Method and apparatus for separating biological materials

• US 9,011,800 B2
• Filed: 07/16/2009
• Issued: 04/21/2015
• Est. Priority Date: 07/16/2009
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Leach, Michael D., Chavarria, Jason
• Primary Examiner(s): LEVKOVICH, NATALIA A
• Application Number:
  US12/504,413
• Publication Number:
  US 20110014705A1
• Time in Patent Office: 2,105 Days
• Field of Search: 422/72, 422/506, 422/533, 422/537, 422/548
• US Class Current: 422/533
• 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: A61M 2202/0437 Blood stem cells
• CPC Class Codes: A61M 2202/10 Bone-marrow
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: B01D 21/262 by using a centrifuge
• CPC Class Codes: B01D 21/307 Passive control mechanisms without external energy, e.g. using a float
• CPC Class Codes: B01D 2221/10 Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues

Abstract

According to various embodiments, a system can be provided to separate undifferentiated cells and/or stromal cells from a whole tissue sample. The whole tissue sample can be any appropriate tissue sample obtained directly from a patient. The tissue sample can be obtained during a selected operating procedure for immediate or quick application or re-application to the patient. Accordingly, autologous cells can be obtained intraoperatively for application to a patient substantially soon after obtaining a whole tissue sample.

Claims

1. A separation system to separate a multiple component material into at least two fractions, comprising:

a separation container defining a volume within an interior wall, a first end wall, and a second end wall;

a buoy separation system in the volume operable to move to a selected interface of the multiple component material when the multiple component material is separated, the buoy separation system including;

a first buoy portion having a passage between a first side and a second side of the first buoy portion;

a second buoy portion at a selected distance from the second side of the first buoy portion, wherein the selected distance defines a collection volume between the second side of the first buoy portion and the second buoy portion;

a third buoy portion extending between the first buoy portion and the second buoy portion;

a valve assembly extending from the third buoy portion, the valve assembly has a sealing member the is formed separate and distinct and is moveable relative to a flexible member, wherein the flexible member is positioned between the sealing member and the second buoy portion and holds the sealing member against the first buoy portion to seal the passage in the first buoy portion to separate the collection volume from a volume exterior to the collection volume on the first side of the first buoy portion;

wherein the valve assembly is operable to be unsealed from the first buoy portion to allow a selected fraction to move into the collection volume.

2. A separation system of claim 1, further comprising:

a centrifuge system having a centrifuge bucket operable to hold the separation container and spin the separation container around a central axis of the centrifuge bucket and apply a centrifugal force along a longitudinal axis of the separation container.

3. The separation system of claim 2, further comprising:

a withdrawal port extending through the first end wall of the separation container; and

a connection tube interconnecting the withdrawal port and the collection volume between the first buoy portion and the second buoy portion to allow withdrawal of the stromal cells when the valve assembly is sealed;

wherein the buoy separation system is operable to move relative to the separation container based upon a force imparted on the buoy separation system by the multiple component material when the separation container is centrifuged in the centrifuge system.

4. The separation system of claim 1,

wherein each of the sealing member and the flexible member have an inner wall defining a passage to fit the valve assembly around a central tube extending from the first buoy portion into the collection volume;

wherein at least a portion of the flexible member is fixed relative to the first buoy portion.

5. The separation system of claim 4, further comprising:

an extraction port formed through an outer wall of the central tube to allow withdrawal access to the collection volume.

6. The separation system of claim 5, wherein the second buoy portion has an upper wall that defines a central sump to collect a pellet of stromal cells.

7. The separation system of claim 4, wherein the flexible member has a peripheral edge spaced a distance outward from the inner wall of the flexible member, wherein the peripheral edge is configured to move to allow the sealing member to unseal from the first buoy portion.

8. The separation system of claim 7, wherein the flexible member includes a first portion that is cantilevered and flexes relative to a second portion of the flexible member.

9. The separation system of claim 1, wherein the interior wall of the separation container substantially defines a cylindrical volume;

wherein the first buoy portion includes an annular member extending around a central post and a spoke member extending from the central post to the annular member;

wherein the spoke and the annular member define the passage;

wherein the valve assembly contacts the first side of the first buoy portion substantially adjacent the collection volume to seal the passage through the first buoy portion.

22. The separation system of claim 7, wherein the valve assembly further includes a holding cylinder to position the flexible member to contact the sealing member.

