Method and apparatus for separating and concentrating a component from a multi-component material including macroparticles

• US 20060273049A1
• Filed: 05/25/2006
• Published: 12/07/2006
• Est. Priority Date: 05/24/2002
• Status: Active Grant

• 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., Leach, Michael D.
• Granted Patent: US 7,832,566 B2
• Time in Patent Office: Days
• US Class Current: 210/787
• CPC Class Codes: A61K 35/12 Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells vaccines or medicinal preparations containing antigens or antibodies A61K39/00
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• 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 2300/0681 Filter
• 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 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: 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 least three fractions in the apparatus. It also provides for a new method of extracting the buffy coat phase from a whole blood sample and mesenchymal stem cells from bone reaming material. 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 system for separating and extracting selected fractions of a whole sample, the system comprising:

a container;

a filtration system;

a separation system; and

an extraction system;

wherein the filtration system allows for separation of a macroparticle from a fluid of the whole sample.

2. The system of claim 1, wherein the separation system comprises a piston system, including:

a first piston having a first density;

a second piston having a second density;

a connection member operably interconnecting said first piston and said second piston;

a first piston collection face defined by said first piston;

wherein a selected fraction is operable to be collected in said collection face between said first piston and said second piston.

3. The system of claim 1, wherein said filtration system comprises a porous mesh filter.

4. The system of claim 1, wherein said filtration system and said piston system are in fluid communication.

5. The system of claim 3, comprising a plurality of the porous mesh filters.

6. The system of claim 1, wherein said filtration system and said separation system are disposable within said container during a centrifuge process.

7. The system of claim 2, wherein said second piston defines a second piston collection face;

wherein said second piston collection face is substantially complementary to said first piston collection face, such that said second piston collection face may substantially mate with said first piston collection face to substantially eliminate any volume defined between said second piston collection face and said first piston collection face.

8. The system of claim 2, wherein said post further defines a port extending between said first piston collection face and said cannula defined by said connection member.

9. The system of claim 2, wherein said filtration system abuts said first piston.

10. The system of claim 1, wherein the filtration system is removable from the container.

11. The system of claim 2, wherein said second piston is movable relative to said first piston along said connection member.

12. The system of claim 2, further comprising an extraction member that is operable to produce a force through said cannula, such that said second member is urged toward said first piston to assist in extraction of the second fraction.

13. The system of claim 1, wherein said filtration system and said piston system are removably engaged from said container.

14. The system of claim 1, wherein said separation system includes a buoy and a plunger.

15. A separation system for use in a centrifuge device, comprising:

a container to contain a selected sample;

a filtration member disposable in said container; and

a separation system disposable in said container.

16. The separation system of claim 15, wherein the separation system includes:

a first separation member disposable in said container;

a second separation member disposable in said container; and

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

wherein said first separation member and said second separation member are disposable relative to one another during separation of a selected sample; and

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

17. The separation system of claim 16, wherein said first separation member is movable relative to said second separation member.

18. The separation system of claim 17, wherein at least one of said separation members has a density less than the density of a mesenchymal stem cell sample and a different at least one of said separation systems has a density greater than the density of said mesenchymal stem cell.

19. The separation system of claim 16, wherein said first separation member includes a density of about 1.00 g/cc to about 1.10 g/cc.

20. The separation system of claim 15, wherein said filtration member is disposable with said container.

21. The separation system of claim 20, wherein said filtration member comprises at least one porous mesh filter having a mesh size of about 50 micrometers.

22. The separation system of claim 15, wherein said filtration member comprises a porous mesh having a mesh size larger than a diameter of at least one of whole blood, mesenchymal stem cells, white blood cells, platelets, or combinations thereof.

23. The separation system of claim 16, 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.

24. The separation system of claim 15, further comprising:

a centrifuge;

wherein said container is disposable in said centrifuge during a centrifugation process to form at least two fractions of the selected sample.

25. The separation system of claim 15, wherein said separation system includes a buoy and a plunger.

26. A method of separating a fraction from a whole sample, comprising:

obtaining a volume of a whole heterogenous material, including a liquid and a solid;

separating the solid from the liquid;

forming a fraction of the liquid; and

extracting the fraction.

27. The method of claim 26, further comprising forming a scaffold of a selected material for implantation relative to the anatomy.

28. The method of claim 26, wherein obtaining a volume of the whole heterogenous material includes withdrawing from the anatomy a selected volume of whole blood.

29. The method of claim 26, wherein obtaining a volume of the whole heterogenous material includes obtaining from the anatomy a select volume of bone reaming material.

30. The method of claim 26, wherein at least one of forming a fraction, separating, or combinations thereof include:

positioning the obtained volume of the whole heterogenous material in a container; and

applying a force to the container to form at least two fractions of the whole heterogenous material.

31. The method of claim 30, wherein forming the at least two fractions, includes:

positioning the whole heterogenous material in a container including a separating member including a specific gravity substantially dependent upon at least one of the two fractions.

32. The method of claim 30, wherein forming the at least two fractions includes:

centrifuging the container to move the separating member to a selected position relative to the volume of a fraction of the whole heterogenous material.

33. The method of claim 26, further comprising applying the fraction to an implantable medical device, applying the fraction to a wound, applying the fraction to a reamed bone, applying the fraction to a resected bone, or combinations thereof.

34. The method of claim 26, further comprising:

removing a filtration system from a container containing the whole heterogeneous sample prior to forming a fraction of the liquid.

35. The method of claim 26, wherein separating the solid from the liquid, including supporting a mesh to hold the solid in a selected location.