Method of separating a selected component from a multiple component material

• US 8,119,013 B2
• Filed: 10/04/2010
• Issued: 02/21/2012
• Est. Priority Date: 04/12/2007
• Status: Active Grant

• Current Assignee: Hanuman, LLC, Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Hanuman, LLC, Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Leach, Michael D., Dorian, Randel, Hoeppner, Jacy C.
• Primary Examiner(s): Kim, John
• Application Number:
  US12/897,401
• Publication Number:
  US 20110021334A1
• Time in Patent Office: 505 Days
• Field of Search: 210/242.1, 210/512.1, 210/513, 210/515, 210/516, 210/518, 210/519, 210/523, 210/781, 210/782, 210/789, 422/101, 494/37
• US Class Current: 210/789
• CPC Class Codes: A61M 1/029 Separating blood components present in distinct layers in a container, not otherwise provided for containers for storing blood or blood components A61J1/05; sampling or analysing blood by separating blood components G01N33/491
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61P 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• CPC Class Codes: A61P 41/00 Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution
• CPC Class Codes: A61P 7/08 Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock artificial tears A61P27/04
• CPC Class Codes: B01D 21/26 Separation of sediment aided by centrifugal force or centripetal forcecentrifuges B04B; cyclones B04C
• CPC Class Codes: B01D 21/262 by using a centrifuge
• 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 3/50215 using a float to separate phases
• CPC Class Codes: G01N 33/491 by separating the blood components G01N15/05 takes precedence

Abstract

A separator that uses centrifugation to fractionate a suspension such as blood comprises a separation container and a buoy. The buoy is carried in the separation container and has a tuned density that is configured to reach an equilibrium position in a suspension. The guide surface is carried on the buoy upper surface and is inclined to an accumulation position near a buoy perimeter. The buoy suspension fractionation system can be used in a method of isolating a fraction from a suspension, and in a method for re-suspending particulates for withdrawal.

Claims

1. A method of isolating and withdrawing a selected component from a multiple component material using a buoy, comprising:

filling a separation container with the multiple component material, the separation container having a buoy with a tuned density, wherein the separation container defines a container longitudinal axis;

centrifuging the separation container to cause the multiple component material to separate into at least two fractions of varying densities by,

allowing the buoy in the separation container to reach an equilibrium within the fractions,

positioning at least a portion of one of the two fractions within a collection space near the buoy, and

conveying the selected component of at least one of the two fractions along a guide surface of the buoy to an accumulation position near a perimeter of the buoy, wherein the buoy has a buoy maximum transverse dimension that is defined by a line that is transverse to the container longitudinal axis and the guide surface is inclined substantially through the container longitudinal axis and relative to a buoy sidewall for at least two-thirds of the buoy maximum transverse dimension of the buoy; and

withdrawing the selected component.

2. The method of claim 1, wherein conveying the selected component of at least one of the two fractions includes concentrating particulates of the material within an accumulation portion.

3. The method of claim 2, wherein withdrawing the selected component includes withdrawing the concentrated particulates from the accumulation portion.

4. The method of claim 2, wherein concentrating particulates includes concentrating at least one particulate from a platelet, a stromal cell, white blood cells, or combinations thereof.

5. The method of claim 1,

wherein the guide surface is defined by the buoy upper surface and is inclined substantially towards a single portion of the perimeter of the buoy.

6. The method of claim 1, wherein the transverse dimension is a width of the buoy extending from a first edge of the perimeter, through a center of the buoy, and to a second edge of the perimeter.

7. The method of claim 2, further comprising:

agitating the concentrated particulates to at least partially re-suspend the concentrated particulates with a portion of at least one of the at least two fractions prior to withdrawing the selected fraction.

8. The method of claim 1, further comprising:

obtaining a volume of whole blood;

wherein filling the separation container with the multiple component material includes filling the separation container with the obtained volume of whole blood.

9. A method of isolating and withdrawing a selected component from a multiple component material using a buoy, comprising:

filling a separation container having a buoy with a tuned density with the multiple component material, the separation container defining a container axis and the buoy having at least one maximum dimension along a line transverse to the container axis;

centrifuging the separation container to cause the multiple component material to separate into fractions of varying densities by,

allowing the buoy in the separation container to reach an equilibrium within the fractions,

concentrating particulates by moving at least a portion of the multiple component material along a guide surface of the buoy, wherein the guide surface is substantially through a center of the container and is inclined at least two-thirds of the at least one maximum dimension of the buoy to an accumulation position near a perimeter of the buoy, and

conveying the particulates along the guide surface of the buoy to a collection space; and

withdrawing the selected component.

