Plasma Concentrator Device

• US 20090236297A1
• Filed: 06/02/2009
• Published: 09/24/2009
• Est. Priority Date: 02/07/2005
• Status: Active Grant

• Current Assignee: Hanuman, LLC, Biomet Biologics LLC (Zimmer Biomet Holdings, Inc.)
• Original Assignee: Hanuman, LLC, Biomet Biologics, Inc. (Zimmer Biomet Holdings, Inc.)
• Inventors: Storrs, Richard Wood, Leach, Michael D., Dorian, Randel
• Granted Patent: US 7,901,584 B2
• Time in Patent Office: Days
• US Class Current: 210/782
• CPC Class Codes: A61M 1/0204 Blood stirrers, e.g. for defibrination
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 2202/0415 Plasma
• CPC Class Codes: Y10T 436/25375 Liberation or purification of sample or separation of material from a sample [e.g., filtering, centrifuging, etc.]
• CPC Class Codes: Y10T 436/255 including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

A plasma concentrator having a concentrator chamber, concentrator gel beads, a filter, and an agitator. The agitator end is positioned in the concentrator chamber and supported for rotation about its central axis and for reciprocal movement along its central axis. A filter is selected to block effective flow of plasma therethrough under ambient gravity conditions and permit plasma and plasma concentrate flow therethrough under centrifugal forces of the separation gravity. A method concentrates plasma by removing water without significantly denaturing the fibrinogen in the plasma. Then centrifugal force can be applied to the concentrated plasma in an amount sufficient to separate a substantial portion of the plasma concentrate from the beads.

Claims

1. A method for concentrating plasma by removing water without significantly denaturing the fibrinogen in the plasma, comprising:

positioning a plurality of concentrator gel beads in a concentrator chamber of the plasma concentrator;

positioning a sample volume of plasma in the concentrator chamber of the plasma concentrator;

moving an actuator stem having a lower agitator end to agitate the sample volume of plasma and the concentrator gel beads in the concentrator chamber with agitator blades extending outwardly from the lower agitator end being positioned in the concentrator chamber;

concentrating the plasma by removing at least a portion of water from the sample volume of plasma to the concentrator gel beads to form a concentrated plasma volume; and

removing the concentrated plasma volume through a filter in a lower opening of the concentrator chamber;

wherein the concentrator chamber includes a top with an upper opening through which an upper end of the actuator stem extends.

2. The method of claim 1, wherein moving the agitator stem at least one of rotating the agitator about its central axis and reciprocally moving the agitator stem about its central axis.

3. The method of claim 1, further comprising agitating the sample volume of plasma and the concentrator gel beads including moving the total volume of the sample volume of plasma and the concentrator gel beads at least by moving the agitator blades near a cylindrical inner wall of the concentrator chamber and the agitator blades have an outer edge in close proximity to the inner wall with a space between the outer edge and the inner wall being less than a diameter of the gel beads.

4. The method of claim 1, further comprising:

limiting or eliminating upward axial movement by contacting a stop sleeve extending from a top of the concentrator into the concentrator chamber with stop projections of the agitator stem,

wherein the stop sleeve has a lower abutment surface and the stop projections extend outward beyond the diameter of the stop sleeve, an upper surface of the stop projections positioned to stop upward axial movement of the agitator when contacting a lower abutment surface of the stop sleeve.

5. The method of claim 4, further comprising:

limiting or eliminating downward movement of the agitator by contacting an upper surface of the filter with a lower surface of the agitator blades; and

sweeping the upper surface of the filter by contacting the upper surface of the filter with the lower surface of the agitator blades;

wherein the downward motion of the blades during the reciprocal movement of the agitator being arrested by abutment with the upper surface of the filter.

6. The method of claim 1, further comprising:

blocking effective flow of plasma through the filter under ambient gravity conditions, but permitting free plasma concentrate flow therethrough under centrifugal forces at the separation gravity.

7. The method of claim 6, wherein the separation gravity is greater than 10 g'"'"'s.

8. The method of claim 1, further comprising:

removing the plasma concentrate from the plasma concentrator through a plasma concentrate outlet conduit from a plasma concentrate reservoir;

wherein removing the plasma concentrate from the plasma concentrate reservoir includes moving the plasma concentrate from a sump formed in a floor of the plasma concentrate reservoir.

13. The method of claim 8, further comprising:

wherein introducing plasma includes introducing up to 50 mL of plasma into concentration chamber.

14. The method of claim 8, wherein removing water from the plasma includes forming a plasma concentrate having a protein concentration 1.5 to 3 times greater than the protein concentration of the untreated plasma.

