Oxygen reduction disposable kits, devices and methods of use thereof

• US 10,058,091 B2
• Filed: 03/15/2017
• Issued: 08/28/2018
• Est. Priority Date: 03/10/2015
• Status: Active Grant

• Current Assignee: Hemanext Inc.
• Original Assignee: New Health Sciences, Inc.
• Inventors: Wolf, Michael, Sarita, Jancarlo, Sutton, Jeffrey Karl, Cordero, Rafael, Zocchi, Michael, Keegan, Philip, Renganathan, Narendran, Harhen, Robert
• Primary Examiner(s): Hurst, Jonathan M
• Application Number:
  US15/459,813
• Publication Number:
  US 20170181426A1
• Time in Patent Office: 531 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 1/0263 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: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61K 35/00 Medicinal preparations containing materials or reaction products thereof with undetermined constitution
• 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: C12M 23/14 Bags

Abstract

The present disclosure relates to Oxygen Reduction Disposable kits (ORDKit), devices and methods for the improved preservation of whole blood and blood components. The improved devices and methods for the collection of blood and blood components provide for whole blood and blood components having reduced levels of oxygen. The devices and methods provide for the rapid preparation of deoxygenated blood and blood components for storage that improves the overall quality of the transfused blood and improves health outcomes in patients.

Claims

1. An oxygen depletion device 10 for depleting oxygen from blood prior to anaerobic storage comprising:

an outer receptacle 101 substantially impermeable to oxygen;

an inner collapsible blood container 102 comprising one or more chambers that are permeable to oxygen;

a spacer 110 having open areas;

an oxygen or oxygen and carbon dioxide sorbent 103 sachet situated within said outer receptacle 101; and

wherein said spacer is not part of a sachet and does not enclose said oxygen or oxygen and carbon dioxide sorbent.

2. The oxygen depletion device 10 of claim 1, wherein said inner collapsible blood container 102 comprises a material having a permeability to oxygen of greater than about 1.0×

10<sup>−

8</sup> cm³O₂(STP)/((cm²s)*(cm Hg cm<sup>−

1</sup>)).

3. The oxygen depletion device 10 of claim 1, wherein said inner blood compatible container 102 has a surface area to volume ratio of at least 4.48 centimeters²/milliliter (cm²/ml) when filled with blood for depletion and enclosed within said outer receptacle 101.

4. The oxygen depletion device of claim 1, wherein said inner collapsible blood container 102 comprises a first and second membrane 113 joined by a peripheral tie layer 105 consisting of silicone.

5. The oxygen depletion device of claim 1, wherein said oxygen sorbent 103 has a total mass of 1 to 100 grams contained in one or more said sachets.

6. The oxygen depletion device of claim 1, wherein said oxygen depletion device 10 further comprises a headspace defined by said inner collapsible blood container 102 and said outer receptacle 101, wherein said oxygen or oxygen and carbon dioxide sorbent 103 is disposed, and said headspace has a volume of between 10 and 500 milliliters (ml).

7. The oxygen depletion device of claim 1, wherein said spacer material 110 is a mesh comprising at least one interstice 111 comprising between 50% to 80% of the total area of said spacer material 110.

8. The oxygen depletion device of claim 1, further comprising an oxygen indicator 206 in between said outer receptacle 101 and said inner collapsible blood container 102.

9. The oxygen depletion device of claim 1, further comprising at least one inlet/outlet 30 passing through said outer receptacle 101 comprising a tube 301, a bond 302, and a port 303, wherein said tube 301 and said bond 302 are substantially impermeable to oxygen, and said inlet/outlet 30 is in fluid communication with said inner collapsible blood container 102.

10. The oxygen depletion device of claim 1, wherein said inner collapsible blood container 102 comprises mixing structure 119.

11. The oxygen depletion device of claim 1, wherein said inner collapsible blood container 102 comprises silicone having a thickness of between 5 μ

m and 200 μ

m.

12. The oxygen depletion device 10 of claim 1, wherein oxygenated blood collected in said oxygen depletion and oxygen depletion device 10 is deoxygenated at a rate constant of at least −

0.5×

10<sup>−

2</sup>min<sup>−

1</sup>.

13. The oxygen depletion device of claim 11, wherein said inner collapsible blood container 102 comprises silicone having a thickness of between 20 μ

m and 50 μ

m.

14. The oxygen depletion device 10 of claim 1, wherein said spacer is selected from the group consisting of a mesh, a molded mat, a woven mat, a non-woven mat, a strand veil, and a strand mat.

15. An oxygen depletion device 10 for depleting oxygen from blood prior to anaerobic storage comprising:

an outer receptacle 101 substantially impermeable to oxygen;

an inner collapsible blood container 102 comprising one or more chambers that are permeable to oxygen;

a non-sachet spacer 110 having open areas; and

an oxygen or oxygen and carbon dioxide sorbent 103 sachet situated within said outer receptacle 101, wherein said spacer does not enclose said oxygen or oxygen and carbon dioxide sorbent.

16. The oxygen depletion device 10 of claim 15, wherein said inner blood compatible container 102 has a surface area to volume ratio of at least 4.48 centimeters²/milliliter (cm²/ml) when filled with blood for depletion and enclosed within said outer receptacle 101.

17. The oxygen depletion device 10 of claim 15, wherein said non-sachet spacer is selected from the group consisting of a mesh, a molded mat, a woven mat, a non-woven mat, a strand veil, and a strand mat.

18. An oxygen depletion device 10 for depleting oxygen from blood prior to anaerobic storage comprising:

an outer receptacle 101 substantially impermeable to oxygen;

an inner collapsible blood container 102 comprising one or more chambers that are permeable to oxygen;

a non-oxygen or non-oxygen and carbon dioxide sorbent spacer 110 having open areas;

an oxygen or oxygen and carbon dioxide sorbent 103 sachet situated within said outer receptacle 101; and

wherein said spacer is not part of a sachet and does not enclose said oxygen or oxygen and carbon dioxide sorbent.

19. The oxygen depletion device 10 of claim 18, wherein said inner blood compatible container 102 has a surface area to volume ratio of at least 4.48 centimeters²/milliliter (cm²/ml) when filled with blood for depletion and enclosed within said outer receptacle 101.

20. The oxygen depletion device 10 of claim 18, wherein said non-oxygen or non-oxygen and carbon dioxide sorbent spacer is selected from the group consisting of a mesh, a molded mat, a woven mat, a non-woven mat, a strand veil, and a strand mat.