ABSTRACT
This paper reports a sensor-integrated telemetric stent targeted at wireless detection and monitoring of restenosis, a common vascular complication induced by stent implantation. The developed "smart" stent incorporates the design and fabrication approaches that raise the practicality of the device, being tested in an in vivo study that validates its operating principle. The stent is produced to have a gold-coated helical-like structure that serves as a high-performance inductor/antenna and integrated with a novel capacitive pressure sensor chip, all based on medical-grade stainless steel. The stent device forms an inductor-capacitor resonant tank that enables radio-frequency (RF) wireless pressure sensing in an operating frequency range of 30-80 MHz. With an overall length of 20 mm, the device is designed to be compatible with standard balloon catheters and necessary crimping process. The balloon-expanded devices are characterized in saline and blood to determine selective coating of passivation layer, Parylene C, with tailored thicknesses in order to maximize both RF and sensing abilities. In vitro testing of the devices reveals a frequency sensitivity up to 146 ppm/mmHg over a pressure range of 250 mmHg. Tests in pig models show wireless detection of device's resonance and frequency response to variations in local blood pressure, the targeted function of the device.
