Round Window Coupler for Middle Ear Implant Vibrational Transfer

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Solution Overview

Problem

Existing round window coupling techniques for middle ear implants face challenges in accurately positioning the mechanical transducer, leading to inefficient vibrational energy transfer to the cochlea, resulting in suboptimal hearing improvement, especially for lower frequencies.

Innovation Solution

A round window coupling device with a rigid outer shell and a coupling filling, such as silicone, that securely fits into the round window niche, directly couples mechanical vibrations from a floating mass transducer to the perilymph fluid within the cochlea with minimal attenuation, ensuring efficient energy transfer and proper positioning during surgery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional round window coupling techniques are used, then the surgical procedure is simpler, but the positioning accuracy of the mechanical transducer deteriorates, leading to inefficient vibrational energy transfer

Engineering Contradiction:
Improvepositioning accuracy of mechanical transducerVSAvoidcomplexity of coupling device
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent introduces a coupling device as an intermediary component between the mechanical transducer and the round window membrane. This coupling device includes a positioning structure with features such as a flange and positioning pins that mediate the connection, ensuring accurate positioning while distributing mechanical stresses. The intermediary structure resolves the contradiction by providing both precise positioning and manageable complexity through modular design.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The coupling device incorporates pre-formed positioning features (flange, positioning pins, guide holes) that are prepared in advance during device manufacturing. These preliminary structural elements enable accurate positioning to be achieved without requiring complex surgical procedures or intraoperative adjustments, thus improving positioning accuracy while keeping the surgical process relatively simple.

Inventive Principle:
Principle #10Preliminary action

2Loss of energy

If direct coupling of mechanical transducer to round window is attempted, then the device structure is simpler, but the vibrational energy transfer efficiency deteriorates due to positioning errors and energy loss

Engineering Contradiction:
Improvevibrational energy lossVSAvoidstructure complexity of coupling device
Core Design Contradiction:
Loss of energyVSDevice complexity

Solution Approach 1:

The coupling device serves as a mediator that optimizes vibrational energy transfer from the mechanical transducer to the round window membrane. It includes a drive surface that couples to the transducer and a coupling surface that interfaces with the round window, with a coupling element (such as silicone material) that efficiently transmits vibrations while minimizing energy loss. The intermediary structure reduces energy dissipation through proper mechanical coupling and stress distribution.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The coupling device utilizes composite material construction, combining rigid structural elements (for positioning and support) with flexible coupling materials (such as silicone or other elastomers for vibration transmission). This composite approach allows the device to maintain structural integrity while efficiently transmitting vibrational energy, thereby reducing energy loss without requiring overly complex designs.

Inventive Principle:
Principle #40Composite materials

3Reliability

If secure fixation of the coupling device is achieved, then the reliability of energy transfer improves, but the surgical implantation becomes more difficult

Engineering Contradiction:
Improvereliability of vibrational energy transferVSAvoidease of surgical implantation
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The coupling device incorporates pre-designed fixation features such as a flange with fixation holes and positioning pins that are prepared in advance. These preliminary structural elements guide the surgical implantation process and enable secure fixation through relatively simple surgical steps, such as drilling pilot holes and inserting fixation elements, thereby maintaining ease of operation while ensuring reliable fixation.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The coupling device is segmented into functional components: a positioning structure (flange with positioning pins), a coupling element (for vibration transmission), and a fixation structure (with holes for secure attachment). This segmentation allows each component to perform its specific function optimally while simplifying the surgical implantation process, as each segment can be positioned and fixed independently, improving both reliability and ease of operation.

Inventive Principle:
Principle #1Segmentation

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 device achieves enhanced vibrational energy transfer to the cochlea, improving hearing outcomes by securely fixing the coupling device and electrode lead, and minimizing energy loss, thereby enhancing sound perception across various frequencies.

Implementation Method 1

A coupling filling is enclosed within the outer shell and is configured to couple mechanical vibrations from the proximal end of the outer shell to the distal end of the outer shell with minimal attenuation

Methodology Applied
Scientific EffectVibration: Vibration

Implementation Method 2

a drive face is located at the distal end of the outer shell and is configured to interface to perilymph fluid within the cochlea of the recipient patient to deliver vibrations from the coupling filling to the perilymph fluid with minimal attenuation for perception as sound

Methodology Applied
Scientific EffectVibration: Vibration

Data Source

PatentEP3565513B1Middle ear implant coupler for mechanical cochlea stimulation via the round window
Publication Date: 2022.06.22 MED EL ELEKTROMEDIZINISCHE GERAETE GMBH
  • EP3565513B1 patent drawingFigure 1
  • EP3565513B1 patent drawingFigure 2~3
  • EP3565513B1 patent drawingFigure 4A~4C

AI summary

A round window coupling device is described for a hybrid electric-mechanical stimulation hearing implant system. A rigid outer shell securely fits into a round window niche in a cochlear outer surface of a recipient patient. An electrode groove in the outer surface of the outer shell snuggly fits around a portion of a cochlear implant electrode array passing through the round window niche. A coupling filling is enclosed within the outer shell to couple mechanical vibrations from the proximal end to the distal end with minimal attenuation. A transducer receiver at the proximal end connects to and receives vibrations from a drive surface of a mechanical transducer. And a drive face at the distal end interfaces to perilymph fluid within the cochlea of the recipient patient to deliver vibrations from the coupling filling to the perilymph fluid with minimal attenuation for perception as sound.