Multi-Chamber Parenteral Nutrition for Stable Heat-Sterilized Micronutrients
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Solution Overview
Problem
Existing parenteral nutrition formulations face challenges in stably accommodating all essential vitamins and trace elements due to incompatibilities and instability issues, particularly during terminal heat-sterilization, necessitating manual addition before administration, which increases risks and waste.
Innovation Solution
A terminally heat-sterilized multi-chamber bag containing separate chambers for carbohydrates, amino acids, lipids, trace elements, and vitamins, ensuring stability and compatibility of all nutrients within the formulation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If micronutrients are added manually to parenteral nutrition bags before administration, then the complete nutritional requirements can be met, but the risk of contamination and medication errors increases
Solution Approach 1:
The parenteral nutrition system is segmented into multiple chambers within a single bag, with each chamber containing specific nutrients (macronutrients in larger chambers, micronutrients in smaller chambers). This segmentation allows nutrients to be stored separately in a sterile, ready-to-use format while eliminating the need for manual mixing, thereby maintaining safety without increasing operational complexity.
2Ease of operation
If vitamins and trace elements are mixed together in the same bag, then preparation is simplified, but trace elements promote oxidation of vitamins reducing stability
Solution Approach 1:
Vitamins and trace elements are placed in separate chambers within the same bag, preventing direct contact and chemical interaction. The chambers are separated by semipermeable membranes that allow controlled interaction only after reconstitution, maintaining vitamin stability while simplifying the overall preparation process.
Solution Approach 2:
Semipermeable membranes act as intermediaries between chambers containing vitamins and trace elements. These membranes prevent direct chemical interaction that would cause oxidation, while still allowing the system to function as an integrated parenteral nutrition delivery system.
3Stability of the object's composition
If multiple separate bags are used for macronutrients and micronutrients, then stability is maintained, but handling complexity and waste increase
Solution Approach 1:
Multiple nutrient components that would traditionally require separate bags are merged into a single multi-chamber bag system. Each chamber maintains the stability requirements of its contents through physical separation, while the integrated design reduces the number of separate components from multiple bags to one unified system, thereby reducing handling complexity and waste.
4Reliability
If terminal heat-sterilization is applied to the complete formulation, then sterility is ensured, but vitamins and trace elements become unstable
Solution Approach 1:
The multi-chamber design allows different sterilization approaches for different nutrient types. Chambers containing heat-sensitive micronutrients can be sterilized by filtration or other non-thermal methods, while macronutrient chambers can undergo terminal heat-sterilization. The semipermeable membranes maintain separation during processing, enabling tailored sterilization strategies that preserve nutrient stability while ensuring overall sterility.
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
Provides a ready-to-use, safe, and stable parenteral nutrition product that meets clinical guidelines without manual additions, reducing medical risks and waste, and ensuring extended shelf-life.
Implementation Method 1
A terminally heat-sterilized ready-to-use parenteral nutrition product in the form of a multi-chamber bag that comprises macronutrients (carbohydrates, lipids and amino acids) and micronutrients (trace elements and vitamins)
Implementation Method 2
terminally heat-sterilized ready-to-use parenteral nutrition product
Data Source
AI summary
The present disclosure relates to a terminally heat-sterilized ready-to-use parenteral nutrition formulation comprising all macronutrients and micronutrients required to meet the clinical guidelines for parenteral nutrition, wherein all said micronutrients and macronutrients are provided in one multi-chamber bag (MCB). The disclosure is also directed to a parenteral nutrition formulation comprising all such macronutrients and micronutrients. More specifically, the present disclosure is directed to a MCB comprising at least five chambers containing a carbohydrate formulation in a first chamber, an amino acid formulation in a second chamber, a lipid formulation in a third chamber, a fourth chamber comprising a vitamin formulation and a fifth chamber comprising a trace element formulation, wherein the carbohydrate formulation, amino acid formulation and/or the lipid formulation may also contain certain vitamins and certain trace elements that can be stably accommodated therein.