Cochlear Implant Electrode Array Real-Time Insertion Monitoring

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Solution Overview

Problem

Current cochlear implant insertion methods lack real-time feedback on electrode array placement within the cochlea, leading to potential misplacement and reduced performance, as surgeons cannot visually confirm the exact insertion depth during surgery, and imaging techniques are often unavailable or delayed.

Innovation Solution

A method and system that measure electrode impedance values to determine the insertion status of the electrode array in real-time, using conductivity measurements between contacts and a remote ground electrode or other contacts, providing immediate feedback on user interfaces to ensure accurate placement and detect issues like tip fold-overs, buckling, or air bubbles.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If imaging techniques like X-ray or MRI are used to determine electrode array placement, then positioning accuracy is improved, but device complexity and surgical time increase due to additional equipment and post-surgical delays

Engineering Contradiction:
Improveelectrode array placement accuracyVSAvoidimaging equipment requirements
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The system continuously monitors impedance values during electrode array insertion and provides real-time feedback to the surgeon through a display interface. This allows immediate detection of proper insertion depth without requiring post-surgical imaging, thereby improving placement accuracy while avoiding additional equipment and delays

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The patent replaces complex mechanical imaging systems (X-ray, MRI) with an electrical measurement system that uses impedance sensing. This substitution provides equivalent or superior placement information without the need for heavy imaging equipment, reducing device complexity and enabling intraoperative decision-making

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Manufacturing precision

If imaging techniques are used to confirm electrode array insertion, then placement accuracy is improved, but loss of time occurs due to delayed imaging after surgery

Engineering Contradiction:
Improveelectrode array placement accuracyVSAvoidsurgical delay
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The system performs placement verification during the surgical procedure itself by continuously monitoring impedance values as the electrode array is inserted. This preliminary action eliminates the need for post-surgical imaging delays, allowing the surgeon to confirm proper placement before completing the surgery

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Real-time impedance monitoring provides immediate feedback during insertion, enabling the surgeon to adjust placement if needed before finalizing the surgery. This eliminates time loss associated with delayed imaging and potential re-surgery

Inventive Principle:
Principle #23Feedback

3Manufacturing precision

If real-time impedance monitoring is implemented, then electrode array placement accuracy is improved, but device complexity increases due to additional measurement and control circuitry

Engineering Contradiction:
Improveelectrode array placement accuracyVSAvoidmeasurement and control circuitry
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The impedance measurement circuitry serves multiple functions: it monitors electrode array insertion depth, detects proper placement, and identifies potential complications. This multi-functionality justifies the added circuitry complexity by providing comprehensive surgical guidance without requiring separate systems

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The electrode array itself serves as the sensing element by utilizing its inherent electrical properties (impedance) that change with insertion depth. This self-service approach minimizes additional complexity as the existing electrode structure provides the measurement signal without requiring separate sensors

Inventive Principle:
Principle #25Self-service

4Device complexity

If no real-time feedback is provided during electrode array insertion, then device complexity is reduced, but loss of information occurs regarding exact insertion depth

Engineering Contradiction:
Improvefeedback system complexityVSAvoidinsertion depth information
Core Design Contradiction:
Device complexityVSLoss of information

Solution Approach 1:

The system provides continuous feedback during insertion by monitoring impedance changes and displaying real-time status information. This prevents information loss about insertion depth by making the data available to the surgeon during the procedure, enabling informed decision-making without excessive system complexity

Inventive Principle:
Principle #23Feedback

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables real-time monitoring and correction of electrode array placement during surgery, distinguishing between tissue and air bubble-induced impedance changes, thereby optimizing cochlear implant performance and reducing the need for post-surgical adjustments.

Implementation Method 1

measuring an electrode impedance value (EIV) associated with the electrode contact

Methodology Applied
Scientific EffectElectrical Impedance: Electrical Resistance

Data Source

PatentEP3137157B1Real time cochlear implant insertion status indicator
Publication Date: 2019.01.02 MED EL ELEKTROMEDIZINISCHE GERAETE GMBH
  • EP3137157B1 patent drawingFigure 1
  • EP3137157B1 patent drawingFigure 2
  • EP3137157B1 patent drawingFigure 3~5

AI summary

A method of determining insertion status of a cochlear implant electrode array into a cochlea of a patient is provided. The method includes measuring conductivity associated with an electrode in the electrode array. Insertion status of the electrode is determined based, at least in part, on the measured conductivity.