Nitinol actuated soft structures towards transnasal drug delivery: a pilot cadaver study

Sudden hearing loss can be treated noninvasively by administering drugs to the middle ear (≈1 ml) via the eustachian tube. The nasopharyngeal cavity requires high dexterity manipulation as it is restricted by the nasal vestibule, and precise drug delivery through the small cavity can allow previously unreachable areas to be reconsidered for localized delivery. Nitinol has shape memory capabilities and can be used for distal actuation accessed from small lumen and a tortuous path. The drug delivery device (DDD) is a soft and needle-sized (2 mm) and comprises of Nitinol, ribbon spring, and a drug delivery tube. By controlling the input voltage to the Nitinol, bending of the device at different angles could be achieved, and the ribbon spring works antagonistically to the Nitinol to revert to the initial position once deactivated. The actuation of the device and its corresponding bending are calculated in vitro and found to have a bending angle ranging between 36.2 and 66.8° for applied voltages of 1.2-2.0 V, with surface temperature of 45.6-154 °C. The DDD is able to actuate 200 cycles with ≈91-76% retention of bending performance, with a temperature increase of ≈8.5-9% when 1.2-2.0 V is applied. Addition of soft insulating material shows ≈34-62% reduction in the surface temperature in the first cycle and ≈37-59% over 200 cycles when actuated at 1.2-2.0 V. The active steering and navigation capabilities of the DDD are demonstrated in simulated environments (based on the eustachian tube dimensions of adult and infant). Preclinical testing in human cadavers is demonstrated and suggests the developed DDD controlled by varying the input voltages for bending, and mechanically varied drug delivery may be a feasible option for localized drug delivery in eustachian tube. Graphical abstract.