Method and apparatus for producing autologous clotting components

• US 20060243676A1
• Filed: 04/27/2005
• Published: 11/02/2006
• 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 J,, Leach, Michael D., Hecker, Barry F.
• Granted Patent: US 7,694,828 B2
• Time in Patent Office: Days
• US Class Current: 210/782
• 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;

wherein said mixing assembly assists in contacting said member with a portion of the 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 1, further comprising:

a piston moveable within said container to compress the mixture formed by mixing the multi-component material and 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 operable to move said piston within said container towards an end of said container.

7. The apparatus of claim 1, further comprising:

a cap operable to close an 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 fixation member may selectively release said piston to allow movement of said piston within said container.

13. The apparatus of claim 1, 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 activating bead and said desiccating bead within said container.

14. 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.

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

16. 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.

17. The apparatus of claim 1, wherein said activating bead is selected from a group consisting of polystyrene beads, glass beads, or combinations thereof.

18. The apparatus of claim 1, wherein said activating bead is operable to activate platelets in a whole blood sample positioned in said container.

19. The apparatus of claim 1, wherein said desiccating bead includes a bead of a material formed to desiccate a whole blood sample positioned in the container.

20. A kit for forming a selected component from a whole blood sample, comprising:

a first whole blood separation apparatus comprising;

a container operable to contain the multi-component material;

an activating member and/or a desiccating 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 activating member and/or said desiccating member;

a second whole blood separation apparatus comprising;

a container operable to contain a volume of whole blood;

a first piston operable to move through the volume of the whole blood;

a second piston operable to move through the whole blood and defining a platelet collection area;

a withdrawal member operable to interconnection said platelet collection area and an outlet port;

wherein said first whole blood separation device and said second whole blood separation device are operable to separate and/or concentrate selected and different components of the whole blood sample.

21. The kit of claim 20 further comprising:

a container including a selected volume of ethanol;

wherein said container is operable to provide to said first whole blood separation apparatus a volume of ethanol to achieve about 4 percent to about 7 percent ethanol when added to the mixture of the whole blood sample.

22. The kit of claim 20, further comprising:

a volume of calcium chloride operable to allow a selected volume of the volume of calcium chloride to be introduced into the first whole blood separation apparatus;

wherein the selected volume of the calcium chloride volume allows for about 0.10 milliliters to about 0.03 milliliters of one molar of calcium chloride to each milliliter of the whole blood sample.

23. The kit of claim 20, wherein said activating member of said first whole blood separation apparatus is formed of glass.

24. The kit of claim 20, wherein said activating member of said first whole blood separation apparatus includes polystyrene resin wherein about 0.10 grams to about 0.20 grams of polystyrene resin is provided per milliliter of the whole blood sample.

25. The kit of claim 20, wherein said desiccating member is formed of polyacrylamide resin so that about 0.10 grams to about 0.03 grams of the polyacrylamide resin is provided per about 1 milliliter of the whole blood sample.

26. The kit of claim 20 further comprising:

at least one component selected from the group consisting of a sample collecting syringe, a gauze pad, an adhesive, a label, an alcohol prep pad, a blank container, a collection device, or combinations thereof.

27. The kit of claim 20, wherein said second piston of said second whole blood separation device includes a density either alone or in combination with said first piston of said second whole blood separation device that is substantially between the density of a platelet component of the whole blood sample and a red blood cell component of the whole blood sample.

28. The kit of claim 20, further comprising:

a centrifuge operable to apply a centrifugal force to at least one of said first whole blood separation apparatus or said second whole blood separation apparatus.

29. The kit of claim 20, further comprising:

a first withdrawing device to withdraw a concentrated clotting component material from said first whole blood separation apparatus;

a second withdrawing device to withdraw a platelet rich material from said second whole blood separation apparatus.

30. 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 the container;

mixing the whole blood sample with the member with the mixing assembly 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;

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

31. The method of claim 30, wherein collecting a whole blood sample includes drawing from a patient a selected volume of whole blood.

32. The method of claim 31, wherein withdrawing a volume of a fluid including concentrated clotting components includes withdrawing an autologous concentrated clotting component.

33. The method of claim 32, further comprising:

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

34. The method of claim 30, further comprising:

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

35. The method of claim 34, further comprising:

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

36. The method of claim 30, wherein mixing the whole blood sample with the desiccating beads and the activating beads includes manually manipulating the mixing assembly from a position exterior to the container.

37. The method of claim 30, further comprising:

positioning the member into the container.

38. The method of claim 30, further comprising:

positioning a desiccating member and an activating member in the container.

39. The method of claim 30, wherein the member is a bead positioned in the container.

40. The method of claim 30, further comprising:

assembling the mixing assembly relative to a 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.

41. The method of claim 30, further comprising:

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

42. The method of claim 41, 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.

43. The method of claim 30, further comprising:

admixing ethanol to the mixed whole blood sample.

44. The method of claim 30, further comprising:

admixing ethanol to the mixed whole blood sample to achieve a concentration of about 4 percent to about 7 percent ethanol in the mixed whole blood sample.

45. The method of claim 30, further comprising:

adding calcium chloride to the container;

mixing the whole blood sample with the calcium chloride, the desiccating beads, and the activating beads.

46. The method of claim 30, 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.

47. A device for separating a multi-component material, comprising:

a container having a first end and a second end operable to contain a multi-component material;

a piston positioned in said container between said first end and said second end;

a delivery tube extending from near said first end past said piston and towards said second end operable to position the multi-component material relative to said piston within said container;

wherein said container and/or said piston are selectable between a constraining configuration and a free configuration, wherein when one of said container and/or said piston are in said constraining configuration said piston is held at a selected location in said container and when said container and/or said piston is in said free configuration, said piston is operable to move relative to said container.

48. The device of claim 47, wherein at least one of an activating bead, a desiccating bead, or combinations thereof, are positioned near said second end of said container and separated from said first end of said container by said piston.

49. The device of claim 47, wherein said container is flexible under an external force.

50. The device of claim 49, wherein said free configuration is formed when said external force is applied to said container such that said piston is not held in a selected position relative to said container.

51. The device of claim 47, wherein the multi-component material includes whole blood that is delivered with said delivery tube past said piston towards said second end of said container.

52. The device of claim 47, wherein said container is operable to be positioned in a centrifuge device:

wherein, during centrifugation a selected component of the multi-component material is operable to move past said piston towards said first end of said container;

wherein, when said centrifugation is completed, said piston or said container are in said constrained configuration to operably separate the selected component of the multi-component material from the remaining components of the multi-component material.

53. The device of claim 47, further comprising:

a closing member;

wherein said closing member includes a withdrawing port to withdraw a material positioned near the first end of said container.

54. The device of claim 53, wherein said piston is operable to separate a selected component of the multi-component material from the remaining components of multi-component material after a separation process, to allow removal of the selected component of the multi-component material through said second port.

55. The device of claim 47, further comprising:

a collection system, including a flexible tube interconnected with a closing member positioned near said first end of said container to withdraw a material positioned near the first end of said container and separated from the second end of the container by said piston.

56. The device of claim 47, further comprising:

a closing member, including a delivery port;

wherein said delivery tube is operably interconnected with said delivery port so that a material can be passed through said delivery port to said delivery tube to be positioned near said second end of said container past said piston.

57. The device of claim 47, wherein the delivery tube remains in said container during the centrifugation of the container.