Aseptic Refill Set for Implantable Infusion Pumps
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Solution Overview
Problem
Current refill sets for implanted medication pumps are prone to microbiological contamination due to the need for multiple manual manipulations that break the aseptic seal, especially when transferring infusion solutions between syringes, which increases the risk of bacterial introduction during the emptying and refilling process.
Innovation Solution
A refill set with a T-port or three-way check valve system that maintains a closed hose system by automatically opening and closing the flow paths between the cannula, emptying syringe, and storage syringe, ensuring aseptic conditions during both emptying and filling by using a Luer lock activation mechanism.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If multiple manual manipulations are performed to transfer infusion solution between syringes, then the refilling process can be completed, but the risk of microbiological contamination increases
Solution Approach 1:
The system divides the refilling process into distinct functional segments: a storage syringe for bulk medication, a filling syringe for transfer, and a three-way non-return valve that segments the fluid pathways. This segmentation allows each component to perform its specific function while maintaining aseptic conditions through the valve's isolation capabilities.
Solution Approach 2:
The three-way non-return valve acts as an intermediary device between the storage syringe and filling syringe. It mediates the fluid transfer while maintaining a closed system, preventing direct exposure to contaminants and eliminating the need for manual manipulation that would break the aseptic seal.
2Object-affected harmful factors
If a closed hose system is maintained during emptying and filling, then microbiological contamination is prevented, but the device complexity increases
Solution Approach 1:
The three-way non-return valve serves multiple functions: it enables fluid transfer from storage to filling syringe, prevents backflow during emptying, maintains closed system integrity, and allows for sterile connection/disconnection. This multi-functionality reduces the need for additional separate components, thereby limiting the increase in device complexity.
Solution Approach 2:
The non-return valve automatically controls fluid flow direction based on pressure differentials during emptying and filling operations. The system self-regulates the open/closed states of pathways without requiring external control mechanisms, simplifying the overall system design while maintaining aseptic conditions.
3Stress or pressure
If syringes with small diameters are used to overcome the internal pressure of the implanted drug pump, then the physical conditions are met, but the number of syringes required increases
Solution Approach 1:
The storage syringe is pre-filled with the complete required volume of infusion solution (e.g., 40 ml). This preliminary preparation eliminates the need to perform multiple separate filling operations with smaller syringes, as all the medication is already available in the storage syringe for single-step transfer to the filling syringe.
Solution Approach 2:
The system combines the storage function and filling function into an integrated setup where the storage syringe connects directly to the filling syringe via the three-way valve and cannula. This merging allows the entire medication volume to be transferred in one continuous operation rather than requiring multiple separate syringes and manual transfer steps.
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 effectively prevents microbiological contamination by maintaining a closed and aseptic hose system, ensuring safe and efficient transfer of medication without risking bacterial introduction, thereby reducing the risk of infection and improving the reliability of the refill process.
Implementation Method 1
which has a sealing rubber lip in the vertical T-outlet, which pushes open through the inner Luer cone when a Luer lock is screwed on becomes
Implementation Method 2
The 3-way valve blocks the flow with its non-return valve so that no liquid rises into the storage syringe and filling tip when emptying
Implementation Method 3
The filling septum of the infusion pump is punctured using the cannula
Data Source
Figure 1
AI summary
The set has a supply syringe (1) for supplying medicine solution, and a filling syringe (3) connected with the supply syringe by a three-way valve (4). A connection hose (6) is guided from the three-way valve to a cannula (7) that is inserted through a septum of an infusion pump. A T-port (5) is inserted into the hose in or at the valve. The T-port opens a path from the cannula to an emptying syringe (2) upon setting the emptying syringe to the T-port. The T-port is activated by a luer connecting piece of the emptying syringe. A bacteria filter is arranged between the valve and the T-port.