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

• US 9,844,615 B2
• Filed: 10/27/2015
• Issued: 12/19/2017
• Est. Priority Date: 10/12/2009
• Status: Active Grant

• Current Assignee: Hemanext Inc.
• Original Assignee: New Health Sciences, Inc.
• Inventors: Yoshida, Tatsuro, Vernucci, Paul
• Primary Examiner(s): Greene, Jason M
• Application Number:
  US14/924,179
• Publication Number:
  US 20160045650A1
• Time in Patent Office: 784 Days
• CPC Class Codes: A01N 1/021 Preservation or perfusion media, liquids, solids or gases used in the preservation of cells, tissue, organs or bodily fluids
• CPC Class Codes: A01N 1/0226 Physiologically active agents, i.e. substances affecting physiological processes of cells and tissue to be preserved, e.g. anti-oxidants or nutrients
• 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 1/0294 Electromagnetic, i.e. using electromagnetic radiation or electromagnetic fields
• CPC Class Codes: A61M 1/0209 Multiple bag systems for separating or storing blood components
• CPC Class Codes: A61M 1/0231 with gas separating means, e.g. air outlet through microporous membrane or gas bag
• 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 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: B01D 19/0031 by filtration

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

1. A method for preparing whole blood for transfusion comprising:

obtaining whole blood;

depleting oxygen and carbon dioxide from said whole blood prior to storage to prepare oxygen and carbon dioxide depleted whole blood;

storing said oxygen and carbon dioxide depleted whole blood in a anaerobic storage bag comprising an outer bag having a barrier film that is impermeable to oxygen and carbon dioxide, an inner bag in contact with said whole blood, and an oxygen and carbon dioxide sorbent disposed between said inner bag and said outer bag.

2. The method of claim 1, further comprising oxygenating said stored oxygen and carbon dioxide depleted whole blood.

3. The method of claim 1, further comprising leukoreducing said whole blood prior to said depleting.

4. The method of claim 1, wherein said inner bag comprises polyvinyl chloride (PVC).

5. The method of claim 4, wherein said inner bag comprises di(2-ethylhexyl) phthalate (DEHP)-plasticized PVC.

6. The method of claim 1, further comprising inactivating pathogens before storage of said oxygen and carbon dioxide depleted whole blood.

7. The method of claim 6, wherein said inactivating pathogens comprises riboflavin and light therapy.

8. The method of claim 1, wherein said depleting oxygen and carbon dioxide comprises passing said whole blood through a combined leukoreduction and oxygen and carbon dioxide depletion device.

9. The method of claim 8, wherein said depleting oxygen and carbon dioxide from said whole blood comprises passing said whole blood through a device having a disposable housing, an inlet port, an outlet port, one or more gas permeable membranes adapted to receiving and conveying whole blood, an oxygen sorbent and a carbon dioxide sorbent to form oxygen and carbon dioxide depleted whole blood.

10. The method of claim 9, wherein said oxygen sorbent and said carbon dioxide sorbent of said anaerobic storage bag, of said combined leukoreduction and oxygen and carbon dioxide depletion device, or of said anaerobic storage bag and said combined leukoreduction and oxygen and carbon dioxide depletion device, are a combined oxygen and carbon dioxide sorbent.

11. The method of claim 1, further comprising adding an additive solution to said whole blood to form a suspension of whole blood.

12. The method of claim 11, 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.

13. The method of claim 1, wherein said anaerobic storage bag having depleted whole blood is stored under refrigeration.

14. The method of claim 13, wherein said storage temperature is from 1 to 6°

C.

15. The method of claim 1, further comprising one or more steps selected from the group consisting of:

irradiating said whole blood or said oxygen and carbon dioxide depleted whole blood;

inactivating pathogens in said whole blood or said oxygen and carbon dioxide depleted whole blood; and

editing said whole blood or said oxygen and carbon dioxide depleted whole blood.

16. A kit for the collection and storage of whole blood comprising

a phlebotomy needle;

a collection bag having an anticoagulant solution;

a depletion device comprising a housing, a plurality of membranes permeable to both oxygen and carbon dioxide and are adapted to receiving and conveying whole blood extending within the housing from an entrance to an exit thereof;

an amount of both an oxygen sorbent and carbon dioxide sorbent packed within the housing and contiguous to said plurality of membranes; and

a storage bag comprising an outer bag having a barrier film, an inner bag in contact with said whole blood, and a sorbent disposed between said inner bag and said outer bag.

17. The kit of claim 16, further comprising a leukoreduction device.

18. The kit of claim 17, wherein said leukoreduction device is a combined leukoreduction and depletion device.