Lyophilization

• US 10,539,367 B2
• Filed: 01/05/2018
• Issued: 01/21/2020
• 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, III, Frank, Hlavinka, Dennis J., Pareta, Rajesh, Hillam, Mark E.
• Primary Examiner(s): Gravini, Stephen M
• Application Number:
  US15/863,390
• Publication Number:
  US 20180128544A1
• Time in Patent Office: 746 Days
• Field of Search: 34 92, 34296, 34284, 34287
• 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 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 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.

2. The container of claim 1, wherein the seal comprises one or more of a clamp, a weld, a frangible, or combinations thereof.

3. The container of claim 2, wherein the first chamber further comprises a first port for adding a blood component into the interior volume of the first chamber.

4. The container of claim 3, wherein the second chamber further comprises a second port for adding a rehydration fluid into the interior volume of the second chamber.

5. The container of claim 4, wherein the second chamber further comprises a third port for removing a rehydrated blood component from the interior volume of the first chamber.

6. The container of claim 5, wherein the at least a portion of the second wall comprises a nonwoven textile.