Flexible Plug for Medical Fluid Particulate Control
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing medical fluid treatment systems, particularly those using premade or bagged solutions, face challenges with particulate matter (PM) contamination when connectors are punctured or frangible seals are broken, which can lead to PM being carried into the medical fluid flow.
Innovation Solution
A flexible plug assembly is introduced, comprising a rigid sealing cap, a flexible sealing member, and a rigid member holder, assembled within a port tube. This assembly is designed to be aseptically opened by bending the port tube, allowing the flexible sealing member to bend and break its seal, enabling medical fluid flow without generating particulate matter.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If connectors are punctured or frangible seals are broken to establish fluid flow, then medical fluid flow is enabled, but particulate matter is generated and carried into the fluid
Solution Approach 1:
The sealing member transitions from a rigid sealed state to a flexible deactivated state through dynamic deformation. The sealing surface is designed to flex and separate from the connector opening when force is applied, enabling fluid flow without generating particulate matter through controlled dynamic motion rather than static breaking
Solution Approach 2:
The sealing member utilizes a flexible membrane or diaphragm structure that can elastically deform to open the seal. This flexible thin film approach allows the seal to be broken through bending and flexing motions that do not generate particulate contamination, unlike rigid puncture or fracture mechanisms
2Object-generated harmful factors
If rigid sealing mechanisms are used to prevent particulate matter, then PM generation is reduced, but the force required to activate fluid flow increases
Solution Approach 1:
The sealing system is divided into separate functional components: a rigid connector body that maintains structural integrity and a flexible sealing member that provides the seal. This segmentation allows the rigid portion to resist particulate generation while the flexible portion requires minimal activation force
Solution Approach 2:
The sealing assembly combines rigid and flexible materials in a composite structure. The rigid connector provides structural support and sealing surface, while the flexible sealing member (made of elastomeric or polymeric material) provides the seal and requires low force for activation through elastic deformation
3Reliability
If complex sealing assemblies are used to ensure sterile fluid path, then sterility is maintained, but device complexity increases
Solution Approach 1:
Multiple sealing functions are merged into a single integrated sealing member component. The sealing member simultaneously provides the fluid seal, the activation mechanism through flexing, and the particulate-free opening action, eliminating the need for separate complex sealing components
Solution Approach 2:
The sealing member serves multiple functions: it creates the initial seal, provides the opening mechanism through elastic deformation, maintains sterility during activation, and prevents particulate generation. This multi-functionality reduces the overall device complexity while maintaining reliable sterile fluid path
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 flexible plug assembly effectively prevents the generation of particulate matter during activation, reduces the force required for fluid flow, mitigates patient dexterity issues, and ensures a sterile fluid path, enhancing the safety and efficiency of medical fluid treatments.
Implementation Method 1
a flexible sealing member (40) including a flexible section (44) that extends to a head (46)
Data Source
AI summary
A flexible plug for a medical fluid comprises a sealing member including a flexible cylindrical section that extends to a head; a rigid member holder secured to the sealing member; and a rigid sealing cap including a wall defining an opening, the head of the sealing member sealed within the opening to prevent the flow of medical fluid through the flexible plug. The flexible plug is sealed, e.g., solvent bonded, within a port tube, sleeve port or a Y-connector to form a flexible plug assembly. The user grasps and twists or torques the rigid member holder and the rigid sealing cap through the port tube, sleeve port or a Y-connector to unseal the head from the opening to allow the flow of medical fluid through the flexible plug. A method of manufacturing the flexible plug and associated assembly is also disclosed.