Slidable Clamp Port Isolation Fluid Contamination
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Solution Overview
Problem
The contamination of blood and blood components with pathogens during transfusions remains a risk due to the presence of pathogens in ports of fluid containers, which can lead to recontamination and the undesirable presence of debris from frangible connection mechanisms, preventing effective pathogen inactivation.
Innovation Solution
A slidable clamp is used to isolate ports of fluid containers by compressing them to create a fluid-tight seal, preventing recontamination and eliminating the need for frangible mechanisms, allowing for effective pathogen inactivation and safe fluid transfer.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a frangible connection mechanism is used in a port to provide selective communication, then the port can be opened to allow fluid flow, but a separated portion of the mechanism floats in the fluid and debris may break off during the breaking process
Solution Approach 1:
The patent removes the frangible connection mechanism from the port entirely and replaces it with a valve mechanism that opens by lifting a valve member off a valve seat. This extraction of the harmful frangible mechanism eliminates the source of debris and floating particles while maintaining the ability to open the port for fluid flow.
Solution Approach 2:
Instead of using a disposable frangible mechanism that breaks and creates debris, the patent employs a reusable valve mechanism that can be opened and closed multiple times without generating contaminants. The valve member and seat are designed to withstand repeated use without degrading into harmful particles.
2Productivity
If ports remain open during fluid filling, then fluid can enter the container, but pathogens may be trapped in the ports and cause recontamination after inactivation
Solution Approach 1:
The patent applies a slidable clamp to close the port before the pathogen inactivation process begins. This preliminary action ensures that any fluid trapped in the port during filling is sealed off and will be exposed to photoradiation when the container is illuminated, allowing complete pathogen inactivation without risk of recontamination.
Solution Approach 2:
The slidable clamp acts as an intermediary mechanism that seals the port during inactivation but can be easily removed or slid away to allow fluid transfer afterward. This intermediary device enables the port to remain closed during the critical inactivation phase while still permitting efficient fluid filling and subsequent transfer operations.
3Object-affected harmful factors
If ports are substantially opaque to prevent external contamination, then pathogen inactivation is effective, but photoradiation cannot reach fluid trapped within the ports
Solution Approach 1:
The slidable clamp closes the port before inactivation, sealing any trapped fluid inside the port. Since the clamp is applied externally and the port is sealed at the opening, the opaque port material no longer prevents photoradiation from reaching the trapped fluid—the light travels through the transparent container wall to illuminate the sealed fluid within the port, achieving complete inactivation.
4Reliability
If a slidable clamp is used to close the port, then the port is sealed to prevent recontamination, but the clamp must be positioned precisely in a slit, recess, or indentation of the container
Solution Approach 1:
The slidable clamp is designed to engage with pre-formed structural features (slits, recesses, or indentations) in the container. These features guide the clamp into the correct position automatically, and the clamp's sliding mechanism allows it to self-align and secure itself without requiring precise manual positioning, thereby maintaining ease of operation while ensuring reliable sealing.
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 slidable clamp effectively prevents recontamination of pathogen-reduced fluids by isolating ports during the inactivation process, ensuring the fluid remains sterile and free from debris, thereby enhancing the safety of blood transfusions.
Implementation Method 1
By sliding the clamp in the slit such that a slot in the clamp compresses the port to close the port, the port may be sealed to prevent any liquid from entering the port
Data Source
AI summary
Embodiments described herein generally relate to an apparatus and methods for preventing the recontamination of a pathogen-reduced fluid by pathogens trapped in one or more ports of an inactivation fluid container. Through the use of a slidable clamp positioned in an area of the container immediately adjacent to a port to be isolated, the port may be sealed to prevent any liquid product from entering the port and associated tubing when liquid product is added to the container. The slidable clamp includes a slot, in which the distal end of the slot has a larger width than the proximal end of the slot. The width of the slot at the narrowest, most proximal portion allows for a fluid-tight seal to be created when the slidable clamp is slid into the closed position with respect to the port to be isolated.