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 having a reservoir for the sustained release of therapeutic agents. The device is configured to be at least partially implanted in an eye and include a retention structure and a penetrable element coupled to and extending within at least a portion of the proximal end region of the device. The device includes a porous drug release element is positioned in fluid communication with an outlet of the device and a reservoir having a volume configured to contain one or more therapeutic agents in fluid communication with the outlet through the porous drug release element. The device is at least partially inserted along an axis of insertion.

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: An implantable device having a reservoir for the sustained release of therapeutic agents. The device is configured to be at least partially implanted in an eye and include a retention structure and a penetrable element coupled to and extending within at least a portion of the proximal end region of the device. The device includes a porous drug release element is positioned in fluid communication with an outlet of the device and a reservoir having a volume configured to contain one or more therapeutic agents in fluid communication with the outlet through the porous drug release element. The device is at least partially inserted along an axis of insertion.

Abstract: A therapeutic device for extended release drug delivery including a refillable reservoir configured to receive a therapeutic agent and having an outlet for delivery of the therapeutic agent to a patient from the reservoir over an extended period. A porous structure is coupled near the outlet of the reservoir, the porous structure formed of sintered material. A barrier layer is coupled to the reservoir on or adjacent a surface of the porous structure such that the therapeutic agent passes through both the porous structure and the barrier layer upon delivery from the reservoir through the outlet. The porous structure is tuned to deliver the therapeutic agent at a diffusion rate and the barrier layer is adapted to block passage of particles having an average particle size within an average particle size range that is outside an average particle size range blocked by the porous structure. Related methods and systems are provided.

Abstract: A device for injecting a therapeutic agent into an ocular implant at least partially implanted in an eye including an injection lumen providing a pathway for injecting the therapeutic agent into the implant; an outlet lumen providing a pathway for pre-existing fluid in the ocular implant to exit the implant; and a collection chamber fluidly coupled to the outlet lumen that provides a first fluid outflow resistance and a second fluid outflow resistance. The first fluid outflow resistance is lower than a first resistance to outflow of the implant. The second fluid outflow resistance is greater than a force imparted onto the implant by intraocular pressure of the eye. Injection of therapeutic agent into the implant via the injection lumen causes the pre-existing fluid to exit the implant and enter the collection chamber via the outlet lumen and causes a second pre-existing fluid to displace from the collection chamber.

Abstract: A therapeutic device for extended release drug delivery including a refillable reservoir configured to receive a therapeutic agent and having an outlet for delivery of the therapeutic agent to a patient from the reservoir over an extended period. A porous structure is coupled near the outlet of the reservoir, the porous structure formed of sintered material. A barrier layer is coupled to the reservoir on or adjacent a surface of the porous structure such that the therapeutic agent passes through both the porous structure and the barrier layer upon delivery from the reservoir through the outlet. The porous structure is tuned to deliver the therapeutic agent at a diffusion rate and the barrier layer is adapted to block passage of particles having an average particle size within an average particle size range that is outside an average particle size range blocked by the porous structure. Related methods and systems are provided.

Abstract: A device for injecting a therapeutic agent into an ocular implant at least partially implanted in an eye including an injection lumen providing a pathway for injecting the therapeutic agent into the implant; an outlet lumen providing a pathway for pre-existing fluid in the ocular implant to exit the implant; and a collection chamber fluidly coupled to the outlet lumen that provides a first fluid outflow resistance and a second fluid outflow resistance. The first fluid outflow resistance is lower than a first resistance to outflow of the implant. The second fluid outflow resistance is greater than a force imparted onto the implant by intraocular pressure of the eye. Injection of therapeutic agent into the implant via the injection lumen causes the pre-existing fluid to exit the implant and enter the collection chamber via the outlet lumen and causes a second pre-existing fluid to displace from the collection chamber.

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: Described are implantable devices having expandable reservoirs for the sustained release of therapeutic agents. The device is configured to be at least partially implanted in an eye and includes a retention structure and a penetrable element coupled to and extending within at least a portion of the retention structure. A porous drug release mechanism is positioned in fluid communication with an outlet of the device; and a reservoir having a volume configured to contain one or more therapeutic agents is in fluid communication with the outlet through the porous drug release mechanism. The device is at least partially inserted along an axis of insertion. The reservoir enlarges from an insertion configuration having a first three-dimensional shape to an expanded configuration having a second three-dimensional shape, the second three-dimensional shape being eccentrically positioned relative to the axis of insertion.

