De-cellularized Amniotic Fluid Storage Stability via Temperature Control
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Solution Overview
Problem
The stability of amniotic fluid during long-term storage is a concern, as existing methods may lead to loss of biological functions of molecules naturally present in the fluid, making it unsuitable for therapeutic applications.
Innovation Solution
Methods for preparing de-cellularized human amniotic fluid (D-HAF) involve centrifugation, filtration, and storage under controlled temperature conditions, either as a liquid or lyophilized powder, to maintain the stability and biological activity of critical amniotic factors.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If amniotic fluid is stored for long-term periods, then availability for therapeutic applications is improved, but biological function of molecules is lost
Solution Approach 1:
The patent applies parameter changes by controlling storage temperature (refrigeration at 2-8°C versus freezing at -20°C to -85°C) and physical state (liquid versus lyophilized powder) to maintain biological activity during long-term storage. These parameter adjustments prevent molecular degradation while extending storage duration.
Solution Approach 2:
The patent utilizes phase transitions by offering both liquid and lyophilized powder storage forms. The lyophilization process transforms the liquid amniotic fluid into a dry powder state, which enhances stability and extends storage life without compromising biological function, allowing the product to be stored at higher temperatures.
2Manufacturing precision
If centrifugation and filtration are applied, then purity of amniotic fluid is improved, but loss of biological molecules occurs
Solution Approach 1:
The patent applies local quality by using sequential filtration with progressively smaller pore sizes (5-10μ, then 1μ, then 0.45μ or 0.2μ). Each filtration stage removes different sizes of contaminants while preserving biological molecules, achieving high purity without excessive loss of beneficial substances.
Solution Approach 2:
The patent employs partial action by performing centrifugation and filtration only when necessary to achieve the desired level of purity for specific therapeutic applications. The process can be adjusted based on the intended use, balancing purification needs against retention of biological molecules.
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 D-HAF retains at least 50% of total protein content after storage, with refrigeration reducing inflammatory molecules, and is effective in various therapeutic applications due to its stability and low toxicity.
Implementation Method 1
de-cellularizing the amniotic fluid via centrifugation
Implementation Method 2
a series of filtration steps
Implementation Method 3
D-HAF is lyophilized to be stored as a dry powder
Data Source
AI summary
Methods of preparing sterile de-cellularized human amniotic fluid that is amenable for long-term storage without loss of biological functions have been developed. In particular, the methods involve refrigeration steps to maximize shelf-life while retaining most of the important growth factors and other molecules present in the fresh amniotic fluid for effective therapeutic application. Use of the compositions is intended for therapeutic purposes and will alleviate pain or discomfort associated with any disorders or diseases, particularly those involving eyes and joints, or fibrotic disorders such as COPD.