Devices, systems, and methods for treating ear disorders

A system for delivering a therapeutic gel formulation to a round window niche of a cochlea under direct endoscopic visualization, the system comprising:

• an endoscope including an endoscope shaft with a distal tip portion sized to be positioned within a middle ear;
• a sleeve device defining:
• (i) a first lumen through which the endoscope shaft extends such that the distal tip portion of the endoscope is positionable through a tympanic membrane and into a middle ear to visualize a round window niche of a cochlea while the sleeve device is entirely external from the tympanic membrane, and (ii) a second lumen adjacent to the first lumen;
• a gel injection device including a proximal actuator and an injection shaft with an injector distal tip portion defining a side-cut delivery port positioned proximally of a distal-most end of the injection shaft to dispense a therapeutic gel formulation, the injection shaft sized to be slidably received in the second lumen of the sleeve device while the endoscope shaft is slidably received in the first lumen of the sleeve device, wherein the injector distal tip portion of the gel injection device is positionable through the tympanic membrane and movable distally of the distal tip portion of the endoscope such that the side-cut delivery port of the gel injection device is advanceable to the round window niche to dispense the therapeutic gel formulation to the round window niche while the distal tip portion of the endoscope is spaced proximally from the side-cut delivery port of the injection injector shaft to provide visualization of the injection;
• and
• a gel formulation source in fluid communication with the gel injection device so that the side-cut delivery port is configured to deliver the therapeutic gel formulation at the round window niche in response to movement of the proximal actuator of the gel injection device.