Inner ear drug delivery devices and methods of use
Inventors
Sacherman, Kevin W. • Erickson, Signe • Peris, Hugo • de Juan, Jr., Eugene
Assignees
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Publication Number
US-12102785-B2
Publication Date
2024-10-01
Expiration Date
Abstract
An implantable device for delivering a therapeutic agent to treat an ear of a patient includes a body having a distal end region and a proximal end region. The body defines, at least in part, a reservoir configured to contain the therapeutic agent. The device includes a shaft attached to the distal end region of the body and a lumen extending through the shaft having at least one inlet at a proximal end region in fluid communication with the reservoir and at least one outlet at a distal end region. Upon implantation of the body in a region of the ear, a length of the shaft is sufficient to extend from the body to at least the round window membrane of the ear. The device is configured to deliver the therapeutic agent to the ear from the reservoir via passive diffusion. Related devices and methods are described.
Core Innovation
The invention relates to delivering a therapeutic fluid to a round window niche of a cochlea by injecting a therapeutic fluid comprising dexamethasone into a proximal port of an elongate fillable body that is axially aligned with a central lumen of a distal delivery shaft. The elongate fillable body is positioned entirely external to a tympanic membrane of an ear, and the distal delivery shaft has a smaller diameter than an outer diameter of the elongate fillable body.
After injection into the proximal port axially aligned with the central lumen, the therapeutic fluid is delivered from the distal end of the elongate fillable body through the distal delivery shaft that is positioned through the tympanic membrane. Delivery includes depositing the therapeutic fluid comprising dexamethasone into a distal-most outlet adjacent to a round window niche of a cochlea, with about 5 μL to about 500 μL deposited into the round window niche.
The therapeutic fluid deposited into the round window niche comprises a gel composition for sustained release of the dexamethasone. The disclosure further includes a distal delivery shaft having a fluid release element at the distal-most outlet, where the fluid release element can include a porous surface.
Claims Coverage
The provided content identifies one independent claim directed to delivery of a dexamethasone therapeutic fluid to a cochlea round window niche using an externally positioned elongate fillable body aligned to a distal delivery shaft through a tympanic membrane. The claim includes structural alignment and positioning features, a deposited volume range, and a sustained-release gel composition requirement.
Axially aligned external elongate fillable body and distal delivery shaft through the tympanic membrane
Injecting a therapeutic fluid comprising dexamethasone into a proximal port of an elongate fillable body axially aligned with a central lumen of a distal delivery shaft extending from the distal end of the elongate fillable body, while the elongate fillable body is positioned entirely external to a tympanic membrane, the distal delivery shaft having a smaller diameter than an outer diameter of the elongate fillable body and the central lumen of the distal delivery shaft being filled entirely by the therapeutic fluid.
Round window niche delivery from a distal-most outlet adjacent to the round window niche
After injection, delivering the therapeutic fluid from the distal end of the elongate fillable body through the distal delivery shaft positioned through the tympanic membrane to a distal-most outlet adjacent to a round window niche of a cochlea.
Deposited volume range for round window niche delivery
Depositing about 5 μL to about 500 μL of the therapeutic fluid comprising dexamethasone into the round window niche.
Sustained-release gel composition of dexamethasone
Wherein the therapeutic fluid comprising dexamethasone deposited into the round window niche comprises a gel composition for sustained release of the dexamethasone.
Coverage centers on axially aligned delivery from an externally positioned elongate fillable body through a distal delivery shaft positioned through the tympanic membrane to a distal-most outlet adjacent to the cochlea round window niche, with a limited deposited volume range and a dexamethasone sustained-release gel composition.
Stated Advantages
Sustained release of dexamethasone from the round window niche via a gel composition.
Documented Applications
Delivering a therapeutic fluid comprising dexamethasone to a cochlea round window niche.
Using a distal fluid release element at the distal-most outlet, including embodiments with a porous surface.
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