Dispense Assembly End-of-Life Detection via Attachment Time
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Solution Overview
Problem
Medical devices for delivering multiple drug agents from separate reservoirs face challenges such as contamination, microbial growth, and blockages in fluidic channels, which can lead to unsafe and unreliable drug delivery, potentially causing harm to users.
Innovation Solution
A medical device equipped with a sensor and control unit that detects the attachment of a dispense assembly and determines its end-of-life based on attachment time, preventing further use when the assembly is deemed contaminated or compromised, thereby ensuring safety and reliability of drug delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of moving object
If the dispense assembly is left attached to the medical device for extended use, then the device remains operational and can deliver medication, but the risk of contamination and microbial growth in the fluidic channels increases
Solution Approach 1:
The system performs preliminary actions by detecting attachment and automatically starting a timer to track the dispense assembly's service life. The end-of-life indication is prepared in advance based on pre-determined time criteria, preventing contamination before it becomes a hazard by prompting timely replacement.
Solution Approach 2:
The system implements feedback through the indicator that continuously monitors and communicates the attachment duration to the user. When the predetermined time limit is reached, the indicator provides feedback by signaling end-of-life, creating a closed-loop system that prevents extended use beyond safe contamination thresholds.
2Reliability
If the dispense assembly is frequently replaced to prevent contamination, then the safety and sterility of medication delivery is maintained, but the operational time and convenience for the user is reduced
Solution Approach 1:
The system performs self-service by automatically tracking the attachment duration through an internal timer and autonomously determining when replacement is necessary. This eliminates the need for users to manually monitor time or make judgment calls about contamination risk, allowing them to simply replace the assembly when the indicator signals end-of-life.
Solution Approach 2:
The system takes preliminary action by pre-determining the safe service life duration and automatically indicating when replacement is needed, allowing users to plan ahead and replace assemblies during convenient moments rather than dealing with unexpected contamination risks or frequent unplanned replacements.
3Reliability
If the medical device includes automatic end-of-life detection and indication, then the safety against contaminated dispensing is improved, but the device complexity increases due to additional sensors and control units
Solution Approach 1:
The system replaces complex mechanical contamination prevention mechanisms with an electronic/time-based monitoring approach. Instead of using physical barriers, filters, or complex mechanical seals that would wear and require maintenance, the invention uses a sensor to detect attachment and a timer to track duration, significantly simplifying the overall system architecture while maintaining or improving safety.
Solution Approach 2:
The system changes the parameter being monitored from physical contamination indicators (which would require complex sensors) to time duration, a simple parameter that can be accurately tracked using basic electronic timing circuits. This parameter transformation enables reliable contamination prevention with minimal additional complexity.
Data Source
AI summary
The technical problem of the present invention to provide a medical device, which exhibits an increased safety of the device and facilitates a safe use is solved by medical device for delivering at least one drug agent, comprising a sensor, a control unit and an attachable dispense assembly, wherein the sensor is configured to detect attachment of the dispense assembly to the medical device, wherein the control unit is configured to determine at least based on a signal from the sensor whether the end of life of the dispense assembly is reached and wherein the medical device is configured to indicate the end of life of the dispense assembly. The technical problem is further solved by a method according to the invention.