As of today, Chronic Total Occlusions (CTO) represent the most technically challenging lesions interventionists face during Percutaneous Coronary Interventions (PCI), with considerably lower success rates (50-90%) in comparison to semi-occluded and acutely occluded arteries . The main technical challenge in PCI of CTOs lies in successfully puncturing and crossing the CTO with a guidewire.
In this section we will focus on crossing challenges. For solutions to puncture the CTO, see the Pulze Hammer I, Pulze Hammer II (coming soon), Cradle Catheter (coming soon), and Wave Catheter (coming soon).
Crossing is challenging as the guidewire cannot be actively steered and deflection can thus not be compensated. This can lead, amongst others, to dissection of the blood vessel wall or subintimal crossing, in which the guidewire crosses the CTO via the blood vessel wall (between the intima and adventitia). Furthermore, it is often challenging to navigate through tortuous CTOs.
A steerable crossing device could be the solution to current crossing challenges, as it will give the interventionist the freedom to actively navigate through the vascular system and CTO freely. Therefore, a steerable prototype nicknamed the Accura was designed with an 8 Degrees Of Freedom (DOF) cable actuated tip (Ø 2 mm, L = 32 mm) divided over 4 steering segments; allowing for constructing complex S-curves. The tip contains a lumen (Ø 1 mm) to allow for the insertion of, amongst others, a balloon catheter, a guidewire, or an IntraVascular UltraSound probe (for visualization purposes). The steerable tip is connected to a rigid shaft (Ø 2 mm, L = 200 mm), which in turn is connected to the handle. The handle consists of an innovative combined locking and steering mechanism to lock the tip position in place and to precisely steer each segment separately. This construction allows for both the tip position and direction to be changed independently, allowing for a scanning movement.
The multisteerable tip has been successfully combined with a single element forward-looking IVUS transducer and Optical Shape Sensing (OSS) fiber to reconstruct a wire frame in front of the tip. This combination will allow for reconstructing and scanning a 3D volume in front of the tip, which can be used to determine the most suitable entry location. Furthermore, the addition of the OSS fiber can potentially minimize the use of X-Ray and contrast fluid during the intervention.
Even though it is still a long way towards a fully applicable clinical tool, the tests have given first insights into the possibilities and advantages of having such a tool in PCI. Currently, a multisteerable catheter is under development.
- Sakes A., Ali A., Janjic, J., and Breedveld P. (2018). Novel Miniature Tip Design for Enhancing Dexterity in Minimally Invasive Surgery. Journal of Medical Devices. Accepted.