Malleable Cochlear Implant Lead Holder for Bone Growth

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Solution Overview

Problem

Cochlear implant electrode arrays in children face retraction due to mastoid bone growth, leading to reduced effectiveness and discomfort, as existing solutions fail to consistently prevent post-surgical mechanical strain and excess lead slack issues.

Innovation Solution

A flexible intracochlear electrode array with a malleable lead holder or string connectors that can be deformed intra-surgically to secure the electrode lead, decoupling mechanical strain and accommodating bone growth, while avoiding pressure on anatomical structures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the electrode lead is made longer to accommodate mastoid bone growth in children, then the growth compensation capability is improved, but excess lead slack presses against the skin causing discomfort and cosmetic issues

Engineering Contradiction:
Improvegrowth compensation capabilityVSAvoidskin pressure discomfort
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The electrode lead is divided into two functional segments: a fixed-length intracochlear portion that maintains stable electrode array positioning, and a separate mastoid bowl portion that can be looped to accommodate growth. This segmentation allows the lead to adapt to bone growth without creating excessive slack that would press against the skin.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The lead management solution transitions from linear lead routing to three-dimensional looping within the mastoid bowl. By creating loops in the mastoid bowl portion, the lead accommodates bone growth in multiple directions without creating linear tension or skin pressure, effectively using spatial dimensionality to resolve the contradiction.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Stability of the object's composition

If the electrode array is inserted deeply into the cochlea to prevent retraction, then the anchoring stability is improved, but the insertion complexity and surgical difficulty increase

Engineering Contradiction:
Improveelectrode array anchoring stabilityVSAvoidinsertion procedure complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The lead is segmented into an intracochlear portion and a mastoid bowl portion with distinct functions. The intracochlear portion provides stable anchoring through moderate insertion, while the mastoid bowl portion with its looping capability provides additional stability without requiring deep cochlear insertion, thereby reducing surgical complexity.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The mastoid bowl acts as an intermediary structure that provides mechanical anchoring for the electrode lead. By routing the lead through the mastoid bowl and creating loops, the system achieves stable anchoring without requiring the electrode array to be inserted deeply into the cochlea, thus simplifying the insertion procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Adaptability or versatility

If the electrode lead is looped in the mastoid opening to compensate for bone growth, then the growth accommodation capability is improved, but the looping variability between surgeons and patients reduces consistency

Engineering Contradiction:
Improvegrowth accommodation capabilityVSAvoidlooping procedure consistency
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The lead is divided into a fixed intracochlear portion and a separate mastoid bowl portion designed specifically for looping. This segmentation provides a standardized looping region that surgeons can consistently manipulate, reducing variability in the procedure while maintaining growth accommodation capability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The lead design incorporates specific parameter changes in the mastoid bowl portion, such as increased flexibility or specific dimensional characteristics, that enable consistent looping behavior. These parameter changes allow the lead to accommodate growth through standardized looping techniques that reduce surgeon-to-surgeon variability.

Inventive Principle:
Principle #35Parameter changes

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

The solution effectively prevents electrode array retraction and reduces discomfort by securely anchoring the electrode lead within the cochlea, allowing for growth compensation without pressing against skin, thus maintaining cochlear implant functionality and aesthetics.

Implementation Method 1

The lead holder is malleable and adapted to be intra-surgically deformed into and retain a new desired shape so as to secure the lead distal end at the electrode opening

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Implementation Method 2

For example, the lead holder may include an embedded nitinol element with malleable characteristics

Methodology Applied
Scientific EffectShape memory effect: Shape Memory Alloy

Data Source

PatentEP3204107B1Modified electrode lead for cochlear implants
Publication Date: 2019.09.25 MED EL ELEKTROMEDIZINISCHE GERAETE GMBH
  • EP3204107B1 patent drawingFigure 1
  • EP3204107B1 patent drawingFigure 2A~2B
  • EP3204107B1 patent drawingFigure 3A~3B

AI summary

An implantable electrode arrangement for a cochlear implant system is described. The arrangement includes a flexible intracochlear electrode array having an outer surface with electrode contacts for applying cochlear stimulation signals to target neural tissue within the implanted cochlea. A flexible extracochlear electrode lead is coupled at a lead proximal end to an implanted signal processor that provides the cochlear stimulation signals, and connected at a lead distal end to a proximal end of the electrode array. A lead holder is connected to the lead distal end and has an initial shape. The lead holder is malleable and adapted to be intra-surgically deformed into and retain a new desired shape so as to secure the lead distal end at the electrode opening into the implanted cochlea and decouple post-surgical mechanical strain at the lead distal end from the electrode array.