Needle Tip Shield with Integrated Filter for Aseptic Drug Prep
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Solution Overview
Problem
Current medical devices for aseptic drug preparation face challenges in maintaining aseptic conditions and preventing drug leakage, with existing solutions requiring extensive space, high costs, and inadequate protection against contamination and exposure to hazardous drugs. Additionally, medical devices with needles pose risks of injury and damage during handling and storage.
Innovation Solution
A medical device arrangement featuring a needle member tip shield integrated with a particulate air filter, which provides both protection against needle injuries and ensures cleaned gas delivery during drug preparation, reducing the number of components and enhancing safety by filtering gas and preventing contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a needle member is used for penetration and gas/liquid transportation, then the medical device can enable drug vial penetration and substance transfer, but the device poses risks of needle injury to handlers and damage to packaging during transport and storage
Solution Approach 1:
The shield is integrated into the needle member structure, with the shield forming an integral part of the needle assembly. The shield can be positioned within or around the needle member, creating a nested configuration where the protective shield is embedded in the functional needle structure, allowing both protection and functionality in a single compact component
Solution Approach 2:
The invention combines the protective shield function and the gas/liquid transportation function into a single integrated medical device component. The shield and needle member are merged into one structure, eliminating the need for separate protective covers and reducing the number of components while maintaining both safety and functionality
2Reliability
If special safety boxes, cabinets or isolators with HEPA filters are used to achieve aseptic conditions, then contamination during drug preparation is prevented, but a lot of space is required and costs are relatively high
Solution Approach 1:
The invention extracts the filtration function from large-scale environmental control systems (HEPA filtered cabinets) and incorporates it directly into the portable medical device itself. By integrating a filter directly into the device, the system achieves aseptic functionality without requiring external clean room infrastructure or large ventilation cabinets
Solution Approach 2:
The integrated filter acts as an intermediary component within the device that mediates between the external environment and the sterile drug preparation process. Instead of requiring a large controlled environment, the filter serves as a localized barrier that allows the device to maintain aseptic conditions independently in smaller spaces
3Object-affected harmful factors
If ventilated cabinets are used to reduce uncontrolled leakage and prevent occupational exposure, then drug leakage to the environment is reduced, but working environment problems due to accidental exposure still occur and protection can be insufficient
Solution Approach 1:
The filter creates a controlled barrier that establishes a protective interface between the drug preparation system and the external environment. By filtering gas flow through an integrated filter, the system creates a controlled atmospheric boundary that prevents uncontrolled leakage of hazardous drugs while maintaining adequate protection levels
4Adaptability or versatility
If multiple separate components are used for needle protection and gas filtration, then each function can be optimized independently, but the total number of components increases and device complexity increases
Solution Approach 1:
The invention merges the protective shield and integrated filter into a single unified component structure. The shield forms an integral part of the needle member assembly, combining protection and filtration functions in one component, thereby reducing the total number of parts while maintaining the ability to optimize both functions
Solution Approach 2:
The integrated shield-filter component performs multiple functions simultaneously: it provides physical protection for the needle member, filters gas flow to maintain aseptic conditions, and serves as part of the overall device structure. This multi-functional design reduces component count while maintaining functional versatility
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 integrated filter shield effectively reduces the risk of contamination and needle injuries while providing a safe and efficient means for gas delivery, minimizing environmental exposure and device damage, thus enhancing the safety and efficiency of drug preparation processes.
Implementation Method 1
the arrangement comprises a filter, preferably a particulate air filter for filtering gas to be transferred out from or into the medical device via the needle member
Data Source
AI summary
The invention relates to an arrangement for use with a medical device which arrangement comprises a shield for a tip of a needle member of a medical device. The arrangement comprises a filter for filtering gas to be transferred out from or into the medical device via the needle member when the arrangement is interconnected with the medical device. The filter is integrated with or constitutes at least a portion of the needle member tip shield.