Method and system for removing oxygen and carbon dioxide during red cell blood processing using an inert carrier gas and manifold assembly

• US 9,968,718 B2
• Filed: 02/04/2015
• Issued: 05/15/2018
• Est. Priority Date: 03/28/2011
• Status: Active Grant

• Current Assignee: New Health Sciences, Inc.
• Original Assignee: New Health Sciences, Inc.
• Inventors: Yoshida, Tatsuro, Vernucci, Paul
• Primary Examiner(s): Klein, Benjamin
• Application Number:
  US14/614,045
• Publication Number:
  US 20150147744A1
• Time in Patent Office: 1,196 Days
• 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 1/0281 Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing
• CPC Class Codes: A61M 1/38 Removing constituents from donor blood and storing or returning remainder to body , e.g. for transfusion
• CPC Class Codes: A61M 2202/0208 Oxygen
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2202/0439 White blood cells; Leucocytes

Abstract

A portable assembly for processing red blood cells RBCs including a disposable blood collection set including a blood bag, an anaerobic storage bag and an oxygen and/or oxygen and carbon dioxide depletion device disposed between the blood collection bag and anaerobic storage bag. The portable assembly further provides for a gas circulation device in fluid communication with the oxygen or oxygen and carbon dioxide depletion device, The gas circulation device includes a pressure source that is able circulate flushing gas through the depletion device as RBCs pass from the blood collection bag, through the depletion device and into the anaerobic storage bag.

Claims

1. A method of processing red blood cells (RBCs) comprising:

filtering a flushing gas source through a gas circulation device to generate sterile flushing gas, said gas circulation device comprising, in fluid communication with each other;

a flushing gas source providing said flushing gas;

a gas outlet manifold;

a first gas sterilization filter;

a second gas sterilization filter;

one or more gas sensor assemblies;

a gas inlet manifold; and

a controller,

wherein said one or more gas sensor assemblies are selected from the group consisting of an oxygen sensor, an oxygen partial pressure sensor, a carbon dioxide sensor, a carbon dioxide partial pressure sensor, and combinations thereof;

providing said sterile flushing gas to an oxygen or oxygen and carbon dioxide depletion (OCDD) device; and

flowing said RBCs through said OCDD device to remove oxygen or oxygen and carbon dioxide from said RBCs, producing oxygen or oxygen and carbon dioxide reduced red blood cells.

2. The method according to claim 1, wherein said gas circulation device is contained in a housing comprising a sorbent disposed between said flushing gas source and said gas outlet manifold, and said method further comprises removing oxygen or oxygen and carbon dioxide from said flushing gas.

3. The method according to claim 2, further comprising determining levels of oxygen or carbon dioxide in said flushing gas, wherein said one or more gas sensor assemblies comprises a first gas sensor assembly comprising a first partial pressure sensor disposed between said flushing gas source and said sorbent, and a second gas sensor assembly comprising a second partial pressure sensor disposed between said sorbent and said gas outlet manifold.

4. The method according to claim 1, wherein said gas circulation device further comprises one or more load cells in communication with said controller to regulate one or more flow regulator valves, and said method further comprises measuring the load of unprocessed RBCs, and controlling said flowing.

5. The method according to claim 4, wherein said controller detects a signal from said one or more load cells and then communicates a signal to restrict or facilitate a flow of RBCs through said one or more flow regulator valves.

6. The method according to claim 1, wherein said one or more gas sensor assemblies comprises an oxygen sensor in communication with said controller to regulate one or more flow valves, and said method further comprises measuring the level of oxygen saturation in said RBCs flowing through said OCDD device.

7. The method according to claim 6, wherein said controller detects a signal from said oxygen sensor and then communicates a signal to restrict or facilitate a flow of RBCs through said one or more flow regulator valves.

8. The method according to claim 1, wherein said flushing gas comprises Ar, He, N₂, Ar/CO₂, He/CO₂, N₂/CO₂, a combination of inert gasses, or any combination of inert gasses and CO₂.

9. The method according to claim 1, wherein said flushing gas source is selected from the group consisting of a pump, a vacuum, and a pressurized container.

10. The method according to claim 1, further comprising depositing said oxygen or oxygen and carbon dioxide reduced red blood cells in a blood storage bag.

11. The method according to claim 1, further comprising adding an additive solution to said RBCs prior to said flowing.

12. The method according to claim 11, wherein said additive solution is selected from the group consisting of OFAS3, SAGM, PAGG-SM, AS-1, AS-3, SOLX, MAPS, and PAGG-GM.

13. The method according to claim 12, wherein said OFAS3 has a pH ranging from about 5.5 to about 7.5.

14. The method according to claim 13, wherein said OFAS3 has a pH of about 6.5.

15. The method according to claim 1, wherein said OCDD device further comprises a leukoreduction filter, and said method further comprises leukoreducing said RBCs.

16. The method according to claim 1, wherein said OCDD device further comprises a leukoreduction filter, and said method further comprises leukoreducing said oxygen or oxygen and carbon dioxide reduced red blood cells.

17. The method according to claim 1, wherein said OCDD device further comprises a plasma separator, and said method further comprises separating plasma from said RBCs prior to said flowing.

18. The method according to claim 1, wherein said one or more gas sensor assemblies further comprise temperature, gas flow rate, total pressure, and humidity detectors.

19. The method according to claim 1, wherein said oxygen or oxygen and carbon dioxide reduced red blood cells has a hemoglobin oxygen saturation level of less than 3%.

20. The method according to claim 1, wherein said oxygen or oxygen and carbon dioxide reduced red blood cells has a carbon dioxide partial pressure of less than 50 Torr at 37°

C.