Closed Fluid Transfer Locking Member for Pressure-Balanced Sealing
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Solution Overview
Problem
Healthcare providers are at risk of exposure to hazardous chemotherapy drugs during reconstitution, transportation, and administration due to unintentional release of these drugs into the atmosphere as gas or aerosol, primarily caused by pressure differentials between vial interiors and the surrounding environment during needle withdrawal and insertion.
Innovation Solution
A system for closed fluid transfer comprising a syringe adapter with a cannula and a vial access device featuring a translating housing with seal membranes and a locking mechanism, ensuring leak-proof sealing and pressure equalization during cannula engagement, transfer, and disengagement, thereby preventing drug exposure to healthcare workers.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a needle is used to transfer drugs from a vial, then fluid transfer can be achieved, but pressure differentials cause drug release into the atmosphere during needle withdrawal and insertion
Solution Approach 1:
A translating housing with seal membranes is introduced as an intermediary component between the syringe adapter and vial access device. This mediator maintains sealed fluid communication during the entire transfer process, eliminating the need for needle withdrawal that causes drug release. The seal membranes provide continuous sealing while allowing controlled fluid passage.
Solution Approach 2:
Seal membranes are used as flexible thin films to create leak-proof seals during cannula engagement and disengagement. These membranes deform to accommodate the cannula while maintaining sealing integrity, preventing drug release into the atmosphere during operations that would otherwise compromise the seal.
2Reliability
If a locking mechanism is added to secure the syringe adapter to the vial access device, then connection stability is improved, but device complexity increases
Solution Approach 1:
The locking member is configured to automatically engage with the vial access device when the syringe adapter is properly positioned. The spring body provides automatic resetting functionality, allowing the locking mechanism to self-rearm after engagement without manual intervention, thereby maintaining reliability while minimizing operational complexity.
Solution Approach 2:
A spring body replaces complex multi-component locking mechanisms with a simple elastic element. This mechanical substitution provides reliable locking through elastic deformation and recovery, eliminating the need for intricate cam mechanisms, latches, or multiple moving parts while maintaining connection stability.
3Reliability
If seal membranes are used to prevent drug leakage, then leak-proof sealing is achieved, but the risk of clogging or damage to the seal increases during cannula insertion
Solution Approach 1:
The translating housing is pre-configured with seal membranes positioned to engage the cannula in a controlled sequence. The housing translates to guide the cannula through predetermined paths that minimize stress on the seals, preventing damage before it can occur during insertion operations.
Solution Approach 2:
The seal membranes are designed with inherent compliance and cushioning characteristics that absorb the impact and stress of cannula insertion. This beforehand cushioning protects the seals from sudden mechanical shocks that could cause tearing or dislodgement, maintaining sealing integrity throughout the process.
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 system provides a leak-proof and pressure-equalized environment, preventing the release of hazardous drugs into the atmosphere, thus minimizing exposure risks for healthcare providers during drug handling and administration processes.
Implementation Method 1
The spring body is deformable between a rested state when the locking member is in the locked position and a biased state when the locking member is in the unlocked position, where the spring body is configured to return to the rested state
Data Source
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AI summary
A connector system for a medical device includes a first connector having an elongate opening, and a second connector including a lock portion, where the first connector is movable relative to the second connector between an initial position where the first connector is not in fluid communication with the second connector and an activated position where the first connector is in fluid communication with the second connector. The system also includes a locking member connected to the first connector. The locking member is transitionable between an unlocked position where the second connector is movable within the elongate opening of the first connector and a locked position where the locking member is configured to engage the lock portion of the second connector to lock the first connector to the second connector in the activated position. The locking member comprises a spring body received by the elongate opening of the first connector.