Decellularized Amniotic Fluid Nebulizer Formulation for Lung Disorders
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Solution Overview
Problem
Current treatments for asthma and chronic obstructive pulmonary diseases (COPD) are limited, and there is a need for effective prevention and treatment options for lung disorders, particularly for conditions exacerbated by environmental exposures and injuries such as those experienced by military personnel.
Innovation Solution
Development of sterile, decellularized human amniotic fluid formulations that are free of amniotic cells and elements, which are administered via nebulizers to target the distal regions of the lungs, improving exercise endurance, reducing inflammation, and increasing blood oxygen saturation, and can be used in combination with other therapeutic agents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional treatments (anti-inflammatory agents or bronchodilators) are used for asthma and COPD, then existing treatment options are available, but the treatment effectiveness is limited and no cure exists
Solution Approach 1:
The patent changes the fundamental parameter of treatment by using decellularized amniotic fluid instead of conventional pharmacological agents. This biological formulation contains growth factors and anti-inflammatory components that actively promote tissue repair and reduce inflammation, thereby improving treatment effectiveness and creating new treatment options for asthma and COPD
Solution Approach 2:
The decellularized amniotic fluid acts as an intermediary substance that mediates between the damaged lung tissue and the healing process. It provides growth factors and anti-inflammatory components that facilitate tissue regeneration and reduce inflammation, serving as a bridge to restore lung function without relying on conventional drugs
2Reliability
If amniotic fluid is used to treat lung disorders, then treatment effectiveness improves, but the formulation must be sterile and free of cells to ensure safety
Solution Approach 1:
The patent applies decellularization technology to extract and remove all cellular components from the amniotic fluid while retaining the beneficial growth factors and anti-inflammatory proteins. This extraction process ensures the formulation is sterile and cell-free for safe administration, while maintaining therapeutic effectiveness through the preserved molecular components
Solution Approach 2:
The patent creates a functional copy of amniotic fluid that retains the therapeutic properties without the cellular elements. The decellularized formulation replicates the beneficial biochemical functions of native amniotic fluid while eliminating the risks associated with cellular components, achieving both safety and effectiveness
3Reliability
If amniotic fluid formulations are administered via nebulizer to distal lung regions, then treatment specificity improves, but device complexity increases
Solution Approach 1:
The patent leverages the universal capability of nebulizers to deliver formulations to distal lung regions, which are already used for asthma and COPD treatments. By using this existing multi-functional delivery device, the patent achieves specific treatment of distal lung regions without requiring entirely new administration equipment, thus limiting the increase in device complexity
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 amniotic fluid formulations effectively alleviate symptoms of lung disorders, improve exercise tolerance, increase baseline blood oxygen saturation, and reduce inflammation, providing a potential alternative or complement to existing treatments for COPD and asthma.
Implementation Method 1
administered via nebulizers to target the distal regions of the lungs
Data Source
AI summary
Formulations of human amniotic fluid and methods of use thereof for treatment of chronic lung disorders have been developed. The formulations are suitable for topical delivery to the lung, for treatment of lung disorders including chronic obstructive pulmonary disorders (COPD), asthma, emphysema, bronchiectasis, chronic bronchitis, interstitial lung disease, alpha-I antitrypsin emphysema. Methods including administering specifically formulated, diluted sterile decellularized human amniotic fluids topically to the lungs, preferably as aerosol droplets, are described. In particular the methods involving administration of the amniotic fluid formulation in the form of aerosol droplets with size between about 1.5 μm to about 5 μm, preferably from about 2.5 μm to about 3.5 μm, inclusive, using apparatus such as high-efficiency vibrating mesh nebulizers, are described. Formulations described can treat, or prevent one or more symptoms of a chronic lung disorder