Oxygen Reduction Disposable Kits, Devices and Methods of Use Thereof
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 .- 89 . (canceled)
90 . 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 prepared from an integrated silicone membrane 113 and comprising one or more chambers that are permeable to oxygen;
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 , and 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 ; and
an oxygen sorbent 103 situated within the headspace.
91 . The oxygen depletion device 10 of claim 90 , wherein the integrated silicone membrane 113 is between about 15 microns (μm) to about 200 μm thick.
92 . The oxygen depletion device 10 of claim 91 , wherein the integrated silicone membrane 113 is less than or equal to 76 μm thick.
93 . The oxygen depletion device 10 of claim 91 , further comprising at least one tie layer 105 .
94 . The oxygen depletion device 10 of claim 93 , wherein the inner collapsible blood container 102 comprises two tie layers 105 .
95 . The oxygen depletion device 10 of claim 93 , wherein the tie layer 105 comprises silicone.
96 . The oxygen depletion device 10 of claim 95 , wherein the tie layer 105 comprises liquid silicone rubber (LSR).
97 . The oxygen depletion device 10 of claim 90 , wherein the inner collapsible blood container 102 has a surface area to volume ratio of at least 4.85 centimeters 2 /milliliter (cm 2 /ml) when filled with blood for depletion and enclosed within the outer receptacle 101 .
98 . 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 prepared from a microporous membrane 113 and comprising one or more chambers that are permeable to oxygen;
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 , and 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 ; and
an oxygen sorbent 103 situated within the headspace.
99 . An oxygen permeable collapsible blood container 102 comprising first and second microporous membranes 113 joined by a peripheral tie layer 105 comprising a material having a melting temperature of at least 3° C. lower than the melting temperature of the microporous membrane 113 .
100 . The oxygen permeable collapsible blood container 102 of claim 99 , wherein the tie layer 105 has a melting temperature at least 10° C. lower than the melting temperature of the microporous membrane 113 .
101 . The oxygen depletion device 10 of claim 98 , wherein the microporous membrane 113 is comprised of a microporous material selected from the group consisting of polysulfone, hydrophobic polyvinylidene fluoride (PVDF), polyolefin, polytetrafluoroethylene (PTFE), cellulose ester, mixed esters of cellulose (MCE), polyethersulfone (PES), polypropylene rendered hydrophobic, and polyacrylonitrile.
102 . The oxygen depletion device 10 of claim 101 , wherein the microporous membrane 113 is comprised of polysulfone, hydrophobic polyvinylidene fluoride (PVDF), polyolefin, or polytetrafluoroethylene (PTFE).
103 . The oxygen depletion device 10 of claim 98 , wherein the peripheral tie layer 105 is comprised of low-density polyethylene (LDPE).
104 .- 108 . (canceled)
109 . The oxygen depletion device 10 of claim 90 , wherein the at least one interstice 111 comprises between 60% to 75% of the total area of the mesh or mat material of the spacer 110 .
110 . The oxygen depletion device 10 of claim 90 , wherein the headspace has a volume that is between 20 and 1000 milliliters (ml).
111 . The oxygen depletion device 10 of claim 90 , wherein the headspace ensures efficient diffusion of oxygen from a surface of the inner collapsible blood container 102 to the oxygen sorbent 103 .
112 . The oxygen depletion device 10 of claim 90 , wherein the spacer 110 is a mat selected from the group consisting of a molded mat, a woven mat, a non-woven mat, and a strand mat.
113 . The oxygen depletion device 10 of claim 102 , wherein the microporous membrane 113 comprises micropores that are between 0.01 microns (μm) and 1.0 μm in diameter.
114 . The oxygen depletion device 10 of claim 113 , wherein the micropores are between 0.03 μm to 0.45 μm in diameter.