During extracorporeal blood treatment, air bubbles often build up in the bloodstream. This occurs as a result of i) microleaks in the connections between the various tubes used, and ii) degassing effects from the blood itself. Ultimately, the presence of air in the bloodstream can lead to fatal (micro) embolisms when circulated back into the patient, hence a need to have technologies that remove the air from the bloodstream. The problem is particularly relevant for microbubbles (2.5 to 50 µm diameter), whose presence in the bloodstream is extremely difficult to detect with current state-of-the-art, and to which current removal solutions fall short.
The Current Solutions in the market:
The most popular way for air bubbles removal is through the use of drip chambers, common in intravenous therapies and that are located just before the bloodstream returns to the patient. It constitutes a filled blood reservoir through which the bloodstream passes, causing air bubbles to rise to the surface of the reservoir and being released. However, drip chambers present two limitations:
•Being a technology that involves a stagnant blood-air interface, blood clotting is promoted; and
•So-called microbubbles (2.5 - >50 µm), having lower buoyancy, will not rise and will stay in the bloodstream.
Part of the microbubbles may be removed when passing the treatment unit but this is insufficient to completely eliminate the microbubbles and the corresponding risk.
Another possibility to remove air bubbles is by reducing the blood flow, hence increasing the probability of microbubbles redissolving in the blood or collapsing, so that the effects of sucking air in through the needle at the beginning of the extracorporeal circuit is evened out when the blood is fed back through the second needle into the patient. While this approach can be quite efficient, it has the downsides of i) requiring lower blood flows that lead to slower treatments (high flows are preferred) and ii) being a reactive strategy instead of a continuous air bubble removal technology.
THE PRESENT SOLUTION
The present technology can efficiently and continuously remove microbubbles (2.5 - >50 µm) from an extracorporeal blood stream during blood treatments.
It has the following advantages:
1- Removal efficiency:the proposed solution completely removes air microbubbles from the extracorporeal bloodstream, down to the smallest size of 2.5 µm.
2- Continuous in-line operation: the solution operates in-line and during the treatment, not requiring blood flow changes or treatment interruption.
3- Blood flow: The solution is able to work and completely remove microbubbles in blood flows of up to 450 mL/min.
4- Bio- and hemo-compatibility: the solution uses bio-compatible materials and meets requirements for hemo-compatibility(hemolysis, complement activation, thrombocyte adhesion and coagulation activation.)
5- Blood clotting prevention: the solution does not promote stagnant phases and/or blood clotting. An increase in the dosage of anti-coagulants that the patients receive is not needed or required.
6- One-time disposable: the solution is eligible for mass production, and manufacturing costs are kept as low as possible.
7- Freedom to practice: the proposed solution offers the client “freedom to practice” meaning there are no third party intellectual property preventing the use of specific equipment and materials for their commercial application.
8- Blood volume: the solution does not increase the volume of blood in the extracorporeal circuit.
9- Ease of use: the solution is to be implemented in clinics but also in home care, where patients and family operate the equipment. Hence, the solution is simple to set-up and operate by a non-trained operator.
Further research required
Building Prototype and testing it.
Current development status
Others
Partners for future research
Medical Companies manufacturing disposable items in this field.
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