Intratympanic injector devices and needles for delivery of drugs and methods of use
Inventors
Sacherman, Kevin W. • Ayoob, Andrew • Erickson, Signe • Peris, Hugo • Limb, Charles • de Juan, Jr., Eugene
Assignees
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Publication Number
US-12138436-B2
Publication Date
2024-11-12
Expiration Date
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.
Core Innovation
The invention relates to an intratympanic drug delivery system for delivering one or more therapeutics to a region of an ear that is internal to a tympanic membrane. The system includes a canal guide configured to be inserted within and fittingly engaged with walls of an ear canal, where the distal-most end of the canal guide remains external to the tympanic membrane. The canal guide provides alignment of a needle assembly within the ear canal relative to the tympanic membrane.
The canal guide comprises a viewing lumen extending between a proximal end and the distal-most end of the canal guide, and a guide lumen extending between proximal and distal openings near the ends. The guide lumen curves from a first axis to a second axis, where the first axis extends through the proximal opening and the second axis extends through the distal opening. The guide lumen is eccentric relative to a longitudinal axis of the canal guide, and the canal guide is adjustably attached to a housing so that the position of the guide lumen relative to the housing is adjusted by rotation.
The system further includes a needle assembly comprising a flexible shaft that extends through the guide lumen, where the flexible shaft defines a fluid delivery lumen. The needle assembly is aligned by the canal guide to deliver therapeutics to a targeted region internal to the tympanic membrane. The system positions the needle assembly within the ear canal using adjustable rotational alignment of the eccentric, curved guide lumen relative to the tympanic membrane.
Claims Coverage
The document contains one independent claim. It provides a core system architecture with alignment through an eccentric, curved guide lumen and a flexible needle assembly having a fluid delivery lumen, for delivering therapeutics to an ear region internal to a tympanic membrane. Dependent claims add a syringe/plunger injection, a lens/viewing implementation, geometric relationships between viewing and guide lumens, and lumen sizing constraints.
Intratympanic therapeutic delivery with alignment canal guide
A system for delivering one or more therapeutics to a region of an ear internal to a tympanic membrane, including a canal guide configured to be inserted within and fittingly engaged with walls of an ear canal, where the distal-most end remains external to the tympanic membrane, and where the canal guide provides alignment of a needle assembly within the ear canal relative to the tympanic membrane.
Eccentric curved guide lumen with rotational adjustability
The canal guide includes a viewing lumen and a guide lumen, where the guide lumen curves from a first axis to a second axis through corresponding proximal and distal openings; the guide lumen is eccentric relative to a longitudinal axis of the canal guide; and the canal guide is adjustably attached to a housing such that the position of the guide lumen relative to the housing is adjusted by rotation.
Flexible needle assembly with fluid delivery lumen through guide lumen
A needle assembly comprising a flexible shaft sized to extend through the guide lumen of the canal guide, the flexible shaft defining a fluid delivery lumen, configured such that the canal guide provides alignment of the needle assembly within the ear canal relative to the tympanic membrane for delivery to the region internal to the tympanic membrane.
Syringe plunger injection via needle assembly
The needle assembly system includes mating with a syringe having a plunger actuator to inject therapeutic fluid through the needle assembly and into a targeted ear site interior to the tympanic membrane.
Lens at proximal viewing lumen
A lens positioned at a proximal end of the viewing lumen.
Parallel offset distal guide-lumen axis relative to viewing lumen axis
The distal opening of the guide lumen has its second axis parallel to and offset from the central longitudinal axis of the viewing lumen.
Relative lumen diameters with constrained guide-lumen sizing
The guide lumen has an inner diameter of about 0.17 mm to about 1.00 mm, and the viewing lumen interior diameter is larger than the guide lumen inner diameter.
Across the independent claim and dependents, the inventive concept centers on an intratympanic delivery system where an eccentric, curved guide lumen in a canal guide provides alignment for a flexible needle assembly defining a fluid delivery lumen. Dependent claims further specify injection via syringe/plunger, add a lens for viewing, define an offset/parallel relationship between guide and viewing axes, and introduce lumen diameter constraints and relative sizing of viewing versus guide lumens.
Stated Advantages
Provides alignment of the needle assembly within the ear canal relative to the tympanic membrane for delivering one or more therapeutics to an ear region internal to a tympanic membrane.
Documented Applications
Delivering therapeutics to a middle/inner ear region internal to a tympanic membrane (intratympanic drug delivery).
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