Medical Access Port Safety Tab and Perforator Design
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Solution Overview
Problem
Existing medical solution containers face challenges in maintaining sterility, are difficult to handle sterily, and have issues with leakage and contamination due to flexible materials and insecure administration ports, which can compromise sensitive solutions and introduce pathogens.
Innovation Solution
A formed, filled, sealed solution container with an access port that includes a valve with a peripheral sealing flange and a perforator with a tri-slope bevel for easy puncture, providing single-handed operation, audible and visible notifications, and a safety tab to prevent inadvertent puncture, ensuring a secure and contamination-free fluid connection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional needles or piercing pins are used to establish fluid connection to flexible containers, then fluid access can be achieved, but obtaining a liquid-tight and leakproof connection is difficult and contamination risk increases
Solution Approach 1:
The patent introduces a valve with a peripheral sealing flange as an intermediary component between the flexible container and the administration set. This valve provides a standardized, rigid interface that accepts hypodermic needles or piercing pins while maintaining liquid-tight seals through its flange structure, thereby eliminating the difficulty of creating reliable connections directly to flexible containers and reducing contamination risks.
Solution Approach 2:
The invention changes the physical state and properties of the connection interface by transitioning from direct flexible container penetration to a rigid valve interface. The valve's peripheral sealing flange provides structural rigidity and standardized geometry, enabling reliable sealing and connection while the container remains flexible. This parameter change from flexible-to-rigid interface resolves the contradiction between achieving liquid-tight connections and preventing contamination.
2Stability of the object's composition
If administration ports are securely bonded to flexible containers, then connection stability is improved, but the ports become the weakest part of the container and compromise oxygen-sensitive solutions
Solution Approach 1:
The patent extracts the administration port function from the flexible container itself and places it in a separate, dedicated valve component. This valve with its peripheral sealing flange can be securely bonded to the container, isolating the port from the flexible container material that might permit gas permeation. The valve becomes the standardized, controlled interface that provides stable connections without compromising the integrity of oxygen-sensitive solutions.
Solution Approach 2:
The valve component can be designed as a disposable element that is securely bonded to the container for the duration of use. This disposable valve provides a stable, non-permeable connection interface that is discarded after single use, ensuring that administration ports do not become recurring weak points in the system and that each new container-valve assembly provides fresh, intact protection against gas permeation.
3Ease of operation
If known access ports are used, then fluid connection can be established, but they require two-handed operation and do not provide adequate protection against touch and air-borne contaminants
Solution Approach 1:
The valve with its peripheral sealing flange is designed to be self-aligning and self-sealing when a needle or piercing pin is inserted. The rigid, standardized interface automatically guides the penetrating instrument to the correct position and angle, eliminating the need for complex two-handed manipulation. This self-service design reduces the opportunity for touch contamination while maintaining ease of operation, as the system guides itself rather than requiring precise manual coordination.
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 solution enhances sterility, reduces contamination risks, minimizes leakage and gas permeation, and simplifies handling by providing a secure, one-handed operation with audible and visible feedback, ensuring a reliable and safe transfer of medical solutions.
Implementation Method 1
a perforator with a tri-slope bevel for easy puncture
Implementation Method 2
a valve with a peripheral sealing flange
Data Source
Figure 1
Figure 2
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AI summary
An access port for a medical fluid container is provided and in one embodiment includes: (i) a shell; (ii) a perforator located within the shell, the perforator including an end configured to pierce a medical fluid container; and (iii) a safety tab connected to the perforator, the safety tab initially preventing the perforator from piercing the medical fluid container, the safety tab manually removable to enable the perforator to pierce the medical fluid container. The shell can include a pair of hingedly moving arms and members connected hingedly to the arms, the members operable to push the perforator towards the medical fluid container when the arms are pushed. The safety tab can include a plurality of frangible fixtures, the fixtures collectively providing a suitably high tamper resistance force, the fixtures individually providing a suitably low tab removal force.