Method and apparatus for producing autologous clotting components

• US 7,694,828 B2
• Filed: 04/27/2005
• Issued: 04/13/2010
• 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: Leach, Michael D, Hecker, Barry F, Swift, Matthew J
• Primary Examiner(s): Menon; Krishnan S
• Assistant Examiner(s): CHRISTIAN, MARJORIE ELLEN
• Application Number:
  US11/116,153
• Publication Number:
  US 20060243676A1
• Time in Patent Office: 1,812 Days
• Field of Search: 210/173, 210/512.1, 210/210, 210/512.3, 210/782, 210/358, 210/359, 210/360, 210/512.2, 210/360.1, 210/360.2, 210/209, 210/208, 210/781, 366/220, 366/241, 604/6, 604/218, 604/403, 494/37, 494/43, 494/50, 422/72, 422/101
• US Class Current: 210/512.3
• 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. An apparatus for separating components of a multi-component material, comprising:

a container operable to contain the multi-component material;

a member positioned in said container and operable to contact the multi-component material;

a mixing assembly operable to mix the multi-component material and said member; and

a piston moveable within said container to compress a mixture of the multi-component material and said member towards a first end of the container, wherein the compression of the piston at least assists in moving a selected component of the multi-component material between a proximal surface of the piston and a second end of the container away from the first end;

wherein said mixing assembly assists in contacting said member with a portion of the multi-component material;

and wherein said mixing assembly includes a mixing shaft extending through a portion of said container and an agitation member extending from said shaft to agitate said member positioned in said container and operable to contact said multi-component material.

2. The apparatus of claim 1, wherein said member is at least one of an activating member or a desiccating member.

3. The apparatus of claim 2, wherein said activating member activates at least a portion of the multi-component material and said desiccating member removes a portion of water from the multi-component material.

4. The apparatus of claim 2, wherein said member is a bead.

5. The apparatus of claim 2, wherein said piston is moveable within said container to compress the mixture formed by mixing the multi-component material and at least one of said activating bead and said desiccating bead.

6. The apparatus of claim 5, further comprising:

a centrifuge operable to form a centrifugal force on said container and said piston, wherein said centrifugal force moves said piston within said container towards said first end of said container away from said second end of said container.

7. The apparatus of claim 1, further comprising:

a cap operable to close said second end of said container and defining a port to allow access to said container.

8. The apparatus of claim 5, wherein said piston includes a mass of about 15 grams to about 30 grams.

9. The apparatus of claim 7, wherein said cap further includes a second port operable to withdraw a material from the container.

10. The apparatus of claim 9, further comprising:

a flexible member interconnecting said cap and a piston movable within said container;

wherein said piston includes a surface defining a collection area and a sump;

wherein said flexible member interconnects said second port on said cap and said sump in said piston.

11. The apparatus of claim 7, wherein said cap includes an internal wall defining a bore through which a portion of said mixing assembly extends;

wherein a user is able to manipulate said mixing assembly externally from said container to mix the multi-component material with said activating bead and said desiccating bead at a selected time.

12. The apparatus of claim 5, further comprising:

a fixing member operable to fix said piston at a selected position relative to said container;

wherein said fixing member may selectively release said piston to allow movement of said piston within said container.

13. The apparatus of claim 1, further comprising:

a delivery shaft including an inner wall defining a bore extending from said container and operable to allow for communication of the multi-component material from a position external to the container to a position internal to the container.

14. The apparatus of claim 13, wherein said delivery shaft defines a portion of said mixing assembly and said shaft extends externally from said container.

15. The apparatus of claim 1, further comprising:

a collection device operable to remove a component of the multi-component material from the container at a selected time.

16. The apparatus of claim 2, wherein said activating bead is selected from a group consisting of polystyrene beads, glass beads, or combinations thereof.

17. The apparatus of claim 2, wherein said activating bead is operable to activate platelets in a whole blood sample positioned in said container.

