Systems and methods for opening the eustachian tubes of a subject are provided. Aspects of the systems include: a swallow inducer; a nasal passage seal; a pressure source configured to apply positive pressure to a sealed nasal passage; a sensor configured to detect a parameter indicative of a swallow resultant palate closure; and a controller operably coupled to the pressure source and the sensor, wherein the controller is configured to cause the pressure source to apply positive pressure to a sealed nasal passage upon detection by the sensor of the parameter indicative of a swallow resultant palate closure. Also provide are methods of using the systems to open eustachian tubes. The systems and methods find use in a variety of different applications, e.g., the treatment of a subject for Otitis Media with Effusion (OME).

Disclosed is a device for incision and insertion of a ventilation tube during myringotomy, comprising a cutter member configured to make an incision; a holder member configured to dispose the ventilation tube in an orientation in which a longitudinal axis of the ventilation tube is substantially perpendicular to the cutter member; and a pusher member configured to apply a pushing force to a first end of the ventilation tube in a direction substantially perpendicular to the longitudinal axis, the first end of the ventilation tube being disposed closer to the cutter member than a second end of the ventilation tube; wherein the holder member comprises a pivot element configured to releasably engage the second end of the ventilation tube such that the ventilation tube is pivotable under the pushing force applied to the first end of the ventilation tube by the pusher member, for insertion of the first end of the ventilation tube into the incision.

A myringotomy device includes a housing; an elongated tube extending from the housing; and a retractable cutting tool extendable through the elongated tube, the cutting tool comprising a blade. The cutting tool is configured such that when advanced, the blade of the cutting tool extends beyond a distal end of the elongated tube. The cutting tool is also configured such that when retracted, the blade is retracted into the elongated tube and a fluid conduit is created from the distal end of the elongated tube to the housing.

Certain embodiments described herein provide a method of performing an otological surgical procedure including surgically accessing a middle ear, injecting a perfluorocarbon liquid into the middle ear, and suctioning the isolated blood from the middle ear without removing the perfluorocarbon liquid. The perfluorocarbon liquid is immiscible with blood for isolating blood in the middle ear from the perfluorocarbon liquid. In certain embodiments, the perfluorocarbon liquid has a specific gravity greater than blood to apply positive pressure to surrounding tissues. In certain embodiments, the method includes suctioning the perfluorocarbon liquid from the middle ear after the isolated blood is removed.

A system for delivering a fluid to a Eustachian tube (ET) of a patient includes a guide member and a tubular member. The guide member includes a shaft having a proximal portion, a distal portion, and a bend at the distal portion. The bend is configured to provide access to an opening in the ET. The system further includes a tubular member comprising a proximal end, a distal end, and a lumen extending therebetween. The tubular member is sized to fit within the ET. One or both of the tubular member and the guide member comprises a first stop member configured to engage the other of the tubular member or the guide member. The first stop member is configured to restrict a distal advancement of the tubular member relative to the guide member.

An implant that may maintain position with a Eustachian tube of a patient, the implant includes an engagement body, an anchoring assembly, and a pressure balance assembly. The engagement body includes an exterior surface dimensioned to bear radially outward against the Eustachian tube. The anchoring assembly may lock the implant in the Eustachian tube. The pressure balance assembly includes a vented pathway that may transition between an occluded state and a vented state. The vented pathway may provide fluid communication between the proximal end and the distal end of the implant in the ventilated state while inhibiting fluid communication between the proximal end and the distal end of the implant in the occluded state.

A tympanostomy tube placement device has a stem with a needle having a tip configured to pierce a tympanic membrane. A retainer is on the needle and includes four fingers extending axially at a distance from said axis and at 90° circumferential separations in one example. The retainer is movable from a distal position at which it presses radially inwardly against the tube distal flange tabs to retain the distal flange in a folded position, to a proximal position at which the tube distal flange is free to spring out radially to a deployed position. The retainer fingers extend through tube proximal flange passageways and press the tube distal flange inwardly, while leaving a distally-facing face of the proximal flange exposed radially outwardly of the retainer. Hence, the proximal flange has its final deployed configuration throughout, and so can act as a physical stop member against the tympanic membrane and also provides visualisation for the surgeon because it extends radially outwardly of the stem.

Systems and methods can be employed for trans-tympanic membrane access to the middle ear for delivery of a therapeutic agent, for example, to the round window niche adjacent to the cochlea under direct visualization. The systems and methods can also be used to improve accessibility and visualization for various otological surgical procedures, such as, but not limited to, cholesteatoma removal, tympanic membrane repair and ossicular chain repair.

A tympanostomy tube placement device has a needle with a tip, and a retainer at the needle tip. The retainer is within and retains by pulling radially inwardly a tympanostomy tube distal flange in a folded configuration extending distally. Movement of the needle tip in the proximal direction causes the adhesive bond to break and the distal flange releases to an unconstrained deployed position. Due to the axial folding of the distal flange its radial dimension does not affect deployment through the membrane.

A tympanic membrane prosthesis includes a tubular body having a lumen extending therethrough and open at each of a proximal and distal end. The tubular body forms a structurally self-supporting, body compatible, and body absorbable device. The device is formed of a composite structure that includes an inner portion having an inside surface and an outer portion having an outside surface. The inside surface forms at least a portion of the lumen extending through the tubular body. The inside surface is adapted to provide less resistance to fluid flow than the outside surface. The outside surface is adapted to produce an inflammatory reaction in adjacent tissue at a tympanic membrane. The device is adapted for insertion into an opening through the tympanic membrane for placement with the proximal end and the distal end disposed on opposite sides of the tympanic membrane.