Abstract
Over the past half-century, ultrasound imaging has become a key technology for assessing an ever-widening range of medical conditions at all stages of life. Despite ultrasound's proven value, expensive systems that require domain expertise in image acquisition and interpretation have limited its broad adoption. The proliferation of portable and low-cost ultrasound imaging can improve global health and also enable broad clinical and academic studies with great impact on the fields of medicine. Here, we describe the design of a complete ultrasound-on-chip, the first to be cleared by the Food and Drug Administration for 13 indications, comprising a two-dimensional array of silicon-based microelectromechanical systems (MEMS) ultrasonic sensors directly integrated into complementary metal-oxide-semiconductor-based control and processing electronics to enable an inexpensive whole-body imaging probe. The fabrication and design of the transducer array with on-chip analog and digital circuits, having an operating power consumption of 3 W or less, are described, in which approximately 9,000 seven-level feedback-based pulsers are individually addressable to each MEMS element and more than 11,000 amplifiers, more than 1,100 analog-to-digital converters, and more than 1 trillion operations per second are implemented. We quantify the measured performance and the ability to image areas of the body that traditionally takes three separate probes. Additionally, two applications of this platform are described-augmented reality assistance that guides the user in the acquisition of diagnostic-quality images of the heart and algorithms that automate the measurement of cardiac ejection fraction, an indicator of heart health.
Highlights
Over the past half-century, ultrasound imaging has become a key technology for assessing an ever-widening range of medical conditions at all stages of life
Beyond microelectromechanical systems (MEMS) processing, a complementary metal– oxide–semiconductor (CMOS) integration scheme solves the transducer-to-electronics interconnection problem, which is analogous to the solution of the circuit interconnection problem whose solution by Noyce [12] first birthed the semiconductor integrated circuit (IC) industry
The fabrication involves two separate wafer bonding steps: wafer bonding to fabricate sealed cavities in a substrate and wafer bonding between the MEMS substrate and the CMOS substrate. The former is accomplished with a high-temperature anneal, above 450 °C, to facilitate achieving a strong bond. The latter is performed with a low-temperature metal bond to maintain the integrity of the CMOS which has a thermal budget maximum of 450 °C
Summary
Over the past half-century, ultrasound imaging has become a key technology for assessing an ever-widening range of medical conditions at all stages of life. We describe the design of a complete ultrasound-on-chip, the first to be cleared by the Food and Drug Administration for 13 indications, comprising a two-dimensional array of silicon-based microelectromechanical systems (MEMS) ultrasonic sensors directly integrated into complementary metal–oxide–semiconductor-based control and processing electronics to enable an inexpensive whole-body imaging probe. Since imaging at different depths in the body requires different ultrasound frequencies beyond what a single limited-bandwidth piezoelectric transducer can cover, piezoelectric probes must be designed to serve only a subset of clinical applications. We present a platform for advancing diagnostic care consisting of an ultrasound-on-chip probe, leveraging state-of-the-art silicon-based semiconductor foundries, paired with a mobile device and artificial-intelligence–guided image interpretation and cloud interconnectivity. Presentations of automated guidance for untrained ultrasound users show the potential for further broadening accessibility and utility
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