Human Milk Fortifier Composition and Processing Method
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Solution Overview
Problem
Human milk from donors often lacks sufficient nutritional content for preterm infants, and there is a risk of contamination, making it inadequate for their needs, while mother's own milk may also not provide sufficient nutrients, necessitating a fortified nutritional solution.
Innovation Solution
A method involving the pooling of thawed donor milk, genetic screening for viral contaminants, heating, separation into skim and cream, ultrafiltration of skim, blending with cream, and pasteurization to create a human milk fortifier with specific nutritional constituents, including proteins, fats, carbohydrates, and minerals, which can be added to mother's milk to enhance its nutritional value.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If donor milk is used to feed preterm infants, then the milk is readily available and easy to obtain, but the nutritional content is insufficient and contamination risk exists
Solution Approach 1:
The patent applies parameter changes by modifying the nutritional composition of donor milk through controlled addition of human milk-derived proteins, fats, and carbohydrates. This transforms the milk from insufficient nutritional content to adequate levels while maintaining its status as a readily available alternative to mother's own milk.
Solution Approach 2:
The invention creates a composite human milk fortifier by combining donor milk with concentrated human milk components (proteins, fats, carbohydrates). This composite approach allows the final product to achieve sufficient nutritional content while retaining the base material of donor milk that is already available and safe.
2Reliability
If mother's own milk is used to feed preterm infants, then the immunologic benefits are maximized, but the nutritional content is still insufficient for preterm infant needs
Solution Approach 1:
The patent applies preliminary action by pre-concentrating human milk proteins, fats, and carbohydrates into a fortifier that can be added to mother's own milk. This allows the immunologic benefits of mother's milk to be preserved while the nutritional content is enhanced through the pre-prepared fortification mixture.
Solution Approach 2:
The invention applies local quality by selectively enhancing specific nutritional components (proteins, fats, carbohydrates) in the mother's milk through fortification, while leaving other beneficial components (immunologic factors) unchanged. This targeted approach ensures both immunologic benefits and sufficient nutrition are achieved.
3Device complexity
If raw donor milk is used without processing, then the processing time and complexity are minimized, but bacterial, viral and other contamination risks exist
Solution Approach 1:
The patent applies preliminary action by implementing genetic screening of donor milk before processing to identify and eliminate contaminated samples. This preliminary safety check prevents contamination risks from propagating through the fortification process while maintaining relatively simple subsequent processing steps.
Solution Approach 2:
The invention uses pasteurization as an intermediary treatment that reduces contamination risk in donor milk while preserving its nutritional and immunologic properties. This intermediate step bridges the gap between raw milk safety concerns and the need to maintain milk quality for fortification.
4Quantity of substance
If human milk is fortified with concentrated nutrients through ultrafiltration and blending, then the nutritional content is significantly increased, but the processing time and complexity increase
Solution Approach 1:
The patent applies segmentation by separating the fortification process into distinct stages: ultrafiltration to concentrate proteins, followed by separate concentration of fats and carbohydrates, and finally blending these concentrated components. This segmented approach makes the complex fortification process manageable and systematic.
Solution Approach 2:
The invention maintains continuity of useful action by processing donor milk through a continuous sequence of operations (screening, pasteurization, ultrafiltration, concentration, blending) without interruption. This continuous processing maximizes nutritional content enhancement while minimizing total processing time despite the multiple steps involved.
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 method produces a human milk fortifier that significantly increases the nutritional content of mother's milk, providing preterm infants with essential nutrients and reducing the risk of contamination, thereby improving their nutritional intake and health outcomes.
Implementation Method 1
filtering the skim with an ultrafilter to obtain skim with concentrated nutrients and permeate
Implementation Method 2
heating the pooled human milk at 63°C or greater for 30 minutes or more
Implementation Method 3
separating the pooled human milk into skim and cream
Data Source
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AI summary
The disclosure features human milk fortifier compositions, standardized human milk, and methods of making and using same. In one embodiment, a pasteurized human milk composition includes a human protein constituent of about 35-85 mg/mL; a human fat constituent of about 60-110 mg/mL; and a human carbohydrate constituent of about 60-140 mg/mL.