Apparatus for separating blood components

• US 20060021952A1
• Filed: 03/14/2005
• Published: 02/02/2006
• Est. Priority Date: 09/11/2003
• Status: Active Grant

• Current Assignee: Nuo Therapeutics, Inc.
• Original Assignee: Sorin Group USA Incorporated (LivaNova Plc)
• Inventors: Skinkle, David W., Berch, Stephen W., Schwab, Michael, James, Craig, McGinnis, Daniel, Hunter, Beth Erin, Koenig, Rainer
• Granted Patent: US 7,407,472 B2
• Time in Patent Office: Days
• US Class Current: 210/787
• CPC Class Codes: A61J 1/05 for collecting, storing or administering blood, plasma or medical fluids multiple bags systems for separating or storing blood components A61M1/0209; Infusion or perfusion containers
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• 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 1/362265 Details of valves
• 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 1/3698 Expressing processed fluid out from the turning rotor using another fluid compressing the treatment chamber; Variable volume rotors
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: B04B 5/0428 with flexible receptacles
• CPC Class Codes: B04B 5/0442 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation

Abstract

A centrifuge apparatus for processing blood comprising a bottom spring-loaded support plate; a top support plate; an axial inlet/outlet for blood to be processed and processed components of the blood, the axial inlet/outlet being attached to the top support plate by a rotating seal assembly; a variable volume separation chamber mounted between the bottom support plate and the top support plate, the variable volume separation chamber being fluidly connected to the axial inlet/outlet; a pump fluidly connected to the axial inlet/outlet; and a rotary drive unit attached to the bottom support plate. The top support plate is fixed vertically and the bottom spring-loaded support plate is mounted on springs that maintain pressure on the variable volume separation chamber and allow the bottom support plate to move vertically.

Claims

1. A centrifuge apparatus for processing blood comprising

a bottom spring-loaded support plate;

a top support plate;

an axial inlet/outlet for blood to be processed and processed components of the blood, the axial inlet/outlet being attached to the top support plate by a rotating seal assembly;

a variable volume separation chamber mounted between the bottom support plate and the top support plate, the variable volume separation chamber being fluidly connected to the axial inlet/outlet;

a pump fluidly connected to the axial inlet/outlet; and

a rotary drive unit attached to the bottom support plate,

wherein the top support plate is fixed vertically and the bottom spring-loaded support plate is mounted on springs that maintain pressure on the variable volume separation chamber and allow the bottom support plate to move vertically.

2. An apparatus of claim 1, wherein the top support plate is disposable.

3. An apparatus of claim 1, wherein the variable volume separation chamber is a disk-shaped bag.

4. An apparatus of claim 3, wherein the disk-shaped bag is disposable.

5. An apparatus of claim 1, wherein the pump is a peristaltic pump.

6. An apparatus of claim 1, wherein the rotary drive unit and the pump are both controlled automatically by a processing unit.

7. An apparatus of claim 1, wherein the axial inlet/outlet is connected to a container for blood and to a plurality of containers for receiving separated components of the blood.

8. An apparatus of claim 7, further comprising a multi-position valve for controlling intake of blood from the container for blood and outlet of processed blood components from the axial inlet/outlet to the plurality of containers for blood.

9. An apparatus of claim 8, wherein the multi-position valve has four positions.

10. An apparatus of claim 8, wherein the multi-position valve has a position in which two separate fluid conduits are provided.

11. An apparatus of claim 8, wherein the multi-position valve is controlled automatically by a processing unit.

12. An apparatus of claim 7, wherein the container for blood and the plurality of containers for receiving separated components of the blood are disposable.

13. An apparatus of claim 7, further comprising a sensor for detecting the presence of blood and blood components.

14. An apparatus of claim 1, wherein the rotating seal assembly comprises one or more one piece lip seals.

15. An apparatus of claim 1, wherein the bottom support plate comprises a graduated scale that shows the amount of fluid present in the variable volume separation chamber.

16. A method of processing blood comprising:

providing a centrifuge apparatus, the centrifuge apparatus comprising

a bottom spring-loaded support plate;

a top support plate;

an axial inlet/outlet for blood to be processed and processed components of the blood, the axial inlet/outlet being attached to the top support plate by a rotating seal assembly;

a variable volume separation chamber mounted between the bottom support plate and the top support plate, the variable volume separation chamber being fluidly connected to the axial inlet/outlet;

a pump fluidly connected to the axial inlet/outlet; and

a rotary drive unit attached to the bottom support plate,

wherein the top support plate is fixed vertically and the bottom spring-loaded support plate is mounted on springs that maintain pressure on the variable volume separation chamber and allow the bottom support plate to move vertically;

introducing a quantity of blood into the variable volume separation chamber;

centrifuging the blood; and

removing the separated components of the blood through the axial inlet/outlet.

17. A method of claim 16, wherein the blood is centrifuged for from 5 to 15 minutes.

18. A method of claim 16, wherein the separated components of the blood are removed while the bottom support plate is still spinning.

19. A method of claim 16, wherein the quantity of blood introduced is from 20 to 200 ml.

20. A method of claim 16, wherein the top support plate is disposable.

21. A method of claim 16, wherein the variable volume separation chamber is a disk-shaped bag.

22. A method of claim 21, wherein the disk-shaped bag is disposable.

23. A method of claim 16, wherein the pump is a peristaltic pump.

24. A method of claim 16, wherein the rotary drive unit and the pump are both controlled automatically by a processing unit.

25. A method of claim 16, wherein the axial inlet/outlet is connected to a container for blood and to a plurality of containers for receiving separated components of the blood.

26. A method of claim 25, further comprising a multi-position valve for controlling intake of blood from the container for blood and outlet of processed blood components from the axial inlet/outlet to the plurality of containers for blood.

