Auditory Ossicle Prosthesis with Circumferential Spikes for Stapes Engagement
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Solution Overview
Problem
Existing auditory ossicle prostheses face challenges in achieving a secure and stable fit on the stapes head, requiring individual shaping for each patient, which is impractical, and often result in limited sound conduction due to anatomical differences and mechanical instability.
Innovation Solution
The second coupling element of the prosthesis features spikes distributed around its circumference to ensure a secure mechanical connection with the stapes head, providing a non-slip and positionally stable fit, along with a padded section to prevent cavity formation and enhance sound conduction, and optional features like ball joints for flexibility and biocompatible materials for durability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If individual shaping of the coupling element is performed for each patient, then the fit on the stapes head is optimized, but the manufacturing complexity and cost increase significantly
Solution Approach 1:
The coupling element is divided into standardized geometric components (bell shape, clip shape) with modular features. The spikes are standardized in number (2-4) and configuration, allowing the prosthesis to be manufactured in standard sizes while still achieving secure fit through the distributed spike arrangement that adapts to anatomical variations.
Solution Approach 2:
The invention provides multiple standardized size variants of the prosthesis with different overall dimensions, bell diameters, and spike configurations. By selecting appropriate parameter ranges from predefined sets rather than customizing each component, the system achieves patient-specific adaptation while maintaining manufacturing efficiency.
2Ease of manufacture
If the prosthesis uses a simple standardized design, then the ease of manufacture increases, but the adaptability to individual anatomical differences decreases
Solution Approach 1:
The coupling element is designed with universal features that can accommodate variations in stapes head anatomy. The distributed spikes (2-4 spikes) can engage with different stapes head shapes and sizes, and the bell or clip configurations can adapt to various anatomical conditions, allowing a single standardized design to serve multiple patient anatomies.
Solution Approach 2:
The prosthesis incorporates flexible elements and joint mechanisms that allow dynamic adaptation to anatomical variations. The coupling element can flex and adjust its position to accommodate individual anatomical differences, providing both standardized manufacturing and patient-specific adaptation.
3Strength
If the prosthesis body is made rigid for durability, then the strength increases, but the ability to accommodate anatomical variations and reduce mechanical stress decreases
Solution Approach 1:
The prosthesis employs different material properties or structural characteristics in different regions. The main prosthesis body may be rigid for strength, while the coupling elements and spikes incorporate flexible or compliant features to accommodate anatomical variations and reduce stress concentrations, achieving both durability and adaptability.
Data Source
Figure 1a
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Figure 1c
AI summary
An ossicular prosthesis comprising a sound-conducting prosthesis body formed with a first coupling element and a second coupling element. The second coupling element is designed as a clip or a slotted bell and has an access opening into a receiving space having an inner surface in the axial extension of the prosthesis body. The inner surface is bounded by a peripheral outer edge having multiple interruptions. The second coupling element has, on an outer edge of the inner surface of the receiving space, at least two spikes distributed around the periphery of the outer edge, extending in a direction parallel to the axial extension of the elongate prosthesis body. In an implanted state, the spikes engage into the head of the stapes to effectuate a secure hold of the second coupling element.