IP Library Granted Patent US 11,433,164
Granted Patent B2
US 11,433,164 · App. 16/785,049 · Granted Sep 6, 2022

System for extended storage of red blood cells and methods of use

Inventors: Tatsuro Yoshida (West Newton, MA); Paul Vernucci (Billerica, MA)
Assignee: Hemanext Inc.
A61M1/0209A01N1/021A01N1/0226A01N1/0263A01N1/0294A61M1/0231A61M1/0272B01D19/0031A61M2202/0208A61M2202/0225
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Quick Facts
Patent No.
US 11,433,164
App. No.
16/785,049
Granted
Sep 6, 2022
Kind
B2
Abstract

A system and methodology for the preservation of red blood cells is described in which red blood cells are oxygen or oxygen and carbon dioxide depleted, treated and are stored in an anaerobic environment to optimize preparation for transfusion. More particularly, a system and method for extended storage of red blood cells from collection to transfusion that optimizes red blood cells prior to transfusion is described.

Claims (26)

1. A method of preparing red blood cells for transfusion in the treatment of sickle cell in a subject in need thereof comprising:

obtaining whole blood;

separating red blood cells from said whole blood to form packed red blood cells;

depleting oxygen and carbon dioxide from said packed red blood cells prior to storage to prepare depleted packed red blood cells; and

storing said depleted packed red blood cells in an anaerobic storage bag comprising an outer bag having a barrier film that is impermeable to oxygen and carbon dioxide, and an inner bag in contact with said red blood cells, wherein said depleted packed red blood cells are maintained in an anaerobic condition, to form stored depleted red blood cells.

2. The method of claim 1 , further comprising oxygenating said stored depleted red blood cells.

3. The method of claim 1 , further comprising transfusing said red blood cells into a subject in need thereof.

4. The method of claim 1 , wherein said stored depleted red blood cells comprise an initial oxygen saturation of less than 3 Torr.

5. The method of claim 1 , wherein said subject in need thereof requires 30 or more units of blood per year.

6. The method of claim 1 , wherein said stored depleted red blood cells have higher 24-hr recovery and reduced excess iron when transfused into said subject in need thereof, compared to red blood cells not oxygen depleted.

7. The method of claim 1 , further comprising reducing iron overload in said subject in need thereof.

8. The method of claim 1 , wherein said stored oxygen depleted red blood cells are stored for up to 42 days.

9. The method of claim 1 , wherein said anaerobic storage bag further comprises a sorbent comprising an oxygen sorbent, a carbon dioxide sorbent, or a combination thereof, disposed between said inner bag and said outer bag.

10. The method of claim 1 , further comprising adding an additive solution to said packed red blood cells to form a suspension of packed red blood cells.

11. The method of claim 10 , wherein said additive solution comprises AS-1, AS-3, AS-5, SAGM, PAGG-SM, PAGG-GM, MAP, SOLX, ESOL, EAS61, OFAS1, OFAS3, or any combinations thereof.

12. The method of claim 1 , wherein said anaerobic storage bag is irradiated by gamma or x-ray irradiation.

13. The method of claim 1 , further comprising gamma or x-ray irradiating said depleted packed red blood cells before transfusion.

14. The method of claim 1 , wherein said red blood cells reduce complications from chronic transfusion therapy in said subject in need thereof.

15. The method of claim 14 , wherein said red blood cells have higher 24-hr recovery and reduced excess iron when transfused into said subject in need thereof, compared to red blood cells not oxygen depleted.

16. The method of claim 3 , wherein said red blood cells reduce morbidity from chronic transfusion therapy in a subject in need thereof.

17. A method of preparing red blood cells for transfusion in the treatment of sickle cell in a subject in need thereof comprising:

obtaining previously stored oxygen and carbon dioxide depleted packed red blood cells wherein said depleted packed red blood cells were depleted prior to storage and said storage was in an anaerobic storage bag comprising an outer bag having a barrier film that is impermeable to oxygen and carbon dioxide, and an inner bag in contact with said depleted packed red blood cells;

oxygenating said previously stored depleted red blood cells creating oxygenated red blood cells; and

transfusing said red blood cells into a subject in need thereof.

18. The method of claim 17 , wherein said stored depleted red blood cells comprise an initial oxygen saturation of less than 3 Torr.

19. The method of claim 17 , wherein said stored depleted red blood cells have higher 24-hr recovery and reduced excess iron when transfused into said subject in need thereof: compared to red blood cells not oxygen depleted.

Assignments (2)
CHANGE OF NAME Recorded Jun 8, 2020
From: NEW HEALTH SCIENCES, INC.
To: HEMANEXT INC.
Reel/Frame 052874/0456 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 5, 2020
From: YOSHIDA, TATSURO; PAUL VERNUCCI
To: NEW HEALTH SCIENCES, INC.
Reel/Frame 052849/0971 →
Continuity (13)
Continuation 15811481 · Nov 13, 2017
Continuation 14924179 · Oct 27, 2015
Continuation 13541554 · Jul 3, 2012
Continuation In Part 13289722 · Nov 4, 2011
Continuation In Part 13115532 · May 25, 2011
Continuation 12903057 · Oct 12, 2010
Continuation In Part 12901350 · Oct 8, 2010
Provisional Application 61504640 · Jul 5, 2011
Provisional Application 61504644 · Jul 5, 2011
Provisional Application 61410684 · Nov 5, 2010
Provisional Application 61331693 · May 5, 2010
Provisional Application 61250661 · Oct 12, 2009
Related Publication 20200188565A1 · Jun 18, 2020
Cited By (3)
US 12,447,177 US 12,502,462 US 12,678,460