System, chamber, and method for fractionation, elutriation, and decontamination of fluids containing cellular components

• US 20060147895A1
• Filed: 03/01/2006
• Published: 07/06/2006
• Est. Priority Date: 10/22/2004
• Status: Abandoned Application

• Current Assignee: Cryofacets Incorporated
• Original Assignee: Cryofacets Incorporated
• Inventors: Purdum, Howard E.
• Application Number:
  US11/365,244
• Publication Number:
  US 20060147895A1
• Time in Patent Office: Days
• US Class Current: 435/2
• CPC Class Codes: A01N 1/02 Preservation of living parts
• CPC Class Codes: A01N 1/0205 Chemical aspects
• CPC Class Codes: A01N 1/0215 Disinfecting agents, e.g. antimicrobials for preserving living parts
• CPC Class Codes: A61M 1/0272 Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging
• CPC Class Codes: A61M 1/0281 Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing
• CPC Class Codes: A61M 1/3681 by irradiation
• CPC Class Codes: A61M 1/3687 Chemical treatment A61M1/3675 takes precedence
• CPC Class Codes: A61M 1/3692 Washing or rinsing blood or blood constituents
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: A61M 1/3696 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation
• CPC Class Codes: A61M 2205/058 with ultrasound therapy
• CPC Class Codes: A61M 2205/75 with filters
• CPC Class Codes: B01D 21/0087 Settling tanks provided with means for ensuring a special flow pattern, e.g. even inflow or outflow B01D21/2411 takes precedence
• CPC Class Codes: B01D 21/262 by using a centrifuge
• CPC Class Codes: B01D 2221/10 Separation devices for use in medical, pharmaceutical or laboratory applications, e.g. separating amalgam from dental treatment residues
• CPC Class Codes: B01L 1/00 Enclosures; Chambers provided with manipulation devices or glove boxes B25J21/00
• CPC Class Codes: B04B 2005/0471 with additional elutriation separation of different particles
• CPC Class Codes: B04B 2005/0478 with filters in the separation chamber
• CPC Class Codes: B04B 5/0442 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation

Abstract

A chamber, system, and method for separating a selected component from a fluid are provided. The chamber is capable of rotating about the central axis of a centrifuge device and includes a radially-extending duct having an optimized variable cross-sectional area that decreases in relation to the outward radial distance from the central axis of the centrifuge. The optimized geometrical design of the duct provides that a centrifugal force exerted on the selected component caused by the rotation of the chamber substantially balances the drag force exerted on the selected component by the fluid as the selected component flows through the duct. Thus, the duct allows the selected component to be dispersed in equilibrium along the radial length of the duct such that the selected component may be effectively suspended with the duct and/or separated from the fluid using elutriation or other methods.

Claims

1. A method for decontaminating a biological sample to be stored for a storage interval between a donation and a subsequent transfusion, the biological fluid including a biological fluid, at least one component suspended in the biological fluid and a plurality of contaminants suspended in the biological fluid, the plurality of components including a plurality of pathogens:

exposing the biological sample to a first decontamination process prior to the storage interval, the first decontamination process adapted to preserve the at least one component and eliminate at least a portion of the plurality of pathogens;

exposing the biological sample to a second decontamination process subsequent to the storage interval and prior to the transfusion of the biological sample, the second decontamination process adapted to preserve the at least one component and eliminate substantially all of the plurality of contaminants.

2. The method according to claim 1, wherein the first decontamination process further comprises exposing the biological sample to a treatment media selected from the group consisting of:

nitric oxide;

ozone; and

combinations thereof.

3. The method according to claim 1, wherein the first decontamination process further comprises separating the biological fluid from the at least one component in a centrifugal elutriation chamber.

4. The method according to claim 3, wherein the first decontamination process further comprises replacing the biological fluid with a storage solution for preserving the biological sample during the storage interval, the storage solution comprising additives selected from the group consisting of:

nitric oxide;

platelet additive compounds;

red blood cell additive compounds; and

combinations thereof.

5. The method according to claim 4, wherein the first decontamination process further comprises:

collecting the biological fluid;

subjecting the biological fluid to a UVC light source to substantially decontaminate the biological fluid such that the biological fluid may be used as an additive in the storage solution; and

adding the decontaminated biological fluid to the storage solution prior to the storage interval.

6. The method according to claim 1, wherein the second decontamination process further comprises exposing the biological sample to a treatment media selected from the group consisting of:

nitric oxide;

ozone;

sterile storage solution; and

combinations thereof.

7. The method according to claim 1, wherein the second decontamination process further comprises separating the biological fluid from the at least one component in a centrifugal elutriation chamber.

8. The method according to claim 7, wherein the separating step further comprises substantially eliminating substantially all of a plurality of treatment media from the biological sample.

9. The method according to claim 4, wherein the second decontamination process further comprises separating the storage solution from the at least one component in a centrifugal elutriation chamber.

10. The method according to claim 1, wherein the second decontamination process further comprises exposing the biological sample to a UVC light source to substantially eliminate the plurality of contaminants.

11. The method according to claim 1, further comprising oxygenating the biological sample subsequent to the second decontamination process.

12. The method according to claim 1, further comprising adding nitric oxide to the biological sample subsequent to the second decontamination process.

