Patient specific adjustment of cochlear implant insertion trajectories

Inventors

Frölich, MaxSchurzig, DanielSteinhardt, Uwe

Assignees

MED EL Elektromedizinische Geraete GmbH

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Publication Number

US-12023223-B2

Patent

Publication Date

2024-07-02

Expiration Date


Abstract

An electrode guide device is described for inserting a cochlear implant electrode array into a scala tympany of a patient cochlea has an electrode guide tube and an end positioner at least partially contained within a cavity of the guide tube at the distal end and slidable within the cavity for adjustable extension beyond the distal end. The end positioner has a natural curvature that is constrained by the cavity of the guide tube for any portion contained within the cavity of the guide tube, and any portion of the end positioner extended beyond the distal end follows the natural curvature. The electrode array can be introduced through the groove of the guide tube along a first directional line towards an electrode opening in the patient cochlea, and then the distal end of electrode array emerging from the guide tube is redirected by the extension of the end positioner along a different second directional line through the electrode opening.

Core Innovation

The invention relates to an intrasurgical electrode guide device for inserting an electrode array of a cochlear implant into a scala tympany of a patient cochlea. The device includes a guide tube having a cavity, a proximal end and a distal end connected by a partially enclosed groove having a slot opening along one side, allowing loading and/or unloading of the electrode array so the electrode array can slide within the groove to project a distal end of the electrode array beyond the distal end of the guide tube.

The device further includes an end positioner with a straight section at its proximal end and a curved section at its distal end. The end positioner is slidable and retractable within the cavity, with the curved section entirely contained within the cavity in a retracted position and extending beyond the distal end of the guide tube in an extended position, with the guide tube and end positioner configured for controlled cooperation by a surgeon.

Using this controlled cooperation, the electrode array is introduced through the groove along a first directional line towards an electrode opening in an outer surface of the patient cochlea, and when the curved section is in the extended position the distal end emerging from the distal end of the guide tube is redirected by the curved section in a different second directional line through the electrode opening into the scala tympany. The document describes decoupling of drilling trajectory from insertion trajectory and added degrees of freedom for translation, rotation, and extension/retraction, including patient-specific adjustment for improved patient safety.

Claims Coverage

The partial document contains two independent claims: an intrasurgical electrode guide device and a method for inserting an electrode array. Across these independent claims, the coverage emphasizes a guide tube with a partially enclosed groove and slot opening for loading and sliding along a first directional line, and a curved, retractable end positioner that redirects the electrode array into scala tympany along a different second directional line, including endoscope-assisted guidance in the method claim.

Guide tube with partially enclosed groove and slot opening for sliding projection along a first directional line

A guide tube having a cavity, a proximal end and a distal end connected by a partially enclosed groove having a slot opening along one side to allow loading and/or unloading of the electrode array into the guide tube so that the electrode array can slide within the groove to project a distal end of the electrode array beyond the distal end of the guide tube; the guide tube and the end positioner are configured for controlled cooperation by a surgeon so that the electrode array can be introduced through the groove of the guide tube along a first directional line towards an electrode opening in an outer surface of the patient cochlea.

Retractable curved end positioner with straight and curved sections extending along a second directional line

An end positioner having a straight section at its proximal end and a curved section at its distal end, the end positioner slidable and retractable within the cavity and configured so that the curved section is entirely contained within the cavity in a retracted position and the curved section extends beyond the distal end of the guide tube in an extended position; configured so that the distal end of the electrode array emerging from the distal end of the guide tube is redirected by the curved section of the end positioner in the extended position along a different second directional line through the electrode opening into the scala tympany.

Endoscopic visualization to extend endoscope and curved section toward an optimal insertion angle

Pushing an endoscope through the guide tube to the distal end so as to enable visual observation by a surgeon through the endoscope of the outer surface of the patient cochlea; operating the guide tube and the end positioner to extend the endoscope and the curved section of the end positioner beyond the distal end of the guide tube in the extended position until visual observation through the endoscope indicates that the curved section of the end positioner is pointing along a directional line towards the electrode opening location at an optimal electrode array insertion angle.

Loading electrode array and sliding through groove into scala tympany along the directional line

Loading the electrode array through the proximal end of the guide tube; and sliding the electrode array through the groove of the guide tube to project a distal end of the electrode array beyond the distal end of the guide tube and the curved section of the end positioner in the extended position, through the electrode opening and into the scala tympany of the cochlea along the directional line.

Overall, the independent claims cover an electrode guide device that uses a guide tube with a partially enclosed groove and slot opening to slide an electrode array along a first directional line and an end positioner with a curved section that is retractable and then extends to redirect the distal end through an electrode opening into the scala tympany along a different directional line. The method claim further adds endoscope-assisted extension until a directional line at an optimal insertion angle is visually indicated, followed by loading and sliding of the electrode array into the scala tympany.

Stated Advantages

Improved patient safety, especially in minimally invasive robotic surgery.

Documented Applications

Intrasurgical use for inserting an electrode array of a cochlear implant into the scala tympany of a patient cochlea, including in minimally invasive robotic surgery.

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