Lyophilization

• US 20150354894A1
• Filed: 06/09/2015
• Published: 12/10/2015
• Est. Priority Date: 06/09/2014
• Status: Active Grant

• Current Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Original Assignee: Terumo BCT, Inc. (Terumo Corporation)
• Inventors: CORBIN, Frank III, HLAVINKA, Dennis J., PARETA, Rajesh, HILLAM, Mark E.
• Granted Patent: US 9,863,699 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A01N 1/0252 Temperature controlling refrigerating apparatus, i.e. devices used to actively control the temperature of a designated internal volume, e.g. refrigerators, freeze-drying apparatus or liquid nitrogen baths
• CPC Class Codes: A01N 1/0263 Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving, e.g. cool boxes, blood bags or "straws" for cryopreservation
• CPC Class Codes: A01N 1/0284 Temperature processes, i.e. using a designated change in temperature over time
• CPC Class Codes: A01N 1/0289 Pressure processes, i.e. using a designated change in pressure over time
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/14 Details; Accessories therefor A61J7/00 takes precedence; openers B65D, B67B7/00
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61J 1/1475 Inlet or outlet ports
• CPC Class Codes: A61L 2/07 Steam
• CPC Class Codes: A61L 2/084 Visible light
• CPC Class Codes: A61L 2/085 Infrared radiation
• CPC Class Codes: A61L 2/088 using a photocatalyst or photosensitiser
• CPC Class Codes: A61L 2/10 Ultraviolet radiation
• CPC Class Codes: A61L 2202/11 Apparatus for generating biocidal substances, e.g. vaporisers, UV lamps
• CPC Class Codes: A61L 2202/22 Blood or products thereof
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• 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 1/0286 Handling a large number of blood product units, e.g. storage cabinets, blood bank administration
• CPC Class Codes: A61M 2202/0415 Plasma
• CPC Class Codes: F26B 5/06 the process involving freezing

Abstract

Embodiments of methods, systems, and apparatuses for lyophilizing, storing, and transfusing materials are described. In embodiments, the materials may include whole blood or a component of whole blood such as plasma.

Claims

1. A container for lyophilizing, storing, and transfusing a blood component, the container comprising:

a first wall made from a porous material comprising a polymer cast on a nonwoven textile; and

a second wall attached to the first wall to define an interior volume of the container, wherein the second wall comprises a flexible polymeric material.

2. The container of claim 1, wherein the first wall is permeable to at least one gas.

3. The container of claim 2, wherein the first wall is permeable to water vapor.

4. The container of claim 3, wherein the first wall is water resistant.

5. The container of claim 4, wherein the first wall has a water vapor transmission of at least 15 perms.

6. The container of claim 5, wherein the first wall has a water resistance of greater than 100 cm.

7. The container of claim 1, further comprising a port connector between the first wall and the second wall.

8. The container of claim 1, further comprising lyophilized human plasma in the interior volume.

9. A container for lyophilizing and storing a lyophilized blood component, the container comprising:

a first chamber comprising;

a first wall made from a flexible polymeric material and comprising a first permeability to water vapor; and

a second wall attached to the first wall to define an interior volume of the first chamber, wherein at least a portion of the second wall comprises a region that has a second permeability to water vapor, the second permeability being higher than the first permeability;

a second chamber fluidly connectable to the first chamber through a pathway, the second chamber comprising;

a third wall made from a flexible polymeric material; and

a fourth wall attached to the third side wall to define an interior volume of the second chamber; and

a seal in the pathway, the seal isolating the first chamber from the second chamber, wherein the seal may be opened to allow communication from the first chamber to the second chamber through the pathway.

10. The container of claim 9, wherein the seal comprises one or more of a clamp, a weld, a frangible, or combinations thereof.

11. The container of claim 10, wherein the first chamber further comprises a first port for adding a blood component into the interior volume of the first chamber.

12. The container of claim 11, wherein the second chamber further comprises a second port for adding a rehydration fluid into the interior volume of the second chamber.

13. The container of claim 12, wherein the second chamber further comprises a third port for removing a rehydrated blood component from the interior volume of the first chamber.

14. The container of claim 13, wherein the at least a portion of the second wall comprises a nonwoven textile.

15. A method of lyophilizing material, the method comprising:

maintaining a material in a container;

subjecting the material to a first pressure;

evaporating at least a portion of a liquid component of the material;

cooling the material to freeze any remaining liquid component into a solid;

subjecting the material to a second pressure which is less than the first pressure; and

sublimating a portion of the solid.

16. The method of claim 15, wherein the evaporating comprises adding thermal energy to the material.

17. The method of claim 16, wherein the sublimating comprises adding thermal energy to the material.

18. The method of claim 17, wherein the sublimating comprises adding IR energy to the material.

19. The method of claim 18, further comprising, pressing the material during the cooling.

20. A method of lyophilizing material, the method comprising:

pooling liquid in a container to create pooled liquid;

adding a photosensitizer to the pooled liquid;

exposing the pooled liquid with the photosensitizer to a light source to create a pathogen reduced liquid;

lyophilizing the pathogen reduced liquid, wherein the lyophilizing comprises;

cooling the pathogen reduced liquid to freeze a liquid component to create a solid;

subjecting the solid to a first pressure, which is less than atmospheric pressure; and

sublimating a portion of the solid.

21. The method of claim 20, wherein the photosensitizer comprises riboflavin.

22. The method of claim 21, wherein the light source generates light with a wavelength in the ultraviolet range.

23. The method of claim 20, wherein the liquid comprises human plasma.

24. A system for use in lyophilizing a material, the system comprising:

a first plate with a first surface;

a second plate with a second surface opposed to the first surface, the second plate comprising channels for circulating a fluid; and

a plate moving system operable to increase and decrease a space between the first surface and the second surface.

25. The system of claim 24, further comprising an IR radiating material on the first plate, the IR radiating material comprising the first surface.

26. The method of claim 24, wherein the first surface comprises features for imparting a macro texture

27. The method of claim 24, wherein the first plate and the second plate comprise the same structure.

28. A method of preparing a liquid comprising a blood component for lyophilization, the method comprising:

pooling a plurality of volumes of liquid comprising a blood component to generate a pooled volume of liquid;

removing a portion of liquid from the pooled volume of liquid to create a reduced volume of liquid; and

filling a plurality of containers with the reduced volume of liquid, wherein the plurality of containers comprise a wall that is permeable to water vapor.

29. The method of claim 28, further comprising reducing pathogens in the reduced volume of liquid.

30. The method of claim 29, wherein the reducing pathogens comprises:

adding a photosensitizer to the reduced volume of liquid; and

exposing the photosensitizer and the reduced volume of liquid to a light source.