Systems and methods for treating hearing loss
Inventors
de Juan, Eugene • Erickson, Signe • Limb, Charles • Peris, Hugo • Ayoob, Andrew • Levering, Vrad
Assignees
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Publication Number
US-11467386-B2
Publication Date
2022-10-11
Expiration Date
Abstract
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.
Core Innovation
The disclosed invention provides a system for delivering a therapeutic gel formulation to a round window niche of a cochlea under direct endoscopic visualization. The system uses an endoscope shaft to position a distal end portion through a tympanic membrane and into a middle ear to visualize the round window niche, while an otologic injector device advances a distal tip through the tympanic membrane to deliver the therapeutic gel formulation to the round window niche.
A two-channel alignment sleeve is configured to align the endoscope and the injector while improving access through the tympanic membrane. The two-channel alignment sleeve defines a primary channel and an auxiliary working channel that is laterally separated from the primary channel by an intermediate wall portion, and the central longitudinal axis of the auxiliary working channel is in a non-parallel relationship with the central longitudinal axis of the primary channel.
In one implementation, the two-channel alignment sleeve is compressed against an exterior of the endoscope to affix the sleeve to the endoscope while the endoscope shaft is positioned with the primary channel. The injector device includes a syringe containing a therapeutic gel formulation comprising an anti-inflammatory agent, and an injector shaft connected to the syringe and slidable through the auxiliary working channel, with the distal tip advanceable to the round window niche while maintaining visualization.
Claims Coverage
The partial content shows two independent claims. Across these independent claims, there are three core inventive features: a two-channel alignment sleeve with laterally separated, non-parallel axes to reduce effective crossing diameter; an endoscope positioned through the tympanic membrane in the primary channel to visualize the round window niche; and an otologic injector device that delivers an anti-inflammatory therapeutic gel through a distal injector tip advanced through the tympanic membrane via the auxiliary channel while the endoscope is spaced for visualization.
Non-parallel two-channel alignment sleeve for spaced endoscope and injector access
A two-channel alignment sleeve defining a primary channel having a first diameter extending to a distal end of the two-channel alignment sleeve, and an auxiliary working channel having a second diameter smaller than the first diameter and being laterally separated from the primary channel by an intermediate wall portion of the two-channel alignment sleeve such that a central longitudinal axis of the auxiliary working channel is in a non-parallel relationship with a central longitudinal axis of the primary channel, wherein the non-parallel relationship is oriented to reduce an effective diameter of the endoscope shaft and injector shaft crossing through the tympanic membrane.
Endoscope through tympanic membrane positioned in the primary channel for direct visualization
An endoscope having an endoscope shaft sized to extend through the primary channel of the two-channel alignment sleeve such that a distal end 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 two-channel alignment sleeve is external from the tympanic membrane; and with the distal end portion spaced proximally from the distal tip of the injector shaft to provide visualization of the injector shaft.
Otologic injector device delivering anti-inflammatory therapeutic gel to the round window niche via auxiliary working channel
An otologic injector device including a syringe containing a therapeutic gel formulation comprising an anti-inflammatory agent, and an injector shaft connected to the syringe and slidable through the auxiliary working channel of the two-channel alignment sleeve while the endoscope shaft is positioned within the primary channel of the two-channel alignment sleeve; wherein a distal tip of the injector shaft is positionable through the tympanic membrane and movable distally of the distal end portion of the endoscope such that the distal tip of the injector shaft is advanceable to the round window niche to deliver the therapeutic gel formulation to the round window niche.
Sleeve affixation to the endoscope by compression while allowing distal injector movement
The two-channel alignment sleeve is compressed against an exterior of the endoscope to affix the two-channel alignment sleeve to the endoscope while the endoscope shaft is positioned with the primary channel.
Together, the independent claims focus on delivering an anti-inflammatory therapeutic gel formulation to a cochlear round window niche under direct endoscopic visualization using an endoscope in a primary channel and an injector in a laterally separated auxiliary channel. The non-parallel relationship of the auxiliary and primary channels is used to reduce an effective diameter of the shaft crossing through the tympanic membrane, while spacing and injector distal movement maintain visualization.
Stated Advantages
Allows delivery of a therapeutic gel formulation to a round window niche of a cochlea under direct endoscopic visualization.
The non-parallel relationship of the auxiliary channel and the primary channel is oriented to reduce an effective diameter of the endoscope shaft and injector shaft crossing through the tympanic membrane.
Spacing of the distal end portion of the endoscope proximally from the distal tip of the injector shaft provides visualization of the injector shaft.
Compression of the two-channel alignment sleeve against an exterior of the endoscope affixes the sleeve to the endoscope.
Documented Applications
Systems and methods for delivering a therapeutic anti-inflammatory gel formulation to a cochlea round window niche under direct endoscopic visualization via trans-tympanic access (tymepanic membrane and middle ear visualization).
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