A human heart basically consists of two pumps next to each other, one right and one left pump. The heart pumps blood through both sides simultaneously which fills the atrium with blood. This creates a natural pulsating flow that Realheart TAH imitates.
The problem with existing solutions on the market today, is that they create continual blood flow instead of pulsations and that has many detrimental side effects for the patients. The alien materials introduced into the body create distorted circulatory patterns that may lead to blood clotting in and around the pump.
Realheart is presently performing computer simulation tests together with the University of Bath in the U.K. and tests in hybrid simulators together with Katholieke Universiteit Leuven in order to examine the circulatory patterns to further improve and update the design. Because of these tests, the risks mentioned previously can be minimized.
Furthermore, infections may arise when battery cables protrude the skin in order to reach the battery outside the body. Realheart is planning to use cables for the first version of the released product but will evaluate the possibility of cordless versions in future products.
Bleeding has multifactorial causes; partly from mechanical stress, so called shear stress, but also from the lack of pulsations. Both have been observed as risk factors for bleeding and these are two traits found in the continuous pumps used today. High shear stress may damage the blood, which could lead to unwanted side effects. Realheart and the University of Bath, has concluded that theoretically, a design with pulsating blood flow creates less shear stress to the circulatory system.
Realheart assesses that compared to all other systems available today and under development, Realheart TAH has the greatest chance of reducing side effects because of the natural circulation that the patented design creates. No other technology available today that Realheart is aware of, can achieve the synchronised pulsations on the right and left side combined with a constant flow into the atrium, as no other artificial heart includes an atrium. Possible side effects may be assessed once clinical trials have been carried out on patients. However, it is asserted that the body’s other organs, such as the kidneys and liver, are negatively affected by the unnatural continuous blood flow generated in today’s artificial hearts.
Realheart TAH will be a quiet system with one cable from the heart inside the body to the control panel outside the body. The control panel and the battery are estimated to weigh between 1 and 1,5 kilogrammes.