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.

Abstract: Intra-tympanic injections of therapeutics into the inner ear can be used to treat conditions such as hearing loss. One or more stabilizing devices that define working channels can be temporarily implanted in the tympanic membrane. Purpose-built instruments such as endoscopes, forceps, and injections instruments can be passed through the working channels of the stabilizer devices to access the inner ear where the therapy can be administered. Afterwards, the stabilizing devices can be removed from the tympanic membrane and the tympanic membrane can heal, typically without the need for sutures.

Abstract: Intra-tympanic injections of therapeutics into the inner ear can be used to treat conditions such as hearing loss. One or more stabilizing devices that define working channels can be temporarily implanted in the tympanic membrane. Purpose-built instruments such as endoscopes, forceps, and injections instruments can be passed through the working channels of the stabilizer devices to access the inner ear where the therapy can be administered. Afterwards, the stabilizing devices can be removed from the tympanic membrane and the tympanic membrane can heal, typically without the need for sutures.

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.

Abstract: A system for delivering one or more therapeutics to a region of the ear, the region being internal to a tympanic membrane. The system includes a canal guide configured to be inserted within and fittingly engaged with walls of the ear canal and needle assembly having a flexible shaft sized to extend through the canal guide. The canal guide provides alignment of the needle assembly within the ear canal relative to the tympanic membrane. The canal guide includes a viewing lumen extending between a proximal end to a distal-most end of the canal guide and is sized to remain external to the tympanic membrane. The canal guide includes a guide lumen extending to a distal opening near the distal-most end of the canal guide. The guide lumen curves from a first axis to a second axis. Related devices, systems, and methods are provided.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Abstract: A solution for sustained release of therapeutic, prophylactic and/or diagnostic agent in the inner ear has been developed. The formulation can be injected through a small gauge needle into the inner ear, where it gels to form a sustained release depot for controlled delivery of drug over a few days. In the preferred embodiment, the formulation includes a thermoresponsive sol-gel polymer such as POLOXAMER 407 which forms a stable hydrogel after trans-tympanic injection. As demonstrated by the examples, the hydrogel provides sustained release of an apoptosis inhibitory agent, LPT99, an anti-apoptosis agent that inhibits apoptotic protease activating factor 1 (APAF-1), as well as safety and efficacy in in vitro and in vivo models.

Abstract: Intra-tympanic injections of therapeutics into the inner ear can be used to treat conditions such as hearing loss. One or more stabilizing devices that define working channels can be temporarily implanted in the tympanic membrane. Purpose-built instruments such as endoscopes, forceps, and injections instruments can be passed through the working channels of the stabilizer devices to access the inner ear where the therapy can be administered. Afterwards, the stabilizing devices can be removed from the tympanic membrane and the tympanic membrane can heal, typically without the need for sutures.

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.

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.

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.

Abstract: A solution for sustained release of therapeutic, prophylactic and/or diagnostic agent in the inner ear has been developed. The formulation can be injected through a small gauge needle into the inner ear, where it gels to form a sustained release depot for controlled delivery of drug over a few days. In the preferred embodiment, the formulation includes a thermoresponsive sol-gel polymer such as POLOXAMER 407 which forms a stable hydrogel after trans-tympanic injection. As demonstrated by the examples, the hydrogel provides sustained release of an apoptosis inhibitory agent, LPT99, an anti-apoptosis agent that inhibits apoptotic protease activating factor 1 (APAF-1), as well as safety and efficacy in in vitro and in vivo models.