Needle Kit With Polymeric Conduit for Aseptic Fluid Transfer
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Solution Overview
Problem
Existing fluid dispensing technologies for pharmaceutical fluids often require the product to contact multiple materials, which can lead to contamination and lack aseptic conditions, especially in trans-septal fills where terminal sterilization is not possible.
Innovation Solution
A needle kit with an elongate polymeric conduit that can be inserted through the dispensing cannula or needle, ensuring the product fluid only contacts a single material by extending past the distal end of the cannula or needle, allowing for both open and trans-septal fills while maintaining aseptic conditions through sterilizing filters.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a metallic dispense cannula or fill needle is used with multiple material contacts in the flowpath, then the structural strength and piercing capability are improved, but the risk of contamination increases and aseptic conditions cannot be maintained
Solution Approach 1:
An elastomeric conduit is introduced as an intermediary component between the metallic needle and the product fluid. The conduit has a smooth bore that directs fluid flow while preventing contact with the metallic needle surface and other potential contamination sources. The fluid flows through the elastomeric conduit which is in direct contact with the product, isolating the product from harmful material contacts.
Solution Approach 2:
The elastomeric conduit acts as a flexible shell through which the fluid flows. This thin-walled elastomeric tube provides a smooth, non-reactive surface that maintains aseptic conditions while allowing the rigid metallic needle to perform its piercing function without directly contacting the product fluid.
2Adaptability or versatility
If multiple materials are used in the dispense flowpath, then the functional requirements for piercing and fluid handling are satisfied, but the product contacts multiple materials which compromises aseptic conditions
Solution Approach 1:
The elastomeric conduit serves as a mediator that allows the system to maintain multiple functional capabilities (piercing via metallic needle, fluid handling via conduit) while ensuring the product fluid only contacts the elastomeric material. This intermediary component decouples the functional requirements from direct product contact.
Solution Approach 2:
The harmful aspect of multiple material contacts is extracted from the flowpath by isolating the metallic needle and other components behind the elastomeric conduit. The product fluid pathway is simplified to contact only the elastomeric material, while other components perform their functions without direct product contact.
3Ease of operation
If a blunt cannula is used for open fill, then the simplicity and ease of operation are improved, but the ability to perform trans-septal fills is lost
Solution Approach 1:
The metallic needle is designed to perform multiple functions: it can pierce septums for trans-septal fills and can also be used in open fill configurations. The elastomeric conduit adapts to both fill methods, providing a universal solution that maintains simplicity while enabling versatile application capability.
Solution Approach 2:
The system is designed to be dynamic in its configuration. The elastomeric conduit can be positioned and configured differently depending on whether an open fill or trans-septal fill is being performed, allowing the same basic components to adapt to different operational requirements without compromising ease of use.
Data Source
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AI summary
Asceptic transfer through a needle penetrating a septum is accomplished by inserting an elongate inner tube through the needle and delivering a product fluid through the inner tube. Inner tube is desirably made from a polymer such as PTFE and product fluid does not contact the needle. The present invention relates to the field of fluid dispensing. More specifically, the present invention is directed to a needle kit for dispensing a product fluid.