Amniotic Membrane Composition for Adhesive Ocular Surface Treatment
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Solution Overview
Problem
Existing ocular treatments using amniotic membrane compositions face challenges with adhesiveness and stability, leading to suboptimal application and efficacy, particularly in treating eye injuries and disorders.
Innovation Solution
Development of fetal tissue products, such as amniotic membrane compositions with reduced hyaluronic acid content and retained HC-HA/PTX3 complex, providing enhanced adhesiveness and stability, allowing direct application to ocular surfaces without additional adhesives, and maintaining therapeutic benefits.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If amniotic membrane compositions are used for ocular treatment, then therapeutic benefits are provided, but adhesiveness is insufficient requiring additional adhesives
Solution Approach 1:
The patent modifies the chemical composition parameters of the amniotic membrane by reducing hyaluronic acid content to less than 30 micrograms per 32 cm² (and in some embodiments less than 20 micrograms per 32 cm²). This parameter change fundamentally alters the adhesive properties of the membrane, enabling it to adhere directly to ocular surfaces without requiring additional adhesive agents, thereby resolving the contradiction between maintaining therapeutic benefits and improving ease of application.
2Ease of operation
If hyaluronic acid content is reduced to increase adhesiveness, then application ease is improved, but lubrication capability may be compromised
Solution Approach 1:
The patent applies local quality by creating different functional zones within the amniotic membrane structure. The reduced hyaluronic acid content provides localized adhesive properties at the interface with the ocular surface, while the retained HC-HA/PTX3 complex (with about 20%-90% of HA covalently bonded to heavy chain 1 of IαI complexed with PTX3) provides localized lubrication and therapeutic benefits. This spatial differentiation of properties resolves the contradiction between adhesiveness and lubrication.
Solution Approach 2:
The patent creates a composite material structure within the amniotic membrane by maintaining the HC-HA/PTX3 complex, where hyaluronic acid is covalently bonded to heavy chain 1 of inter-α-trypsin inhibitor and complexed with pentraxin 3. This composite structure integrates multiple functions: the reduced overall HA content provides adhesiveness, while the bonded HC-HA/PTX3 complex provides lubrication and anti-inflammatory properties, thereby resolving the contradiction between improved adhesion and maintained lubrication.
3Object-affected harmful factors
If amniotic membrane is processed for terminal sterilization, then safety is improved, but adhesiveness and biological activity may be reduced
Solution Approach 1:
The patent employs parameter changes by utilizing low-temperature terminal sterilization processes (such as gamma irradiation at temperatures at or below 0°C) that maintain the structural integrity and biochemical properties of the amniotic membrane. This sterilization approach achieves complete sterility while preserving the reduced hyaluronic acid content configuration and HC-HA/PTX3 complex, thereby maintaining both safety and the enhanced adhesive properties.
Solution Approach 2:
The patent applies beforehand cushioning by performing terminal sterilization under controlled conditions that prevent damage to the membrane's adhesive properties. The sterilization process is designed and executed in advance of use with parameters specifically selected to protect the biochemical structures responsible for adhesiveness, ensuring that no harmful effects occur during the sterilization step.
4Reliability
If fetal tissue product is designed for direct application to eye, then treatment efficacy is improved, but risk of cellular or inflammatory infiltrates increases
Solution Approach 1:
The patent applies parameter changes by precisely controlling the hyaluronic acid content to less than 30 micrograms per 32 cm² and maintaining the HC-HA/PTX3 complex structure. These specific parameter changes create an optimized composition that provides effective treatment for ocular conditions while minimizing the risk of adverse reactions such as ulcerations or cellular infiltrates, thereby resolving the contradiction between treatment efficacy and safety.
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 fetal tissue products demonstrate improved adhesion to ocular surfaces, facilitating effective treatment of eye conditions like dry eye and corneal injuries with reduced side effects and increased lubrication, while maintaining shelf-stability for convenient distribution.
Implementation Method 1
increased adhesiveness to a surface e.g., surface of an eye
Implementation Method 2
the significant reduction of total HA, which facilitates lubrication
Data Source
AI summary
This present disclosure describes an amniotic membrane fetal tissue product with adhesive properties for use on an ocular surface to prevent or treat eye indications.