Minimally-invasive tools and methods for accessing the middle and inner ear through the tympanic membrane
Inventors
de Juan, Eugene • Erickson, Signe • Limb, Charles • Peris, Hugo • Talreja, Nikhil • Ayoob, Andrew
Assignees
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Publication Number
US-12164095-B2
Publication Date
2024-12-10
Expiration Date
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.
Core Innovation
The invention relates to a minimally invasive method of treating hearing loss by delivering inner ear therapeutics through the tympanic membrane. The method advances a stabilizer insertion tool carrying a first stabilizer device defining a first working channel, where a stylet with a beveled distal end penetrates the tympanic membrane to create a first fenestration, and the stabilizer insertion tool is advanced to implant the first stabilizer device in the first fenestration.
The method further repeats the fenestration and implantation using a second stabilizer device defining a second working channel. A first instrument is advanced through the first working channel while the first stabilizer device is implanted, and a second instrument is advanced through the second working channel while the second stabilizer device is implanted, supporting access to middle/inner-ear structures, including at or near the round window membrane.
The described system and device architectures include trans-tympanic embodiments with proximal, transmembrane, and distal portions that form a fenestration and channel, as well as ear-canal-only anchoring embodiments with a distal cannula and working channel. The document further describes visualization and aiming features such as endoscopic visualization and illumination, and imaging including OCT and IR imaging, and states that after stabilizer removal the approach enables sutureless healing.
Claims Coverage
The document provides one independent claim directed to a method of treating hearing loss using first and second stabilizer devices implanted in fenestrations of a tympanic membrane, enabling advancement of first and second instruments through corresponding working channels. The claim set includes dependent refinements that specify instrument types and an additional therapeutic delivery operation, including an inner ear therapeutic injection and identification of a biocompatible gel.
Creating first and second tympanic membrane fenestrations using a beveled stylet
Advancing a stabilizer insertion tool carrying a stabilizer device defining a working channel, using a stylet with a beveled distal end extending distally of the stabilizer device to penetrate the tympanic membrane and create a fenestration, and repeating for a second fenestration.
Implanting stabilizer devices in the tympanic membrane to define working channels
Advancing the stabilizer insertion tool to implant a first stabilizer device in the first fenestration and to implant a second stabilizer device in the second fenestration, where each stabilizer device defines a corresponding working channel.
Advancing instruments through implanted working channels
Advancing a first instrument through the first working channel while the first stabilizer device is implanted and advancing a second instrument through the second working channel while the second stabilizer device is implanted.
Using an endoscope as an instrument passed through a working channel
Implementing the method such that the first instrument includes an endoscope.
Using a microcannula as an instrument passed through a working channel
Implementing the method such that the second instrument includes a microcannula.
Injecting an inner ear therapeutic into the middle ear using a microcannula
Advancing an injection operation in which an inner ear therapeutic is injected into a patient's middle ear using a microcannula while the microcannula is advanced through a working channel with an implanted stabilizer device.
Defining the inner ear therapeutic as a biocompatible gel
Characterizing the inner ear therapeutic as a biocompatible gel.
Using forceps as an alternative instrument passed through a working channel
Implementing the method such that the second instrument comprises forceps as an alternative to a microcannula.
Overall, the independent claim centers on creating first and second fenestrations in a tympanic membrane with a beveled stylet during stabilizer insertion, implanting first and second stabilizer devices to define working channels, and advancing first and second instruments through those channels while the stabilizers are implanted. Dependent claims specify instrument types and add delivery by injecting an inner ear therapeutic into the middle ear using a microcannula, with the therapeutic characterized as a biocompatible gel.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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