Endovascular Crossing of Chronic Total Occlusions Using an Impulse: An Explorative Design Study

Abstract

In this study we investigated whether exerting an impulse on a Chronic Total Occlusion (CTO) improves the success rate of CTO crossing as compared to the currently used method of statically pushing the guidewire against the CTO. A prototype (Ø2 mm) was developed that generates translational momentum using a spring-loaded indenter and converts it to an impulse during impact. Mechanical performance was evaluated by measuring the peak force and momentum for different spring compressions and strike distances in air and blood-mimicking fluid. Puncture performance, in terms of number of punctures, number of strikes to puncture, and energy transfer from the indenter to the CTO, was assessed for six tip shapes (stamp, wedge, spherical, pointed, hollow spherical, and ringed) on three CTO models with different weight percentages of gelatin and calcium. As a control, a Ø0.4 mm rigid rod was tested. A maximum indenter momentum of 1.3 mNs (velocity of 3.4 m/s), a peak force of 19.2 N (vs. 1.5 N reported in literature and 2.7 N for the control), and CTO displacement of 1.4 mm (vs. 2.7 mm for the control) were measured. The spherical and ringed tips were most effective, with on average 2.3 strikes to puncture the most calcified CTO model. The prototype generated sufficient peak forces to puncture highly calcified CTO models, which are considered most difficult to cross during PCI. Furthermore, CTO displacement was minimized, resulting in a more effective procedure. In future, a smaller, faster, and flexible clinical prototype will be developed.