Apparatus and method for separating and concentrating fluids containing multiple components

• US 7,780,860 B2
• Filed: 05/19/2008
• Issued: 08/24/2010
• Est. Priority Date: 05/24/2002
• Status: Expired due to Term

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Woodell-May, Jennifer E., Higgins, Joel C., Leach, Michael D., Miller, Brandon
• Primary Examiner(s): SMITH, DUANE
• Application Number:
  US12/123,141
• Publication Number:
  US 20080217265A1
• Time in Patent Office: 827 Days
• Field of Search: 210/782, 210/789, 210/360.1, 210/380.1, 210/516, 422/72, 422/101, 494/43, 494/50, 494/67, 604/6.01, 604/6.05, 604/6.15, 604/218, 604/403
• US Class Current: 210/782
• CPC Class Codes: B01D 17/0217 by centrifugal force
• CPC Class Codes: B01L 1/52 Transportable laboratories; Field kits
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2400/0409 centrifugal forces
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/5021 Test tubes specially adapted for centrifugation purposes centrifuges B04B5/04
• CPC Class Codes: B01L 3/50215 using a float to separate phases
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]

Abstract

An apparatus is disclosed that allows for separating and collecting a fraction of a sample. The apparatus, when used with a centrifuge, allows for the creation of at least three fractions in the apparatus. It also provides for a new method of extracting the buffy coat phase from a whole blood sample. A buoy system that may include a first buoy portion and a second buoy member operably interconnected may be used to form at least three fractions from a sample during a substantially single centrifugation process. Therefore, the separation of various fractions may be substantially quick and efficient.

Claims

1. A method of separating a multi-component fluid using a centrifuge process and buoy system, including a first and a second piston, in a container to hold the multi-component fluid during the centrifuge process, comprising:

interconnecting the first piston and the second piston with a connection member;

forming a first fraction and a second fraction by centrifuging the multi-component fluid disposed in the container;

containing at least a portion of the second fraction in a collection area of the first piston;

disposing the first piston relative to the second piston; and

moving the second piston relative to the first piston to at least assist in withdrawing the second fraction.

2. The method of claim 1, further comprising withdrawing at least a portion of the second fraction including:

forming a cannula in the connection member;

and drawing the portion of the second fraction through the cannula.

3. The method of claim 1, further comprising;

moving the first piston and the second piston substantially as a system through the multi-component fluid;

wherein a first fraction is disposed on a side of at least one of the first piston and the second piston and the second fraction is disposed substantially between the first piston and the second piston.

4. The method of claim 1, wherein the collection area of the first piston includes a first face that is substantially complementary to a second face of the second piston, such that when the second piston including the second face engages the first face of the first piston substantially no volume remains in the first face;

wherein withdrawing the second fraction includes moving the second face of the second piston into the first face of the first piston.

5. The method of claim 1, wherein said first fraction and said second fraction are formed from at least one of a whole blood sample, a bone marrow aspirate, or combinations thereof.

6. The method of claim 1, further comprising:

withdrawing a selected volume of a material including the multi-component fluid from a patient and positioning the volume of the material relative to the first piston and the second piston.

7. The method of claim 6, further comprising:

collecting the material from the patient and placing it directly relative to the first piston and the second piston.

8. The method of claim 7, further comprising:

forming a pressure relative to the first piston and the second piston lower than a pressure of the material within the patient.

9. A method of separating a multi-component fluid using a centrifuge process and buoy system, including a first and a second piston, in a container to hold the multi-component fluid during the centrifuge process, comprising:

interconnecting the first piston and the second piston with a connection member;

forming a first fraction and a second fraction by centrifuging the multi-component fluid disposed in the container;

containing at least a portion of the second fraction in a collection area of the first piston; and

disposing the first piston relative to the second piston;

wherein interconnecting the first piston and the second piston with the connection member further includes;

fixing the connection member to the first piston; and

slidably connecting the second piston to the connection member;

wherein the second piston is operable to move relative to the first piston along the connection member.

10. The method of claim 9, further comprising:

providing a buoy system within the container;

wherein said buoy system includes the first piston and the second piston operably interconnected with the connection member.

11. The method of claim 9, wherein containing the second fraction in the collection area of the first piston includes:

moving the first piston through the multi-component fluid in conjunction with the second piston to collect at least the second fraction in the collection area.

