# US 2015/0147744 A1 · Method and system for removing oxygen and carbon dioxide during red cell blood processing using an inert carrier gas and manifold assembly

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- Number: US 2015/0147744 A1
- Document ID: US20150147744A1
- Status: Published application
- Kind: A1
- Application number: 14/614,045
- Filed: 2015-02-04
- Published: 2015-05-28
- Earliest claimed: 2011-03-28
- Assignees: New Health Sciences, Inc.
- Applicants: New Health Sciences, Inc.
- Inventors: Tatsuro YOSHIDA; Paul VERNUCCI
- Web page: https://patentgrep.com/patent/US20150147744A1

## CPC

- A61M 1/0272: {Apparatus for treatment of blood or blood constituents prior to or for conservation, e.g. freezing, drying or centrifuging}
- A61M 1/0281: {Apparatus for treatment of blood or blood constituents prior to transfusion, e.g. washing, filtering or thawing}
- A61M 1/38: Removing constituents from donor blood and {storing or} returning remainder to body {, e.g. for transfusion}
- A61M 2202/0208: Oxygen
- A61M 2202/0225: Carbon oxides, e.g. Carbon dioxide
- A61M 2202/0439: White blood cells; Leucocytes
- 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)}

## 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

### Claim at position 1

1-27. (canceled)

### Claim 28

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.

### Claim 29 (depends on 28)

The method according to claim 28, 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.

### Claim 30 (depends on 29)

The method according to claim 29, 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.

### Claim 31 (depends on 28)

The method according to claim 28, 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.

### Claim 32 (depends on 31)

The method according to claim 31, 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.

### Claim 33 (depends on 28)

The method according to claim 28, 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.

### Claim 34 (depends on 33)

The method according to claim 33, 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.

### Claim 35 (depends on 28)

The method according to claim 28, 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.

### Claim 36 (depends on 28)

The method according to claim 28, wherein said flushing gas source is selected from the group consisting of a pump, a vacuum, and a pressurized container.

### Claim 37 (depends on 28)

The method according to claim 28, further comprising depositing said oxygen or oxygen and carbon dioxide reduced red blood cells in a blood storage bag.

### Claim 38 (depends on 28)

The method according to claim 28, further comprising adding an additive solution to said RBCs prior to said flowing.

### Claim 39 (depends on 38)

The method according to claim 38, wherein said additive solution is selected from the group consisting of OFAS3, SAGM, PAGG-SM, AS-1, AS-3, SOLX, MAPS, and PAGG-GM.

### Claim 40 (depends on 39)

The method according to claim 39, wherein said OFAS3 has a pH ranging from about 5.5 to about 7.5.

### Claim 41 (depends on 40)

The method according to claim 40, wherein said OFAS3 has a pH of about 6.5.

### Claim 42 (depends on 28)

The method according to claim 28, wherein said OCDD device further comprises a leukoreduction filter, and said method further comprises leukoreducing said RBCs.

### Claim 43 (depends on 28)

The method according to claim 28, 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.

### Claim 44 (depends on 28)

The method according to claim 28, wherein said OCDD device further comprises a plasma separator, and said method further comprises separating plasma from said RBCs prior to said flowing.

### Claim 45 (depends on 28)

The method according to claim 28, wherein said one or more gas sensor assemblies further comprise temperature, gas flow rate, total pressure, and humidity detectors.

### Claim 46 (depends on 28)

The method according to claim 28, wherein said oxygen or oxygen and carbon dioxide reduced red blood cells has a hemoglobin oxygen saturation level of less than 3%.

### Claim 47 (depends on 28)

The method according to claim 28, 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.
