IP Library › Granted Patent US 10,791,731
Granted Patent B2
US 10,791,731 · App. 15/580,980 · Granted Oct 6, 2020

Methods for preparing frozen plasma material for rapid thawing in an emergency situation

Inventors: Michael P. Chapman (Denver, CO); Ernest Moore (Denver, CO)
Assignee: The Regents of the University of Colorado, a body corporate
A01N1/0263A01N1/0273A01N1/0284A61K35/16A61M1/025A61M1/0277A61M1/0281A61M2205/3368A61M2205/366
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Quick Facts
Patent No.
US 10,791,731
App. No.
15/580,980
Granted
Oct 6, 2020
Kind
B2
Abstract

Systems for controlled freezing, storing and thawing a biological material in a bag and supporting apparatus. The systems are adapted to receive the biological material therein for freezing, storing, transporting and rapid thawing immediately prior to administration to a patient in need of the biological material.

Claims (34)

1. A method for preparing a frozen bag of plasma material for rapid thawing at a site of a patient in need of urgent administration of the plasma material comprising:

positioning a bag of plasma material in a support container configured to encapsulate and protect the bag of plasma material;

positioning the support container in a freezer for a time of at least 12 hours in order to freeze the plasma material; and

applying a compression force on the support container before the plasma material begins to freeze and during the time of freezing to compress the bag of plasma material to achieve a flat bag of frozen plasma material having a uniform thickness of less than or equal to 1.3 cm;

wherein the compression force is an active external force supplied independent of the support container and is distributed uniformly across the bag to flatten the bag of plasma material.

2. The method of claim 1 , wherein the uniform thickness is between about 0.127 cm and about 1.3 cm inclusive.

3. The method of claim 1 , wherein the step of positioning the bag of plasma material within the support container in a freezer further comprises positioning the support container horizontally in the freezer, whereby the horizontal orientation of the support container and the compression force together result in the flat bag of frozen plasma material having the uniform thickness.

4. The method of claim 3 , further comprising

horizontally stacking two or more support containers; and

applying the compression force simultaneously across the two or more support containers.

5. The method of claim 1 , further comprising applying a weight to an external surface of the support container to provide the compression force on the bag of plasma material in the support container during freezing.

6. The method of claim 1 , further comprising compressing the support container between two plates to provide the compression force on the bag of plasma material during freezing.

7. The method of claim 6 , wherein the two plates are coupled by springs to provide the compression force sufficient to achieve the flat bag of frozen plasma material.

8. The method of claim 1 , further comprising activating a hydraulic ram during at least a portion of the freezing process to provide the compression force on the support container during freezing.

9. The method of claim 1 , wherein the compression force eliminates void spaces between the support container and the bag of plasma material to provide uniform flattening of the bag.

10. The method of claim 1 , wherein the uniform thickness of the bag of frozen plasma material is such that the bag of frozen plasma material can completely thaw to 37° C. in three minutes or less in a standard temperature control unit.

11. A method of forming a frozen bag of plasma material having a size and shape suitable for rapid thawing in a standard temperature control unit located at a site of a patient in need of immediate administration of the thawed plasma material, the method comprising:

placing a bag of plasma material in a support container, wherein the bag of plasma material flattens to a thickness defined by an interior surface of the support container;

placing the support container in a freezer for an amount of time selected to freeze all of the plasma material; and

compressing the bag of plasma material with an active external force before the plasma material begins to freeze and during the amount of time of freezing to further flatten the bag of plasma material such that the plasma material when frozen has a uniform thickness and a large surface area to volume ratio that allows the frozen plasma material to rapidly thaw in less than 20 minutes when the bag of frozen plasma material is placed in the standard temperature control unit;

wherein the active external force is supplied independent of the support container and is distributed uniformly across the bag to flatten the bag of plasma material.

12. The method of claim 11 , wherein the plasma material fills less than 25% of the volume of the bag such that when the bag of plasma material is compressed during freezing the plasma material flattens within the bag to a thickness less than or equal to 1.3 cm.

13. The method of claim 11 , further comprising inserting one or more compression pads within the support container adjacent to the bag of plasma material to maintain uniform thickness of the bag of plasma material in the support container during freezing.

14. The method of claim 13 , wherein the one or more compression pads are comprised of a sheet of cross-linked polyethylene foam.

15. The method of claim 11 , further comprising draining gas from the bag before freezing.

16. The method of claim 11 , wherein the thickness of the frozen plasma material allows the frozen plasma material to completely thaw to 37° C. in three minutes or less in the standard temperature control unit.

17. The method of claim 11 , wherein the uniform thickness is between 0.127 cm and 1.3 cm, inclusive.

18. A method of shaping a bag of frozen plasma material to facilitate rapid thawing of the frozen plasma material for use in an emergency situation, the method comprising:

placing a support container having a bag of plasma material stored therein in a freezer, wherein the bag of plasma material is protected from damage during freezing by the support container; and

exerting a compressive force on the bag of plasma material before the plasma material begins to freeze and during freezing to create a bag of frozen plasma material having a flat shape and uniform thickness, wherein

the frozen plasma material is configured to thaw in less than 20 minutes when the bag is placed in a standard temperature control unit, and

the compressive force is an active external force supplied independent of the support container and is distributed uniformly across the bag to flatten the bag of plasma material.

19. The method of claim 18 , wherein the flat shape and uniform thickness result in the frozen plasma material completely thawing to 37° C. in three minutes or less in the standard temperature control unit for rapid use of the plasma material in the emergency situation.

20. The method of claim 18 , where the bag having the frozen plasma material stored therein has an ultra-high surface area that allows the plasma material to form the flat shape with the uniform thickness when the bag of plasma material is compressed.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 26, 2018
From: CHAPMAN, MICHAEL P.; MOORE, ERNEST
To: THE REGENTS OF THE UNIVERSITY OF COLORADO, A BODY CORPORATE
Reel/Frame 046206/0607 →
Continuity (2)
Provisional Application 62172667 · Jun 8, 2015
Related Publication 20180177180A1 · Jun 28, 2018