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-11662561-B2
Publication Date
2023-05-30
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 invention provides a system for delivering a therapeutic formulation adjacent to a cochlea by using minimally invasive trans-tympanic delivery with direct visualization of a round window niche. The system comprises first and second tympanic membrane port devices removably implanted in spaced apart positions in a tympanic membrane, where the first port device defines a first lumen and the second port device defines a second lumen.
An endoscope is slidable through the first lumen while the first tympanic membrane port device is implanted so that a distal end portion of the endoscope is positionable in a middle ear to visualize the round window niche of the cochlea. An injector instrument is slidable through the second lumen while the second tympanic membrane port device is implanted so that a curved distal tip portion of the injector instrument is advanceable to the round window niche, and the injector instrument delivers the therapeutic formulation to the round window niche while the distal end portion of the endoscope is spaced apart from the injector instrument to provide visualization of the injector instrument.
In a related aspect, the invention provides a system for delivering an otic treatment fluid adjacent to a cochlea using an ear injection device with a flexible distal tip portion that is adjustable from a longitudinally straight shape to a curved shape during advancement through a tympanic membrane. The curved shape orients a distal delivery port at a round window niche adjacent to the cochlea, and the distal delivery port delivers the otic treatment fluid into the round window niche while the flexible distal tip portion is arranged in the curved shape, in combination with removably implanted first and second tympanic membrane port devices with laterally spaced lumens for passing an endoscope and the ear injection device.
Claims Coverage
The partial content includes two independent claims. Each independent claim centers on a multi-port tympanic membrane access arrangement paired with separate, visualization-compatible delivery to the cochlea round window niche.
Spaced-apart tympanic membrane port devices with dual lumens for separated endoscope and injector access
First and second tympanic membrane port devices removably implanted in spaced apart positions in a tympanic membrane, the first port device defining a first lumen and the second port device defining a second lumen.
Visualization of the round window niche using an endoscope slidable through a first lumen
An endoscope slidable through the first lumen such that a distal end portion of the endoscope is positionable in a middle ear to visualize a round window niche of the cochlea.
Visualization-maintained delivery using an injector slidable through a second lumen with a spaced-apart endoscope
An injector instrument slidable through the second lumen so that a curved distal tip portion is advanceable to the round window niche and delivers the therapeutic formulation to the round window niche while the distal end portion of the endoscope is spaced apart from the injector instrument to provide visualization of the injector instrument.
Flexible distal tip portion shape change to orient a distal delivery port at the round window niche
An ear injection device with a proximal end and a flexible distal tip portion, the flexible distal tip portion adjustable from a longitudinally straight shape during advancement through a tympanic membrane to a curved shape to orient a distal delivery port at a round window niche adjacent to the cochlea.
Fluid-delivery into the round window niche from an otic treatment fluid source with the distal tip in the curved shape
An otic treatment fluid source in fluid communication with the ear injection device so that the distal delivery port is configured to deliver the otic treatment fluid into the round window niche while the flexible distal tip portion is arranged in the curved shape.
Removably implanted laterally spaced tympanic membrane port devices for endoscope passage and ear injection device passage
A first tympanic membrane port device removably implanted in the tympanic membrane defining a first lumen through which the ear injection device passes, and a second tympanic membrane port device removably implanted in a laterally spaced apart position defining a second lumen through which the endoscope passes.
Across the independent claims, the core inventive subject matter is a spaced, dual-portal tympanic membrane access arrangement that enables an endoscope to visualize the round window niche while a separate instrument delivers a therapeutic formulation or otic treatment fluid to the round window niche through laterally spaced lumens.
Stated Advantages
Provides visualization of the injector instrument while delivering the therapeutic formulation to the round window niche.
Orients a distal delivery port at a round window niche adjacent to the cochlea using a flexible distal tip portion adjustable from a longitudinally straight shape to a curved shape.
Documented Applications
Delivery of a therapeutic formulation adjacent to a cochlea via visualization of a round window niche.
Delivery of an otic treatment fluid adjacent to a cochlea into a round window niche using an ear injection device with a flexible distal tip portion that becomes curved during advancement.
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