12. The method of claim 9, further comprising:

withdrawing at least a portion of the second fraction.

13. A system for separating and extracting selected fractions from a container, the system comprising:

a piston system, including;

a first piston having a first density;

a second piston having a second density;

a connection member operably interconnecting said first piston and said second piston;

a first piston collection face defined by said first piston;

wherein a selected fraction is operable to be collected in said first piston collection face between said first piston and said second piston;

wherein said second piston defines a second piston collection face;

wherein said second piston collection face is substantially complementary to said first piston collection face, such that said second piston collection face may substantially mate with said first piston collection face to substantially eliminate any volume defined between said second piston collection face and said first piston collection face.

14. The system of claim 13, further comprising:

a container defining an internal diameter;

wherein said piston system is disposable within said container during a centrifuge process.

15. The system of claim 13, wherein said first piston collection face is a substantially concave surface defined by an upper portion of said first piston;

wherein said first piston collection face is disposed between said first piston and said second piston.

16. The system of claim 13, wherein said connection member further defines a port extending between said first piston collection face and said cannula defined by said connection member.

17. The system of claim 13, wherein said first piston collection face includes an angle of concavity of above 0.5°

to about 45°

relative to a central axis of said connection member.

18. The system of claim 15, wherein said second piston includes an upper surface defining an angle relative to a central axis of said connection member of about 90°

to about 150°

.

19. The system of claim 13, wherein said second piston defines a second piston collection face;

wherein of said second piston collection face is substantially complementary to said first piston collection face.

20. The system of claim 13, further comprising a container operable to contain said piston system.

21. The system of claim 20, further comprising a vacuum creating system interconnected with said container to form a pressure differential in said container relative to a position exterior to said container.

22. The system of claim 21, wherein the vacuum creating system further comprises a resilient bulb interconnected with at least a first valve such that said resilient bulb is operable to withdraw a volume of fluid from said container and expel the volume of fluid from said container while substantially eliminating the re-entry of a volume of fluid into said container.

23. The system of claim 20, further comprising:

a fluid accepting port formed in the container; and

a conduit interconnecting said fluid accepting port and a fluid source.

24. The system of claim 23, wherein said conduit is operable to be interconnected with an intravenous system such that a material is operable to be collected directly from an intravenous area into said container.

25. The system of claim 13, wherein said second piston includes a center axis and an upper surface defining an angle of about 70°

to about 90°

relative to said center axis.

26. The system of claim 25,

wherein the container further comprises a top wall of the container and a port extending from the top wall;

and

a flexible tube extending from the port to a collection member.

27. A system for separating and extracting selected fractions from a container, the system comprising:

a piston system, including;

a first piston having a first density;

a second piston having a second density;

a connection member operably interconnecting said first piston and said second piston;

a first piston collection face defined by said first piston;

wherein a selected fraction is operable to be collected in said collection face between said first piston and said second piston;

wherein said second piston is movable relative to said first piston along said connection member.

28. The system of claim 27, wherein an extraction member is operably connected to and operable to produce a force through said cannula, such that said second piston is urged toward said first piston to assist in extraction of the second fraction.

29. A system for separating and extracting a selected fraction from a container, the system comprising:

a container having a container central axis;

a buoy system, including;

a first buoy, a second buoy, and a connection member operable to be positioned in the container;

a first collection face defined by said first buoy which includes an upper surface defining an angle relative to a buoy central axis defined as extending through the first buoy of about 90°

to about 150°

; and

a second collection face defined by the second buoy substantially complementary to the first collection face such that said second collection face may substantially mate with said first collection face to substantially eliminate any volume defined between said second collection face and said first collection face;

wherein the first buoy has a first density;

wherein the second buoy has a second density;

wherein the connection member connects the first buoy and the second buoy;

wherein the container central axis and the buoy central axis are operable to be aligned;

wherein a selected fraction is operable to be collected in the first collection face between the first buoy and the second buoy;

wherein the connection member defines a passage with a portal operable to gain access to the first collection face.

30. The system of claim 29, further comprising:

a centrifuge device;

wherein the container and the buoy system are operable to be positioned in the centrifuge device.

31. The system of claim 30, wherein the first density of the first buoy and the second density of the second buoy are different such that the first buoy and the second buoy are operable to be separated with a force formed with the centrifuge device.