Needle-Free Drug Reconstitution Tray with Dual-Ended Transfer Needle
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Solution Overview
Problem
Current drug reconstitution methods using syringes with injection needles pose risks of accidental exposure and contamination, and there is a need for a safer, more accurate, and user-friendly system for combining liquid and solid components without needles, while also reducing user handling steps.
Innovation Solution
A tray-based apparatus with a dual-ended transfer needle that aligns and pierces vials and containers under negative pressure, allowing for axial displacement to establish fluid communication without the need for syringes, ensuring central piercing and maintaining alignment for efficient reconstitution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If syringes with injection needles are used for drug reconstitution, then the reconstitution process can be completed, but the risk of accidental exposure and contamination increases
Solution Approach 1:
The invention extracts and eliminates the injection needle from the reconstitution system. Instead of using a syringe with a needle to transfer the diluent, the system uses a needle-free transfer mechanism where the diluent container is inverted and the diluent flows through a controlled opening into the vial, completely removing the needle component that causes exposure risk.
Solution Approach 2:
The invention introduces an intermediary transfer mechanism between the diluent container and the vial. This intermediary system includes a controlled opening in the diluent container and a receiving structure in the vial adapter that enables fluid transfer without direct needle penetration, thereby mediating the transfer process safely without exposure risk.
2Ease of operation
If manual syringe handling is used for reconstitution, then the process can be performed, but the complexity of user handling steps increases
Solution Approach 1:
The invention merges multiple separate handling steps into a single integrated operation. The vial adapter combines the functions of vial holding, diluent reception, and fluid transfer control into one device. The user simply attaches the diluent container to the vial adapter, and the system automatically manages the reconstitution process, reducing multiple manual steps to a single intuitive action.
Solution Approach 2:
The vial adapter serves multiple functions simultaneously: it holds the vial, receives the diluent container, controls the fluid transfer, and prevents contamination. This multi-functional design eliminates the need for separate syringes, needles, and caps, simplifying the overall handling process while maintaining safety and efficacy.
3Productivity
If syringes are used to inject and withdraw fluids, then fluid transfer can be achieved, but fluid remains on the syringe tip creating exposure risk
Solution Approach 1:
The invention extracts the syringe tip from the system and replaces it with a controlled opening mechanism. The diluent flows directly from the container through a controlled opening into the vial without requiring a syringe tip, eliminating the source of fluid retention and subsequent contamination risk.
Solution Approach 2:
The system enables self-service fluid transfer where the diluent container's own weight and the pressure differential automatically drive the fluid flow into the vial. The controlled opening self-regulates the transfer process, and the system automatically prevents fluid retention issues that plague syringe-based methods, without requiring additional wiping or cleaning 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 provides a safer, more accurate, and user-friendly method for reconstituting drugs by eliminating needle exposure risks and reducing user handling, ensuring efficient and sterile reconstitution of drug solutions.
Implementation Method 1
a vial under negative pressure, wherein a tray has a vial cavity for accommodating at least a portion of the vial and a container cavity for accommodating at least a portion of the container
Data Source
AI summary
An apparatus for combining a first liquid component 90 stored in a container 125 and a second component stored in a vial 7 by means of negative pressure is disclosed. A tray 1 has a vial cavity 11 and a container cavity 12. A dual-ended transfer needle 131 is fixedly held at the tray 1 at an intermediate needle holding portion 13 between the vial cavity 11 and the container cavity 12 for establishing a fluid communication between the vial 7 and the container 125 by piercing a rubber stopper of the vial and a bottom of the container, respectively. The vial cavity 11 guides the vial 7 along an axial direction AD from an intermediate position towards the transfer position for fluid communication. And the container cavity 12 guides the container 125 along the axial direction AD from an intermediate position towards the transfer position for fluid communication.


