In the Major Auto Hemo Therapy (MAHT) an amount of blood is drawn from the patient and put in contact with a therapeutic dose of ozone (O3). Ozone is a gas with a high blood solubility and dissolves quickly into blood, generating a cascade of events which may be beneficial in a number of pathologies, where improved tissue oxygenation should be achieved. MAHT is a completely manual procedure where blood, drawn (by gravity, or by applying vacuum) from a patient vein is collected into a glass bottle (glass is inert to ozone) containing a certain amount of anticoagulant. A certain O3 dose is then added to the bottle and kept in direct contact with blood for a few minutes to allow O3 complete dissolution. Then, ozonated blood is reinfused back into the patient. The time required for the whole procedure is 30 to 40 minutes. All the procedure needs to be supervised by an experienced ozonetherapist.
In the new system, which is the combination of a preassembled single use circuit and dedicated equipment (including pumps, controls and O3 generator), called Advanced Major Auto Hemo Therapy (AMAHT) (see figure), blood is drawn into the circuit from the patient vein by means of a blood pump. As soon as blood gets into the circuit, a second pump delivers an amount of citrate, at a 1:10 ratio to blood, for optimal anticoagulation. Blood is then fed into a small Gas Exchange Device (GED) which contains a bundle of micro-porous hollow fibers. Blood flows outside the fibers, while the O3 flows inside the fibers. O3 is transferred to blood through the fiber porosity. In this way, a first blood ozonation takes place. Blood then is collected into a plastic bag. Once the set quantity (usually a value between 100 and 250 ml) into the bag is reached, a reinfusion phase is automatically started by reversing the blood pump rotation. Blood from the bag is passed a second time through the GED in the opposite direction and is further ozonated, before returning to the patient via the same needle used for the draw phase in a matter of minutes. At bag empty, a new draw/reinfusion cycle is automatically generated. The process can be reiterated for as many cycles as desired. In this way, contrarily to the MAHT where only one cycle can be done, a larger blood volume can be treated. The therapeutic O3 dose administered to the patient is obtained multiplying the gas volume passed through the GED by the in-out O3 concentration difference.
The slightly higher AMAHT cost vs. MAHT’s is largely compensated by the following benefits: 1) easier to set up; 2) automated and safer operation; 3) shorter procedure times; 4) exact anticoagulation proportioning; 5) gentler blood ozonation.
AMAHT is particularly useful in pathologies with large patient populations, like those affected by diabetes and dry age-related macula degeneration. For the latter, no effective therapy is presently available.