Blood bag for lyophilization

• US 4,973,327 A
• Filed: 11/01/1989
• Issued: 11/27/1990
• Est. Priority Date: 11/01/1989
• Status: Expired due to Fees

• Current Assignee: Cobe Cardiovascular Incorporated (LivaNova Plc)
• Original Assignee: Cryopharm Corp.
• Inventors: Derksen, Johannes, Goodrich, Raymond P. Jr., Hackett, Roger W.
• Primary Examiner(s): Hafer, Robert A.
• Assistant Examiner(s): Cofsky, Lynda M.
• Application Number:
  US07/429,948
• Time in Patent Office: 391 Days
• Field of Search: 604/403, 604/408, 604/409, 604/410, 604/415, 604/416, 383/104, 383/119
• US Class Current: 604/408
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61M 2205/3606 cooled
• CPC Class Codes: F26B 5/06 the process involving freezing

Abstract

A lyophilization bag is provided in which a fluid, such as blood, ay 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 flexible plastic bag comprising an upper wall and lower wall, said walls sealed at their edges to a peripheral side wall to thereby define the inner volume of said bag;

a major port in said upper wall approximately centrally located in said upper wall, said major port adapted with a sealable conduit;

at least one side port in said side wall, said side port adapted with sealing means and said side port located proximate to the upper edge of said side wall;

securing means on said peripheral side wall adapted to receive removable rigid or semirigid reinforcing members to restrain said side wall from collapse when said reinforcing members are secured to said side wall;

securing means in said upper wall adapted to receive removable rigid or semi-rigid reinforcing members to restrain said upper wall from collapse when said reinforcing members are secured to said upper wall;

securing means on said lower wall adapted to receive removable semi-rigid or rigid lower reinforcing means, wherein said lower reinforcing means comprises a thermoducting material to facilitate conduction of heat to or from the contents of said bag through said lower wall; and

attachment means for suspending said bag in a position whereby at least one of said side ports is at a location for withdrawal of any fluid contents from said bag.

2. A bag according to claim 1 wherein said sealable conduit is adapted with a sterile filter.

3. A bag according to claim 1 comprising at least two of said side ports.

4. A bag according to claim 1 wherein said securing means on said peripheral side wall and on said upper wall comprise loops adapted to receive said reinforcing members in the form of strips.

5. A bag according to claim 1 wherein said securing means on said lower wall comprises a flexible plastic sheet sealed on three edges to said lower wall and to said peripheral wall, thereby forming an exterior open-ended pocket with said lower wall.

6. A lyophilization plastic bag comprising a flexible plastic bag according to claim 1, and said rigid or semi-rigid reinforcing strips retained by said loops against said upper wall and peripheral wall.

7. A lyophilization bag according to claim 6 further comprising a thermally conducting metal plate accommodated by said pocket on said lower wall.

8. A lyophilization bag according to claim 7 wherein said metal plate comprises copper.

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

(a) providing a container according to claim 1 adapted with said reinforcing members in said peripheral wall and upper wall and with said lower reinforcing members in lower wall, and with a sterile filter on said sealable conduit;

(b) positioning said bag from step (a) in a lyophilizer whereby said lower wall is downwardly facing;

(c) introducing said fluid product through at least one of said side ports into said bag to a level at which said major port is in communication with the vapor space within said bag not occupied by said fluid product; and

resealing said port;

(d) freezing and lyophilizing the contents of said bag whereby vapors are withdrawn from said bag through said major port, conduit and filter;

(e) backfilling said bag with sterile dry inert gas and withdrawing said bag from said lyophilizer; and

(f) sealing said sealable conduit.

10. A method according to claim 9 wherein said fluid product comprises blood.

11. A method according to claim 9 wherein said fluid product comprises red blood cells for transfusion.

12. A method according to claim 9 further comprising the step (g) of introducing at least one sterile reconstitution solution into said bag through at least one of said side ports to produce a rehydrated sterile solution suitable for subsequent pharmaceutical use.

13. A method according to claim 9 wherein said fluid product comprises blood components prepared from whole blood, to include serum or blood protein fractions derived from serum.

14. A method according to claim 9 wherein said fluid product comprises a protein-containing solution.