Welcome to the website of the AmbuLung project

 

 

A milestone in the evolution of artificial organs

Concept and project objectives

The quality of life in advanced chronic lung failure is unacceptably low, and mortality runs high, especially when compared with end stage heart failure where medical devices, such as ventricular assist devices, operate for several years.

 

In contrast artificial lungs need large artificial surfaces to generate gas exchange by diffusion.

The resulting biofilm formation and thrombogenicity currently limit the durability of artificial lungs. In addition, the lack of miniaturized, lightweight controls, power and sweep gas supplies limits their wearability.

 

Existing short term artificial lungs in clinical use are slightly modified or unmodified old-fashioned cardiac surgery oxygenators perfused by cardiac surgery blood pumps (ECMO). These systems can provide lifesaving respiratory support for ICU patients in severe acute lung failure, but cannot provide true long-term respiratory support due to invasiveness, weight, immobility and lack of durability.

 

The AmbuLung project team is driven by this medical need, we are clinicians, scientists, engineers and entrepreneurs, or represent various combinations of these roles.

We are convinced that the combined effort of this European team will create a novel product, which will generate future research and development efforts to relieve suffering from end stage lung failure.We therefore aim to resolve the key factors that thwart durability and wearability of extrapulmonary respiratory support systems.

 

These factors are:


Thromobogenicity due to activation of the inflammatory and coagulation cascades by blood-contacting polymeric surfaces. Cellularisation of the gas-exchange membranes with endothelial cells can prevent biofilm formation and clotting thus enhancing durability.

 

The fluid dynamics in current artificial lungs are incompatible with cellular viability, due to shear stress, perfusion angle, unphysiological i.e. non-pulsatile perfusion, etc. This creates the need for bioartificial lung designs that create optimum conditions for the viability and function of cellularized surfaces.


Control systems serving current artificial lungs (i.e., blood pumps, consoles, batteries) are designed for the operating room and/or the intensive care unit. They are far too large and heavy (>15kg) to be wearable and hence are not suitable for ambulatory use. These systems need to be miniaturized to allow extended patient mobility and enhance patients’ quality of life.

 

The AmbuLung project team has expertise in areas that can resolve these design problems for long term artificial lungs.

The three major components of this project are the cell seeded surfaces, the corresponding artificial lung and pump design, and the miniaturization of electronic controls and battery systems.

 

Within this project our team will provide solutions to these design challenges, which will result in creating AmbuLung, a wearable ambulatory artificial lung for clinical use.

 

Our key objectives are:

 

  • Create a diffusion (O2, CO2) -enabling gas exchange membrane that promotes cell seeding and supports functional cell viability for at least one month. The team has expertise in cell seeding on diffusion membranes and in matrix development.
  • Integrate this membrane in a CFD (computational fluid dynamics) optimized artificial lung with physiologic levels of flow velocity/shear stress, pulsatility and flow angle by designing a miniaturized bioartificial lung circuit with an integrated pulsatile blood pump. The team’s leading CFD expertise in artificial lung design has created the first pumpless artificial lung with physiological resistance to blood flow and a blood pump design that is capable of creating pulsatile blood flow with a pulse curve optimized for cell viability. The team has developed vascular access devices in the past for both long-term artificial lungs and hearts (VADs, TAHs).
  • Design a wearable, ambulatory miniaturized console / battery unit to control the single use system described above. The team has designed and also markets small artificial lung consoles that can serve as a basis to drive the miniaturization process towards wearable artificial lungs within the timeline of this project.

 

AmbuLung is a major milestone beyond current extracorporeal, console-based respiratory support systems (>15kg ECMO, iLA actiVVe, etc.) as well as invasive mechanical ventilators that force the diseased lung to perform.

 

It will be the first wearable bioartificial lung worldwide, its impact comparable to the advances from heart- lung machines to artificial hearts (ventricular assist devices, VAD) in the cardiac sector.

 

The probability of success on the medical device side is high (foreseeable medical device development) and the durability enhancement of cell seeding will be a factor of >2 compared to current noncellularized surfaces.

 

This project is designed to maximize the probability of success, knowing that the long-term viability of cellularized surfaces is more difficult to achieve than the underlying medical device development.

However, we believe that once the 1 month durability target has been achieved we will extend durability further in an iterative development process based on feedback from clinical experience with AmbuLung as the first type of this kind of product.

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This project is funded by the European Union EU-Flagge sfp