Granted Patent B2

US 12,604,890 · App. 18/297,193 · Granted Apr 21, 2026

Inventors: Michael Wolf (Brookline, MA); Jancarlo Sarita (Lynn, MA); Jeffrey Karl Sutton (Medway, MA); Rafael Cordero (Bedford, MA); Michael Zocchi (Arlington, MA); Philip Keegan (Newton, MA); Narendran Renganathan (Plano, TX); Robert Harhen (Haverhill, MA)

Assignee: Hemanext Inc.

A01N1/146A01N1/122A61J1/1468A61M1/0272A61J1/10A61K35/00A61M2202/0208C12M23/14

Abstract

Claims (51)

1 . A method to prepare oxygen-reduced blood for storage comprising:

providing an oxygen depletion device 10 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 situated between the outer receptacle 101 and the inner collapsible blood container 102 , wherein the non-sachet spacer 110 is a mesh or mat comprising at least one interstice 111 and maintains a headspace defined by the outer receptacle 101 and the inner collapsible blood container 102 , wherein the at least one interstice 111 comprises between 50% to 80% of the total area of the mesh or mat material of the non-sachet spacer 110 ;

an oxygen or oxygen and carbon dioxide sorbent 103 situated within a sachet and within the headspace; and

flowing the blood into the inner collapsible blood container 102 of the oxygen depletion device 10 ; and

producing oxygen-reduced blood having less than 20% oxygen saturation.

2 . The method of claim 1 , wherein the blood is selected from the group consisting of whole blood, leukoreduced red blood cells (RBCs), platelet reduced RBCs, and leukoreduced and platelet reduced RBCs.

3 . The method of claim 1 , wherein the inner collapsible blood container 102 comprises a first and second membrane joined by a peripheral tie layer consisting of silicone.

4 . The method of claim 1 , wherein the oxygen depletion device 10 further comprises

a. an oxygen indicator 104 situated between the outer receptacle 101 and the inner collapsible blood container 102 ;

b. at least one inlet/outlet 30 passing through the outer receptacle 101 comprising a tube 301 , a bond 302 , and a port 303 , wherein the tube 301 and the bond 302 are substantially impermeable to oxygen, and wherein the at least one inlet/outlet 30 is in fluid communication with the inner collapsible blood container 102 ; or

c. both a and b.

5 . The method of claim 1 , wherein blood collected in the oxygen depletion device 10 is deoxygenated at a rate constant of at least −0.5×10 −2 min −1 .

6 . The method of claim 1 , further comprising storing the oxygen-reduced blood at a storage temperature of between 2° C. and 6° C. for up to 64 days.

7 . The method of claim 1 , further comprising agitating the oxygen depletion device 10 after the flowing for up to 4 hours.

8 . The method of claim 7 , wherein the agitating comprises 3D mixing or linear oscillation mixing.

9 . The method of claim 1 , wherein

a. the headspace has a volume that is between 10 and 500 milliliters (ml);

b. the at least one interstice 111 comprises between 60% to 75% of the total area of the mesh or mat material of the non-sachet spacer 110 ; or

c. both a and b.

10 . A method to prepare stored oxygen-reduced blood comprising:

providing an oxygen depletion device 10 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 situated between the outer receptacle 101 and the inner collapsible blood container 102 , wherein the non-sachet spacer 110 is a mesh or mat comprising at least one interstice 111 and maintains a headspace defined by the outer receptacle 101 and the inner collapsible blood container 102 , wherein the at least one interstice 111 comprises between 50% to 80% of the total area of the mesh or mat material of the non-sachet spacer 110 ; and

an oxygen or oxygen and carbon dioxide sorbent 103 situated within a sachet and disposed within the headspace, wherein the non-sachet spacer 110 does not enclose the oxygen or oxygen and carbon dioxide sorbent 103 ;

flowing the blood into the inner collapsible blood container 102 of the oxygen depletion device 10 ;

producing oxygen-reduced blood having less than 20% oxygen saturation; and

storing the oxygen-reduced blood in the oxygen depletion device 10 .

11 . The method of claim 10 , wherein the mat is selected from the group consisting of a molded mat, a woven mat, a non-woven mat, a strand veil, and a strand mat.

12 . The method of claim 10 , wherein the storing is at a storage temperature of between 2° C. and 6° C. for up to 64 days.

13 . The method of claim 10 , further comprising agitating the oxygen depletion device 10 after the flowing for up to 4 hours.

14 . The method of claim 10 , wherein

a. the headspace has a volume that is between 10 and 500 milliliters (ml);

b. the at least one interstice 111 comprises between 60% to 75% of the total area of the mesh or mat material of the non-sachet spacer 110 ; or

c. both a and b.

15 . A method to prepare oxygen-reduced blood for storage comprising:

providing an oxygen depletion device 10 comprising:

an outer receptacle 101 substantially impermeable to oxygen;

an inner collapsible blood container 102 comprising one or more chambers comprising polyvinyl chloride (PVC) or polyolefin;

a spacer 110 situated between the outer receptacle 101 and the inner collapsible blood container 102 , wherein the spacer 110 is a mesh or mat comprising at least one interstice 111 and maintains a headspace defined by the outer receptacle 101 and the inner collapsible blood container 102 , wherein the at least one interstice 111 comprises between 50% to 80% of the total area of the mesh or mat material of the spacer 110 ;

an oxygen sorbent 103 disposed within the headspace, wherein the headspace ensures efficient diffusion of oxygen from a surface of the inner collapsible blood container 102 to the oxygen sorbent 103 ;

flowing the blood into the inner collapsible blood container 102 of the oxygen depletion device 10 ; and

producing oxygen-reduced blood having less than 20% oxygen saturation.

16 . The method of claim 15 , wherein the inner collapsible blood container 102 comprises a material selected from the group consisting of a multilayered membrane, PVC comprising a citrate plasticizer, at least one layer consisting of polyester, PVC comprising a di(2-ethylhexyl) phthalate (DEHP) plasticizer, a mixing structure, and a hydrophobic microporous membrane.

17 . The method of claim 15 , wherein the oxygen sorbent 103 is an oxygen and carbon dioxide sorbent 103 .

18 . The method of claim 15 , wherein the inner collapsible blood container 102 has a surface area to volume ratio of at least 4.48 centimeters 2 /milliliter (cm 2 /ml) when filled with a unit of blood for oxygen depletion and enclosed within the outer receptacle 101 .

19 . The method of claim 15 , further comprising storing the oxygen-reduced blood at a storage temperature of between 2° C. and 6° C. for up to 64 days.

20 . The method of claim 15 , wherein the blood is selected from the group consisting of whole blood, leukoreduced red blood cells (RBCs), platelet reduced RBCs, and leukoreduced and platelet reduced RBCs.

Assignments (2)

Continuity (7)

References Cited (400)