from a source (600) into said centrifuge bowl (10 A) through said first bowl channel (420 A); rotating said centrifuge bowl (10 A) about an axis (11); removing said higher density component (810) from said bowl (10 A) via said second bowl channel (410 A); and removing said lower density component (820) from said bowl (10 A) via said bowl chamber (740 A). 2. The method of claim 1 wherein said centrifuge bowl (10) further comprises: an outer housing (100 A) with an upper housing end (10 A) and a lower housing end (190 A), wherein said outer housing (100 A) increases in diameter from said upper housing end (110 A) to said lower housing end (190 A), said lower housing end (190 A) having a housing floor (180 A) and said housing upper end (110 A) having a housing outlet (700 A), said outer housing (100 A) having an interior volume (710 A) and adapted for rotation about a center axis (11); a top core (200 A) having an outer wall (210 A), an upper top core end (205 A), and a lower top core end (295 A); said top core (200 A) connected with said outer housing (100 A) for rotation therewith; occupying a top coaxial volume of said interior volume (710 A) of said outer housing (100 A); and providing a top separation volume (220 A) between said top core (200 A) and said outer housing (100 A); said upper top core end (205 A) having a lumen connector (481 A); said lumen connector (481 A) having a first lumen wall (401 A) extending downward from the a top surface (482 A) of the lumen connector (481 A); said lumen connector (481 A) further having an inner lumen wall (325 A) within said first lumen wall (401 A) and extending downward from the top surface (482 A); said inner lumen wall having a top wall end (325 C) and a bottom wall end (325 B); an upper plate (299 A) having a top surface (298 A), a bottom surface (297 A), a second lumen wall (402 A) extending above said top surface (298 A); said upper plate (299 A) having a circumference adapted to form a tight fit with the lower top core end (295 A) for rotation therewith; said second lumen wall (402 A) adapted to overlap with said first lumen wall (401 A) to form a lumen (400 A) having an upper lumen end (480 A) and a lower lumen end (490 A); said lumen (400 A) forming a first bowl channel (420 A) for inflowing said fluid (800) and extending axially through said core 200 A leading to indentation (186 A) and trenches (305 A); a bottom core (201 A) having an outer wall (211 A), a top surface (309 A) contacting and connected with bottom surface (297 A) of upper plate (299 A) for rotation therewith; an upper bottom core end (206 A), a lower bottom core end (296 A), a top surface (309 A) having an indentation (186 A) and a trench (305 A), and a lumen wall (324 A) that has an upper wall end (324 C) and a lower wall end (324 B); said bottom core occupying a bottom coaxial volume of said interior volume (710 A) of said outer housing (100 A) and providing a bottom separation volume (220 B) between said bottom core (201 B) and said outer housing (100 A); said upper wall end (324 C) of lumen wall (324 A) is adapted to engage with bottom wall end (325 B) of inner lumen wall (325 A) to form a second bowl channel (410 A) for removing a first separated fluid component (810); said top surface (309 A) is adapted to engage with the bottom surface 297 A of the upper plate (299 A); a lower plate (300 A) having a top surface (730 A), a bottom surface (730 B), and a hollow cylinder (320 A) near center of lower plate (300 A); said hollow cylinder (320 A) has an opening (302 A) adapted to engage with lower wall end (324 B) of lumen (324 A); and said lower plate (300 A) having a circumference adapted to form a tight fit with the lower bottom core end (296 A) for rotation therewith; a connection sleeve (500 A) having a sleeve flange (790 A) surrounding a lumen mounting recess (851 A); said lumen mounting recess (851 A) and top surface (482 A) of lumen connector (481 A) engaged to form the bowl chamber (740 A) for removing a second separated fluid component (820); said connection sleeve (500 A) further adapted to be secured to said apparatus (10 A) near said housing outlet (700 A) of said outer housing (100 A) for rotation therewith. 3. The method of claim 1 wherein said step of removing said first separated fluid component (810) comprises applying negative pressure to said second bowl channel (410 A). 4. The method of claim 1 wherein said negative pressure is applied by a pump (617). 5. The method of claim 4 wherein said pump (617) provides substantially stable flow. 6. The method of claim 1 wherein said step of removing said first separated fluid component (810) comprises applying positive pressure to said centrifuge bowl (10 A). 7. The method of claim 1 wherein said fluid (800) comprises a biological fluid. 8. The method of claim 7 wherein said biological fluid comprises blood. 9. The method of claim 8 wherein said higher density component (810) comprises red blood cells and said lower density component (820) comprises a buffy coat. 10. The method of claim 9 further comprising the step of collecting platelets from said lower density component (820). 11. The method of claim 9 further comprising the step of reinfusing said higher density component (810) into said source (600). 12. The method of claim 9 further comprising: treating said lower density component (820); and reinfusing said treated lower density component (820) into said source (600) to treat, ameliorate, prevent, or delay the onset of white blood cell or T-cell mediated diseases. 13. The method of claim 12 wherein said method is completed in less than 70 minutes. 14. The method of claim 12 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-Barré 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. 15. The method of claim 12 further comprising ameliorating or preventing organ or tissue transplant rejection. 16. The system of claim 12 wherein said treatment step comprises irradiating said lower density component (820). 17. The method of claim 12 wherein said treatment step is performed so as to induce apoptosis within said lower density component (820). 18. The method of claim 12 wherein said method is performed continuously without the need to batch process said fluid (800)."
  ],
  "description_excerpt": "The present invention generally relates to methods and apparatus for separating a fluid into its components, for example, a biological or sensitive fluid such as blood, and specifically to methods and apparatus that use centrifugal force to separate a fluid into its components by density so as to improve the component yield.\n\nWith the advance of medical sciences, it has become possible to treat a patient's blood in closed-loop processes, returning the patient's own treated blood back to him in one medical treatment. An example of such processes include external treatment methods for diseases in which there is a pathological increase of lymphocytes, such as cutaneous T-cell lymphoma or other diseases affecting white blood cells. In such methods, the patient's blood is irradiated with ultraviolet light in the presence of a chemical or an antibody. Ultraviolet light affects the bonding between the lymphocytes and the chemical or antibody that inhibits the metabolic processes of the lymphocytes.\n\nDuring one of these medical treatments, a centrifuge bowl, such as, for example, a Latham bowl, as shown in U.S. Pat. No. 4,303,193, expressly incorporated by reference in its entirety herein, separates blood into red blood cells (“RBCs”) and buffy coat. The Latham bowl is a blood component separator that has been used for some time in the medical apheresis market as well as in innovative medical therapies such as extracorporeal photopheresis (ECP). PCT Applications WO 97/36581 and WO 97/36634, and U.S. Pat. Nos.",
  "cpc": [
    "A61K 41/0066",
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    "B01D 21/26"
  ],
  "inventors": [
    "Dennis Briggs",
    "Steve Gara",
    "Tom Watters",
    "Mike Hutchinson"
  ],
  "filing_date": "2006-04-19",
  "publication_date": "2006-08-24",
  "priority_date": "2002-03-04",
  "application_number": "US-40698806-A",
  "family_id": "34136674",
  "cited_by_count": 24,
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