Cochlear Implant Electrode Lead Misplacement Detection

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Solution Overview

Problem

During lead insertion procedures for cochlear implants, electrode leads can inadvertently be inserted into the vestibular canal instead of the cochlea, which is not readily detectable intraoperatively due to the lack of visual feedback and ineffective conventional measurement methods.

Innovation Solution

A diagnostic system that applies acoustic stimulation and records evoked response signals to detect anomalies, determining if the electrode lead is mispositioned in the vestibular canal by analyzing changes in amplitude and phase of the evoked responses, and takes remedial actions such as notification or retraction.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional intraoperative measurement methods (impedance, eCAP) are used, then the measurement process is simple, but misplacement of electrode lead cannot be detected

Engineering Contradiction:
Improvedetection accuracyVSAvoidsystem complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent introduces acoustic stimulation as an intermediary to indirectly detect electrode lead placement. Instead of directly measuring electrode position, the system uses acoustic signals that propagate through fluid pathways, with the evoked response serving as a mediator that reveals placement accuracy without requiring direct visualization or complex imaging

Inventive Principle:
Principle #24Intermediary (Mediator)

2Loss of information

If the surgeon cannot see where the electrode lead is being placed, then the insertion procedure is simpler, but misplacement into vestibular canal cannot be detected

Engineering Contradiction:
Improvevisual feedbackVSAvoidmisplacement detection
Core Design Contradiction:
Loss of informationVSDifficulty of detecting and measuring

Solution Approach 1:

The patent replaces the mechanical/visual inspection method with an acoustic field-based detection system. Instead of relying on direct visual observation of the insertion site, the system uses acoustic stimulation and evoked response measurement to infer electrode lead position, substituting a non-invasive acoustic field measurement for direct mechanical visualization

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

3Reliability

If real-time detection of misplacement is implemented, then insertion procedure effectiveness is improved, but procedure time increases

Engineering Contradiction:
Improveinsertion accuracyVSAvoidprocedure duration
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent implements continuous real-time monitoring of evoked responses during the insertion procedure. Rather than performing discrete checks at intervals, the system continuously measures acoustic evoked responses as the electrode lead is being inserted, allowing immediate detection of misplacement without interrupting the procedural flow

Inventive Principle:
Principle #20Continuity of useful action

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

Facilitates real-time detection and correction of electrode lead misplacement, leading to shorter and more effective insertion procedures.

Implementation Method 1

a diagnostic system may be configured to direct an acoustic stimulation generator to apply acoustic stimulation to a recipient of a cochlear implant

Methodology Applied
Scientific EffectAcoustic stimulation: Sound

Implementation Method 2

direct the cochlear implant to use an electrode on the electrode lead to record an evoked response signal that occurs within the recipient in response to the acoustic stimulation

Methodology Applied
Scientific EffectEvoked response signal:

Data Source

PatentUS11918411B2Intraoperative detection of electrode lead misplacement during a lead insertion procedure
Publication Date: 2024.03.05 ADVANCED BIONICS AG
  • US11918411B2 patent drawing
  • US11918411B2 patent drawing
  • US11918411B2 patent drawing

AI summary

An exemplary diagnostic system may be configured to direct an acoustic stimulation generator to apply acoustic stimulation to a recipient of a cochlear implant during an insertion procedure in which an electrode lead coupled to the cochlear implant is supposed to be inserted into a cochlea of the recipient, direct the cochlear implant to use an electrode on the electrode lead to record an evoked response signal that occurs within the recipient in response to the acoustic stimulation, detect an anomaly in the evoked response signal, and determine, based on the anomaly, that the electrode lead is being inserted into a vestibular canal instead of into the cochlea.