23. The separation system of claim 1, wherein the valve assembly further includes a holding cylinder to position the flexible member in contact with the sealing member and to engage a holding portion that is extending from the second buoy portion wherein the holding portion forms a clearance between the holding cylinder and the second buoy portion.

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

a leg extending between the first buoy portion and the second buoy portion.

10. A separation system including a buoy separation system to separate a multiple component material into at least a first fraction, the buoy separation system comprising:

a first buoy portion having a passage between a first side and a second side of the first buoy portion;

a second buoy portion spaced a selected distance from the second side of the first buoy portion, wherein the selected distance defines a collection volume between the second side of the first buoy portion and the second buoy portion; and

a valve assembly having a sealing member and a flexible member, the flexible member having a central portion fixed relative to the first buoy portion and extending a dimension from the central portion to an outer edge great enough to extend substantially the entire selected distance between the first buoy portion and the second buoy portion when at least the central portion is fixed relative to the first buoy portion;

wherein the flexible member holds the sealing member against the first buoy portion to seal the passage in the first buoy portion thus maintaining a separation of the collection volume from a volume exterior on the first side of the first buoy portion;

wherein the valve assembly is operable to be unsealed from the first buoy portion to allow the first fraction to move into the collection volume.

11. The separation system of claim 10, further comprising:

a separation container having a volume defined by an interior wall, a first end wall, and a second end wall.

12. The separation system of claim 11, further comprising:

a withdraw port extending through the first end wall;

an extraction port extending from the first buoy portion;

a tube interconnecting the withdraw portion and the extraction portion; and

a tube extending from the extraction portion into the collection volume.

13. The separation system of claim 12, wherein the tube has an exterior wall that, at least in part, fixes the first buoy portion relative to the second buoy portion the selected distance to define the collection volume between the first buoy portion and the second buoy portion;

wherein a first end of the tube extends to the first buoy portion and a second end of the tube extends to a sump defined by an upper wall of the second buoy portion.

14. The separation system of claim 12, wherein the upper wall of the second buoy portion is formed at an angle relative to an axis of the tube;

wherein the angle is about 45 degrees to about 90 degrees.

15. The separation system of claim 10, wherein the flexible member includes a first disc portion extending radially from a central hub portion, wherein the central hub portion extends substantially the entire selected distance;

wherein the sealing member is an annular member operable to be pressed against the first buoy portion by the flexible member.

25. The separation system of claim 10, further comprising:

a fin extending from the second buoy portion, wherein a clearance between the valve assembly and the second buoy member is formed by contact of the valve assembly with the fin.

16. A separation system including a buoy separation system to separate a multiple component material into at least a first fraction, the buoy separation system comprising:

a first buoy portion having a passage between a first side and a second side of the first buoy portion;

a second buoy portion positioned at a selected distance from the second side of the first buoy portion, wherein the selected distance defines a collection volume between the second side of the first buoy portion and the second buoy portion;

a third buoy portion extending between the first buoy portion and the second buoy portion; and

a valve assembly having a sealing member distinct and separate from a flexible member;

wherein the flexible member is between the sealing member and the second buoy portion and contacts the sealing member to engage the sealing member against the first buoy portion to seal the passage in the first buoy portion thus maintaining a separation of the collection volume from a volume exterior on the first side of the first buoy portion;

wherein the valve assembly is operable to be unsealed from the first buoy portion.

17. The separation system of claim 16,

wherein the sealing member is substantially coextensive and directly contacts the flexible member.

18. The separation system of claim 16, further comprising:

a separation container having a volume defined by an interior wall, a first end wall, and a second end wall;

wherein the first buoy portion, the second buoy portion, the third buoy portion, and the valve assembly are configured to be placed within the separation container to assist with separating a material also placed within the separation container.

19. The separation system of claim 16, wherein the flexible member has a dimension great enough to extend the entire selected distance when contacting the second buoy portion.

20. The separation system of claim 19, wherein the flexible member includes a first disc portion extending radially from the third buoy portion, wherein the third buoy portion extends substantially the entire selected distance;

wherein the sealing member and the flexible member are both annular members, where the sealing member is pressed against the first buoy portion by the flexible member.

21. The separation system of claim 20, wherein the flexible member applies a force between the second buoy portion and the sealing member to seal the passage of the first buoy portion.