Gender-Specific Amniotic Fluid for Targeted Tissue Disease Treatment

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Solution Overview

Problem

Existing treatments using amniotic fluid for tissue disorders, such as erectile dysfunction and Peyronie's disease, are unpredictable and lack specificity due to the absence of differentiation in growth factors based on fetal gender, leading to inconsistent treatment outcomes.

Innovation Solution

Utilizing gender-specific amniotic fluid sourced from either a male or female fetus, which contains distinct growth factors, to develop a composition that targets specific tissue diseases by applying or injecting the amniotic fluid topically or intratissue.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional amniotic fluid is used for treating tissue disorders, then treatment coverage is broad, but treatment outcomes are unpredictable and inconsistent

Engineering Contradiction:
Improvetreatment outcome consistencyVSAvoiddisease-specific targeting
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent segments amniotic fluid into gender-specific categories (male fetal source vs. female fetal source) based on the fetus's gender. This segmentation allows for differentiation of growth factor profiles, where female-derived amniotic fluid contains higher concentrations of certain growth factors (e.g., VEGF, FGF) that are particularly effective for erectile dysfunction and Peyronie's disease, while male-derived amniotic fluid has different growth factor compositions suitable for other tissue disorders. This resolves the contradiction by providing reliable, consistent outcomes through targeted selection rather than using undifferentiated amniotic fluid.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent applies local quality by matching specific growth factor profiles to specific disease conditions. Instead of using a uniform amniotic fluid composition for all tissue disorders, the invention tailors the treatment by selecting amniotic fluid with particular growth factor compositions that locally address the specific pathological needs of different diseases. For example, female-derived amniotic fluid is specifically matched to erectile dysfunction cases where VEGF and FGF are critical for vascular regeneration.

Inventive Principle:
Principle #3Local quality

2Quantity of substance

If amniotic fluid is collected during Caesarean section, then sufficient quantity is obtained, but cells and particles must be removed through complex processing

Engineering Contradiction:
Improveamniotic fluid volumeVSAvoidprocessing steps
Core Design Contradiction:
Quantity of substanceVSDevice complexity

Solution Approach 1:

The patent extracts and removes cells and large particles from amniotic fluid through centrifugation and filtration processes. The collected amniotic fluid undergoes centrifugation at specific speeds (e.g., 3000-10,000 rpm for 10-30 minutes) to separate cellular components, followed by filtration through membranes with defined pore sizes (e.g., 0.22 μm or 0.45 μm) to remove remaining particles. This extraction process produces a cell-free, particle-free amniotic fluid concentrate that maintains sufficient volume while eliminating the need for complex additional processing steps.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent applies parameter changes by optimizing centrifugation parameters (speed, duration, rotor type) and filtration parameters (membrane pore size, flow rate) to achieve the desired balance between quantity retention and purity. By carefully controlling these parameters, the process efficiently removes cells and particles while preserving the growth factor-rich supernatant, reducing processing complexity compared to more aggressive purification methods.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If amniotic fluid is filtered through small pore membranes, then sterility is achieved, but growth factors may be adsorbed or lost

Engineering Contradiction:
Improvesterility assuranceVSAvoidgrowth factor retention
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The patent applies parameter changes by optimizing filtration parameters including membrane pore size (selecting 0.22 μm or 0.45 μm membranes), flow rate control, and pre-wetting procedures. These parameter adjustments minimize adsorption of growth factors to the membrane while ensuring sterility. The controlled slow filtration process prevents concentration-dependent adsorption, and pre-wetting the membrane with buffer or saline reduces initial adsorption peaks, thereby maintaining growth factor retention while achieving sterility assurance.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses an intermediary substance (buffer solution or saline) to pre-wet the filtration membrane before passing the amniotic fluid through it. This intermediary layer reduces direct contact between growth factors and the membrane surface, minimizing adsorption losses. The buffer also maintains physiological conditions that preserve growth factor stability during the filtration process, ensuring both sterility and substance retention.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS12514880B2Amniotic fluid composition and method of using
Publication Date: 2026.01.06 ZAHALSKY MICHAEL P
  • US12514880B2 patent drawing
  • US12514880B2 patent drawing
  • US12514880B2 patent drawing

AI summary

A composition for treating a patient with a tissue disease or malformity has a composition containing amniotic fluid. The amniotic fluid has a quantity of gender specific amniotic fluid based on a gender of a fetal source. A method of treating a patient with a tissue disease or malformity comprises the steps of: identifying the tissue region to be treated and selecting a location to apply either topically or by injection or inhalation a composition containing amniotic fluid; selecting the composition containing amniotic fluid wherein the amniotic fluid has a quantity of gender specific amniotic fluid based on a gender of a fetal source allowing more specific targeted growth factors to be used for specific disease processes; and applying or injecting the composition at or into the selected location.