Apparatus and method for storing and processing blood

• US 4,804,363 A
• Filed: 07/16/1986
• Issued: 02/14/1989
• Est. Priority Date: 07/16/1986
• Status: Expired

• Current Assignee: Autologous Blood Corporation
• Original Assignee: Autologous Blood Corporation
• Inventors: Valeri, Cesare R.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): Costantino, Mario
• Application Number:
  US06/886,196
• Time in Patent Office: 944 Days
• Field of Search: 604/408-415, 604/403, 604/516, 604/262, 604/283, 604/284, 604/905, 422/44, 422/41, 210/782, 210/198.1, 210/257.1
• US Class Current: 604/6.02
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components

Abstract

This disclosure relates to a blood processing and preservation system. Apparatus of the system comprises a primary collection bag, a blood collection tube connected to the bag and adapted to draw a unit of blood from a person and feed the blood into the bag, and a harness connected to the bag for conducting solutions and blood components into and out of the bag. The harness includes a first tube for removing at least one blood component from the bag while retaining another component, a second tube for moving a cryoprotective solution into and out of the bag, a third tube for conducting a wash solution into and out of the bag, and identification on the bag. The foregoing apparatus is usable in a blood system including the method steps of collecting a unit of blood from a person and delivering the blood to the collection bag, processing the blood to separate the components and removing the components except for the red blood cells from the bag, preparing the red blood cells for freezing by conducting a cryoprotective solution into the bag and mixing this solution with the red blood cells, preserving the red blood cells by freezing, subsequently washing the red blood cells by conducting a wash solution and the cells into and out of the bag, and delivering the cells in the same collection bag to a recipient. While the foregoing method may be used in a homologous blood system where the recipient is not the donor, it is especially suited for use in an autologous blood system where the blood is reinfused in the person who furnished the blood, and the identification on the bag assures the recipient that he/she is receiving his/her own blood. Other blood components, such as the plasma, may also be preserved by freezing.

Claims

1. A method of processing blood utilizing a sterile closed assembly including a primary bag having an anticoagulant therein, and a sterilely closed tube harness including a first tube connected to the primary bag, a secondary tube connected to the first tube and first and second sealed ports connected to the first tube, comprising the steps of:

(a) collecting blood from a donor in said primary bag and mixing in said primary bag said blood and said anticoagulant;

(b) separating said blood in said primary bag into a plurality of blood components;

(c) retaining in said primary bag a unit of one of said components while removing through said first tube to said secondary tube the remainder of said components;

(cc) sealing off and removing said secondary tube from said first tube;

(d) sterilely connected to said first port a supply of cryoprotective solution;

(e) feeding said solution into said primary bag through said first port and said first tube and mixing said solution with said unit in said primary bag;

(ee) sealing off and removing said first port from said first tube;

(f) freezing the mixture of said unit and said solution in said primary bag;

(g) subsequently thawing said mixture in said primary bag;

(h) sterilely connecting said second port to a blood processor and a supply of wash solution;

(i) flowing said mixture through said second port to said processor and combining said wash solution with said mixture in said processor;

(j) separating said wash solution and said cryoprotective solution from said unit, flowing said unit into said primary bag through said first tube and said second port; and

(k) removing said primary bag from said blood processor.

2. A method according to claim 1, and further including the step of preparing an identification of said donor, and connecting said identification to said primary bag.

3. A method according to claim 2, and further including the step of administering said blood component to said donor.

4. A method according to claim 1, wherein said unit of one of said components comprises a unit of red blood cells.

5. A method according to claim 1, wherein said tube harness further includes at least one secondary bag connected to said secondary tube, and wherein said remainder of said blood components removed to said secondary tube are flowed into said one secondary bag.

6. A method according to claim 5, wherein blood plasma is flowed into said secondary bag.

7. A method according to claim 1, wherein said tube harness further includes at least one secondary bag connected to said first tube, and further comprising the step after step (e) of flowing any supernatant cryoprotective solution into said secondary bag.

8. A method according to claim 1, and further including the step after step (h) of flowing a portion of said wash solution into said primary bag and mixing with said mixture.

9. A method according to claim 8, wherein said one of said components comprises red blood cells, and further comprising the step of preparing an identification of said donor, and connecting said identification to said primary bag.

10. A method according to claim 9, wherein said step of freezing said mixture in said primary bag comprises bringing the temperature thereof to approximately -80°

C.

11. A method according to claim 1, and further including the step after step (j) of sealing off and removing said first tube from said primary bag.

12. A method according to claim 1, and further including the step after step (k) of refrigerating said primary bag and said unit of blood.

13. A method according to claim 1, and further including the step after step (ee) of wrapping said primary bag in a sealed container, and subsequently thawing the primary bag and the mixture while wrapped in said sealed container.

14. A method of processing a blood component which has been frozen in a collection bag, the bag containing a mixture of the blood component and a cryoprotective agent, and the collection bag having a sterile tube connected thereto, said method comprising the steps of thawing said blood component in said bag, flowing a quantity of wash solution into said bag and forming in said bag a mixture of cryoprotective agent, wash solution and blood component, flowing said mixture into a separator and separating said blood component from the cryoprotective agent and the wash solution, and returning the blood component to the collection bag.