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: Described are implantable devices having expandable reservoirs for the sustained release of therapeutic agents. The device is configured to be at least partially implanted in an eye and includes a retention structure and a penetrable element coupled to and extending within at least a portion of the retention structure. A porous drug release mechanism is positioned in fluid communication with an outlet of the device; and a reservoir having a volume configured to contain one or more therapeutic agents is in fluid communication with the outlet through the porous drug release mechanism. The device is at least partially inserted along an axis of insertion. The reservoir enlarges from an insertion configuration having a first three-dimensional shape to an expanded configuration having a second three-dimensional shape, the second three-dimensional shape being eccentrically positioned relative to the axis of insertion.

Abstract: A therapeutic device for extended release drug delivery including a refillable reservoir configured to receive a therapeutic agent and having an outlet for delivery of the therapeutic agent to a patient from the reservoir over an extended period. A porous structure is coupled near the outlet of the reservoir, the porous structure formed of sintered material. A barrier layer is coupled to the reservoir on or adjacent a surface of the porous structure such that the therapeutic agent passes through both the porous structure and the barrier layer upon delivery from the reservoir through the outlet. The porous structure is tuned to deliver the therapeutic agent at a diffusion rate and the barrier layer is adapted to block passage of particles having an average particle size within an average particle size range that is outside an average particle size range blocked by the porous structure. Related methods and systems are provided.

Abstract: A device for injecting a therapeutic agent into an ocular implant at least partially implanted in an eye including an injection lumen providing a pathway for injecting the therapeutic agent into the implant; an outlet lumen providing a pathway for pre-existing fluid in the ocular implant to exit the implant; and a collection chamber fluidly coupled to the outlet lumen that provides a first fluid outflow resistance and a second fluid outflow resistance. The first fluid outflow resistance is lower than a first resistance to outflow of the implant. The second fluid outflow resistance is greater than a force imparted onto the implant by intraocular pressure of the eye. Injection of therapeutic agent into the implant via the injection lumen causes the pre-existing fluid to exit the implant and enter the collection chamber via the outlet lumen and causes a second pre-existing fluid to displace from the collection chamber.

Abstract: Described are implantable devices having expandable reservoirs for the sustained release of therapeutic agents. The device is configured to be at least partially implanted in an eye and includes a retention structure and a penetrable element coupled to and extending within at least a portion of the retention structure. A porous drug release mechanism is positioned in fluid communication with an outlet of the device; and a reservoir having a volume configured to contain one or more therapeutic agents is in fluid communication with the outlet through the porous drug release mechanism. The device is at least partially inserted along an axis of insertion. The reservoir enlarges from an insertion configuration having a first three-dimensional shape to an expanded configuration having a second three-dimensional shape, the second three-dimensional shape being eccentrically positioned relative to the axis of insertion.

Abstract: Described are implantable devices having expandable reservoirs for the sustained release of therapeutic agents. The device is configured to be at least partially implanted in an eye and includes a retention structure and a penetrable element coupled to and extending within at least a portion of the retention structure. A porous drug release mechanism is positioned in fluid communication with an outlet of the device; and a reservoir having a volume configured to contain one or more therapeutic agents is in fluid communication with the outlet through the porous drug release mechanism. The device is at least partially inserted along an axis of insertion. The reservoir enlarges from an insertion configuration having a first three-dimensional shape to an expanded configuration having a second three-dimensional shape, the second three-dimensional shape being eccentrically positioned relative to the axis of insertion.

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: Described are implantable devices having reservoirs for the sustained release of therapeutic agents. The devices are configured to be at least partially implanted in an eye and include a retention structure and a penetrable element coupled to and extending within at least a portion of the proximal end region of the device. The device includes a porous drug release element is positioned in fluid communication with an outlet of the device and a reservoir having a volume configured to contain one or more therapeutic agents in fluid communication with the outlet through the porous drug release element. The device is at least partially inserted along an axis of insertion.

Abstract: Described are implantable devices having expandable reservoirs for the sustained release of therapeutic agents. The device is configured to be at least partially implanted in an eye and includes a retention structure and a penetrable element coupled to and extending within at least a portion of the retention structure. A porous drug release mechanism is positioned in fluid communication with an outlet of the device; and a reservoir having a volume configured to contain one or more therapeutic agents is in fluid communication with the outlet through the porous drug release mechanism. The device is at least partially inserted along an axis of insertion. The reservoir enlarges from an insertion configuration having a first three-dimensional shape to an expanded configuration having a second three-dimensional shape, the second three-dimensional shape being eccentrically positioned relative to the axis of insertion.