Devices, systems, and methods for otology

Inventors

de Juan, EugenePeris, HugoErickson, SigneLevering, VradTalreja, Nikhil

Assignees

Spiral Therapeutics Inc

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Publication Number

US-12360350-B2

Patent

Publication Date

2025-07-15

Expiration Date


Abstract

Devices, systems, and methods can be employed to facilitate performing procedures in the outer, middle, and/or inner ear in order to diagnose and/or treat disorders including, but not limited to, hearing loss and other ear disorders. For example, this document describes devices, systems and methods that include instruments and techniques to minimize the invasiveness and/or to enhance the efficacy of procedures that are performed in the outer, middle, and/or inner ear spaces such as mastoidectomy, tympanoplasty, cholesteatoma treatments, otosclerosis treatments, and Eustachian tube treatments.

Core Innovation

The invention relates to otology devices and instruments, and to methods for treating cholesteatoma in a middle ear using a minimally invasive trans-tympanic membrane approach. An instrument is advanced into the middle ear via an outer ear canal and through a lumen in the tympanic membrane having an access diameter of 0.5 mm to 1.0 mm, and a distal tip is positioned to contact cholesteatoma at a location spaced posteriorly away from a Eustachian tube.

The instrument is configured to provide a combination of injection and ultrasound emulsification, delivering both a therapeutic agent injection and ultrasound emulsification from the distal tip to debulk the cholesteatoma via the trans-tympanic membrane approach at a first time. After the first debulking, at a second later time, a subsequent instrument is advanced through a subsequent lumen having the same access diameter range so that the distal tip contacts regrowth of the cholesteatoma at the same posterior location.

The subsequent instrument delivers a subsequent therapeutic treatment that includes both subsequent therapeutic agent injection and ultrasound emulsification from the distal tip to debulk the cholesteatoma via the trans-tympanic membrane approach at the second later time. The described concepts further associate this trans-tympanic access with a therapeutic agent injection and ultrasound emulsification combination for minimally invasive cholesteatoma debulking.

Claims Coverage

The independent claim defines the core method for treating cholesteatoma with a trans-tympanic membrane approach that combines therapeutic agent injection and ultrasound emulsification, performed at a first time for initial debulking and again at a second later time for regrowth.

Trans-tympanic membrane access with limited lumen diameter

Advancing, via an outer ear canal and a trans-tympanic membrane approach into the middle ear, a shaft of an instrument through a lumen in the tympanic membrane having an access diameter of 0.5 mm to 1.0 mm such that a distal tip of the instrument comes into contact with the cholesteatoma at a location spaced posteriorly away from a Eustachian tube.

Combined therapeutic agent injection and ultrasound emulsification debulking

While the shaft is positioned in the lumen, delivering a therapeutic treatment that includes both a therapeutic agent injection and ultrasound emulsification from the distal tip to the cholesteatoma to debulk the cholesteatoma via the trans-tympanic membrane approach at a first time.

Repeat treatment for regrowth using a subsequent lumen and subsequent instrument

After delivering the therapeutic treatment at the first time, advancing at a second later time, a subsequent instrument through a subsequent lumen in the tympanic membrane having an access diameter of 0.5 mm to 1.0 mm such that a distal tip of the subsequent instrument comes into contact with regrowth of the cholesteatoma at the location spaced posteriorly away from the Eustachian tube; and while at least a portion of the shaft of the subsequent instrument is positioned in the subsequent lumen, delivering a subsequent therapeutic treatment that includes both a subsequent therapeutic agent injection and ultrasound emulsification from the distal tip to the cholesteatoma to debulk the cholesteatoma via the trans-tympanic membrane approach at the second later time.

Claim coverage is centered on a trans-tympanic membrane method that uses a restricted access diameter lumen to reach posteriorly located cholesteatoma, applies a combined injection plus ultrasound emulsification debulking at a first time, and repeats the injection plus ultrasound emulsification debulking at a second later time for regrowth.

Stated Advantages

Documented Applications

No documented applications found

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