Apparatus and method for separating and concentrating fluids containing multiple components

• US 8,048,321 B2
• Filed: 08/11/2010
• Issued: 11/01/2011
• 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: Higgins, Joel C., Leach, Michael D., Woodell-May, Jennifer E., Miller, Brandon
• Primary Examiner(s): Reifsnyder; David A
• Application Number:
  US12/854,643
• Publication Number:
  US 20100324450A1
• Time in Patent Office: 447 Days
• Field of Search: 210/782, 210/789, 210/360.1, 210/380.1, 210/516, 222/401, 422/72, 422/101, 422/527, 600/577, 600/583, 604/6.01, 604/6.05, 604/6.15, 604/142, 604/205, 604/217, 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 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 withdrawing a material directly from a patient and collecting a selected fraction of the material, comprising:

forming an access port to the patient;

forming a pressure differential between a collection container and the patient;

connecting the collection container to the port;

filling the collection container to a selected volume with the material; and

centrifuging the collection container containing the selected volume of the material to separate the material to form the selected fraction, wherein a separating member moves relative to a boundary of the selected fraction to substantially form a mechanical separation of the selected fraction.

2. The method of claim 1, wherein forming an access port to the patient includes at least one of positioning a member substantially intravenously in the patient, positioning a syringe substantially intravenously in the patient, or combinations thereof.

3. The method of claim 2, further comprising interconnecting the access port in the patient with the collection container such that a material in the intravenous portion is operable to move substantially directly to the collection container.

4. The method of claim 1, wherein forming a pressure differential in the collection container includes forming a pressure in the collection container substantially less than a pressure in the patient.

5. The method of claim 1, wherein forming a pressure differential includes removing a selected volume of a fluid from the collection container with at least one of a resilient bulb, a mechanical pump, a fluid pump, or combinations thereof.

6. The method of claim 1, wherein separating centrifuging the material to form the selected fraction includes:

forming at least a first fraction and a second fraction; and

applying a force to the collection container to substantially urge the formation of the first fraction and the second fraction from the material.

7. The method of claim 1, wherein centrifuging the collection container includes:

forming at least a first fraction and a second fraction of the material in the collection container;

wherein the separating member moves relative to a boundary of the first fraction and the second fraction to substantially form the mechanical separation between the first fraction and the second fraction.

8. The method of claim 1, further comprising:

forming a vacuum in the collection container relative to the patient to form the pressure differential in the collection container;

urging a volume of a fluid to flow from the patient through the access port based on the pressure differential; and

stopping the flow of the fluid being urged from the patient when the collection container is filled to the selected volume.

9. A method of withdrawing a material directly from a patient and collecting a selected fraction of the material, comprising:

connecting a collection container directly to the patient;

forming a pressure differential between the collection container and the patient;

filling the collection container with the material;

centrifuging the collection container including the material to separate the material to form the selected fraction, wherein a member having a specific gravity substantially tuned to the selected fraction moves to a position relative to the selected fraction when a force is applied to the collection container during centrifuging; and

removing the selected fraction from the collection container.

10. The method of claim 9, wherein connecting a collection container directly to the patient includes connecting a member intravenously to the patient via a communication tube connected directly to the separation container.

11. The method of claim 10, wherein forming a pressure differential includes venting the collection container such that an intravenous pressure of the patient is maintained greater than a pressure within the collection container.

12. The method of claim 10, wherein the member includes a buoy system within the collection container that moves during centrifuging the collection container;

wherein centrifuging the collection container to separate the material to form the selected fraction includes forming at least a first fraction and a second fraction wherein the buoy system moves to a selected location within the material and near an interface between the first fraction and the second fraction.

13. The method of claim 12, wherein the buoy system includes a first buoy member and a second buoy member;

wherein the first buoy member moves within the collection container during the centrifuging such that the selected fraction is positioned within a collection face of the first buoy member, wherein the collection face defines a concave area in the first buoy member.

14. The method of claim 13, wherein removing the selected fraction from the collection container includes withdrawing the selected fraction from the collection face through a portal to an exterior of the collection container after centrifuging the collection container to separate the material and form the selected fraction.

15. The method of claim 9, wherein forming a pressure differential includes forming a vacuum within the collection container relative to ambient pressure outside of the collection container.

16. The method of claim 15, wherein forming the vacuum in the collection container includes operating a bulb system to remove a volume of air from the collection container.

17. A method of withdrawing a material directly from a patient and collecting a selected fraction of the material, comprising:

connecting a collection container directly to the patient, wherein there is first pressure differential between the collection container and the patient;

forming a second pressure differential between the collection container and the patient, after connecting the collection container directly to the patient, wherein the second pressure differential is greater then the first pressure differential;

filling the collection container with a selected volume of the material;

centrifuging the collection container to cause a buoy to move within the container, wherein the buoy is operable to rest at a selected location to physically separate the selected fraction from another fraction of the material; and

removing the selected fraction from a region between a top of the collection container and the buoy.

18. The method of claim 17, wherein connecting the collection container directly to the patient includes directly connecting the collection container intravenously to the patient with a delivery tube;

wherein forming the pressure differential in the collection container includes maintaining a pressure in the collection container less than an intravenous pressure of the patient.

19. The method of claim 18, wherein maintaining a pressure in the collection container less than the intravenous pressure of the patient, includes forming a vacuum in the collection container relative to an ambient pressure outside of the collection container.

20. The method of claim 19, wherein forming a vacuum in the collection container includes withdrawing a volume of air from the collection container through a one way valve.

21. The method of claim 20, wherein forming the vacuum in the collection container includes operating a bulb system to remove a volume of air from the collection container.

22. The method of claim 17, further comprising:

connecting a withdrawal system to the buoy through the collection container;

wherein removing the selected fraction includes removing the selected fraction from a collection face of the buoy.