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Mariana

Reaching beyond the third branch

The benefits of minimally invasive approaches have become more and more evident over the last decennia. However, not all structures of the human body are accessible with current medical instruments. The fourth branch of the airways can be as narrow as 3-4mm in diameter. Figure 1 illustrates how quickly the branches become more narrow and how sharp the turn to the (right) upper lung can be.

Currently, these areas are practically only reachable percutaneously, making the procedure quite invasive compared to “regular” bronchoscopy. All the while, cancerous tissue can occur at these locations deep inside the lungs, and lung cancer still is the most deadly cancer, with a mortality of 1.8 million worldwide deaths in 2018, with 2.2 million new cases each year [1]. The number of patients in need of better diagnostic devices is substantial.

Additionally, when performing the procedure where no direct visualisation is possible, the procedures are currently visualised through fluoroscopy. The surgeon and patient suffer from x-ray exposure.

Figure 1: An illustration of the branches of the bronchi, indicating up to the fourth level
Figure 1: An illustration of the branches of the bronchi, indicating up to the fourth level

Håkon Leira, pulmonologist of St. Olavs Hospital, Trondheim, Norway: 

“Through multiple breakthrough innovations, the MARIANA will introduce real-time diagnosis and therapy of lung cancer into the clinic”

 

The solution lies in a full, innovative system

Figure 2: A picture of the Mariana guidewire exiting a 3D-printed phantom of the human bronchi
Figure 2: A picture of the Mariana guidewire exiting a 3D-printed phantom of the human bronchi

DEAM has developed the steerable catheter-guidewire system to the advanced image-guided platform, with high precision electromagnetic tracking. The steerable tip of this system is visible in figure 2, exiting one of the branches of a 3D printed model of the lung’s bronchi.
With this system, DEAM and their partners aim to diagnose and treat intraluminal diseases, such as lung cancer.

The position of the tip of the guidewire-catheter combination is visualised in a virtual, 3D lung model, which is based on preoperative scans.

Expand the reach, decrease OR time and x-ray exposure

This system aims to do three things; eliminate the need for invasive procedures in order to diagnose and treat cancer of the outer airways, make these procedures faster by intuitive visualisation and finally reduce radiation exposure by replacing fluoroscopy with the electromagnetic tracking.
Altogether, the Mariana device will decrease the risks for the patient as well as the surgeon and increase the reach during bronchoscopy dramatically. An illustration of the use of the Mariana system is presented in figure 3.

Figure 3: The use of the Mariana system
Figure 3: The use of the Mariana system

An international collaboration with global aspirations

This instrument is being developed in cooperation with SINTEF and CEETRON. This collaboration was founded many years ago and the benefits of its multi-disciplinary nature are still reaped every day.

DEAM, as well as the partners, have all developed their side of the full, working prototype of the platform. Currently, the group is looking for options to start manufacturing the system!

October 30, 2020