Reconstitution Device with Integrated Vent Conduit
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
The current methods for reconstituting medications in dry form for intravenous administration are cumbersome and prone to spillage, especially when dealing with multi-chamber IV bags, which have frangible seals and are often underfilled, making it difficult to apply pressure for reconstitution.
Innovation Solution
A reconstitution device that establishes a fluid pathway between a drug vial and an IV bag, using a vent conduit to facilitate reconstitution without requiring pressure, and includes a cylindrical collar to engage the vial and a piercing member to connect with the IV bag port, allowing for direct reconstitution and infusion into the IV bag.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If manual reconstitution method is used with needle and syringe, then the procedure can be performed with simple equipment, but the process is cumbersome and prone to spillage
Solution Approach 1:
The patent introduces a reconstitution device as an intermediary tool between the vial and IV bag. This device includes a connector that attaches to the IV bag port and a mechanism that pierces the vial stopper, creating a controlled fluid pathway. The intermediary device eliminates the need for manual needle insertion and syringe handling, thereby preventing spillage while maintaining operational simplicity.
Solution Approach 2:
The reconstitution device incorporates a vacuum mechanism that automatically draws the reconstituted solution from the vial into the IV bag without requiring manual aspiration. The device self-regulates the fluid transfer process, eliminating the need for healthcare providers to manually control the suction and transfer, thereby preventing spillage and reducing steps.
2Stress or pressure
If pressure is applied to multi-chamber IV bags for reconstitution, then fluid can be pushed into the vial, but the frangible seals and underfilled condition make pressure application difficult
Solution Approach 1:
Instead of applying pressure to push fluid from the IV bag into the vial, the patent inverts the approach by using vacuum suction to draw fluid from the IV bag through the reconstitution device into the vial. This reversal of the pressure differential eliminates the need to overcome frangible seals and underfilled bag constraints, as the vacuum naturally pulls fluid through the established pathway.
Solution Approach 2:
The patent employs pneumatic principles by utilizing vacuum pressure to drive fluid flow. The reconstitution device incorporates a vacuum source that creates a pressure differential, causing IV fluid to be automatically drawn through the connector and into the vial. This pneumatic approach replaces manual pressure application, making the process easier to perform with multi-chamber bags.
3Stability of the object's composition
If dry form active agents are stored in sealed containers, then stability is maintained, but reconstitution requires multiple steps including removing protective covers and wiping stoppers
Solution Approach 1:
The patent combines multiple reconstitution steps into a single integrated device operation. The reconstitution device simultaneously performs piercing of the stopper, creation of fluid pathway, and initiation of fluid transfer, eliminating the need for separate steps of removing protective covers, wiping stoppers, and manual fluid transfer. This merging reduces device complexity from multiple separate tools to one unified device while maintaining drug stability through the sealed connection.
Solution Approach 2:
The reconstitution device is designed as a universal tool that can be used with various sealed vial types and IV bag configurations. The connector adapts to different IV bag ports, and the piercing mechanism works with standard vial stoppers, eliminating the need for specialized equipment for each step. This multi-functionality maintains drug stability while simplifying the reconstitution process across different medication types.
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 solution ensures complete reconstitution and immediate delivery of the drug into the IV bag, reducing degradation risks, minimizing microbiological contamination, and simplifying the preparation process by eliminating the need for manual handling and pressure application, while being suitable for multi-chamber bags.
Implementation Method 1
With the vial still inverted, the vacuum inside the vial draws the IV fluid from the IV bag into the vial through the fluid pathway.
Implementation Method 2
The vent conduit facilitates reconstitution by allowing air to enter the vial, equalizing pressure differences that prevent complete fluid transfer.
Data Source
Figure 1
Figure 2
Figure 3
AI summary
A reconstitution device includes a body, a first piercing member located at a first end of the body, and a receptacle located at the second end of the body. The receptacle includes a collar configured to engage a vial, and a cap extending from the collar and holding a second piercing member. The second piercing member is disposed within the collar. The reconstitution device includes a first fluid pathway formed within and extending from the first piercing member to the second piercing member. The reconstitution device includes a second fluid pathway formed within and extending from the second piercing member to a portion of the body between the first piercing member and the second piercing member.