Devices, systems, and methods for treating ear disorders
Inventors
de Juan, Eugene • Peris, Hugo • Erickson, Signe • Levering, Vrad
Assignees
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Publication Number
US-11906719-B2
Publication Date
2024-02-20
Expiration Date
Abstract
Systems and methods can be employed for trans-tympanic membrane access to the middle ear for delivery of a formulation or implant device to a target location 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 gel formulation to a round window niche of a cochlea under direct endoscopic visualization. The system includes an endoscope with an endoscope shaft and a distal tip portion sized to be positioned within a middle ear, and the endoscope is positioned through a tympanic membrane to visualize the round window niche of a cochlea.
A sleeve device defines a first lumen and a second lumen. The first lumen allows the endoscope shaft to pass such that the distal tip portion can be positioned through the tympanic membrane and into the middle ear while the sleeve device is entirely external from the tympanic membrane, and the second lumen is adjacent to the first lumen and receives an injection shaft slidably to enable delivery while maintaining visualization through the spaced endoscope.
A gel injection device includes a proximal actuator and an injection shaft with an injector distal tip portion defining a side-cut delivery port. The injector distal tip portion is positionable through the tympanic membrane and movable distally of the distal tip portion of the endoscope so that the side-cut delivery port is advanceable to the round window niche, and the side-cut delivery port dispenses the therapeutic gel formulation in response to movement of the proximal actuator.
Claims Coverage
The partial content provides one independent claim and multiple dependent claims that refine the delivery system, including sleeve/endoscope/injection geometry, quantified dimensional relationships, shaped injector distal tips, and specified therapeutic gel formulation content.
Direct endoscopic gel delivery to a cochlear round window niche
A system delivering a therapeutic gel formulation to a round window niche of a cochlea under direct endoscopic visualization using an endoscope positioned through a tympanic membrane into a middle ear to visualize the round window niche.
Sleeve device with separated endoscope and injector lumens external to the tympanic membrane
A sleeve device defining a first lumen for an endoscope shaft and a second lumen adjacent to the first lumen, where the sleeve device is entirely external from the tympanic membrane and the endoscope distal tip portion is positionable through the tympanic membrane into the middle ear while the endoscope shaft slidably extends through the first lumen.
Side-cut delivery port advanced beyond a spaced endoscope for visualization
A gel injection device with an injector distal tip portion defining a side-cut delivery port positioned proximally of a distal-most end of the injection shaft, where the injection shaft is slidably received in the sleeve device second lumen while the endoscope shaft is slidably received in the first lumen, and where the injector distal tip portion is positionable through the tympanic membrane and movable distally of the endoscope distal tip portion such that the side-cut delivery port is advanceable to the round window niche while the endoscope distal tip portion is spaced proximally to provide visualization of the injection.
Gel formulation source in fluid communication with actuator-driven dispensing
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.
Curved-to-straight injector distal tip orientation for round window targeting
The injector distal tip portion of the gel injection device is adjusted from a longitudinally straight shape to a curved shape to orient the side-cut delivery port toward the round window niche.
Quantified tympanic membrane port lumen and openings
At least one tympanic membrane port device removably implanted in a tympanic membrane includes a central port lumen having a specified diameter, and the system further includes an endoscope shaft positioned through the tympanic membrane via an opening having a specified diameter.
Curated anti-inflammatory steroid agent selection within therapeutic gel
The therapeutic gel formulation includes an anti-inflammatory agent chosen from a list of steroid medications.
Across the independent and dependent claims, the inventive concepts focus on delivering a therapeutic gel to the cochlear round window niche under direct endoscopic visualization by using a sleeve device that separates endoscope and injection lumens with the sleeve external to the tympanic membrane, advancing a side-cut delivery port to the niche while keeping the endoscope spaced for viewing, and refining targeting and payload scope through shaped injector distal tips, quantified lumen/opening relationships, and selection of anti-inflammatory steroid agents.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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