2023 journal article

Intravascular Sono-Ablation for In-Stent Restenosis Relief: Transducer Development and the In-Vitro Demonstration

IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, 70(7), 2172–2180.

By: H. Kim n , H. Wu n, M. Chen n, X. Dai, R. Zhou * & X. Jiang n

co-author countries: Korea (Republic of) πŸ‡°πŸ‡· United States of America πŸ‡ΊπŸ‡Έ
author keywords: In stent restenosis; focused ultrasound; tissue ablation; interstitial transducer; small aperture
MeSH headings : Humans; Coronary Restenosis; Stents; Computer Simulation; Treatment Outcome
Source: Web Of Science
Added: August 7, 2023

This study aimed to propose a new clinical modality for the relief of in-stent restenosis (ISR) using focused ultrasound (FUS) ablation. In the first research stage, a miniaturized FUS device was developed for the sonification of the remaining plaque after stenting, known as one of the causes of ISR.This study presents a miniaturized (<2.8 mm) intravascular FUS transducer for ISR treatment. The performance of the transducer was predicted through a structural-acoustic simulation, followed by fabrication of the prototype device. Using the prototype FUS transducer, we demonstrated tissue ablation with bio-tissues over metallic stents, mimicking in-stent tissue ablation. Next, we conducted a safety test by detecting the existence of thermal damage to the arterial tissue upon sonication with a controlled dose.The prototype device successfully delivered sufficient acoustic intensity (>30 W/cm2) to a bio tissue (chicken breast) through a metallic stent. The ablation volume was approximately 3.9 Γ— 7.8 Γ— 2.6 mm3. Furthermore, 1.5 min sonication was sufficient to obtain an ablating depth of approximately 1.0 mm, not thermally damaging the underlying artery vessel.We demonstrated in-stent tissue sonoablation, suggesting it could be as a future ISR treatment modality.Comprehensive test results provide a key understanding of FUS applications using metallic stents. Furthermore, the developed device can be used for sonoablation of the remaining plaque, providing a novel approach to the treatment of ISR.