Inner ear electrode implantation outcome assessment

Inventors

LONG, Christopher Joseph • Smith, Zachary Mark • Carter, Paul Michael • Gibson, Peter

Assignees

Cochlear Ltd

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Publication Number

US-12324915-B2

Patent

Publication Date

2025-06-10

Expiration Date


Abstract

Presented herein are techniques for assessing one or more outcomes associated with implantation of one or more electrodes into the inner ear of a recipient.

Core Innovation

The invention relates to intra-operatively assessing outcomes of inner-ear cochlear electrode implantation by forming at least a portion of a hole in an apical region of an inner ear of a recipient, positioning an apical electrode of a first electrode assembly at the portion of the hole, and performing one or more electrical measurements via electrodes of a second electrode assembly implanted in, or in proximity to, the inner ear. The measured data is analyzed to determine whether the apical electrode has a low-impedance path to a perilymphatic fluid space of the inner ear.

The invention further evaluates whether an apical cochleostomy is electrically sealed after sealing by comparing impedance-based indications of contact and electrical barriers, including references to high-impedance and bone resistivity. It also assesses and optimizes apical electrode placement using supplemental electrical measurements and analysis of current flow patterns and spatial profile behavior, including cross-turn current flow and generalized impedance/current-flow patterning.

The document also describes performing named electrical measurement modalities including Electrode Voltage Tomography (EVT) and Neural Response Telemetry (NRT), and analyzing spatial profile patterns and masking behavior associated with NRT responses. Supporting observations are described using cadaver specimens and measurements such as EVT curves and transverse current distributions, including summed transverse current changes during apical electrode insertion/removal, to correlate proper apical perilymph contact with lower-impedance electrical pathways.

Claims Coverage

The provided independent claims include 2 independent methods. Across these claims, the inventive coverage focuses on apical-region hole formation and apical electrode positioning with electrical-measurement-based determination of a low-impedance path to the perilymphatic fluid space, and a multi-component basal and apical implantation framework that also supports delivery of respective therapies.

Apical-region hole formation and low-impedance perilymph determination

forming at least a portion of a hole in an apical region of an inner ear of a recipient; positioning at least one electrode of a first electrode assembly at the at least the portion of the hole in the apical region of the inner ear of the recipient; performing one or more electrical measurements via electrodes of a second electrode assembly implanted in, or in proximity to, the inner ear; and analyzing data obtained as a result of the one or more electrical measurements performed via the electrodes of the second electrode assembly to determine whether the at least one electrode of the first electrode assembly has a low-impedance path to a perilymphatic fluid space of the inner ear.

Basal-region component plus apical-region component with dual therapy

inserting a first component into a basal region of an inner ear of a recipient; forming at least a portion of a hole at an apical region of the inner ear; inserting a second component into the at least the portion of the hole formed at the apical region of the inner ear; delivering a first therapy to the inner ear via the first component; and delivering a second therapy to the inner ear via the second component.

Claim coverage centers on determining whether an apical electrode positioned in an apical-region hole achieves a low-impedance path to the perilymphatic fluid space using electrical measurements and data analysis, and on implanting components in both basal and apical regions to deliver respective therapies.

Stated Advantages

Documented Applications

Intra-operatively assessing outcomes of inner-ear cochlear electrode implantation, particularly apical electrode placement, by determining whether an apical electrode has a low-impedance path to the perilymphatic fluid space and by assessing electrical sealing of an apical cochleostomy.

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