Apparatus and method for separating and concentrating fluids containing multiple components

• US 8,062,534 B2
• Filed: 12/06/2010
• Issued: 11/22/2011
• 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: Swift, Matthew, Gordon, Nathan, Higgins, Joel C., Hecker, Barry F.
• Primary Examiner(s): Soohoo; Tony G
• Assistant Examiner(s): Mellon; David C
• Application Number:
  US12/961,191
• Publication Number:
  US 20110077596A1
• Time in Patent Office: 351 Days
• Field of Search: 210/787, 210/788, 210/789, 210/800, 210/360.1, 210/380.1, 604/6.15, 604/403, 494/45, 494/50, 494/67
• US Class Current: 210/787
• CPC Class Codes: B01D 17/0217 by centrifugal force
• CPC Class Codes: B01D 17/12 Auxiliary equipment particularly adapted for use with liquid-separating apparatus, e.g. control circuits
• CPC Class Codes: B01D 21/262 by using a centrifuge
• 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 3/50215 using a float to separate phases
• CPC Class Codes: B01L 9/54 Supports specially adapted for pipettes and burettes automated pipetting stations G01N35/10
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

An apparatus that allows for separating and collecting a fraction of a sample. The apparatus, when used with a centrifuge, allows for the creation of at various fractions in the apparatus. 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. Also selected fractions from the sample can be applied to a patient, either alone or as part of a mixture.

Claims

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

a container to contain the whole material; and

a separation system operable to be positioned within the container, including;

a first separation member;

a second separation member;

a third separation member operably interconnecting said first separation member and said second separation member; and

a check valve positioned relative to the second separation member that allows for movement of a material past said second separation member through a checked passage defined between said third separation member and said second separation member;

wherein each of said first member, said second member, and said third member of the separation system is at least partially fixed at a position relative to each other of said first member, said second member, and said third member of the separation system; and

wherein said third separation member allows access to a volume defined between said first separation member and said second separation member.

2. The separation system of claim 1, wherein the separation system includes a density of about 1.00 g/cc to about 1.10 g/cc.

3. The separation system of claim 1, wherein said second separation member includes a lower surface defining an apex;

wherein the portion of said second separation member that engages a bottom of said container is substantially limited to said apex.

4. The separation system of claim 1, further comprising a pressure system operable to form a pressure differential in said container different from a pressure external to said container.

5. The separation system of claim 4, further comprising an intravenous conduit operable to be connected with an intravenous portion of a patient and directly to said container such that the pressure formed in said container is different from a pressure in the intravenous system operable to form a flow of material into said container.

6. The separation system of claim 1, wherein said third separation member defines a passage extending between a volume defined between said first separation member and said second separation member and an end of said third separation member.

7. The separation system of claim 1, further comprising:

an extraction instrument operable to be interconnected with said third separation member to withdraw a selected volume from between said first separation member and said second separation member.

8. The separation system of claim 1, further comprising a port extending from said container;

a flexible tube interconnecting said third separation member and said port;

wherein said extraction instrument operably interconnects with said port to be fluidly connected to a volume between said first separation member and said second separation member;

wherein said flexible tube maintains a connection between said third separation member and said port during a centrifugation of said container with said separation system positioned within said container.

9. The separation system of claim 1, further comprising:

a centrifuge;

wherein said container is disposable in said centrifuge during a centrifugation process to form at least two fractions of a selected sample and said separation system is operable to move to a position within said container during said centrifugation process to at least separate the two fractions.

10. The separation system of claim 1, wherein said separation system is formed from a single member.

11. The separation system of claim 1, wherein said first separation member, said second separation member and said third separation member are formed as separate pieces that are fixably interconnected.

12. The separation system of claim 11, wherein the fixed interconnection of the first separation member, the second separation member, and the third separation member includes adhesives, welding, injection molding, mechanical fixation and the like.

13. The separation system of claim 1, wherein said check valve includes a flexible washer, a member including a living hinge, a spring, or combinations thereof.

14. The separation system of claim 1, wherein said check valve is operable to move during extraction of a volume with said extraction instrument.

15. The separation system of claim 1, wherein said second separation member defines a passage therethrough and said check valve is operable to close at least a portion of the passage defined by said second separation member.

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

a container to contain the whole material; and

a separation system positioned within said container, including;

a first separation member;

a second separation member;

a third separation member operably interconnecting said first separation member and said second separation member, wherein said third separation member includes a passage extending into at least a portion of a dimension of said third separation member; and

a check valve positioned relative to said third separation member to selectively seal a checked passage formed relative to said first separation member to allow for movement of a material relative to said first separation member;

wherein the first separation member is fixed relative to the second separation member;

wherein said passage of said third separation member allows access to a volume defined between said first separation member and said second separation member;

wherein said check valve allows for passage of a selected material upon the application of a force through said checked passage;

wherein said check valve is operable to open said checked passage upon the application of a vacuum to withdraw a material from between said first separation member said second separation member through said passage in said third separation member.

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

a container to contain the whole material; and

a separation system positioned within said container, including;

a first separation member;

a second separation member;

a third separation member operably interconnecting said first separation member and said second separation member, wherein said third separation member includes a passage extending at least a portion of a dimension of said third separation member; and

a check valve positioned relative to said third separation member to selectively seal a checked passage formed relative to said first separation member to allow for movement of a material relative to said first separation member;

wherein the first separation member is fixed relative to the second separation member;

wherein said passage of said third separation member allows access to a volume defined between said first separation member and said second separation member;

wherein said check valve allows for passage of a selected material upon the application of a force through said checked passage;

wherein said check valve includes a flexible member having a portion to engage said first separation member to seal said checked passage.

18. The system of claim 17, wherein said flexible member includes at least one of a substantially flexible washer, a silicone material, or a rigid material including a living hinge.

19. The system of claim 18, wherein said second separation member includes a concave collection surface and said first separation member includes a concave collection surface, wherein the first collection surface and the second collection surface are non-complementary;

wherein said checked passage is defined between said first separation member and said third separation member and said flexible member extends from said third separation member to selectively seal said checked passage.

20. A method for separating and extracting selected fractions from a container, comprising:

centrifuging a container with a separation system therein, the separation system having a first separation member, a second separation member, and a third separation member to form a fraction of a whole material between the first separation member and the second separation member;

wherein a check valve selectively seals a checked passage formed between said first separation member and said third separation member and allows movement of at least a portion of the whole material past said first separation member;

wherein said third separation member is interconnecting said first separation member and said second separation member and said first separation member is fixed relative to said second separation member;

wherein access to a volume between said first separation member and said second separation member is allowed through said third separation member.

21. The method of claim 20, further comprising:

withdrawing said fraction from between said first separation member and said second separation member via a passage extending through at least a portion of a dimension of a third separation member.

22. The method of claim 21, wherein said check valve further selectively unseals the checked passage during at least one of said centrifuging the separation system in said container to allow at least a portion of the whole material to pass through said checked passage or during a said withdrawal of said fraction from said container to equalize a pressure during withdrawal of said fraction.