Method and apparatus for producing autologous clotting components

• US 8,551,344 B2
• Filed: 04/09/2010
• Issued: 10/08/2013
• Est. Priority Date: 04/27/2005
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Swift, Matthew, Hecker, Barry F., Leach, Michael D.
• Primary Examiner(s): BASS, DIRK R
• Application Number:
  US12/757,492
• Publication Number:
  US 20100198130A1
• Time in Patent Office: 1,278 Days
• Field of Search: None
• US Class Current: 210/767
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• CPC Class Codes: A61M 2202/0427 Platelets; Thrombocytes
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: B01D 15/00 Separating processes involving the treatment of liquids with solid sorbents using liquid sorbents B01D11/00; ion exchange processes or materials, sorbent materials in general B01J, e.g. sorbents for chromatography B01J20/281; for investigating or analysing materials G01N30/00; Apparatus therefor
• CPC Class Codes: B01D 17/0202 by ab- or adsorption
• CPC Class Codes: B01D 17/0217 by centrifugal force
• CPC Class Codes: B01D 17/10 with stationary filtering elements
• CPC Class Codes: B01J 20/046 containing halogens, e.g. halides
• CPC Class Codes: B01J 20/10 comprising silica or silicate
• CPC Class Codes: B01J 20/26 Synthetic macromolecular compounds
• CPC Class Codes: B01J 20/261 obtained by reactions only involving carbon to carbon unsaturated bonds macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds per se C08F
• CPC Class Codes: B01J 20/262 obtained otherwise than by reactions only involving carbon to carbon unsaturated bonds, e.g. obtained by polycondensation macromolecular compounds obtained otherwise than by reactions only involving unsaturated carbon-to-carbon bonds per se C08G
• CPC Class Codes: B01J 2220/46 Materials comprising a mixture of inorganic and organic materials materials coated or impregnated on a carrier B01J20/32

Abstract

A method and apparatus for obtaining various components of a multi-component material. Generally, a component of a whole blood sample may be concentrated from a patient and re-introduced to the same patient. For example, a clotting component, such as thrombin, from a whole blood sample may be extracted and concentrated in an apparatus and collection to be reapplied or reintroduced into a patient.

Claims

1. A method of separating a clotting component from a whole blood sample in a container having a mixing assembly and a member, comprising:

collecting a whole blood sample;

introducing the whole blood sample into a single chamber of the container;

manipulating the mixing assembly to mix the whole blood sample with the member to at least one of activate a portion of the whole blood sample or to withdraw a selected volume of water from the whole blood sample, wherein the mixing assembly includes a central member with radially extending agitation members;

moving a piston within the single chamber of the container to compress the mixture of the whole blood sample and the member towards a first end of the container, wherein the compression with the piston at least assists in moving a selected component of the whole blood sample between a proximal surface of the piston and a second end of the container away from the first end; and

withdrawing a volume of a fluid including concentrated clotting components from the single chamber of the container after mixing the whole blood sample with the member.

2. The method of claim 1, wherein collecting a whole blood sample includes drawing from a patient a selected volume of whole blood.

3. The method of claim 2, wherein withdrawing a volume of a fluid including concentrated clotting components includes withdrawing an autologous concentrated clotting component.

4. The method of claim 3, further comprising:

applying the concentrated clotting components to the patient from which the whole blood sample was collected.

5. The method of claim 1, further comprising:

passing the collected whole blood sample through a first port defined in a portion of the container.

6. The method of claim 5, further comprising:

moving the collected whole blood sample past a piston disposed in the single chamber of the container to a void defined by the single chamber of the container to be mixed.

7. The method of claim 1, further comprising:

positioning the member into the container.

8. The method of claim 1, further comprising:

positioning at least one of a desiccating member and an activating member as the member in the container.

9. The method of claim 8, wherein the member includes a bead positioned in the container.

10. The method of claim 1, further comprising:

assembling the mixing assembly relative to the piston and positioning both the mixing assembly and the piston in the container such that the mixing assembly is operable to mix the whole blood sample with the member by rotating the central member to move the agitation members.

11. The method of claim 1, further comprising:

centrifuging the container including the mixed whole blood sample with the member.

