Apparatus and method for separating and concentrating fluids containing multiple components

• US 10,393,728 B2
• Filed: 01/10/2018
• Issued: 08/27/2019
• Est. Priority Date: 05/24/2002
• Status: Expired due to Term

• Current Assignee: Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Woodell-May, Jennifer E.
• Primary Examiner(s): Mellon, David C
• Application Number:
  US15/866,658
• Publication Number:
  US 20180196030A1
• Time in Patent Office: 594 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 35/14 Blood; Artificial blood perfluorocarbons A61K31/02; umbilical cord blood A61K35/51; haemoglobin A61K38/42
• CPC Class Codes: A61K 35/17 Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes when activated by a specific antigen A61K39/00
• CPC Class Codes: A61K 35/19 Platelets; Megacaryocytes
• CPC Class Codes: A61K 35/28 Bone marrow; Haematopoietic stem cells; Mesenchymal stem cells of any origin, e.g. adipose-derived stem cells
• 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: 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. 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 isolating fraction comprising nucleated cells comprising:

obtaining a volume of whole blood from a patient through venipuncture;

obtaining a volume of bone marrow aspirate from the patient;

centrifuging a mixture of the volume of whole blood and the volume of bone marrow aspirate so as to create a fraction of the mixture comprising nucleated cells;

collecting the fraction comprising nucleated cells;

applying the fraction comprising nucleated cells to a scaffold; and

implanting the scaffold in the patient.

2. The method of claim 1, wherein the fraction comprising nucleated cells comprises cells selected from the group consisting of platelets, white blood cells, stem cells, and mixtures thereof.

3. The method of claim 1, wherein the centrifuging creates a plurality of distinct fractions comprising a red blood cell fraction, a buffy coat fraction, and a plasma fraction.

4. The method of claim 1, further comprising loading the volume of whole blood and the volume of bone marrow aspirate into a separator container to compose the mixture, the separator container holding the mixture during centrifuging.

5. The method of claim 4, wherein the separator comprises a buoy having a selected density, and the method further comprises centrifuging the mixture within the separator container so that the buoy physically separates a plurality of fractions of the mixture based on the density of the fractions.

6. The method of claim 5, further comprising moving the buoy within the mixture during centrifuging until the buoy reaches an equilibrium between a first of the plurality of fractions and a second of the plurality of fractions, due to the buoy'"'"'s density.

7. The method of claim 6, wherein the buoy has a density that is less than a density of the first fraction and greater than a density of the second fraction.

8. The method of claim 6, wherein the buoy has a density less than the density of red blood cells and a density greater than the density of the fraction comprising nucleated cells.

9. A method of isolating a fraction of a biologic material comprising:

obtaining a volume of whole blood from a patient through venipuncture;

obtaining a volume of bone marrow aspirate from the patient;

centrifuging a mixture of the volume of whole blood and the volume of bone marrow aspirate so as to create a plurality of distinct fractions of the mixture, the fractions comprising a red blood cell fraction, a buffy coat fraction, and a plasma fraction; and

collecting and separating at least one of the plurality of fractions from a remainder of the plurality of fractions.

10. The method of claim 9, further comprising applying the at least one fraction to a scaffold, and implanting the scaffold in the patient.

11. The method of claim 9, further comprising loading the volume of whole blood and the volume of bone marrow aspirate into a separator container to compose the mixture, the separator container holding the mixture during centrifuging.

12. The method of claim 11, wherein the separator comprises a buoy having a selected density, and the method further comprises centrifuging the mixture within the separator container so that the buoy physically separates the plurality of fractions based on the density of the fractions.

13. The method of claim 12, further comprising moving the buoy within the mixture during centrifuging until the buoy reaches an equilibrium between a first of the plurality of fractions and a second of the plurality of fractions, due to the buoy'"'"'s density.

14. The method of claim 13, wherein the buoy has a density that is less than a density of the first fraction and greater than a density of the second fraction.

15. The method of claim 9, wherein the at least one of the plurality of fractions comprises the plasma fraction.

16. A method of isolating a fraction of biologic material comprising:

obtaining a volume of whole blood from a patient through venipuncture;

obtaining a volume of bone marrow aspirate from the patient;

centrifuging a mixture of the volume of whole blood and the volume of bone marrow aspirate so as to create a plurality of distinct fractions of the mixture; and

collecting and separating a first of the plurality of fractions from a remainder of the plurality of fractions, the first fraction comprising a platelet-rich plasma (PRP) fraction.

17. The method of claim 16, further comprising applying the PRP fraction to a scaffold, and implanting the scaffold in the patient.

18. The method of claim 16, further comprising loading the volume of whole blood and the volume of bone marrow aspirate into a separator container to compose the mixture, the separator container holding the mixture during centrifuging.

19. The method of claim 18, wherein the separator comprises a buoy having a selected density, and the method further comprises centrifuging the mixture within the separator container so that the buoy physically separates the plurality of fractions based on the density of the fractions.

20. The method of claim 19, further comprising moving the buoy within the mixture during centrifuging until the buoy reaches an equilibrium between the PRP fraction and a second of the plurality of fractions, due to the buoy'"'"'s density, the second fraction comprising a red blood fraction.