18. The apparatus of claim 2, wherein said desiccating bead includes a bead of a material formed to desiccate a whole blood sample positioned in the container.

19. An apparatus for separating components of a multi-component material, comprising:

a container operable to contain the multi-component material between at least a top wall and a bottom wall;

a member positioned in said container and operable to contact the multi-component material;

a mixing assembly having a main elongated member extending from the top wall towards the bottom wall and an elongated agitation member extending from the main elongated member towards an outer wall of the container, wherein the mixing assembly is operable to mix the multi-component material and said member;

a piston within the container between the top wall and the elongated agitation member, the piston moveable within the container relative to at least a portion of the mixing assembly;

a passage formed in the piston to allow a portion of the multi-component material to move towards the top wall past the piston; and

a withdrawing port formed near the top wall to allow access to and withdrawal of the portion of the multi-component material that has moved past the piston.

20. The apparatus of claim 19, wherein the piston is formed of a first material and a second material.

21. The apparatus of claim 20, wherein the piston includes an outer shell formed of the first material and an inner core formed of the second material.

22. The apparatus of claim 19, wherein the elongated agitation member extends generally perpendicular to the main elongated member.

23. The apparatus of claim 19, wherein the elongated agitation member includes a plurality of agitation members;

wherein the plurality of agitation members are spaced longitudinally and circumferentially around the main elongated member;

wherein the plurality of agitation members radially extend from the main elongated member;

wherein the plurality of agitation members are operable to agitate directly the member and the multi-component material.

24. The apparatus of claim 19, wherein the piston is operable to move relative to the bottom wall and collect within a sump a selected portion of the multi-component material.

25. The apparatus of claim 19, wherein the piston further comprises

an extension that is operable to extend through the top wall and has an exterior threaded portion;

a locking member having an internal thread to engage the exterior threaded portion of the extension; and

a tang extending from the locking member to engage the top wall;

wherein the locking member threadably engages the extension by connection of the exterior threaded portion with the internal thread and the tang holds the locking member and the piston fixed relative to the top wall when the locking member engages the extension.

26. The apparatus of claim 19, further comprising:

a passage through the top wall and the piston to introduce the multi-component material between the piston and the bottom wall.

27. An apparatus for separating components of a multi-component material, comprising:

a container operable to contain the multi-component material between at least a top wall and a bottom wall;

a member positioned in said container and operable to contact the multi-component material;

a mixing assembly having a central member and an agitation member to mix the multi-component material and said member;

a piston within the container surrounding the central member and above the agitation member, the piston moveable within the container relative to at least a portion of the mixing assembly with a centrifugal force;

a holding assembly incorporated with the piston that includes,

an extension that is operable to extend through the top wall and having an exterior threaded portion;

a locking member having an internal thread to engage the exterior threaded portion of the extension; and

a tang extending from the locking member to engage the top wall;

wherein the locking member threadably engages the extension by connection of the exterior threaded portion with the internal thread and the tang holds the locking member and the piston fixed relative to the top wall when the locking member engages the extension.

28. The apparatus of claim 27, wherein the agitation member includes a plurality of elongated agitation members extending radially from the central member towards an outer wall of the container.

29. The apparatus of claim 28, wherein the plurality of elongated agitation members are spaced longitudinally and circumferentially around the central member to radially extend from the central member;

wherein the plurality of elongated agitation members are operable to agitate directly the member and the multi-component material;

wherein the elongated member extends through a top wall of the container to be manipulated to at least rotate and move the plurality of elongated agitation members.

30. The apparatus of claim 29, wherein the elongated agitation members extend substantially orthogonal to a longitudinal axis of the central member.

31. The apparatus of claim 27, wherein the piston includes an outer shell formed of a first material and an inner core formed of a second material.

32. The apparatus of claim 27, further comprising:

a passage through the top wall and the piston to introduce the multi-component material between the piston and the bottom wall.

33. The apparatus of claim 32, wherein the central member of the mixing assembly extends through the piston and defines the passage.