In vivo and in situ evaluation of a wireless magnetoelastic sensor array for plastic biliary stent monitoring.

This paper presents the in vivo and in situ evaluation of a system that wirelessly monitors the accumulation of biliary sludge in a plastic biliary stent. The sensing element, located within the stent, is a passive array of magnetoelastic resonators that is queried by a wireless electromagnetic signal. The in vivo and in situ testing uses commercially-available plastic biliary stents, each enhanced with an array of ribbon sensors (formed from Metglas™ 2826 MB). The sensor array is approximately 70 mm long and contains individual resonators that are 1 mm in width and have lengths of 10 mm, 14 mm, and 20 mm. The array is anchored into the 2.8 mm inner-diameter stent using a thermal staking technique. For the in situ testing, an instrumented stent is placed in various locations within the abdominal cavity of a female domestic swine carcass to evaluate the wireless range of the system; these results show that a wireless signal can be obtained from a range of at least 7.5 cm from a sensor array covered in bile. The in vivo testing includes the endoscopic implantation of an instrumented stent into the bile duct of a swine. After implantation, the swine was housed for a period of 4 weeks, during which the animal showed no ill effects and followed the expected growth curve from 29 kg to 42 kg. At the conclusion of the in vivo test, the animal was euthanized, and the instrumented stent explanted and examined. The results presented in this paper indicate that the monitoring system does not adversely affect the health of the animal and can feasibly provide sufficient wireless range after implantation.