Adjustable Middle Ear Prosthesis with Deformable Stapes Legs
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Solution Overview
Problem
Existing middle ear prostheses often fail to accommodate the varying anatomical dimensions of individual patients, leading to potential trauma and further hearing loss due to mismatched lengths between the tympanic membrane and the stapes, resulting in bias loads on the oval window membrane.
Innovation Solution
A middle ear prosthesis made of stiff deformable material with adjustable U-shaped stapes engagement legs and a planar head end, allowing for flexible engagement with the tympanic membrane and stapes, and featuring a method of production using micro-laser cutting to ensure precise adaptation and reduced tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional middle ear prostheses with fixed-length attachment legs are used, then the device structure is simple and easy to manufacture, but the prosthesis cannot accommodate varying anatomical dimensions of individual patients, leading to mismatched lengths and bias loads on the oval window membrane
Solution Approach 1:
The attachment legs are designed as deformable elements that can be adjusted in length during surgery by cutting them to the required length. This dynamic adjustability allows the prosthesis to adapt to varying anatomical dimensions of individual patients while maintaining a relatively simple base structure.
Solution Approach 2:
The length parameter of the attachment legs can be changed during the surgical procedure to match the specific anatomical requirements of each patient. This parameter adjustment resolves the contradiction between needing fixed simple structure and requiring adaptability to varying dimensions.
2Reliability
If fixed-length attachment legs are used in middle ear prostheses, then manufacturing is simple, but tissue trauma and hearing loss may occur due to mismatched lengths causing bias loads on the oval window membrane
Solution Approach 1:
The attachment legs are designed to be cut to the required length during surgery, allowing precise matching to each patient's anatomy. This reduces the risk of tissue trauma and hearing loss from mismatched lengths while keeping the manufacturing process simple and scalable.
Solution Approach 2:
The prosthesis is manufactured with attachment legs that are longer than the final required length, allowing surgeons to trim them to the exact length needed during surgery. This preliminary over-length design enables both simple manufacturing and precise surgical customization to prevent tissue damage.
3Manufacturing precision
If adjustable-length engagement legs are implemented, then customizable fit to patient dimensions is achieved, but the manufacturing process becomes more complex requiring micro-laser cutting
Solution Approach 1:
Traditional mechanical cutting methods are replaced with micro-laser cutting technology to achieve precise length adjustments of the attachment legs. This substitution enables high manufacturing precision while maintaining ease of manufacture through automated, computer-controlled processes.
Solution Approach 2:
The length parameter of the engagement legs can be precisely controlled during manufacturing using micro-laser cutting, allowing customization to match specific patient anatomy. This precise parameter control achieves high manufacturing precision while the automated laser process keeps manufacturing relatively simple.
Data Source
AI summary
A middle ear prosthesis is made of a stiff deformable material and includes a planar head end with a central portion having a central diameter. The head end is adapted for engagement with a tympanic membrane from the middle ear of an implanted patient. An opposing pair of U-shaped stapes engagement legs bend down from the central portion so that an end distance between ends of the engagement legs is less than the central diameter. The engagement legs are adapted for adjustable length engagement with the stapes in the middle ear of the implanted patient. The head end and the engagement legs are adapted to transmit vibrations from the tympanic membrane to the stapes for perception as sound by the implanted patient.


