High-Frequency 64-Element Ring-Annular Array Transducer: Development and Preclinical Validation for Intravascular Ultrasound Imaging

Intravascular ultrasound (IVUS) imaging has become an essential method for diagnosing coronary artery disease. However, traditional mechanically rotational IVUS catheters encounter issues such as mechanical wear and imaging distortions in curved vessels. The ring-annular IVUS array has gained attention because it offers superior imaging performance without the need for mechanical rotational parts, thereby avoiding rotational imaging distortion. An optimized mechanical micromachining process employing precision dicing technology is proposed in this study, with the objective of achieving higher operating frequencies and minimized outer diameters for a 64-element ring-annular array. This method broadens the range of fabrication options and improves the imaging sensitivity of ring-annular IVUS arrays, as well as eliminating imaging distortion in rotational IVUS catheters, particularly in curved vessels. The probe has a 7.5 Fr (2.5 mm) outer diameter, with key fabrication steps including precision dicing, flexible circuit integration, and Parylene C encapsulation. The ring-annular array has a center frequency of 21.51 MHz with 67.87% bandwidth, with a 56 µm axial resolution and a 276 µm lateral resolution. The imaging performance is further validated by in vitro phantom imaging and ex vivo imaging.