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

• US 7,211,037 B2
• Filed: 09/03/2003
• Issued: 05/01/2007
• Est. Priority Date: 03/04/2002
• Status: Expired due to Term

• 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, Watters, Tom, Hutchinson, Mike
• Primary Examiner(s): Reifsynder; David A
• Application Number:
  US10/654,742
• Publication Number:
  US 20040124157A1
• Time in Patent Office: 1,336 Days
• Field of Search: 210/380.1, 210/206, 494/41, 494/43, 494/44, 494/67, 494/76, 494/77, 604/4.01, 604/6.01, 604/6.04, 604/5.01, 604/5.04, 604/6.08
• US Class Current: 494/44
• 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 wherein three separate fluid pathways are provided to allow continuous separation of biological fluids.

Claims

1. An apparatus for separating components of a fluid 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;

a base said outer housing and said base having an interior volume between them and said outer housing 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 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 extending axially through said core forming a first bowl channel for inflowing said fluid and said lumen having fluid communication with the separation volume via a trench;

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, said 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 between said outer housing and said base;

said upper wall end of lumen wall is adapted to engage with bottom wall end of inner lumen wall to form an inner lumen having an upper lumen end and a lower lumen end;

said inner lumen forming a second bowl channel for removing a first separated fluid component;

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

said hollow cylinder has an opening adapted to engage with lower wall end of said 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 a 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.

2. The apparatus of claim 1 wherein said outer wall of said top core increases in diameter from said upper end to said lower end.

3. The apparatus of claim 1 wherein said outer wall of said bottom core increases in diameter from said upper end to said lower end.

4. The apparatus of claim 1 wherein said outer wall of said top core increases in diameter from said upper end to said lower end and said outer wall of said bottom core increases in diameter from said upper end to said lower end.

5. The apparatus of claim 1 wherein said lumen having a height and said lumen wall having a height and the height of said lumen is about one third to about four times the height of said lumen wall.

6. The apparatus of claim 5 wherein the height of said lumen and the height of said lumen wall are about the same.

7. The apparatus of claim 1 wherein the top surface of said bottom core has one to 10 trenches.

8. The apparatus of claim 7 wherein the top surface of said bottom core has three to six trenches.

9. The apparatus of claim 1 wherein said connection sleeve is adapted to fluidly connect a first and second bowl channels, and a bowl chamber to a corresponding conduit channel of an external conduit.

10. 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.

11. The apparatus of claim 10 wherein said locking mechanism comprises protrusions.

12. The apparatus of claim 11 wherein said locking mechanism comprises a key slot.

13. The apparatus of claim 1 wherein said lower plate is circular.

14. The apparatus of claim 1 wherein said apparatus is adapted for use without a rotatable seal.

15. The apparatus of claim 1 wherein said apparatus is closed to undesired contagions.

16. The apparatus of claim 1 wherein said apparatus is adapted to allow rotation of said upper bottom cores and said lower bottom core, said lower plate, said upper plate, and said outer housing about said lumens.

17. The apparatus of claim 1 further comprising means for rotating said outer housing about said axis.

18. The apparatus of claim 17 wherein said means for rotating comprises a bracket.

19. The apparatus of claim 18 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 bowl chamber.

20. The apparatus of claim 19 wherein said rotation means is adapted to rotate said outer housing and said external conduit using 1-omega/2-omega spin technology.

21. The apparatus of claim 17 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 bowl chamber; and

means to treat said second separated fluid component subsequent to being removed via bowl chamber.

22. The apparatus of claim 21 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.

23. The apparatus of claim 22 wherein said reinfusion means comprises a needle or catheter.

24. The apparatus of claim 21 further comprising an anticoagulant source fluidly connected between said means to remove said fluid from said source and said first bowl channel.

25. The apparatus of claim 21 wherein said means to remove said fluid from said source comprises a needle or catheter.

26. The apparatus of claim 21 wherein said means to remove said first separated fluid component comprises a pump.

27. The apparatus of claim 21 wherein said treatment means comprises a chamber and a source of ultraviolet radiation.