Oxygen reduction disposable kits, devices and methods of use thereof (ORDKit)
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.
1. An oxygen depletion device 10 for depleting oxygen and carbon dioxide from blood comprising:
an outer receptacle 101 substantially impermeable to oxygen and carbon dioxide;
an inner collapsible blood container 102 comprising one or more chambers comprising a material having a permeability to oxygen of at least 25 Barrer;
a spacer 110 situated between said outer receptacle 101 and said inner collapsible blood container 102 ;
and an oxygen sorbent 103 situated between said outer receptacle 101 and said inner collapsible blood container 102 ,
wherein said spacer 110 is a mesh comprising at least one interstice 111 and maintains a headspace defined by said outer receptacle 101 and said inner collapsible blood container 102 , wherein said at least one interstice 111 comprises between 50% to 80% of the total area of said mesh material of said spacer 110 , and wherein said headspace ensures efficient diffusion of oxygen from a surface of said inner collapsible blood container 102 to said oxygen sorbent 103 .
2. The oxygen depletion device 10 of claim 1 , wherein said oxygen sorbent 103 further comprises a carbon dioxide sorbent 103 .
3. The oxygen depletion device 10 of claim 2 , wherein said oxygen and carbon dioxide sorbent 103 is situated within a sachet disposed within said headspace.
4. 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 centimeters 2 /milliliter (cm 2 /ml) when filled with a unit of blood for depletion and enclosed within said outer receptacle 101 .
5. The oxygen depletion device 10 of claim 1 , wherein said inner collapsible blood container 102 comprises a first and second membrane 113 joined by a peripheral tie layer 105 .
6. The oxygen depletion device 10 of claim 5 , wherein said peripheral tie layer 105 consists of silicone.
7. The oxygen depletion device 10 of claim 1 , wherein said headspace has a volume of between 10 and 500 milliliters (ml).
8. The oxygen depletion device 10 of claim 1 , wherein said at least one interstice 111 comprises between 60% to 75% of the total area of said mesh material of said spacer 110 .
9. The oxygen depletion device 10 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 10 of claim 1 , wherein said inner collapsible blood container 102 comprises a mixing structure 119 .
11. The oxygen depletion device 10 of claim 1 , wherein blood collected in said oxygen depletion device 10 is deoxygenated at a rate constant of at least −0.5×10 −2 min −1 .
12. The oxygen depletion device 10 of claim 1 , wherein said inner collapsible blood container 102 comprises polyvinyl chloride (PVC).
13. The oxygen depletion device 10 of claim 1 , wherein said inner collapsible blood container 102 comprises a plasticizer selected from the group consisting of diethylhexyl phthalate (DEHP) and citrate.
14. The oxygen depletion device 10 of claim 1 , wherein said at least one interstice 111 has an open area of greater than 0.75 square millimeters (mm 2 ).
15. A method to prepare blood for storage comprising:
providing an oxygen depletion device 10 comprising:
an outer receptacle 101 substantially impermeable to oxygen and carbon dioxide;
an inner collapsible blood container 102 comprising one or more chambers comprising a material having a permeability to oxygen of at least 25 Barrer and enclosed within said outer receptacle;
a spacer 110 situated between said outer receptacle 101 and said inner collapsible blood container 102 ;
and an oxygen sorbent 103 situated between said outer receptacle 101 and said inner collapsible blood container 102 ,
wherein said spacer 110 is a mesh comprising at least one interstice 111 and maintains a headspace defined by said outer receptacle 101 and said inner collapsible blood container 102 , wherein said at least one interstice 111 comprises between 50% to 80% of the total area of said mesh material of said spacer 110 , and wherein said headspace ensures efficient diffusion of oxygen from a surface of said inner collapsible blood container 102 to said oxygen sorbent 103 ;
flowing said blood into said inner collapsible blood container 102 of said oxygen depletion device 10 , and producing oxygen-reduced blood having less than 20% oxygen saturation.
16. The method of claim 15 , wherein said inner collapsible blood container comprises polyvinyl chloride (PVC).
17. The method of claim 15 , wherein said inner collapsible blood container comprises a plasticizer selected from the group consisting of diethylhexyl phthalate (DEHP) and citrate.
18. The method of claim 15 , wherein said oxygen sorbent 103 further comprises a carbon dioxide sorbent 103 .
19. The oxygen depletion device 10 of claim 1 , wherein said material is polyolefin.