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We present a double-ballooned catheter that enables both local drug delivery and blood bypassing at the same time. Such catheters are targeted for high-dose local drug treatment of cardiovascular diseases, such as atherosclerosis and restenosis, allowing for extended use without causing downstream ischemia. The device is composed of two flexible balloons that can isolate the lesion under inflation. Local drug delivery can be achieved using the inner catheters while a blood bypassing catheter allows for continuous blood flow. The functionalities of the catheter are validated in both benchtop and live pig experiments.

We herein present a novel intravascular catheter, with dual-functions of electrical impedance spectroscopy (EIS) and flow fraction reserve (FFR), validated in live pig animal for atherosclerosis/plaques diagnostics. FFR has been the standard tool in determining plaque vulnerability yet could produce false negative results when stenosis is relatively small. Meanwhile, EIS has been demonstrated to specifically distinguish the lipid-rich pool, the signifying feature of rupture-prone plaques. The synergetic performance of these two functionalities can significantly enhance state-of-art diagnostics accuracy for atherosclerosis.

It is of great clinical interest to have easy and reliable diagnostic techniques to localize and identify vulnerable plaques. Here, an in-vivo, catheter-integrated and balloon-mounted Parylene-C micro electrode impedance sensor was developed for intra-vascular interrogation of atherosclerotic vulnerable plaques using Electrical Impedance spectroscopy (EIS). Successful in vivo experiments of the EIS device were demonstrated using high-fat-dieted New Zealand rabbits. The results showed that electrical impedance spectroscopy (EIS) with micro parylene electrodes is promising to distinguish unstable plaques.