9. A method for concentrating plasma by removing water without significantly denaturing the fibrinogen in the plasma, comprising:

a) introducing the plasma into a concentration chamber containing a plurality of dehydrated concentrator gel beads and an agitator;

b) removing water from the plasma until the plasma has a protein concentration greater than 1.5 times the protein concentration of the untreated plasma while;

i) moving the agitator to stir the beads while they are absorbing water from the plasma to reduce plasma polarization, and

ii) moving the agitator to break up clumps of beads that form during the agitation; and

c) applying centrifugal force to the concentrated plasma in an amount sufficient to separate a substantial portion of the plasma concentrate from the beads.

10. The method of claim 9, wherein the concentration chamber contains an agitator having agitator blades extending outwardly from its lower end, wherein the agitator is supported for rotation about its central axis and for reciprocal movement along its central axis, wherein the agitator is rotated to stir the beads while they are absorbing water from the plasma to reduce plasma polarization, and the agitator is moved along its central axis in a reciprocal motion to break up clumps of beads that form during the agitation.

11. The method claim 10, wherein the agitator blades rest on the upper surface of a filter, the agitator blades have a lower portion that sweeps the upper surface of the filter during rotation, and impacts the upper surface of the filter during reciprocal motion of the agitator along its central axis, wherein the agitator is rotated to sweep the upper surface of the filter and stirring beads resting thereupon to reduce plasma polarization, and the agitator is moved in a reciprocal motion to impact the upper surface of the filter and bead clumps forming on the surface during the stirring.

12. The method of claim 11, wherein the filter has a pore that blocks effective flow of plasma therethrough under ambient gravity conditions and permits plasma and plasma concentrate flow therethrough under forces of the centrifugal force.

15. A method for concentrating plasma by removing water without significantly denaturing the fibrinogen in the plasma, comprising:

a) introducing the plasma into a concentration chamber containing a plurality of dehydrated concentrator gel beads and an agitator;

b) removing water from the plasma until the plasma has a protein concentration greater than 1.5 times the protein concentration of the untreated plasma while;

i) moving the agitator to stir the beads while they are absorbing water from the plasma to reduce plasma polarization, and

ii) moving the agitator to break up clumps of beads that form during the agitation; and

c) applying centrifugal force to the concentrated plasma in an amount sufficient to separate a substantial portion of the plasma concentrate from the beads.

16. The method of claim 15, wherein moving the agitator includes at least one of rotating the agitator about its central axis and reciprocally moving the agitator about its central axis.

17. The method of claim 15, wherein moving the agitator includes moving the total volume of the plasma and the concentrator gel beads at least because concentration chamber has a cylindrical inner wall and the agitator blades have an outer edge in close proximity to the inner wall with a space between the outer edge and the inner wall being less than a diameter of the gel beads.

18. The method of claim 15, further comprising:

limiting or eliminating upward axial movement by contacting a stop sleeve extending from a top of the plasma concentrator into the concentration chamber with stop projections of the agitator stem, wherein the stop sleeve has a lower abutment surface and the stop projections extend outward beyond the diameter of the stop sleeve, an upper surface of the stop projections constituting abutment surfaces positioned to stop upward axial movement of the agitator when contacting a lower abutment surface of the stop sleeve;

limiting or eliminating downward movement of the agitator by contacting an upper surface of a filter with a lower surface of the agitator blades; and

sweeping the upper surface of the filter by contacting the upper surface of the filter with the lower surface of the agitator blades;

wherein the downward motion of the blades during the reciprocal movement of the agitator being arrested by abutment with the upper surface of the filter.

19. The method of claim 15, further comprising:

blocking effective flow of plasma through a filter under ambient gravity conditions, but permitting free plasma concentrate flow therethrough under centrifugal forces at the separation gravity.

20. The method of claim 19, wherein applying the centrifugal force to the concentrated plasma in an amount sufficient to separate a substantial portion of the plasma concentrate from the beads includes:

placing the plasma concentrator in a receptor of a centrifuge;

applying centrifugal forces to the plasma concentrator with the centrifuge;

removing the plasma concentrate from the surface of the gel beads, and

causing the plasma concentrate to flow through the filter.

21. The method of claim 20, wherein applying centrifugal forces to the plasma concentrator includes applying at least 10 g'"'"'s of force to cause the plasma concentrate to flow through the filter.

22. The method of claim 21, further comprising:

collecting the concentrated plasma in a plasma concentrate reservoir positioned downstream of the flow of the plasma concentrate through the filter, but within the plasma concentrator.

23. The method of claim 22, further comprising:

removing the plasma concentrate from the plasma concentrator through a plasma concentrate outlet conduit extending from a plasma concentrate reservoir and integrated with the plasma concentrator.

24. The method of claim 23, further comprising:

moving the plasma concentrate to a sump formed in a floor of the plasma concentrate reservoir;

wherein the plasma concentrate outlet conduit is in fluid communication with the sump.