Multi-Lumen Spike for Aseptic Powdered Medication Reconstitution
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Solution Overview
Problem
The need for a streamlined apparatus that allows a lay person to aseptically reconstitute and compound powdered intravenous medications outside a clean room environment without medical training, addressing the complexity and cost of current methods that require sterile cleanroom environments and refrigeration.
Innovation Solution
A multi-lumen spike designed for use with a mixing and loading apparatus, enabling a lay person to reconstitute powdered medications using a syringe and elastomeric infusion pump under sterile conditions, allowing for immediate intravenous infusion.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If medications are reconstituted in a sterile cleanroom environment and stored at refrigerated temperatures, then medication stability is maintained for up to 14 days, but the complexity of the process and cost increase significantly
Solution Approach 1:
The invention extracts the critical sterile barrier function from the complex cleanroom environment and concentrates it into a single reusable sterile hub that can be sterilized independently. This allows the reconstitution process to occur outside the cleanroom while maintaining sterility through the hub's barrier membrane, thereby reducing process complexity while preserving medication stability
Solution Approach 2:
The sterile hub acts as an intermediary component between the external environment and the medication vial. It provides a sterile barrier membrane that allows fluid passage while preventing contamination, enabling lay persons to perform reconstitution at home without requiring cleanroom facilities, thus simplifying the overall process while maintaining medication stability
2Reliability
If medications are reconstituted using conventional methods requiring cleanroom environments, then sterility is maintained, but the ease of operation decreases for lay persons
Solution Approach 1:
The sterile hub is designed to be self-sterilizing through autoclaving and includes pre-attached sterile components. The system enables lay persons to perform the reconstitution process themselves at home without requiring professional medical training or access to cleanroom facilities, thereby improving ease of operation while maintaining sterility through the hub's barrier membrane
Solution Approach 2:
The invention segments the reconstitution system into distinct components: a reusable sterile hub that can be sterilized and reused, disposable vials, and connection components. This segmentation allows the critical sterile function to be concentrated in the hub while simplifying the user interface, making the process accessible to lay persons while maintaining sterility
3Stability of the object's composition
If medications are stored at refrigerated temperatures after reconstitution, then stability is maintained, but the loss of time for deliveries increases due to frequent replenishment
Solution Approach 1:
The sterile hub is pre-sterilized and prepared before use, allowing the reconstitution to occur immediately before administration at the point of care. This eliminates the need for advance preparation in cleanrooms and reduces the time required for medication availability, as the hub can be sterilized and stored ready for use without requiring frequent deliveries
4Duration of action of stationary object
If medications are manufactured as sterile lyophilized powders, then shelf life is improved, but the ease of manufacture decreases due to additional reconstitution steps
Solution Approach 1:
The invention extracts the sterile barrier function from the complex cleanroom manufacturing environment and concentrates it into a single reusable sterile hub. This allows the medication to be manufactured as stable lyophilized powder while the reconstitution process is simplified through the hub's pre-sterilized components, thereby maintaining shelf life while improving ease of manufacture
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
Enables efficient and safe reconstitution of medications at room temperature, reducing the need for frequent deliveries and refrigeration, improving healthcare access in areas lacking cleanroom environments or continuous electricity.
Implementation Method 1
an inlet lumen connected to the syringe via a first conduit, and an outlet lumen connected to a second conduit capable of carrying fluid outside of the housing
Data Source
Figure 1A~1C
Figure 2A~2B
Figure 3A~3B
AI summary
A multi-lumen spike for mixing and reconstituting a medication in a dry state designed to provide the ability for a lay person to aseptically reconstitute a powdered medication for use with an infusion apparatus. The multi-lumen spike can be included as part of a medication mixing and loading apparatus capable of using one or more syringes for reconstituting the medication.