Patient Line Fluid Verification Module for Hygienic Priming
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Solution Overview
Problem
Conventional patient lines in medical fluid delivery systems face issues with accidental reuse, clumsy and unhygienic priming practices, and the need for enforcing recommended replacement schedules to ensure patient safety.
Innovation Solution
An administration line with a fluid verification module that includes a body with inlet and outlet ports, tubing sections, and features like sheet materials that change state upon contact with priming fluid, allowing the system to determine the line's status and prevent reuse, while ensuring hygienic priming and safe operation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If tubing sets are designed for finite single-use to prevent cross-contamination, then patient safety is improved, but device complexity and cost increase due to frequent replacement
Solution Approach 1:
The patent applies preliminary action by pre-configuring the tubing set with a fluid verification module that automatically detects and records priming events. This pre-built verification system eliminates the need for manual tracking and enforcement of replacement schedules, resolving the contradiction by maintaining single-use safety while reducing operational complexity through automated preliminary verification.
Solution Approach 2:
The patent implements feedback mechanisms where the fluid verification module continuously monitors fluid flow and priming events, providing real-time information to the controller. This feedback loop automatically enforces replacement schedules by detecting when the tubing set has been primed or used, thereby maintaining patient safety while eliminating manual intervention and reducing operational complexity.
2Reliability
If priming is performed by injecting fluid through the patient line, then air injection is prevented, but contamination of the sterile tip occurs due to unhygienic practices
Solution Approach 1:
The patent applies segmentation by separating the priming function from the patient injection function. The fluid verification module includes a dedicated priming port and priming cavity that isolates the priming operation from the sterile patient line. This segmentation allows priming to occur in a separate, controlled environment, preventing contamination of the sterile tip while maintaining air injection prevention through the same fluid verification mechanism.
Solution Approach 2:
The patent introduces an intermediary priming cavity between the fluid source and the patient line. This intermediary chamber receives priming fluid and allows verification of fluid presence before the actual patient injection. The intermediary structure acts as a buffer that prevents direct contact between priming operations and the sterile tip, eliminating contamination risk while maintaining the air prevention function.
3Reliability
If the fluid verification module monitors priming and usage status, then reuse prevention is improved, but device complexity increases
Solution Approach 1:
The patent merges multiple functions into the fluid verification module: priming verification, usage monitoring, and reuse prevention are all integrated into a single compact device. The module combines fluid detection capabilities, status recording, and controller communication in one unit, thereby improving reuse prevention while minimizing the increase in device complexity through functional integration.
Solution Approach 2:
The fluid verification module operates autonomously, automatically detecting priming events, recording usage status, and communicating with the controller without external intervention. This self-service capability improves reuse prevention by ensuring consistent monitoring while reducing the operational complexity burden on users, as the system manages its own verification and enforcement functions.
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 ensures hygienic priming and prevents reuse of patient lines, enhancing patient safety by enforcing replacement schedules and preventing cross-contamination, thus improving the reliability and safety of medical fluid delivery systems.
Implementation Method 1
a second sheet material which transitions from an opaque state to an at least partially translucent state when the second sheet material is contacted by the priming fluid
Implementation Method 2
a capillary channel in fluid communication with the priming cavity and configured to take up at least a portion of the priming fluid via capillary action
Data Source
AI summary
An administration line for use with a fluid injector system includes a fluid verification module configured to be in operative communication with a housing of the fluid injector system such that the fluid injector system can determine a status of the administration line. The fluid verification module includes a body defining an inlet port, an outlet port, and a fluid channel extending from the inlet port to the outlet port; a first tubing section connected to the inlet port; and a second tubing section connected to the outlet port.