# US 11,433,164 B2 · System for extended storage of red blood cells and methods of use

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- Number: US 11,433,164 B2
- Document ID: US11433164B2
- Status: Granted
- Kind: B2
- Application number: 16/785,049
- Filed: 2020-02-07
- Published: 2020-06-18
- Granted: 2022-09-06
- Earliest claimed: 2009-10-12
- Assignees: Hemanext Inc.
- Applicants: Hemanext Inc.
- Inventors: Tatsuro Yoshida; Paul Vernucci
- Web page: https://patentgrep.com/patent/US11433164B2

## CPC

- A61M 1/0209: {Multiple bag systems for separating or storing blood components}
- A01N 1/122: Preservation or perfusion media
- A01N 1/126: Physiologically active agents, e.g. antioxidants or nutrients
- A01N 1/146: Non-refrigerated containers specially adapted for transporting or storing living parts whilst preserving
- A01N 1/168: using electromagnetic fields or radiation; using acoustic waves or corpuscular radiation
- A61M 1/0231: {with gas separating means, e.g. air outlet through microporous membrane or gas bag}
- A61M 1/0272: {Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging}
- B01D 19/0031: {by filtration}
- A61M 2202/0208: Oxygen
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- B01D: SEPARATION (separating solids from solids by wet methods B03B, B03D; by pneumatic jigs or tables B03B; by other dry methods B07; magnetic or electrostatic separation of solid materials from solid materials or fluids, separation by high-voltage electric fields B03C; centrifuges, vortex apparatus B04; presses per se for squeezing-out liquid from liquid-containing material B30B9/02; treatment of water C02F, e.g. softening by ion-exchange C02F1/42; {arrangements of air intake cleaners in gas turbine plants F02C7/05} ; arrangements or mounting of filters in air-conditioning, air-humidification or ventilation F24F13/28)

## 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

### Claim 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.

### Claim 2 (depends on 1)

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

### Claim 3 (depends on 1)

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

### Claim 4 (depends on 1)

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

### Claim 5 (depends on 1)

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

### Claim 6 (depends on 1)

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.

### Claim 7 (depends on 1)

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

### Claim 8 (depends on 1)

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

### Claim 9 (depends on 1)

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.

### Claim 10 (depends on 1)

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.

### Claim 11 (depends on 10)

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.

### Claim 12 (depends on 1)

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

### Claim 13 (depends on 1)

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

### Claim 14 (depends on 1)

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

### Claim 15 (depends on 14)

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.

### Claim 16 (depends on 3)

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

### Claim 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.

### Claim 18 (depends on 17)

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

### Claim 19 (depends on 17)

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.