Aseptic Enteral Feeding Container With Circumferential Seal
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Solution Overview
Problem
Current systems for collecting and dispensing biological fluids, such as breast milk and medicinal materials, face challenges in maintaining aseptic integrity and ensuring freshness and prevention of contamination, particularly in applications involving premature infants where regulatory compliance is critical.
Innovation Solution
A container system with a hollow tube and circumferential seal assembly, designed for fluid collection, storage, and dispensing, featuring a plunger and cap configuration that ensures aseptic integrity through a continuous outer profile and removable sealing mechanisms, compatible with various pump designs for controlled fluid delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a traditional fluid collection and dispensing system is used, then the system structure is simple, but the aseptic integrity and prevention of contamination are compromised
Solution Approach 1:
The system is divided into separate sterile and non-sterile zones using a sterile barrier that partitions the container interior. This segmentation allows the fluid collection chamber to remain isolated from contamination sources while maintaining a relatively simple overall system structure.
Solution Approach 2:
A sterile barrier acts as an intermediary element between the sterile fluid collection chamber and the non-sterile exterior environment. This barrier maintains aseptic integrity by preventing contamination transmission while allowing the system to remain structurally simple and functional.
2Object-affected harmful factors
If a sterile barrier is introduced to maintain aseptic integrity, then contamination prevention is improved, but the device complexity increases
Solution Approach 1:
The sterile barrier is implemented as a flexible thin film or membrane that can be integrated into the container structure. This approach provides effective contamination prevention while minimizing the increase in device complexity, as the thin film can be molded or attached during standard manufacturing processes.
Solution Approach 2:
The sterile barrier serves multiple functions simultaneously: it prevents contamination, maintains structural integrity of the container, and can facilitate controlled fluid delivery. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in device complexity.
3Ease of operation
If a plunger system is used for controlled fluid delivery, then the delivery control is improved, but the risk of contamination increases
Solution Approach 1:
The sterile barrier serves as an intermediary that allows the plunger to exert force on the fluid for controlled delivery while preventing direct contact between the non-sterile plunger exterior and the sterile fluid interior. This maintains contamination prevention while enabling ease of operation through controlled plunger movement.
Solution Approach 2:
The system may utilize pneumatic or hydraulic principles where the plunger creates pressure differential to control fluid delivery through the sterile barrier. This allows precise control of fluid flow rates while maintaining the sterile seal, combining ease of operation with contamination prevention.
4Shape
If a continuous outer profile is maintained for seamless dispensing, then the dispensing smoothness is improved, but the sealing mechanism complexity increases
Solution Approach 1:
The sterile barrier is merged with the container wall structure or cap assembly to create a continuous outer profile. This integration eliminates visible seams or protrusions that would disrupt the smooth appearance while the sealing function is maintained through the barrier's attachment mechanism, balancing aesthetic smoothness with functional simplicity.
Data Source
AI summary
A container for collecting, storing and dispensing fluid, as in enteral feeding and/or medication deliver to neonatal infants. The container includes a hollow tube with a body, a first end, a second end, and an outer diameter. The hollow tube is configured to receive a movable plunger that advances and retracts therein to define a variable contained volume. The container also includes a sealing head assembly removably mounted at an end of the hollow tube. The sealing head assembly has a diameter or outside dimension that is substantially similar or identical to a corresponding outside diameter or dimension of the hollow tube, so that the container lies flat within the receiver of an enteral feeding pump.