MIT collaboration with Eindhoven Medical Robotics

Looking back

We are proudly looking back at a successful collaboration project between Eindhoven Medical Robotics and LifeTec Group. In September of 2020 the collaboration project,  funded by the MIT-zuid instrument from the Dutch government, was finished after having run for 2 years. This funding instrument aims on joint innovation and stimulates companies from the southern provinces of The Netherlands to collaborate on R&D projects in such a way that the progress is mutually beneficial to the project partners.

 

The aim of this particular project was twofold: to continue the development of a smart steerable catheter design and to develop a realistic platform to test the prototype of the smart catheter in realistic circumstances. This smart catheter prototype is under development by Eindhoven Medical Robotics and it has an actuator incorporated which facilitates steerability function. Because navigation is an important aspect in ablation procedures, this function could bring big advantages both in accuracy of therapy delivery as well as short procedural duration. LifeTec Group further developed and improved the available pathways towards the heart in the CBS platform, making them as human-like as possible. These vascular access paths were used to evaluate the smart catheter prototypes in a realistic anatomical configuration whilst being able to interact with the tissues of the heart, but other access pathways that will benefit future interventional device studies were also investigated.

Navigating to the heart

Vascular access

For LifeTec Group, the challenge in this project was to add anatomically relevant entrances into the heart such that delivery systems can be used whilst they are in a realistic shape during deployment of a device or navigating a catheter tip inside the heart. One of the commonly used access paths is from the Inferior Vena Cava, via the right atrium through the atrial wall to end up in the left atrium; the so-called trans-septal approach. Remarkable about this pathway is the difference in porcine anatomy compared to human, where LifeTec Group translated their CBS platform to a human-like approach based on human CT images. The image shows a segmentation from the clincal imaging (in blue), as well as the prolonged vena cava model that allows the insertion of a delivery system into the right atrium from a correct angle as in humans. 

In a similar fashion, the femoral pathway was obtained through de iliac arteries, up to the aorta, all the way through the aortic valve to end in the left ventricle. Recreating the human morphology on the CBS platform was of importance here.

 

Connecting pulmonary veins

Ablation targets

The ablation target area was also investigated, focusing on the pulmonary veins entering the left atrium. When treating atrial fibrillation, ablation is commonly used to create scar tissue around the pulmonary vein entrances into the atrium. This is done to electrically isolate the pulmonary veins from the atrium, solving the problem of atrial fibrillation. During this procedure there's often the need to position a wire in the pulmonary veins to support the navigation. Venous flow may influence catheter positioning and may have an effect on the effectiveness of the ablation itself by flushing generated heat away from the target area. To recreate this setting, an experimental setup was developed where a porcine heart with intact lungs was isolated and reperfused on the CBS platform, which could be perfused with functional cardiac output.

Differences between species

Atrial anatomy

Porcine hearts have a different anatomy compared to human, so also the atria have a different shape and size. This means that there is less space inside the porcine left atrium to navigate and position catheter-based devices. To better mimic the shape and size of a human left atrium, without having to depend on the use of human cadaveric hearts, the use of 3D printed materials and their attachment to cardiac tissue was studied. The geometry of a human left atrium was 3D-printed and sutured on a porcine heart. Of course the 3D-printed material does not reflect the important tissue properties when it comes to ablation, but this approach proved useful to study catheter navigation especially for relatively bulky devices or delivery systems with limited bending curvatures towards the catheter tips.

Project Outcome

The vascular entrance paths towards the heart are becoming more and more relevant because of the trend of going towards minimally invasive therapies. As presented above, our LifeTec Group team has developed several interesting new vascular access approaches adding to the already existing Cardiac BioSimulator platform. On top of that, we have gained valuable insights in differences between porcine and human anatomies that may be very helpful in translating research from animals to human trials. On top of that, our partner Eindhoven Medical Robotics gained space to further develop their smart catheter and in the experiments with LifeTec Group, they could study the functionality and perfomance of their current prototypes at a very early stage without the need for animal research. This resulted in valuable insights for Eindhoven Medical Robotics on how to improve their catheter system even further and prepare for the next phases.

The project has also been a great showcase of how LifeTec Group can adapt to the needs of specific interventions. The Cardiac BioSimulator is a good basis for many studies, but our team relishes the challenge to identify what is important for a successful intervention study and subsequently customize our tools to create the relevant and realistic setting you need to make progress.

Head of MedTech Innovation

Marco Stijnen

R&D Engineer

Marcel Wijlaars

Senior Research Engineer

Sjoerd van Tuijl

R&D Engineer

Bart Smeets

R&D engineer

Dave Wanders

R&D Engineer

Mattia D'Alessi

R&D Engineer

Bertus van de Wetering

Interested to learn more about LifeTec Group? Please contact Sheila.

Partner Relations Manager
Sheila Owen
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