A Wearable Ultrasonic Vagus Nerve Stimulator

Abstract

Vagus nerve stimulation serves as an approach to manage drug-resistant epilepsy. Focused ultrasound stands out as a unique tool, offering a non-invasive modality for VNS. With its excellent depth of penetration and sub-millimeter focusing capabilities in soft tissue, ultrasound allows for precise targeting of the vagus nerve without the need for surgical intervention. This technology relies on piezoelectric transducers that convert electrical energy into ultrasonic waves. However, the high costs and technical difficulties associated with the production of these arrays have led to limited commercialization of piezoelectric transducer arrays.

This thesis investigates the design, fabrication, and optimization of a small, low-cost phased-array piezoelectric ultrasonic transducer. The transducer is specially designed for non-invasive UVNS applications in the form of a small patch for the neck. The research is dedicated to the fabrication of the transducer array, designing a transducer capable of both transmitter (TX) and receiver (RX) functions, which in the future can be used for simultaneous image-guided neural regulation. Two prototypes were fabricated: one is a 256-element 2MHz rectangular transducer array integrated into an 8-layer stacked rigid printed circuit board (PCB), and the other is a dual-frequency array integrated into a 4-layer flexible PCB substrate, explicitly designed for simultaneous imaging and neural modulation.

The study utilized two key materials, the well-known PZT and the lesser-known but promising <001> oriented PMN-0.3PT piezoelectric single crystal. Through extensive optimization, air-filled PZT transducer arrays were realized, and the cutting parameters for PMN-PT were significantly improved. A unique aspect of the fabrication was the use of flip-chip technology to directly integrate the air-filled 2D array onto the PCB, a method seldom detailed in existing research.

While exhaustive testing on phase-delayed beam-forming and imaging capabilities could not be conducted due to equipment limitations, preliminary evaluations of the capacity to generate plane waves were made. The properties of the bulk PZT and PMN-PT transducers were characterized. It was observed that the PMN-PT transducer generated significantly lower ultrasonic pressure compared to the PZT transducer, which aligns with expectations due to the fragile nature of PMN-PT. The first prototype of the PZT array transducer was successfully fabricated and assessed, achieving a pressure of 176 kPa at its 10 mm natural focal point. Subsequently, the internal array second of the prototype was fabricated and evaluated, registering a pressure of 1.14 MPa at the 1.2 mm natural focus point.

The results demonstrate the feasibility of building complex piezoelectric arrays using optimized fabrication methods. This lays the foundation for future prototypes to test beam-forming capabilities and for fabrication of the complete equipment afterwards.