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US 12,663,629 B2Granted
Systems and methods for treating hearing loss
AssigneeSpiral Therapeutics Inc.
InventorsEugene de Juan, Signe Erickson, Charles Limb, Hugo Peris, Andrew Ayoob, Vrad Levering
Life of this patent
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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.
Claims20
A method for delivering a therapeutic gel formulation to a round window niche of a cochlea under direct endoscopic visualization, the method comprising:
- providing direct visualization of the round window niche of the cochlea using an endoscope in which a distal end of an endoscope shaft of the endoscope is inserted through a tympanic membrane and into a middle ear to visualize the round window niche of the cochlea, wherein the endoscope is configured to be coupled to an injector shaft of an otologic injector device using a two-channel alignment sleeve;
- during direct visualization of the round window niche of the cochlea using the endoscope shaft inserted through the tympanic membrane, advancing the injector shaft of the otologic injector device such that a distal tip of the injector shaft moves toward the round window niche while the distal end of the endoscope is spaced proximally from the distal tip of the injector shaft to provide simultaneous direct visualization of the injector shaft and the round window niche, wherein the otologic injector device includes:
- a syringe containing the therapeutic gel formulation comprising an anti-inflammatory agent and a polymer composition including (i) a functional polymer comprising a first functional group that is about 5% to about 15% by weight of the polymer composition, (ii) a crosslinker comprising a second functional group that is about 0.2% to about 0.6% by weight of the polymer composition, and (iii) water, and wherein the injector shaft is configured to be connected to the syringe;
- delivering the therapeutic gel formulation from the distal tip of the injector shaft to the round window niche while the endoscope provides said simultaneous direct visualization of the injector shaft and the round window niche of the cochlea, wherein the therapeutic gel formulation is at least partially cured to become a gel substance in situ after said delivering to the round window niche of the cochlea;
- and
- after said delivering the therapeutic gel formulation to the round window niche of the cochlea, using the endoscope to visually verify retention of the therapeutic gel formulation at the round window niche of the cochlea.
3 more elements
A method for delivering a therapeutic gel formulation to a round window niche of a cochlea under direct visualization, the method comprising:
- providing direct visualization of the round window niche of the cochlea using a visualization shaft inserted through a tympanic membrane and into a middle ear to visualize the round window niche of the cochlea, wherein the visualization shaft is coupled to an injector shaft of an otologic injector device in a side-by-side configuration;
- during direct visualization of the round window niche of the cochlea using the visualization shaft, advancing the injector shaft of the otologic injector device such that a distal tip of the injector shaft moves toward the round window niche of the cochlea while a distal end of the visualization shaft is spaced proximally from the distal tip of the injector shaft to provide simultaneous direct visualization of both the injector shaft and the round window niche using the visualization shaft, wherein the otologic injector device includes:
- the injector shaft connected with a syringe containing the therapeutic gel formulation including an anti-inflammatory agent and a polymer composition that comprises (i) a functional polymer comprising a first functional group that is about 5% to about 15% by weight of the polymer composition, (ii) a crosslinker comprising a second functional group that is about 0.2% to about 0.6% by weight of the polymer composition, and (iii) water;
- delivering the therapeutic gel formulation from the distal tip of the injector shaft to the round window niche of the cochlea while the visualization shaft provides said simultaneous direct visualization of the injector shaft and the round window niche of the cochlea, wherein the first functional group of the functional polymer and the second functional group of the crosslinker are configured to form a gel at body temperature after said delivering the therapeutic gel formulation to the round window niche of the cochlea;
- and
- after said delivering the therapeutic gel formulation to the round window niche of the cochlea, using the visualization shaft to verify retention of the therapeutic gel formulation at the round window niche of the cochlea using direct visualization.
3 more elements
Dependencies are inferred from the claim text.