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

• US 7,914,477 B2
• Filed: 04/19/2006
• Issued: 03/29/2011
• Est. Priority Date: 03/04/2002
• Status: Active Grant

• Current Assignee: Mallinckrodt Critical Care Finance Inc (Mallinckrodt plc), Mallinckrodt Pharma Ip Trading DAC (Mallinckrodt plc)
• Original Assignee: Therakos, Inc (Mallinckrodt plc)
• Inventors: Gara, Steve, Briggs, Dennis, Hutchinson, Mike, Watters, Tom
• Primary Examiner(s): Soohoo; Tony G
• Assistant Examiner(s): Mellon; David C
• Application Number:
  US11/406,988
• Publication Number:
  US 20060186061A1
• Time in Patent Office: 1,805 Days
• Field of Search: 604/5.04, 604/6.08, 604/4.01, 604/6.01, 604/5.01, 604/6.04, 494/44, 494/41, 494/43, 494/67, 494/76, 494/77, 494/31, 494/34, 494/37, 210/260, 210/380.1, 2103601-3602, 210/378, 210/382, 210/782, 210/787
• US Class Current: 604/5.04
• CPC Class Codes: A61K 41/0066 Psoralene-activated UV-A photochemotherapy (PUVA-therapy), e.g. for treatment of psoriasis or eczema, extracorporeal photopheresis with psoralens or fucocoumarins
• CPC Class Codes: A61M 1/0227 and means for securing the filter against damage, e.g. during centrifugation
• CPC Class Codes: A61M 1/361 before treatment
• CPC Class Codes: A61M 1/362227 the interface providing means for actuating on functional elements of the cassette, e.g. plungers
• CPC Class Codes: A61M 1/36224 with sensing means or components thereof
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 1/362263 Details of incorporated filters
• CPC Class Codes: A61M 1/362265 Details of valves
• CPC Class Codes: A61M 1/362266 Means for adding solutions or substances to the blood
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3683 using photoactive agents
• CPC Class Codes: A61M 1/3686 by removing photoactive agents after irradiation
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 1/72 Cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 1/77 Suction-irrigation systems aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463
• CPC Class Codes: A61M 2202/0092 starting product created by centrifuging
• CPC Class Codes: A61M 2202/0427 Platelets; Thrombocytes
• CPC Class Codes: A61M 2205/051 with radiation therapy
• CPC Class Codes: A61M 2205/053 : ultraviolet
• CPC Class Codes: A61M 2205/12 : with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/125 : with incorporated filters
• CPC Class Codes: A61M 2205/35 : Communication
• CPC Class Codes: A61M 2205/50 : with microprocessors or computers
• CPC Class Codes: A61M 2205/52 : with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/60 : with identification means
• CPC Class Codes: A61M 2205/75 : with filters
• CPC Class Codes: A61M 3/0201 : Cassettes therefor
• CPC Class Codes: B04B 2005/0464 : with hollow or massive core in centrifuge bowl
• CPC Class Codes: B04B 2005/0492 : with fluid conveying umbilicus between stationary and rotary centrifuge parts
• CPC Class Codes: B04B 5/0442 : with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: F04B 43/1253 : by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing
• CPC Class Codes: F16L 33/00 : Arrangements for connecting hoses to rigid members; Rigid hose connectors, i.e. single members engaging both hoses
• CPC Class Codes: F16L 39/02 : for hoses

Abstract

The present invention provides an apparatus for separating components of a fluid having an outer housing containing a core and other components wherein three separate fluid pathways are provided to allow continuous separation of biological fluids; this apparatus is particularly useful for the administration of extracorporeal photopheresis in that it enhances the collection of the desired blood components, the return of the treated blood, and the speed with which the therapy is administered.

Claims

1. 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 bowl chamber;

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 bowl chamber

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 has a housing floor and said upper housing end has a housing outlet, said outer housing having an interior volume and adapted for rotation about a center axis;

a top core having an outer wall, an upper top core end, and a lower top core end;

said top core connected with said outer housing for rotation therewith;

occupying a top coaxial volume of said interior volume of said outer housing; and

providing a top separation volume between said top core and said outer housing;

said upper top core end having a lumen connector;

said lumen connector having a first lumen wall extending downward from the a top surface of the lumen connector;

said lumen connector further having an inner lumen wall within said first lumen wall and extending downward from the top surface;

said inner lumen wall having a top wall end and a bottom wall end;

an upper plate having a top surface, a bottom surface, a second lumen wall extending above said top surface;

said upper plate having a circumference adapted to form a tight fit with the lower top core end for rotation therewith;

said second lumen wall adapted to overlap with said first lumen wall to form a lumen having an upper lumen end and a lower lumen end;

said lumen forming a first bowl channel for inflowing said fluid and extending axially through said core leading to indentation and trenches;

a bottom core having an outer wall, a top surface contacting and connected with bottom surface of upper plate for rotation therewith;

an upper bottom core end, a lower bottom core end, a top surface having an indentation and a trench, and a lumen wall that has an upper wall end and a lower wall end;

said bottom core occupying a bottom coaxial volume of said interior volume of said outer housing and providing a bottom separation volume between said bottom core and said outer housing;

said upper wall end of lumen wall is adapted to engage with bottom wall end of inner lumen wall to form a second bowl channel for removing a first separated fluid component;

said top surface is adapted to engage with the bottom surface of the upper plate;

a lower plate having a top surface, a bottom surface, and a hollow cylinder near center of lower plate;

said hollow cylinder has an opening adapted to engage with lower wall end of lumen; and

said lower plate having a circumference adapted to form a tight fit with the lower bottom core end for rotation therewith;

a connection sleeve having a sleeve flange surrounding a lumen mounting recess;

said lumen mounting recess and top surface of lumen connector engaged to form the bowl chamber for removing a second separated fluid component;

said connection sleeve further adapted to be secured to said apparatus near said housing outlet of said outer housing for rotation therewith and further wherein a drive tube is fixed to said lumen that rotates said centrifuge bowl.

2. The method of claim 1 wherein said step of removing said first separated fluid component comprises applying negative pressure to said second bowl channel.

3. The method of claim 1 wherein said negative pressure is applied by a pump.

4. The method of claim 3 wherein said pump provides substantially stable flow.

5. The method of claim 1 wherein said step of removing said first separated fluid component comprises applying positive pressure to said centrifuge bowl.

6. The method of claim 1 wherein said fluid comprises a biological fluid.

7. The method of claim 6 wherein said biological fluid comprises blood.

8. The method of claim 7 wherein said higher density component comprises red blood cells and said lower density component comprises a buffy coat.

9. The method of claim 8 further comprising the step of collecting platelets from said lower density component.

10. The method of claim 8 further comprising the step of reinfusing said higher density component into said source.

11. The method of claim 8 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.

12. The method of claim 11 wherein said method is completed in less than 70 minutes.

13. The method of claim 11 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, Mé

niè

re'"'"'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, Sjö

gren'"'"'s Syndrome, Stiff-Man Syndrome, Systematic Lupus Erythematosus, Takayasu Arteritis, Temporal Arteritis/Giant Cell Arteritis, Ulcerative Colitis, Uveitis, Vasculitis, Vitiligo, and Wegener'"'"'s Granulomatosis.

14. The method of claim 11 further comprising ameliorating or preventing organ or tissue transplant rejection.

15. The system of claim 11 wherein said treatment step comprises irradiating said lower density component.

16. The method of claim 11 wherein said treatment step is performed so as to induce apoptosis within said lower density component.

17. The method of claim 11 wherein said method is performed continuously without the need to batch process said fluid.