US-12616837-B2 - Methods and apparatuses for extracochlear stimulation

US12616837B2US 12616837 B2US12616837 B2US 12616837B2US-12616837-B2

Abstract

Devices and methods for extracochlear stimulation are described herein. Such devices and methods may be configured for improving hearing in a subject in need thereof in any frequency range. In some embodiments, high frequency ranges are particularly targeted by the energy delivery elements provided herein. Low frequency ranges may be amplified by an acoustic amplifier, in various embodiments. Further, an external surface of the cochlea may be minimally prepared or altered prior to or during electrode placement on the cochlear surface. Such minimal preparation may include: disrupting mucosa on the external surface of the cochlea, applying an acid to the external surface of the cochlea, or applying a tissue growth factor to the external surface of the cochlea.

Inventors

Jay DHULDHOYA
Francis Wong
Peter Luke Santa Maria
Ina Bianca Yu
David Hindin
Saniya Ali

Assignees

THE BOARD OF TRUSTEES OF THE LELAND STANFORD JUNIOR UNIVERSITY

Dates

Publication Date: 20260505
Application Date: 20211015

Claims (9)

1 . A method, comprising: using an energy delivery element for stimulating a spiral ganglion of a cochlea from a middle ear cavity, wherein the energy delivery element comprises: (i) a flexible substrate configured to conform to a curvature of one or more of: a cochlear promontory, one or more projections of a hypotympanum, a cavity within a round window niche, or a combination thereof within a middle ear cavity; (ii) one or more electrical contacts coupled to the flexible substrate and configured to deliver electrical stimuli to activate a spiral ganglion of a basal turn of a cochlea; and (iii) characterized in that the energy delivery element further comprises one or more perforations defined by the flexible substrate and configured to promote long-term electrical contact with one or more of: the cochlear promontory, the one or more projections of the hypotympanum, the cavity within the round window niche, or the combination thereof within the middle ear cavity; and delivering the electrical stimuli to activate spiral ganglion of a cochlea from a middle ear cavity and for improving high-frequency hearing while preserving a residual low-frequency hearing.
2 . The method of claim 1 , wherein the improving high frequency hearing comprises improving hearing in a frequency range of about 2 kHz to about 8 kHz.
3 . The method of claim 1 , wherein the residual low-frequency hearing comprises having pure tone audiometric thresholds lower than about 70 dB in a frequency range of about 125 Hz to about 500 Hz.
4 . The method of claim 1 , further comprising implanting the energy delivery element, wherein the implanting comprises establishing electrical communication by adhesively attaching the energy delivery element to one or more tissues.
5 . The method of claim 1 , further comprising implanting the energy delivery element, wherein the implanting comprises establishing electrical communication by at least one of applying mechanical force to the energy delivery element against one or more tissues, or mechanically attaching the energy delivery element to one or more tissues.
6 . The method of claim 1 , further comprising confirming electrical communication between the energy delivery element and one or more tissues based on an impedance measurement.
7 . The method of claim 1 , wherein the delivering electrical stimuli comprises current steering with energy delivery element.
8 . The method of claim 1 , further comprising individualizing the electrical stimuli by mapping a position of the energy delivery element to a tonotopicity of the basal turn of the cochlea.
9 . The method of claim 1 , further comprising implanting the energy delivery element, wherein the implanting occurs without drilling a bone of the cochlear promontory.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the priority benefit of U.S. Provisional Patent Application Ser. Nos. 63/091,933 filed Oct. 15, 2020; and 63/193,396 filed May 26, 2021; both of which are herein incorporated by reference in their entireties. INCORPORATION BY REFERENCE All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety, as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference in its entirety. TECHNICAL FIELD This disclosure relates generally to the field of medical device implants, and more specifically to the field of cochlear implants. Described herein are methods and apparatuses for extracochlear stimulation. BACKGROUND Sensorineural hearing loss is a condition estimated to affect over one third of US adults aged between 65 and 74, over half of adults over 75 years old, and over 460 million people worldwide. There are many causes of sensorineural hearing loss including aging, noise exposure, and drug-induced ototoxicity that may ultimately lead to dysfunction or loss of hair cells within the cochlea that are responsible for transducing acoustic waves to neuronal signals. It typically affects higher frequencies first and, for patients with the most severe degree of sensorineural loss where hearing aids are no longer effective, it severely impairs speech comprehension which has a profound effect on quality-of-life. These profound effects on quality-of-life include well established links to social withdrawal, isolation, depression, and dementia. Currently, mild-to-moderate hearing loss is well treated with hearing aids, whereas severe hearing loss or severe-to-profound hearing loss is best addressed with a cochlear implant, which electrically stimulates the tonotopically arranged neurons within the cochlea. However, despite its effectiveness, a cochlear implant is considered an irreversible and invasive procedure that involves insertion of an electrode into the cochlea that often damages the delicate structures within the inner ear and carries a high risk of residual hearing loss. The only option for those with good low frequency hearing, but poor high frequency hearing, is to attempt a hybrid style cochlear implant. However, even this hybrid style comes with a high chance of residual hearing loss. This risk of residual hearing loss that occurs with placing an electrode inside the cochlea prevents many patients from considering cochlear implants as a treatment option, and so they continue to struggle with hearing aids that cannot work for their hearing loss. BRIEF DESCRIPTION OF THE DRAWINGS The foregoing is a summary, and thus, necessarily limited in detail. The above-mentioned aspects, as well as other aspects, features, and advantages of the present technology are described below in connection with various embodiments, with reference made to the accompanying drawings. FIG. 1 shows the tonotopic arrangement of a cochlea. FIG. 2 shows one example of a system diagram showing the components of an extracochlear implant system. FIG. 3 shows one embodiment of a device comprising a multi-channel electrode array coupled to the cochlear promontory. FIG. 4 shows another embodiment of an energy delivery element positioned against the cochlear promontory and connected to an implanted stimulator. FIG. 5 shows a method of delivering an energy delivery element through a mastoid approach, such that the array is attached to a stimulator via a cable routed through the facial recess. FIG. 6 shows one embodiment of an energy delivery element attached to a stimulator via a cable routed through a transcanal approach and connected to a stimulator located behind the ear. FIG. 7 shows another embodiment of an energy delivery element that is delivered to the middle ear and cochlear promontory through a transcanal approach. FIG. 8 shows a combination of an energy delivery element for electrical stimulation of high frequencies with acoustic sound wave amplification of lower frequencies. FIG. 9A shows a perspective view of a configuration of electrodes on an array surface. FIG. 9B shows a side view of two different shapes of an energy delivery element. FIG. 9C shows a side view of a flexed configuration of at least part of an energy delivery element. FIG. 10A shows a front view of another embodiment of an electrode configuration of an energy delivery element. FIG. 10B shows a back view of the embodiment of FIG. 10A. FIG. 10C shows a zoomed-in view of the embodiment of FIG. 10A. FIGS. 11A-11C show various steps of a method of energy delivery element attachment that comprises implanting the array in the submucosal space underlying the cochlea promontory. FIG. 12 shows another method of energy delivery element attachment that comprises a capillary network of adhesive and associated device structure. FIG. 13 shows one embodiment of an energy delivery element