27. A method of claim 26, wherein the multi-position valve has four positions.

28. A method of claim 26, wherein the multi-position valve has a position in which two separate fluid conduits are provided.

29. A method of claim 26, wherein the multi-position valve is controlled automatically by a processing unit.

30. A method of claim 25, wherein the container for blood and the plurality of containers for receiving separated components of the blood are disposable.

31. A method of claim 25, further comprising a sensor for detecting the presence of blood and blood components.

32. A method of claim 16, wherein the rotating seal assembly comprises one or more one piece lip seals.

33. A method of claim 16, wherein the bottom support plate comprises a graduated scale that shows the amount of fluid present in the variable volume separation chamber.

34. A centrifuge apparatus for processing blood comprising

a bottom support plate;

a top support plate;

an axial inlet/outlet for blood to be processed and processed components of the blood, the axial inlet/outlet being attached to the top support plate by a rotating seal assembly;

a variable volume separation chamber mounted between the bottom support plate and the top support plate, the variable volume separation chamber being fluidly connected to the axial inlet/outlet;

a pump fluidly connected to the axial inlet/outlet; and

a rotary drive unit attached to the bottom support plate,

wherein the top holder is fixed vertically and the bottom support plate is mounted on a mechanical actuator that maintains pressure on the variable volume separation chamber and allows the bottom support plate to move vertically.

35. An apparatus of claim 34, wherein mechanical actuator is controlled automatically by a processing unit.

36. An apparatus of claim 34, wherein the mechanical actuator is a ball-screw actuator.

37. A disposable cartridge comprising a plurality of ports for receiving or dispensing blood or blood components and a fluid sensor pathway for displaying blood or blood components for analysis, the cartridge being adapted to be mounted on a multi-position valve for directing flow between the ports and the fluid sensor pathway being adapted to be mounted adjacent to one or more sensors for analyzing blood.

38. A disposable set comprising:

a container for blood;

a plurality of containers for receiving separated components of the blood;

a disk-shaped bag;

a top support plate for a centrifuge;

an axial inlet/outlet for blood to be processed and processed components of the blood, the axial inlet/outlet being attached to the top support plate by a rotating seal assembly;

and tubing.

39. A disposable set of claim 38, further comprising a disposable cartridge comprising a plurality of ports for receiving or dispensing blood or blood components and a fluid sensor pathway for displaying blood or blood components for analysis, the cartridge being adapted to be mounted on a multi-position valve for directing flow between the ports and the fluid sensor pathway being adapted to be mounted adjacent to one or more sensors for analyzing blood.

40. A centrifuge apparatus for processing blood comprising

a bottom spring-loaded support plate;

a top support plate;

an axial inlet/outlet for blood to be processed and processed components of the blood, the axial inlet/outlet being attached to the top support plate by a rotating seal assembly;

a variable volume separation chamber mounted between the bottom support plate and the top support plate, the variable volume separation chamber being fluidly connected to the axial inlet/outlet;

a pump fluidly connected to the axial inlet/outlet; and

a rotary drive unit attached to the bottom support plate,

wherein the top support plate is fixed vertically and the bottom spring-loaded support plate is mounted on springs that maintain pressure on the variable volume separation chamber and allow the bottom support plate to move vertically, and

wherein a disposable cartridge has been mounted on the apparatus, the disposable cartridge comprising a plurality of ports for receiving or dispensing blood or blood components and a fluid sensor pathway for displaying blood or blood components for analysis, the cartridge being adapted to be mounted on a multi-position valve for directing flow between the ports and the fluid sensor pathway being adapted to be mounted adjacent to one or more sensors for analyzing blood.

41. An apparatus of claim 40, wherein the disposable cartridge snaps on to the apparatus.

42. A disposable bag comprising three compartments separated by perforated portions that allow each compartment to be separated from the others, each compartment being adapted to contain blood or blood products.

43. A method of producing platelet rich plasma comprising:

providing a centrifuge apparatus;

introducing a quantity of blood into the centrifuge apparatus;

centrifuging the blood; and

removing a platelet rich plasma portion from the centrifuge apparatus,

wherein the final hematocrit of the platelet rich plasma portion is selected from a range of hematocrit values and the appropriate amount of additional red blood cells are added to the platelet rich plasma portion.

44. A method of claim 43, wherein the final hematocrit selected is within the range of from 0 to 25.

45. A method of claim 43, wherein the final hematocrit selected is within the range of from 5 to 25.

46. A method of producing platelet rich plasma comprising:

providing a centrifuge apparatus;

introducing a quantity of blood into the centrifuge apparatus;

centrifuging the blood; and

removing a platelet rich plasma portion from the centrifuge apparatus,

wherein a spin time and a rotational speed of the centrifuge apparatus are automatically selected based on the volume of blood or plasma introduced into the centrifuge apparatus.

47. A method of claim 46, wherein a first and second spin time and a first and second rotational speed are automatically selected based on the volume of blood or plasma introduced into the centrifuge apparatus.

48. A centrifuge apparatus for processing blood comprising:

an inlet/outlet for blood to be processed and processed components of the blood;

a centrifuge separation chamber that is fluidly connected to the inlet/outlet;

a container for blood that is fluidly connected to the inlet/outlet;

a plurality of containers for receiving separated components of the blood that are fluidly connected to the inlet/outlet;

two visible light emitters having different wavelengths and a first corresponding receiver that receives light from both visible light emitters;

an infrared light emitter and a second corresponding receiver that receives light from the infrared light emitter;

a processor that detects signals from the two corresponding receivers and sends a signal to a control device that switches the output of the inlet/outlet between the plurality of containers for receiving separated components of the blood.