Blood bag for lyophilization

• US 5,257,983 A
• Filed: 04/12/1991
• Issued: 11/02/1993
• Est. Priority Date: 04/12/1991
• Status: Expired due to Fees

• Current Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Original Assignee: Cryopharm Corp.
• Inventors: Garyantes, Tina K., Jones, Daniel F., Cho, Miller, Gilbert, Hardin
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): RIMELL, SAMUEL G
• Application Number:
  US07/685,465
• Time in Patent Office: 935 Days
• Field of Search: 604/403, 604/408-410, 604/405, 604/406, 383/104, 383/119
• US Class Current: 604/403
• 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 2205/3606 cooled
• CPC Class Codes: F26B 25/16 mainly closed, e.g. drum
• CPC Class Codes: F26B 5/06 the process involving freezing

Abstract

A lyophilization bag is provided in which a fluid, such as blood, may be introduced, lyophilized without collapsing the bag, stored, reconstituted and distributed from the bag without intermediate transfer of the useful contents from the bag.

Claims

1. A rigid container for containing liquid contents during lyophilization thereof and for retaining the resulting lyophilized product therein under subatmospheric pressure subsequent to lyophilization, said container comprising:

a lower container body comprising a lower wall in a continuous peripheral side wall;

containing means located adjacent to the upper edge of said side wall and exterior to said container body, said container means accommodating a deformable porous spacer and a rigid cover for said container body, said rigid cover adapted with means to slidably attach to said upper edge and seal said container;

wherein the upper surface of said spacer is in contact with said cover in a manner to retain said cover above said container body whereby exertion of a sufficient downward force upon said cover compresses said spacer and allows said cover to securely attach to said upper edge and seal said container, whereby said compressed spacer is prevented from contact with the contents within the sealed container; and

at least one sealable port in said cover or in said lower container body.

2. A container according to claim 1 further comprising a plurality of dividing means, said dividing means dividing the interior of said container such that the fluid contents are distributed in a plurality of interconnecting compartments defined by said dividing means whereby the fluid contents and vapor contents in each of said compartments communicates with the fluid and vapor contents of adjacent compartments;

said dividing means further providing upon drying of any fluid contents to divide the resultant lyophilized solid product into a plurality of pieces.

3. A container according to claim 1 wherein said means on said cover to securely attach to said upper edge of said container body comprises a slot of width and depth sufficient to slidably receive said upper edge and seal said container.

4. A method for lyophilizing a fluid product comprising the steps of:

(a) introducing a product to be dried into a container according to claim 1;

(b) introducing said container into a vacuum whereby vapors are withdrawn from said container through said porous spacer, whereby as the pressure within said container is reduced, a differential in pressure from the exterior of the container causes said cover to compress said spacer until said cover securely attaches and seals to the upper edge of said peripheral wall, thereby enclosing said container; and

(c) exposing said container to atmospheric pressure whereby said container is maintained in a sealed condition by the pressure differential between the vacuum within said container and atmospheric pressure exterior to said container.