Recent studies have called attention to the safety and efficacy of blood products that have been stored beyond 30 days. Infusion of these older blood products is associated with much higher morbidity and mortality than “fresher” blood products.
The older stored blood products undergo changes to the characteristics of their membranes which make them less distensible. A significant characteristic of a healthy Red Blood Cell (RBC) is the ability to be distensible so that an 8 micron RBC can squeeze intact through a 2 micron capillary. RBC’s which lose their distenilbility tend to aggregate and clump at terminal capillaries, and thus do not deliver oxygen properly to the end organs and are associated with thrombus formation.
Loss of distenilbility is classified as “Non-Lethal” blood damage where gross hemolysis is called lethal RBC damage. Non lethal damage can also be induced in RBC’s by turbulent flow and high shear forces. Both turbulent flow and high shear forces can be created and influenced by the geometry of the device blood is run through such as an add on warming cartridge disposable.
Life Warmers technology in development has no such add on cartridges or changes in the geometry of the tubing. The Reynolds number calculation predicts laminar flow as well as shear forces well below normal human physiological shear forces in our technology.
Although not available yet in the United States, the Military is funding development of a freeze dried plasma product for field use. We are monitoring the development of freeze dried plasma products and anticipate full compatibility and safety with our technology.