IntroductionMechanically driven ultrasound imaging catheters (UICs) using single, focused elements are examples of a class of emerging catheter tip ultrasound devices beginning to be used for intravascular imaging. To develop a practical, cost effective imager that is both a good catheter from the interventionalist's standpoint and provides high quality images, we have had to develop new materials, design methods, and fabrication techniques. Present day diagnostic catheter's now being used widely by interventional radiologists were re-examined, and modified for acoustic imaging. Design philosophies that embodied the conventional wisdom of 20 or so years of ultrasound transducer manufacture had to be dissected, and in some cases discarded, and fabrication techniques more familiar to the semiconductor industry applied to the manufacture of intricate, miniature ultrasound crystals.
Initial SystemOur first objective was to prove the fundamental practicality of a very high frequency acoustic imaging system (20+ MHz) that would operate in a manner consistent with current interventional catheterization methods to provide diagnostic quality images of lumens of clinical interest. We began simple in vitro experiments in early 1986 with a manually rotated, side viewing 20 MHz miniature transducer (Craig Hartley, Houston, TX).The quality of the images, even in such a limited system, suggested that work should proceed toward a practical catheterbased design.Although it was clear that a single catheter design could not have all the performance characteristics necessary for the wide range of vessel sizes, we chose a mid -range size of 6 French (2mm) for the first UIC prototypes.This approach was practical from a fabrication standpoint and could work in vessels of the 2 -8mm range found in the periphery and extremities. The design information gained from this first version was to be optimized and then scaled up or down for other applications.Two experimental display systems using simple analog electronics were built in 1987 and used for catheter development and in -vitro and in -vivo experiments[l).The result of this development program was enough basic imaging performance information to allow us to design the first human -rated ultrasound imaging catheters from existing diagnostic catheters that had been modified for better acoustic performance. This early work also led to practical design formulas for the rotating coaxial drive system and transducers with various scanning angles, using novel guidewire technology combined with new microfabrication techniques.
IntroductionMechanically driven ultrasound imaging catheters (UICs) using single, focused elements are examples of a class of emerging catheter tip ultrasound devices beginning to be used for intravascular imaging. To develop a practical, cost effective imager that is both a good catheter from the interventionalist's standpoint and provides high quality images, we have had to develop new materials, design methods, and fabrication techniques.Present day diagnostic catheters...