Helical Coil Ossicular Prosthesis for Stable Incus Engagement
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Solution Overview
Problem
Current incudo-stapedial joint prostheses are inadequate for spanning gaps between the incus and stapes, often unstable, and may cause delayed pressure necrosis due to difficult orientation and crimping, leading to reoccurrence of ossicular discontinuity and decreased hearing.
Innovation Solution
A titanium ossicular prosthesis featuring an open helical coil with adjustable windings and a connecting element, including a bell head or piston, designed to fit various anatomical shapes and angles, eliminating the need for crimping and providing a stable interface between ossicles.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional incudo-stapedial joint prostheses are used, then the gap between incus and stapes can be bridged, but the prostheses are difficult to orient, require crimping, and may cause delayed pressure necrosis
Solution Approach 1:
The prosthesis is divided into distinct functional segments: a helical coil portion for engaging the incus, a connecting element (strut) for structural support, and an engagement structure (bell head or piston) for engaging the stapes. This segmentation allows each component to be optimized for its specific function while simplifying the overall implantation process.
Solution Approach 2:
Instead of requiring the prosthesis to be crimped into place (complex manipulation during implantation), the design inverts the approach by providing a pre-formed helical coil that expands or self-positions within the incus, eliminating the need for crimping operations and reducing implantation complexity.
2Reliability
If current incudo-stapedial joint prostheses are used, then the ossicular chain can be reconstructed, but the prostheses are unstable and lead to reoccurrence of ossicular discontinuity
Solution Approach 1:
The helical coil portion of the prosthesis utilizes a curved, spiral geometry that naturally conforms to the anatomical shape of the incus. This curved design provides inherent stability and distributes mechanical stresses more evenly throughout the ossicular chain, preventing instability and reoccurrence of discontinuity.
Solution Approach 2:
The prosthesis combines different material properties in a single device: the helical coil and connecting element are formed from a first material (such as titanium or stainless steel) providing structural strength, while the engagement structures may utilize different materials or surface treatments to enhance bonding with the ossicular bones, creating a composite structure optimized for both stability and durability.
3Adaptability or versatility
If traditional prostheses are used, then the incus and stapes can be connected, but the prostheses are difficult to orient and require crimping
Solution Approach 1:
The helical coil portion is designed with dynamic characteristics, allowing it to be compressed during implantation and then expand to its full functional size, or be adjusted intraoperatively to accommodate different anatomical configurations. This dynamic capability provides adaptability to various anatomical variations without increasing structural complexity.
Solution Approach 2:
The prosthesis design incorporates universal features that allow it to be applied across different anatomical configurations. The helical coil can engage with various incus shapes and sizes, and the engagement structures (bell head or piston) can be selected or adjusted to match different stapes anatomies, making the prosthesis multi-functional and adaptable to diverse patient requirements.
Data Source
AI summary
An ossicular prosthesis includes a proximal end provided with an open conically helical coil for engaging a first ossicular structure, and a distal bell head, piston, or shoe for engaging a second ossicular structure. A connecting element extends therebetween the two to hold the helical coil structure which engages the second ossicular engagement structure in a preferably fixed relationship. The helical coil defines a plurality of spaced apart adjacent windings, with open spaces between the windings. Each adjacent winding decreases in diameter from the proximal to distal end. The windings of the coil may be adjusted relative to each other in length or angle to fit the anatomy. In accord with a one method of use, the helical coil and optionally other portions of the prosthesis function as an armature or endoskeleton. A cement may be provided over the prosthesis to reconstruct the eroded or missing ossicles.