Actuated electrode lead in minimally invasive cochlear implant surgery

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Solution Overview

Problem

Cochlear implantation surgeries face challenges in reducing surgery time, patient stress, and risk of facial nerve damage due to difficulties in inserting electrode arrays through minimally invasive techniques, where geometrical boundary conditions limit visual access and require additional electrode lead length for safe insertion and storage.

Innovation Solution

An implantable electrode arrangement with a lead structure control element, potentially using shape memory alloy elements, that changes shape from a straight insertion state to a coiled storage state within the mastoid tunnel, allowing for secure insertion and self-storing excess lead length without additional cavities, thereby reducing manual handling and mechanical load.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Loss of time

If minimally invasive cochlear implantation technique is used, then patient stress and surgery time are reduced, but visual access to cochlea opening is limited and mechanical load on electrode lead increases

Engineering Contradiction:
Improvesurgery timeVSAvoidvisual access to cochlea opening
Core Design Contradiction:
Loss of timeVSEase of operation

Solution Approach 1:

The electrode lead is pre-formed with a memory shape that includes a coiled configuration. Before insertion, the lead is constrained in a straight configuration to fit through the narrow mastoid tunnel. After insertion, the constraint is released and the lead automatically transforms to its pre-programmed coiled memory shape, providing storage capacity without requiring additional surgical cavities.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The electrode lead utilizes shape memory alloy material that changes its physical configuration in response to temperature changes. The lead is heated to above its transformation temperature to transform from the coiled memory shape to a straight insertion shape, then cooled to transform back to the coiled storage shape, thereby adapting to different spatial requirements during surgery.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If additional electrode lead length is provided for safe insertion, then mechanical load and risk of damage are reduced, but excess lead requires storage space in the limited surgical field

Engineering Contradiction:
Improvemechanical load on electrode leadVSAvoidstorage space in mastoid tunnel
Core Design Contradiction:
ReliabilityVSArea of stationary object

Solution Approach 1:

The electrode lead is designed with a coiled or helical configuration for storage, transforming from a straight insertion shape to a curved/coiled storage shape. This coiled configuration efficiently packs the excess lead length into a compact volume within the limited mastoid tunnel space, eliminating the need for additional storage cavities while maintaining the necessary lead length for safe insertion and handling.

Inventive Principle:
Principle #14Spheroidality (Curvature)

3Ease of operation

If conventional mastoidectomy is used, then visual access and space for surgical insertion mechanisms are adequate, but surgery time increases and risk of facial nerve damage increases

Engineering Contradiction:
Improvevisual access and surgical spaceVSAvoidsurgery time
Core Design Contradiction:
Ease of operationVSLoss of time

Solution Approach 1:

The patent extracts the function of lead storage from the surgical field by utilizing the mastoid tunnel itself as the storage location. The electrode lead is designed to autonomously transform and store within the tunnel after insertion, eliminating the need for separate storage cavities or additional surgical steps, thereby reducing surgery time while maintaining ease of operation.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The electrode lead is self-actuating through its memory shape properties. After insertion through the minimally invasive approach, the lead automatically transforms from its constrained straight configuration to its coiled storage configuration without requiring additional surgical intervention or manual manipulation, thereby reducing surgery time and eliminating the need for additional storage cavities.

Inventive Principle:
Principle #25Self-service

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 minimally invasive cochlear implantation by automatically coiling excess electrode lead within the mastoid tunnel, reducing surgery time and minimizing risk of facial nerve damage through controlled shape transformation and secure storage, eliminating the need for additional storage cavities and manual handling.

Implementation Method 1

An implantable electrode arrangement with a lead structure control element, potentially using shape memory alloy elements, that changes shape from a straight insertion state to a coiled storage state within the mastoid tunnel

Methodology Applied
Scientific EffectShape memory alloy: Shape Memory Alloy

Implementation Method 2

changes shape from a straight insertion state to a coiled storage state through controlled shape transformation

Methodology Applied
Scientific EffectPhase change: Phase Change

Data Source

PatentEP3510797B1Actuated electrode lead in minimally invasive cochlear implant surgery
Publication Date: 2020.06.10 MED EL ELEKTROMEDIZINISCHE GERAETE GMBH
  • EP3510797B1 patent drawingFigure 1
  • EP3510797B1 patent drawingFigure 2A~2B
  • EP3510797B1 patent drawingFigure 3

AI summary

An implantable electrode arrangement for a cochlear implant system is described. An electrode lead contains a lead structure control element configured to control a lead shape of the electrode lead between an insertion state wherein the electrode lead within a mastoid tunnel has a longitudinal lead axis lying entirely along the tunnel axis, and a post-insertion state wherein a facial recess portion of the electrode lead fitting within a limited diameter portion of the mastoid tunnel associated with a facial recess portion of the mastoid bone has a longitudinal lead axis along the tunnel axis, and a storage portion of the electrode lead fitting within an enlarged diameter portion of the mastoid tunnel lateral to the facial recess portion has a longitudinal lead axis coiled in a helical shape radially around the tunnel axis.