Method and apparatus for producing autologous clotting components

• US 9,011,687 B2
• Filed: 10/07/2013
• Issued: 04/21/2015
• Est. Priority Date: 04/27/2005
• Status: Active Grant

• Current Assignee: Biomet Manufacturing, LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Inventors: Swift, Matthew, Hecker, Barry F., Leach, Michael D.
• Primary Examiner(s): BASS, DIRK R
• Application Number:
  US14/047,363
• Publication Number:
  US 20140034567A1
• Time in Patent Office: 561 Days
• Field of Search: None
• US Class Current: 210/287
• 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 kit for forming a selected component from a whole blood sample, comprising:

a first whole blood separation apparatus comprising;

a container operable to contain a first volume of whole blood;

an activating member and/or a desiccating member positioned in said container and operable to contact the first volume of whole blood;

a mixing assembly having a first member extending along an axis of the container and a plurality of second members extending transverse to the axis operable to mix the first volume of whole blood and said activating member and/or said desiccating member;

a second whole blood separation apparatus comprising;

a container operable to contain a second volume of whole blood;

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

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

a withdrawal member operable to interconnect 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.

2. The kit of claim 1 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.

3. The kit of claim 1, 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.

4. The kit of claim 1, wherein said activating member of said first whole blood separation apparatus is formed of glass.

5. The kit of claim 1, 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.

6. The kit of claim 1, 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.

7. The kit of claim 1 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.

8. The kit of claim 1, 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.

9. The kit of claim 1, 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.

10. The kit of claim 1, 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.

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

a first whole blood separation apparatus comprising;

a first container operable to contain a multi-component material;

an activating member and/or a desiccating member positioned in said first container and operable to contact the multi-component material;

a mixing assembly having an agitation member operable to mix the multi-component material and said activating member and/or said desiccating member; and

a piston section positioned within the first container between a top of the first container and the agitation member; and

a second whole blood separation apparatus comprising;

a second container operable to contain at least a portion of the whole blood sample;

a first piston operable to move through the at least a portion of the whole blood sample;

a second piston operable to move through the at least a portion of the whole blood sample and defining a concave platelet collection area;

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;

wherein said piston section includes at least a core portion and a plunger section;

wherein the mixing assembly includes a mixer shaft that extends through the piston section;

wherein the agitation member includes a plurality of agitation members; and

wherein the mixer shaft extends along an axis and wherein each of the agitation members of the plurality of agitation member extends transverse to the axis.

12. The kit of claim 11, further comprising:

a withdrawal member interconnecting the concave platelet collection area and an outlet port through the second container.

13. The kit of claim 11, further comprising:

a third container including a volume of ethanol 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 multi-component material.

14. The kit of claim 11, further comprising:

a fourth container including 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.

15. The kit of claim 11, wherein said activating member of said first whole blood separation apparatus is formed of at least one of glass, polystyrene resin, polyacrylamide resin.

16. The kit of claim 11, 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.

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

a first whole blood separation apparatus comprising;

a first container operable to contain a multi-component material;

an activating member and/or a desiccating member positioned in said first container and operable to contact the multi-component material;

a mixing assembly having a mixer shaft extending from a top of the first container and an agitation member extending transverse to said mixer shaft, wherein the mixing assembly is operable to mix the multi-component material and said activating member and/or said desiccating member; and

a piston section positioned within the first container between a top of the container and the agitation member, the piston section having a throughbore through which the mixer shaft extends; and

a second whole blood separation apparatus comprising;

a second container operable to contain at least a portion of the whole blood sample;

a first piston operable to move through the at least a portion of the whole blood sample and defining a platelet collection area;

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.

18. The kit of claim 17, further comprising:

a second piston moveable through the at least a portion of the whole blood sample;

a withdrawal member interconnecting the concave platelet collection area and an outlet port through the second container through the second piston.

19. The kit of claim 18, wherein said activating member of said first hole blood separation apparatus is formed of at least one of glass, polystyrene resin, polyacrylamide resin.

20. The kit of claim 18, wherein said first piston of said second whole blood separation device includes a density 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.

21. The kit of claim 17, 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.

22. The kit of claim 17, wherein the agitation member includes a plurality of separate agitation fingers and each agitation finger extends transverse to the axis and are spaced apart along the mixer shaft.