12. The method of claim 10, further comprising:

collecting a volume of material including a concentration of clotting components higher than a concentration of the clotting components in the whole blood sample on a first side of the piston and higher in the container and moving the piston lower in the container due to centrifuging the container;

wherein introducing the whole blood sample into the container is introducing the whole blood sample to a second side of the piston opposite the first side.

13. The method of claim 1, further comprising at least one of:

admixing ethanol to the mixed whole blood sample;

or

adding calcium chloride to the container and mixing the whole blood sample with the calcium chloride and the member.

14. The method of claim 1, further comprising:

forming a clot of the concentrated clotting components with a selected material for positioning relative to a patient from which the whole blood sample was collected and from which the concentrated clotting components were formed.

15. The method of claim 9, wherein mixing the whole blood sample with the desiccating member and the activating member includes manually manipulating the mixing assembly from a position exterior to the container.

16. The method of claim 1, further comprising:

centrifuging the whole blood sample and the piston within the container to cause the piston to move within the container;

wherein the piston moves towards the first end of the container away from the second end of the container.

17. The method of claim 1, wherein withdrawing the volume of fluid, includes:

moving the volume of fluid through a flexible member interconnecting a cap and the piston movable within the container, wherein the flexible member is positioned near a sump defined by the piston.

18. A method of separating a clotting component from a whole blood sample in a container having a mixing assembly and a member, comprising:

collecting a whole blood sample;

introducing the whole blood sample into a volume of the container;

manipulating the mixing assembly to mix the whole blood sample with the member within the volume to at least one of activate a portion of the whole blood sample or to withdraw a selected volume of water from the whole blood sample, wherein the mixing assembly includes a plurality of radially extending agitation members;

centrifuging the container to move a piston within the volume to at least assist in separation of a fluid including concentrated clotting components; and

withdrawing a volume of the fluid including concentrated clotting components from the volume of the container after mixing the whole blood sample with the member.

19. The method of claim 18, wherein manipulating the mixing assembly to mix the whole blood sample with the member includes manually manipulating the mixing assembly from a position exterior to the container.

20. The method of claim 19, wherein manipulating the mixing assembly to mix the whole blood sample with the member occurs prior to centrifuging the container.

21. The method of claim 18, wherein introducing the whole blood sample into the volume of the container includes introducing at least a portion of the whole blood sample through at least a bore formed through the mixing assembly into the container.

22. The method of claim 18, further comprising:

disengaging the piston from a portion of the container such that the piston is operable to move within the container and a portion of the fluid moves past the piston during the centrifuging the container to move the piston.

23. The method of claim 18, wherein the member includes at least one of a desiccating bead or an activating bead.

24. The method of claim 18, further comprising:

providing a passage though the piston to allow the volume of fluid to pass the piston and move towards a top wall of the container; and

providing a withdrawing port formed near the top wall to allow access the volume of fluid that has moved past the piston.

25. The method of claim 18, wherein the plurality of agitation members extend radially from a main member are spaced longitudinally and circumferentially around the main member.

26. The method of claim 22, wherein engaging the piston from the portion of the container includes:

moving a locking member having an internal thread to disengage an exterior threaded portion of the piston.

27. A method of separating a clotting component from a whole blood sample in a container having a mixing assembly and a member, comprising:

collecting a whole blood sample;

introducing the whole blood sample into a single chamber defined by a wall of the container through a bore defined by a mixing assembly, wherein the single chamber of the container further contains the mixing assembly and the member, wherein the mixing assembly includes a plurality of radially extending agitation members;

manipulating the mixing assembly to mix the whole blood sample with the member within the single chamber to at least one of activate a portion of the whole blood sample or to absorb a selected volume of water from the whole blood sample; and

withdrawing a volume of a fluid including concentrated clotting components from the single chamber of the container after mixing the whole blood sample with the member.

28. The method of claim 27, further comprising:

centrifuging the container including the mixed whole blood with the member to assist in concentrating clotting components, wherein the centrifugation causes a piston to move within the single chamber to assist in separating the clotting component from other components of the whole blood sample.

29. The method of claim 28, further comprising:

disengaging the piston from a portion of the container such that the piston is operable to move within the container during centrifuging the container and allow at least a portion of the whole blood to move past the piston.

30. The method of claim 27, wherein the mixing assembly includes a shaft extending through at least a portion of the wall of the container and a projection extending transverse to the shaft and into the singe chamber.