Corneal Cross-Linking Mask for Spatial Drug Concentration Control

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Solution Overview

Problem

Current refractive surgical procedures, such as riboflavin/UV-A corneal cross-linking, lack control over the distribution and concentration of cross-linking agents in the cornea, leading to unpredictable changes in focusing power and optical aberrations.

Innovation Solution

A device and method for administering a cross-linking agent to the cornea with controlled and variable distribution, using a mask to define penetration areas and a light source for photo-activation, allowing precise correction of optical aberrations by varying the concentration of the agent across the corneal surface.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If riboflavin/UV-A corneal cross-linking is performed without controlled distribution, then the procedure is simple and minimally invasive, but the change in focusing power cannot be predicted or controlled

Engineering Contradiction:
Improvecontrol over cross-linking agent distributionVSAvoidcomplexity of administration system
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The corneal surface is divided into multiple treatment zones using a mask with selectively positioned openings. This segmentation allows different regions of the cornea to receive varying concentrations of cross-linking agent, enabling precise control over the spatial distribution of cross-links and thus the focal power changes in different zones.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The mask creates local variations in cross-linking agent concentration by allowing the agent to penetrate only through specific openings at specific locations. This local quality control enables tailored treatment of different corneal regions, with each zone receiving the exact concentration needed to achieve the desired refractive correction.

Inventive Principle:
Principle #3Local quality

2Manufacturing precision

If uniform cross-linking agent concentration is applied across the cornea, then the administration process is simple, but optical aberrations cannot be precisely corrected

Engineering Contradiction:
Improveprecision of optical aberration correctionVSAvoidease of agent administration
Core Design Contradiction:
Manufacturing precisionVSEase of operation

Solution Approach 1:

The mask segments the corneal surface into treatable and non-treatable zones, with openings positioned to target specific areas requiring correction. This segmentation transforms the simple uniform application process into a precision tool that can address localized optical aberrations while maintaining ease of operation through a single mask placement.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The mask acts as an intermediary device between the cross-linking agent and the corneal surface. It mediates the distribution of the agent, allowing simple application of a uniform solution while achieving non-uniform concentration patterns through the mask's selective opening design, thus simplifying the operator's task while maintaining precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Adaptability or versatility

If the cross-linking agent concentration is varied across the corneal surface, then personalized corneal reshaping is achieved, but the device complexity increases

Engineering Contradiction:
Improvepersonalization of treatmentVSAvoidcomplexity of delivery device
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The mask enables local quality variation by creating specific patterns of openings that correspond to the patient's individual refractive needs. Each opening's position, size, and shape can be customized to achieve the desired corneal reshaping pattern, providing personalized treatment while keeping the device structure relatively simple.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The system achieves personalization by varying parameters of the cross-linking agent distribution (concentration, spatial location, depth) through the mask design. Different mask configurations with varying opening patterns allow adjustment of treatment parameters to match individual patient requirements without requiring complex delivery mechanisms.

Inventive Principle:
Principle #35Parameter changes

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

Enables personalized and precise reshaping of the cornea to correct refractive disorders by controlling the spatial distribution and concentration of the cross-linking agent, achieving a predetermined change in corneal biomechanics without invasive procedures.

Implementation Method 1

a light source for emitting photoactivating light sufficient for activating cross-linking in the corneal tissue by exciting the cross-linking agent to produce a reactive singlet oxygen from oxygen content in corneal tissue of the eye

Methodology Applied
Scientific EffectPhoto-activation: Photopolymerisation

Implementation Method 2

a mask adapted to selectively allow the photoactivating light to be transmitted therethrough. The regions of the mask allowing the photoactivating light to be transmitted define a pattern of activation of the cross-linking agent

Methodology Applied
Scientific EffectSelective light transmission: Filter (optical)

Implementation Method 3

There are several methods for applying a photo-enhancer agent into the cornea through tissue incisions

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentEP3989895B1Device, system and method for treating a corneal tissue
Publication Date: 2025.09.03 VISION ENGINEERING ITALY SRLVISION ENGINEERING ITALY SRL
  • EP3989895B1 patent drawingFigure 1~2
  • EP3989895B1 patent drawingFigure 3
  • EP3989895B1 patent drawingFigure 4~7

AI summary

Device for delivering a drug into a cornea (EC), the device comprising a body (B) having an internal cavity (CV) and a first aperture (Bll) communicating with said internal cavity, wherein the first aperture is conformed or conformable to hermetically adhere to the periphery of a surface (EY) of said cornea; a second aperture (B2, 12) to introduce said drug in said cavity (CV), the device comprising a mask (MK), supported by said body in correspondence of said first aperture which, in operative condition, adheres to a portion (ECI) of said surface of said cornea, and said mask (MK) comprising a plurality of through openings (OP) of opportunely variable size, such as to achieve a corresponding variable spatial concentration of the drug across the cornea.