Multi-Layer Cochlear Implant Electrode for Low-Trauma Drug Release
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Solution Overview
Problem
Cochlear trauma and inadequate drug delivery during cochlear implant insertion are challenges in existing cochlear implant systems, with issues such as mechanical trauma, unclear drug distribution, and insufficient anti-inflammatory effects.
Innovation Solution
A cochlear hearing aid system with a multi-layer electrode lead coated with chemically and physically cross-linked gelatin layers, embedded with dexamethasone sodium phosphate, to enhance lubricity and controlled drug release, reducing trauma and providing a desired temporal drug profile.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If sodium hyaluronate is applied on top of the round window before electrode array insertion, then cochlear trauma may be reduced, but the drug may be wiped from the electrode array by the round window membrane during insertion
Solution Approach 1:
The gelatin coating is applied to the electrode array before insertion, with drugs embedded in the coating layers. This preliminary preparation ensures the drug is already in position on the electrode surface, preventing the wiping effect that occurs when applying lubricant separately before insertion.
Solution Approach 2:
The invention uses a composite structure combining gelatin coating with embedded drug molecules. The gelatin provides lubrication while simultaneously serving as a carrier matrix for the anti-inflammatory drugs, ensuring both mechanical protection and pharmacological delivery during insertion.
2Reliability
If anti-inflammatory drugs are loaded on the silicone component enclosing the electrode array, then drug delivery is enabled, but the amount of drug released during the first days after implantation is comparatively low
Solution Approach 1:
The gelatin coating is applied selectively on the outer surface of the electrode array where it contacts the cochlear tissue. This localized application ensures concentrated drug delivery at the critical interface between the implant and surrounding tissue, maximizing the anti-inflammatory effect where it is most needed.
Solution Approach 2:
The invention changes the physical and chemical parameters of the drug delivery system by using gelatin coating with controlled cross-linking. This creates a matrix that enables sustained drug release over time, with the coating structure controlling the release kinetics to provide adequate drug amounts during the critical first days after implantation.
3Ease of manufacture
If anti-inflammatory drugs are injected through the tympanic membrane into the middle ear cavity, then drug delivery is simplified, but the extent of drug diffusion from the middle ear cavity into the inner ear is unclear
Solution Approach 1:
The gelatin-coated electrode array serves as an intermediary carrier that directly delivers drugs from the external environment into the cochlear space. By embedding drugs in the coating that contacts the cochlea during insertion, the system bypasses the uncertain diffusion pathway through the round window membrane and Eustachian tube, ensuring precise drug placement in the target location.
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 system significantly reduces cochlear trauma by 30% and achieves a controlled drug release profile, with short-term and long-term anti-inflammatory effects, minimizing inflammation and ensuring effective acoustic stimulus perception.
Implementation Method 1
a first layer of gelatin which is coated and chemically cross-linked selectively on a silicone outer surface of the electrode lead
Implementation Method 2
a second layer of gelatin which is coated and physically cross-linked onto the first layer
Implementation Method 3
significantly enhances the lubricity of the electrode lead, thereby significantly reducing a maximum insertion and/or friction force acting on the recipient's cochlea during insertion
Implementation Method 4
achieves a controlled drug release profile, with short-term and long-term anti-inflammatory effects
Data Source
AI summary
A cochlear hearing aid system for providing electrical stimulation to auditory nerve fibers of a cochlea of a recipient of the cochlear hearing aid system is disclosed. The cochlear hearing aid system comprises a microphone configured to receive an acoustical signal and provide an audio signal based on the acoustical signal; a signal processor unit configured to receive the audio signal and process the audio signal; an electrode lead including a plurality of electrodes configured to stimulate the auditory nerve fibers based on the processed audio signal, wherein the electrode lead comprises: an electrode carrier maintaining the electrode contacts and wires, wherein the electrode carrier is made of silicone and is loaded by dexamethasone; a first layer (or sub-layers) of gelatin which is coated and chemically cross-linked selectively on a silicone outer surface of the electrode lead, wherein dexamethasone sodium phosphate is embedded in the first layer (or sub-layers); and a second layer of gelatin which is coated and physically cross-linked onto the first layer.