Human Milk Fortifier Composition and Processing Method

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

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

VSEngineering 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

Engineering Contradiction:
Improveease of obtaining milkVSAvoidnutritional content
Core Design Contradiction:
Ease of manufactureVSQuantity of substance

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.

Inventive Principle:
Principle #35Parameter changes

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.

Inventive Principle:
Principle #40Composite materials

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

Engineering Contradiction:
Improveimmunologic benefitsVSAvoidnutritional content
Core Design Contradiction:
ReliabilityVSQuantity of substance

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.

Inventive Principle:
Principle #10Preliminary action

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.

Inventive Principle:
Principle #3Local quality

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

Engineering Contradiction:
Improveprocessing complexityVSAvoidcontamination risk
Core Design Contradiction:
Device complexityVSObject-affected harmful factors

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.

Inventive Principle:
Principle #10Preliminary action

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.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

Engineering Contradiction:
Improvenutritional contentVSAvoidprocessing complexity
Core Design Contradiction:
Quantity of substanceVSDevice complexity

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.

Inventive Principle:
Principle #1Segmentation

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.

Inventive Principle:
Principle #20Continuity of useful 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 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

Methodology Applied
Scientific EffectUltrafiltration: Semipermeable Membrane

Implementation Method 2

heating the pooled human milk at 63°C or greater for 30 minutes or more

Methodology Applied
Scientific EffectPasteurization: Heating

Implementation Method 3

separating the pooled human milk into skim and cream

Methodology Applied
Scientific EffectDensity separation: Centrifugal Separation

Data Source

PatentEP3485742B1Human milk compositions and methods of making and using same
Publication Date: 2021.09.01 PROLACTA BIOSCIENCE INC
  • EP3485742B1 patent drawingFigure 1
  • EP3485742B1 patent drawingFigure 2

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.