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Taking sharp turns in endovascular surgery

The human blood vessels can branch at very sharp angles, sometimes even at 90 degrees or more. An example of the sharp angles are illustrated in Figure 1.

It is quite difficult to enter these branches with currently available equipment or conventional techniques, and the longer the specialist needs to reach their destination inside the vessel, the more radiation is applied. To the patient and to the specialist!

Some pre-bent or even steerable catheters exist, but these do not possess the ability to steer in all planes (360 steering), nor do they incorporate a tracking system which does not require radiation.

Figure 1: This figure shows some of the branches at very sharp angles with the aorta, like the renal arteries
Figure 1: This figure shows some of the branches at very sharp angles with the aorta, like the renal arteries

Dr. Frode Manstad-Hulaas, associate professor at the NTNU, Trondheim, Norway: 

“SiFlex will become the most precise navigation platform for complex endovascular procedures in the world with a huge potential for safer and more cost-effective procedures, reduced procedure-time and less reliance on harmful radiation imaging.”

DEAM ensures safe navigation to target area

Figure 2: Using the SiFlex to reach the renal artery during a AAA stent placement
Figure 2: Using the SiFlex to reach the renal artery during a AAA stent placement

DEAM’s part in this project is to develop the hardware to navigate the branches of the aorta, during procedures such as abdominal aortic aneurysm (AAA) stent placement. The SiFlex is a catheter steerable in all planes, without having to rotate the entire length of the catheter. This avoids flipping of the catheter tip due to stick-slip in the rotational movement, making the procedure more intuitive, and reducing the time needed. It also decreases the risk of damaging the insides of the vessels, as less friction is applied. The SiFlex, illustrated in Figure 2 is designed to be a specialistic tool for endovascular repair (EVAR), where the SiFlex is intended to be used to place a guidewire leading to the area where the stent-graft is needed.

Using the SiFlex, physician radiation exposure is up to 50% less than current steerable catheters and the cannulation time is comparable to robotic systems while being 3 times cheaper.

The first prototypes have been evaluated extensively in animal models and the design is ready to be developed into a marketable product.

The ultimate aim is to make the SiFlex suitable for more procedures, where this steerable system can offer a better and faster way to reach the target area in the patient’s vascular system.

This project is in collaboration with SINTEF, Quadrant Scientific and St. Olavs hospital. This collaboration ensures the optimal outcomes of the SiFlex, where tracking technology, steering solutions and human-centred design come together as one.

Figure 3: The SiFlex handle and 360 steerable tip of the SiFlex in bent position
Figure 3: The SiFlex handle and 360 steerable tip of the SiFlex in bent position

August 6, 2020