Increased Susceptibility of Arterial Tissue to Wire Perforation with the Application of High Frequency Mechanical Vibrations

High frequency mechanical vibrations (20–50 kHz), delivered via small diameter flexible wire waveguides represent a minimally invasive technology for the treatment of chronic total occlusions (CTOs) and in other tissue ablation applications. Tissue disruption is reported to be caused by repetitive mechanical contact and cavitation. This work focuses on the effects of vibrating wire waveguides in contact with arterial tissue. An apparatus with clinically relevant parameters was used, characterized as operating at 22.5 kHz and delivering amplitudes of vibration of 17.8 - 34.3 µm (acoustic intensity, ISATA: 1.03 - 3.83 W/cm2) via 1.0 mm diameter waveguides. Inertial cavitation (in water at 370C) was determined to occur above amplitudes of vibration greater than 31.4 µm (ISATA = 3.21 W/cm2). The energized waveguides were advanced through tissue samples (porcine aorta) and the force profiles were measured for a range of acoustic intensities. The results show that the tissue perforation initiation force, perforation initiation energy and total energy required to perforate the tissue reduces with increasing acoustic intensity. No significant reduction in perforation force or energy was observed in the inertial cavitation region. Multistage perforation was evident through the force profile and histological examination of the tissue samples post wire waveguide perforation

Arterial Tissue Perforation Using Ultrasonically Vibrating Wire Waveguides

Chronic Total Occlusions (CTOs) are fibrous and calcified atherosclerotic lesions which completely occlude the artery. They are difficult to treat with standard dilation procedures as they cannot be traversed easily. Their treatment is also associated with a high risk of arterial perforation. Low frequency ultrasonic vibrations delivered via wire waveguides represent a minimally invasive treatment for CTOs and other tissue ablation applications. These devices typically operate at 20–50 kHz delivering wire waveguide distal tip amplitudes of vibration of 0-60 μm. The diseased tissue is ablated or disrupted by repetitive direct mechanical contact and cavitation. This research assesses the susceptibility of arterial tissue to perforation and residual damage under the action of ultrasonically energised wire waveguides. Using Finite Element Analysis (FEA), a linear acoustic model of the wire waveguide distal tips can predict the pressures for a range of operating parameters typically used for these devices. High mesh densities (140 EPW) were required to solve the entire acoustic field, including complex wave interactions. The FEA model was used to aid in the further design and modification of an ultrasonic apparatus and wire waveguide (0–34.3 μm at 22.5 kHz). Using a test rig, the effects of distal tip amplitudes of vibration, feedrate and angled entry on the perforation forces, energy and temperature were measured. The perforation forces reduced (≈ 60%, 6.13 N - 2.46 N mean) when the wire waveguide was energised at low amplitudes of vibrations (\u3c 27.8 μm). There were no significant change in tissue perforation forces above this or when the waveguide was operating above the cavitation threshold. Histological analysis also showed tissue removal. While this knowledge is useful in the prediction and avoidance of perforations during CTO operations; it is also envisaged that this information can aid in the design and development of generic ultrasonic wire waveguide tissue cutting tools