Apparatus and method for separating and concentrating fluids containing multiple components

• US 9,642,956 B2
• Filed: 08/27/2012
• Issued: 05/09/2017
• Est. Priority Date: 08/27/2012
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Landrigan, Matthew D., Swift, Matthew
• Primary Examiner(s): Mellon, David C
• Application Number:
  US13/595,461
• Publication Number:
  US 20140054246A1
• Time in Patent Office: 1,716 Days
• 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: B01D 17/0217 by centrifugal force
• CPC Class Codes: B01D 21/262 by using a centrifuge
• CPC Class Codes: B01D 2221/10 Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues apparatus for dental treatment A61C17/065
• CPC Class Codes: B01L 2400/0409 centrifugal forces
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 2400/0605 check valves
• CPC Class Codes: B01L 2400/0638 membrane valves, flap valves
• CPC Class Codes: B01L 3/50215 using a float to separate phases
• CPC Class Codes: B01L 9/06 Test-tube stands; Test-tube holders

Abstract

A buoy or float can be positioned within a separation container to assist in a physical separation of components of a whole material positioned in the separation container. The buoy can be positioned within the container to move from between and separation a first end and a second end of the container substantially unaffected by a portion of the whole material, including a clotted portion thereof. A first port can be provided near the first end of the container for introduction of the whole material and a second port can be provided near the second end of the container for removal of at least a portion of a separated material.

Claims

1. A system to separate a whole material including multiple components, comprising:

a container having an external wall defining a container volume within the external wall and extending along a long axis between a first end and a second end of the container;

a separation buoy moveable within the container volume between the first end and the second end, the separation buoy comprising at least one of a selected specific gravity and density to move the separation buoy in the whole material to a selected location within the container upon fractionation of the whole material by centrifugation;

a first fill port at the first end of the container;

a valve assembly formed within the first fill port and comprising a valve body including a boss configured to support the separation buoy and defining at least one passage adjacent the boss;

a second withdrawal port at the second end of the container; and

a stand including;

a stand end wall for supporting the container on a surface,

an outer stand wall extending from the stand end wall to engage at least one of the first end or the external wall of the container to enclose the first fill port,

wherein the outer stand wall has an outer dimension that is substantially equivalent to an outer dimension of the external wall of the container, and an inner stand wall extending from the stand end wall to engage the first fill port;

wherein the first fill port is configured to receive the whole material into the container and the second withdrawal port is configured to permit withdrawal of at least a selected component of the whole material from the container through the second withdrawal port.

2. The system of claim 1, wherein the valve assembly includes a check valve assembly formed within the first fill port having a flexible valve member and a valve seat, wherein an edge of the flexible valve member is moveable from a closed position when the flexible valve member sealingly engages the valve seat to an open position when the edge of the flexible valve member at least partially disengages the valve seat;

wherein the boss engages a central portion of the flexible valve member to hold the valve member in place.

3. The system of claim 1, wherein the first end includes a first end wall;

wherein the first fill port includes an extension portion that extends beyond the first end wall.

4. The system of claim 1, wherein the separation buoy substantially physically separates the first end of the container from the second end of the container;

wherein the first fill port at the first end of the container is positioned in the container relative to the separation buoy to minimize interference of a coagulated material during an operation of the separation buoy.

5. The system of claim 4, wherein the separation buoy includes at least a first buoy member and a second buoy member configured to define a separation volume between the first buoy member and the second buoy member;

wherein the second withdrawal port is in fluid communication with the separation volume to remove a selected fraction from the container through the second withdrawal port, where the second withdrawal port is separated from the first fill port by at least one of the first buoy member or the second buoy member.

6. The system of claim 1, wherein the stand operably engages the first end of the container to support the container in a centrifuge device during centrifugation of the container.

7. The system of claim 1, wherein the first end includes a first end wall;

wherein the first fill port is substantially flush with the first end wall.

8. The system of claim 1, wherein the separation buoy includes at least a first buoy member and a second buoy member;

wherein the first buoy member includes a first wall having a steep angle to ease passage of at least a portion of the whole material past the separation buoy within the container.

9. The system of claim 1, further comprising:

a cap configured to interconnect with the first fill port;

wherein the inner stand wall engages the cap when the stand is coupled to the container.

10. A system to separate a whole material including multiple components, comprising:

a container having an external wall defining a container volume within the external wall and extending along a long axis between a first end and a second end of the container;

a separation buoy positioned within the container volume between the first end and the second end;

a first fill port at the first end of the container having a connection that extends beyond the first end of the container;

a check valve assembly formed within the first fill port, the check valve assembly having a flexible valve member, a valve seat, and a valve body including a boss and defining at least one passage adjacent the boss, wherein an edge of the flexible valve member is moveable from a closed position when the flexible valve member sealingly engages the valve seat to an open position when the edge of the flexible valve member at least partially disengages the valve seat, wherein the boss configured to support the separation buoy and engage a central portion of the flexible valve member to hold the valve member in place;

a second withdrawal port at the second end of the container; and

a stand including;

a stand end wall for supporting the container on a surface,

an outer stand wall extending from the stand end wall to engage at least one of the first end or the external wall of the container to enclose the first fill port, wherein the outer stand wall has an outer dimension that is substantially equivalent to an outer dimension of the external wall of the container, and

an inner stand wall extending from the stand end wall to engage the first fill port;

wherein the first fill port is configured to receive the whole material into the container and the second withdrawal port is configured to permit withdrawal of at least a selected component of the whole material from the container through the second withdrawal port.

11. The system of claim 10, wherein the separation buoy includes a buoy density of about 1.01 grams per cubic centimeter to about 1.10 grams per cubic centimeter.

12. The system of claim 11, wherein the separation buoy includes a first buoy member and a second buoy member combined to include the buoy density.

13. The system of claim 10, wherein the separation buoy substantially physically separates the first end of the container from the second end of the container.

14. The system of claim 10, wherein the stand operably engages the first end of the container to support the container in a centrifuge device during centrifugation of the container.

15. The system of claim 10, wherein the first end includes a first end wall;

wherein the first fill port is substantially flush with the first end wall.

16. The system of claim 10, wherein the separation buoy includes at least a first buoy member and a second buoy member;

wherein the first buoy member includes a first wall having a steep angle to ease passage of at least a portion of the whole material past the separation buoy within the container.

17. The system of claim 10, further comprising:

a cap configured to interconnect with the first fill port;

wherein the inner stand wall engages the cap when the stand is coupled to the container.