10. The method of claim 9, wherein concentrating particulates includes concentrating at least one particulate of a platelet, a stromal cell, white blood cells, or combinations thereof.

11. The method of claim 9, wherein allowing the buoy in the separation container to reach the equilibrium within the fractions includes allowing the buoy to move to a selected position relative a position between at least two fractions to separate at least a first fraction from the a second fraction of the at least two fractions.

12. The method of claim 11, wherein the equilibrium position is reached by providing a buoy having a density of about 1.0 g/cc to about 1.10 g/cc in a fractionated suspension of a volume of whole blood.

13. The method of claim 9

wherein conveying the particulates along the guide surface of the buoy includes conveying the particulates between an isolation member spaced a distance from the buoy, wherein the isolation member is connected to the buoy.

14. The method of claim 13, further comprising:

agitating the concentrated particulates prior to withdrawing the selected fraction.

15. The method of claim 14, further comprising:

forming a bubble in a collection space between the isolation member and the buoy;

wherein agitating includes moving the separation container with the formed bubble to at least partially re-suspend the concentrated particulates.

16. A method of isolating and withdrawing a selected component from a multiple component material using a buoy, comprising:

placing a volume of the multiple component material in a separation container;

applying a centrifugal force to the separation container, the volume of the multiple component material, and a buoy; and

moving the buoy to a position relative to the separation container and the volume of the multiple component material such that a submerged volume of the buoy below an equilibrium interface is greater than an un-submerged volume of the buoy above the equilibrium interface;

wherein the position of the buoy is based upon the buoy having a selected density and with a selected configuration, wherein the selected configuration includes;

a buoy top wall and a buoy bottom wall with a buoy perimeter sidewall defining a maximum height extending between the buoy top wall and the buoy bottom wall and a minimum height extending between the buoy top wall and the buoy bottom wall, and

a guide surface defined by the buoy top wall extending from a first edge at the buoy perimeter sidewall defining the maximum height through a central axis of the buoy to a second edge at the buoy perimeter sidewall defining the minimum height, wherein the guide surface extends from the first edge to the second edge at a first angle.

17. The method of claim 16, further comprising:

accumulating the selected component in an accumulation sump, wherein the accumulation sump is at least partially defined by the buoy top wall at the second edge;

wherein the accumulation sump is defined by an accumulation surface that is inclined at a second angle greater than the first angle.

18. The method of claim 17, further comprising:

moving at least a portion of the selected component along the guide surface towards the accumulation sump;

wherein the guide surface is substantially planar.

19. The method of claim 17, further comprising:

moving at least a portion of the selected component along the guide surface towards the accumulation sump;

wherein moving the at least a portion includes moving the material towards a midline of the buoy and towards the accumulation sump.

20. The method of claim 17, further comprising:

providing an isolator relative to the buoy such that the isolator is closer to a center of an axis of the centrifugal force; and

withdrawing the selected component from between the isolator and the buoy.

21. The method of claim 16, wherein the first angle of the guide surface is inclined relative to the buoy sidewall at an average angle of about 10 degrees to about 70 degrees.

22. A method of isolating and withdrawing a selected component from a multiple component material using a buoy, comprising:

filling a separation container with the multiple component material;

centrifuging the separation container to cause the multiple component material to separate into at least two fractions of varying densities and to cause a buoy that has a maximum cross-sectional area to move near an equilibrium interface between two separated fraction, wherein the buoy includes a maximum transverse dimension in the maximum cross-sectional area;

conveying the selected component of at least one of the two fractions along a guide surface of the buoy to an accumulation position near a perimeter of the buoy, wherein the guide surface is inclined in substantially one direction relative to a buoy sidewall for more than half of the buoy maximum transverse dimension; and

withdrawing the selected component.

23. The method of claim 22, further comprising:

withdrawing the selected component from between an isolator and the buoy;

wherein the isolator is positioned a distance from the buoy.