Inner ear drug delivery devices and methods of use

Inventors

Sacherman, Kevin W. • Erickson, Signe • Peris, Hugo • de Juan, Jr., Eugene

Assignees

Spiral Therapeutics Inc

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Publication Number

US-11273295-B2

Patent

Publication Date

2022-03-15

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 disclosed invention relates to an implantable device for delivering a therapeutic agent to treat an ear of a patient. The device includes a body having a reservoir configured to contain the therapeutic agent, and a shaft attached to a distal end region of the body. The shaft comprises a lumen extending through the shaft, with at least one inlet in fluid communication with the reservoir and at least one outlet at a distal end region of the shaft.

Upon implantation, the length of the shaft is sufficient to extend from the body to at least the round window membrane of the ear. The delivery is configured to deliver the therapeutic agent from the reservoir to the ear via passive diffusion. The device further includes an annular anchor with an outer ring surface configured to seal against a perimeter of the round window membrane and an inner ring surface.

The annular anchor includes a first distensible membrane coupled to a proximal side and a second distensible membrane coupled to a distal side opposite the first distensible membrane. The first distensible membrane is non-permeable to the therapeutic agent, while the second distensible membrane is permeable to the therapeutic agent. A chamber located within the annular anchor is defined collectively by the inner ring surface, an inner surface of the first distensible membrane, and an inner surface of the second distensible membrane, and diffusion-based delivery is directed by these permeable and non-permeable portions.

Claims Coverage

The partial content identifies one independent claim: clm-00001. Its claim structure contains multiple inventive feature groupings: reservoir-to-lumen delivery, round-window annular anchoring with distensible membranes forming a chamber, and passive diffusion delivery.

Reservoir and lumen shaft for therapeutic agent delivery to the ear

A body defining, at least in part, a reservoir configured to contain the therapeutic agent; a shaft attached to the distal end region of the body and comprising a lumen extending through the shaft, the lumen 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, with the length sufficient to extend from the body to at least the round window membrane upon implantation.

Round-window sealing annular anchor with permeable and non-permeable distensible membranes forming a chamber

An annular anchor having an outer ring surface configured to seal against a perimeter of a round window membrane and an inner ring surface; a first distensible membrane coupled to a proximal side and a second distensible membrane coupled to a distal side opposite the first, wherein the first distensible membrane is non-permeable to the therapeutic agent and the second distensible membrane is permeable to the therapeutic agent; and a chamber within the annular anchor defined collectively by the inner ring surface and inner surfaces of the first and second distensible membranes.

Passive diffusion delivery configuration from reservoir via the annular anchor

A device configured to deliver the therapeutic agent to the ear from the reservoir via passive diffusion.

Passive diffusion through the permeable distensible membrane

The device in which passive diffusion of the therapeutic agent occurs through the second distensible membrane.

Across the identified independent claim, the coverage centers on an implantable reservoir and lumen-containing shaft extending to the round window membrane, coupled to an annular anchor that seals to the round window perimeter and uses a non-permeable first distensible membrane and a permeable second distensible membrane to define a chamber and enable passive diffusion delivery to the ear.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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