De-cellularized Amniotic Fluid Eye Drops for Ocular Healing

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Solution Overview

Problem

Current treatments for ocular diseases and disorders, such as dry eye syndrome and cataracts, are often ineffective, requiring frequent applications of artificial tears and involving invasive procedures with human amniotic membrane, which are costly and disrupt vision, while lacking long-term benefits for chronic conditions.

Innovation Solution

A sterile, de-cellularized human amniotic fluid formulation, devoid of amniotic stem cells and micronized membrane particles, is developed for topical application as a liquid ocular solution or gel, containing over 300 growth factors, which is easy to use, affordable, and accessible, providing sustained relief from symptoms like dryness, redness, and inflammation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If human amniotic membrane (HAM) is used to treat eye surface injuries, then treatment efficacy is improved, but device complexity and ease of operation worsen due to requiring physician skills and invasive procedures

Engineering Contradiction:
Improvetreatment efficacyVSAvoidease of use
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The invention extracts the beneficial therapeutic components (growth factors, cytokines, extracellular matrix) from the human amniotic membrane and formulates them into a liquid composition that can be administered topically without requiring surgical implantation of the entire membrane tissue

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention changes the physical state and form of the amniotic membrane from solid tissue requiring surgical implantation to a liquid topical formulation that can be easily applied as eye drops, fundamentally altering the administration parameters while preserving therapeutic benefits

Inventive Principle:
Principle #35Parameter changes

2Reliability

If human amniotic membrane (HAM) is used to treat eye surface injuries, then treatment efficacy is improved, but device complexity and cost worsen due to requiring additional expense and physician skills

Engineering Contradiction:
Improvetreatment efficacyVSAvoidcost
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The invention extracts only the necessary bioactive components from the amniotic membrane and formulates them in a cost-effective liquid vehicle, eliminating the need for expensive surgical procedures and specialized membrane processing while maintaining therapeutic efficacy

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The invention uses a disposable liquid formulation that can be easily manufactured and distributed at lower cost compared to surgical membrane procedures, providing an affordable alternative for chronic condition management

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Reliability

If human amniotic membrane is used to treat eye conditions, then treatment benefits are achieved, but illumination intensity worsens because the membrane is non-transparent and disrupts vision

Engineering Contradiction:
Improvetreatment benefitsVSAvoidvisual clarity
Core Design Contradiction:
ReliabilityVSIllumination intensity

Solution Approach 1:

The invention changes the physical form from opaque solid membrane to transparent liquid formulation, fundamentally altering the optical properties while maintaining the therapeutic bioactive components, thereby eliminating visual disruption during treatment

Inventive Principle:
Principle #35Parameter changes

4Reliability

If amniotic membrane procedure is used, then treatment benefits are achieved, but duration of action worsens because benefits last only as long as the membrane is in place, making it not useful for chronic conditions

Engineering Contradiction:
Improvetreatment benefitsVSAvoidduration of benefit
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The invention enables continuous delivery of therapeutic growth factors through repeated topical applications in liquid form, allowing sustained treatment of chronic conditions rather than providing only temporary benefits limited by membrane retention time

Inventive Principle:
Principle #20Continuity of useful action

Solution Approach 2:

The invention utilizes periodic administration of the liquid formulation (e.g., multiple applications per day) to maintain continuous therapeutic presence of growth factors in the ocular environment, addressing chronic conditions effectively

Inventive Principle:
Principle #19Periodic action

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 formulation effectively alleviates or prevents symptoms of dry eye, Sjogren's syndrome, corneal neovascular disorders, and cataracts, promoting healing and improving visual acuity, with daily applications delivering a sustainable level of growth factors, reducing the need for frequent artificial tear use and minimizing invasive procedures.

Implementation Method 1

D-HAF contains over 300 human growth factors. Daily applications of D-HAF deliver a sustainable level of beneficial growth factors.

Methodology Applied
Scientific EffectGrowth factor delivery:

Data Source

PatentUS20230218677A1Amniotic fluid topical formulation
Publication Date: 2023.07.13 MAM HOLDINGS OF WEST FLORIDA LLC

AI summary

A human amniotic fluid formulation has been developed for topical application to the eye, which is useful for the treatment of ocular diseases and injuries including dry eyes, Sjogren's Syndrome, cataracts, burns and injuries to the eye tissues. The formulation is a sterile de-cellularized human amniotic fluid (D-HAF), devoid of amniotic stem cells and elements of micronized membrane or chorion particles. Methods for treating, or preventing various ocular diseases, injuries and disorders using the formulation, optionally in combination with one or more therapeutic, prophylactic or diagnostic agents are described.