Infusion Insert with Piercing Spike for Sterile Drug Transfer
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Solution Overview
Problem
Current methods for administering drugs in extracorporeal circuits, such as during hemodialysis, require a double transfer of substances from vial to syringe and then to the circuit, involving disposable needles and posing risks of contamination and increased workload for nursing staff.
Innovation Solution
An infusion insert that allows direct engagement of the drug vial, eliminating the need for syringes and needles, automatically opening and closing with the vial connection, enabling slow substance administration without staff intervention and maintaining sterility by using a resilient piercing spike and main body designed for one-step transfer and pressure equilibrium.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional syringes and needles are used for drug transfer, then the drug can be transferred from vial to circuit, but disposable materials must be used and staff are exposed to needle pricks
Solution Approach 1:
The invention extracts and eliminates the needle and syringe components from the drug transfer process. Instead, a piercing spike integrated into the insert directly penetrates the vial stopper to enable drug transfer, removing the harmful needle element while maintaining the essential function of drug administration.
Solution Approach 2:
The insert acts as an intermediary device between the vial and the extracorporeal circuit. It provides a safe intermediate mechanism (piercing spike) that enables drug transfer without requiring direct needle insertion, thus mediating the harmful interaction between staff and needles.
2Productivity
If conventional syringes are used for drug transfer, then the drug can be administered, but a double transfer process is required from vial to syringe and then to circuit
Solution Approach 1:
The invention merges the vial piercing function and the circuit connection function into a single integrated insert. The piercing spike and channels are combined in one component that directly connects the vial to the extracorporeal circuit, eliminating the separate syringe transfer step and simplifying the overall process.
Solution Approach 2:
The insert is segmented into functional components (piercing spike, channels, resilient element) that work together to enable direct transfer. This segmentation allows the device to perform multiple functions (piercing, fluid transfer, sealing) in a single integrated unit, reducing process complexity.
3Ease of operation
If the circuit remains open for drug administration, then the drug can be infused, but the circuit is vulnerable to contamination
Solution Approach 1:
The resilient element is pre-positioned to automatically close the channels when the vial is removed or not properly connected. This preliminary protective action prevents contamination by ensuring the circuit remains sealed whenever the insert is not actively engaged with a vial, countering the contamination risk before it can occur.
Solution Approach 2:
The insert performs self-protection through the resilient element that automatically seals the channels. The device monitors its own state and takes protective action (closing channels) when needed, eliminating the need for manual intervention to prevent contamination.
4Extent of automation
If a resilient element is used to automatically close channels, then the circuit closes upon vial removal, but the piercing spike must be held in open position during vial engagement
Solution Approach 1:
The piercing spike is designed to be movable rather than fixed, allowing it to dynamically transition between open and closed positions. During vial engagement, the spike moves to the open position to allow drug flow, then automatically returns to the closed position when the vial is removed, providing both automation and reduced engagement force.
Solution Approach 2:
The resilient element changes its mechanical state (compressed vs. relaxed) based on vial presence. When the vial is engaged, the element is compressed allowing the spike to remain open; when the vial is removed, the element relaxes and automatically closes the channels. This parameter change enables automatic operation.
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 insert facilitates direct and sterile transfer of drugs from vials to extracorporeal circuits, reducing the need for disposable materials, minimizing staff exposure to needles, and automating the administration process, thereby enhancing safety and efficiency in therapeutic treatments.
Implementation Method 1
a resilient element (24) and a piercing spike (26). The piercing spike (26) has an axis X and defines a first channel (261) and a second channel (262) and is movable relative to the main body (22) along the axis X between a first closed position A and a second open position B. Moreover the resilient element (24) acts on the piercing spike (26) so as to keep it in the first closed position A when no external forces are applied
Data Source
AI summary
The present invention relates to an insert 20 for the infusion of drugs. The insert 20 is suitable for connection Io a vial 18 and preferably to a circuit 16 or an infusion line. Moreover the insert comprises a main body 22, a resilient element 24 and a piercing spike 26, The piercing spike has an axis X and defines a first channel 261 and a second channel 262 and is movable relative to the main body along the axis X between a first closed position A and a second open position B. Moreover the resilient element presses against the piercing spike so as to keep it in the first closed position A when no external forces are applied.