Flexible Titanium Backplate for Keratoprosthesis
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Solution Overview
Problem
Current keratoprosthesis systems face complications such as corneal graft melting, necrosis, infection, and glaucoma due to non-adherence of corneal tissue to plastic stems, which disrupts bio-integration and increases the risk of pathogen entry and inflammation, and aqueous leaks can cause vision loss.
Innovation Solution
A keratoprosthesis apparatus with a flexible titanium alloy backplate featuring an annular rim with tabs and radially extending appendages, allowing for secure coupling to an optical stem without disrupting the corneal endothelium, using materials like titanium nickel alloy or nitinol for enhanced bio-integration and mechanical support.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a plastic stem (PMMA) is used in the keratoprosthesis, then the device can be manufactured with simple materials and processes, but the corneal tissue cannot adhere to the stem, preventing bio-integration and increasing the risk of infection and inflammation
Solution Approach 1:
The patent employs a composite structure combining biocompatible plastic materials with biointegrable surface treatments or coatings. The stem is made of PMMA or similar biocompatible plastic, but incorporates surface modifications (such as porous coatings, hydroxyapatite layers, or other biointegrable surfaces) that enable corneal tissue adherence while maintaining the manufacturing advantages of plastic materials.
2Strength
If the corneal graft tissue is sutured to the host cornea, then mechanical support is provided to the stem and graft, but the corneal endothelium is disrupted, increasing the risk of infection, graft failure, and glaucoma
Solution Approach 1:
The patent utilizes a flexible backplate design made of thin, compliant material that can be positioned behind the corneal endothelium without disrupting it. This backplate provides the necessary mechanical support and stability to the implant while maintaining the integrity of the corneal endothelium, thereby reducing infection risk and preserving natural corneal function.
3Stability of the object's composition
If a rigid backplate is used to provide mechanical support, then the device structural stability is improved, but the ability to adapt to corneal movement and maintain tissue bio-integration is reduced
Solution Approach 1:
The patent employs a dynamic backplate design that transitions from rigid to flexible characteristics. The backplate is constructed with flexible materials or incorporates flexible elements that allow it to adapt to corneal movements and physiological changes while maintaining sufficient structural stability to support the implant. This dynamic design enables the device to move with the cornea rather than restricting its natural motion.
4Reliability
If the corneal endothelium is disrupted during implantation, then the keratoprosthesis can be securely implanted, but the risk of pathogen entry, inflammation, and glaucoma increases
Solution Approach 1:
The patent employs preliminary positioning and securing mechanisms that allow the keratoprosthesis to be implanted without disrupting the corneal endothelium. The device includes pre-designed features such as engagement ridges, interlocking mechanisms, or adhesive interfaces that secure the implant in place before any potential endothelial disruption could occur, thereby ensuring implantation security while preserving endothelial integrity.
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 flexible backplate design reduces the risk of infection, graft failure, and glaucoma, while maintaining corneal endothelium integrity, promoting better bio-integration and reducing complications like aqueous leaks and inflammation, thus enhancing the stability and safety of the implantation.
Implementation Method 1
a circular backplate composed, at least in part, of a titanium alloy, wherein the circular backplate includes an annular rim portion having a central aperture extending therethrough, a plurality of tabs positioned along the annular rim portion and extending radially inwardly into the aperture, and a plurality of flexible appendages extending radially outwardly from the annular rim portion and positioned along the annular rim portion at locations corresponding to the plurality of tabs. The plurality of flexible appendages is configured to provide leverage to pivot the plurality of tabs outwardly.
Data Source
AI summary
The present disclosure relates to keratoprosthesis apparatuses comprising a flexible backplate and methods of manufacturing and implanting the new keratoprosthesis apparatuses. The keratoprosthesis apparatuses include a circular backplate composed, at least in part, of a titanium alloy. The circular backplate includes an annular rim portion having a central aperture extending therethrough. A plurality of tabs is positioned along the annular rim portion and extend radially inwardly into the aperture. A plurality of flexible appendages extends radially outwardly from the annular rim portion and is positioned along the annular rim portion at locations corresponding to the plurality of tabs.