13. The method according to claim 1, wherein at least one of the first and second decontamination processes further comprises:

providing a radially-extending chamber defining a duct adapted to be rotated about a central axis of a centrifuge device, the chamber defining a duct cross-sectional area oriented parallel to the central axis, the duct cross-sectional area being configured to decrease in relation to a radial distance from the central axis;

rotating the radially extending chamber, the biological fluid, and the at least one component disposed therein about a chamber about the central axis of the centrifuge device such that a centrifugal force exerted on the at least one component of the biological fluid by the chamber rotating about the central axis of the centrifuge device substantially opposes a drag force exerted on the at least one component by the biological fluid along a length of the duct such that the at least one component is separable from the fluid.

14. The method according to claim 13, wherein the providing step further comprises:

providing a duct upper wall extending radially outward from the central axis; and

providing a duct lower wall extending radially outward from the central axis;

forming a convergent profile between the duct upper wall and the duct lower wall about a plane of rotation defined by a radius extending radially outward from the central axis.

15. The method according to claim 13, wherein the providing step further comprises providing a duct that extends radially outward 360 degrees about the central axis.

16. The method according to claim 13, wherein the fluid comprises a plurality of components having a corresponding plurality of sizes, including a minimum size and a maximum size, and wherein the providing step further comprises:

providing a duct entrance defining an entrance area between the duct upper and lower walls, disposed at a first radial distance from the central axis, the entrance area being configured such that a centrifugal force exerted on a component having the maximum size substantially opposes a drag force exerted on the component having the maximum size at the first radial distance, such that the component having the maximum size is substantially suspended at the first radial distance;

providing a duct exit, defining an exit area between the duct upper and lower walls, disposed at a second radial distance from the central axis, the exit area configured such that a centrifugal force exerted on a component having the minimum size substantially opposes a drag force exerted on the component having the minimum size at second radial distance, such that the component having the minimum size is substantially suspended at the second radial distance; and

wherein the forming step further comprises;

forming the convergent profile between the duct upper wall and the duct lower wall such that the plurality of components having sizes between the minimum and maximum size exhibit a substantially uniform distribution between the first and second radial distances.

17. The method according to claim 16, wherein the forming step further comprises forming the convergent profile such that the substantially uniform distribution comprises a substantially uniform number of the plurality of components per a unit volume of the duct between the first and second radial distances.

18. The method according to claim 16, wherein the forming step further comprises forming the convergent profile between the upper and lower walls in relation to a radial distance from the central axis and a square of the plurality of sizes.

19. The method according to claim 16, wherein the biological fluid comprises plasma and wherein the plurality of components comprises a plurality of red blood cells having a maximum size of about 8 microns and a minimum size of about 7 microns, and wherein the forming the convergent profile step further comprises forming a convergent profile to suspend, between the first and second radial distances, the plurality of components having a ratio of maximum size to minimum size selected from a group consisting of:

between about 1 and 1.5 to 1;

between about 1 and 1.3 to 1; and

between about 1 and 1.05 to 1.

20. The method according to claim 16 wherein the biological fluid comprises plasma and wherein the plurality of components comprises a plurality of platelets having a maximum size of about 4 microns and a minimum size of about 2 microns, and wherein the forming the convergent profile step further comprises forming a convergent profile to suspend, between the first and second radial distances, the plurality of components having a ratio of maximum size to minimum size selected from a group consisting of:

between about 1.5 and 3 to 1;

between about 1.75 and 2.5 to 1; and

between about 2 and 2.25 to 1.

21. The method according to claim 16 wherein the biological fluid comprises plasma and wherein the plurality of components comprises a plurality of monocytes having a maximum size of about 20 microns and a minimum size of about 10 microns, and wherein the forming the convergent profile step further comprises forming a convergent profile to suspend, between the first and second radial distances, the plurality of components having a ratio of maximum size to minimum size selected from a group consisting of:

between about 1.5 and 3 to 1;

between about 1.75 and 2.5 to 1; and

between about 2 and 2.25 to 1.

22. The method according to claim 13, further comprising directing a supply of elutriation fluid radially inward through the duct in a substantially uniform radial flow so as to wash the plurality of contaminants out of the fluid and away from the at least one component disposed therein.

23. The method according to claim 22, wherein the supply of elutriation fluid includes a treatment media dissolved therein, the treatment media selected from the group consisting of:

nitric oxide;

ozone;

sterile storage solution; and

combinations thereof.

24. The method according to claim 23, further comprising passing the elutriation fluid through at least one sterile filter operably engaged with the radially-extending chamber and disposed between the duct and the supply of elutriation fluid, the at least one sterile filter configured to be capable of sterilizing the elutriation fluid prior to directing the supply of elutriation fluid radially inward through the duct.

25. The method according to claim 22, further comprising passing the elutriation fluid through at least one device configured to direct the supply of elutriation fluid radially inward through the duct in a substantially uniform radial flow.

26. The method according to claim 22, further comprising filtering the plurality of contaminants from the elutriation fluid using a filter device disposed radially inward from the duct.

27. The method according to claim 22, further comprising collecting the elutriation fluid and the plurality of contaminants in a collection reservoir in fluid communication with an elutriation outlet defined by a inner radial wall of the at least one duct.

28. The method according to claim 13, further comprising emitting an ultrasound signal into the chamber from an ultrasound device operably engaged with the chamber.

29. The method according to claim 13, further comprising collecting the at least one component from a component braking zone defined by a radially-inner wall of the chamber, the component braking zone having a braking zone cross-sectional area that is greater than the duct-cross sectional area, and the component braking zone being disposed radially inward from the duct so as to prevent the at least one component from advancing radially inward beyond the duct.

30. The method according to claim 13, further comprising:

defining at least one collection outlet in the chamber;

operably engaging the at least one collection outlet with a collection device; and

selectively removing the at least one component from the duct using the collection device.