Negative Pressure Reconstitution Device for Aseptic Pharmaceutical Mixing
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Solution Overview
Problem
Current methods for reconstituting pharmaceutical compositions are labor-intensive, prone to contamination, and require medical professionals, making them unsuitable for remote or emergency use, especially for drugs with chemical instability and short shelf life, and they do not effectively prevent needle stick injuries.
Innovation Solution
A device utilizing a negative pressure differential system with adapters and a transfer port to automatically mix and transfer pharmaceutical components between vials, reducing exposure to needles and allowing for easy, aseptic reconstitution without the need for medical professionals.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If manual reconstitution method is used, then reconstitution can be performed, but it is labor intensive and introduces numerous opportunities for contamination
Solution Approach 1:
The patent introduces a transfer device as an intermediary between the diluent vial and the drug powder vial. This device includes a transfer syringe with a needle that pierces through the vial stoppers, creating a sealed connection that allows automatic transfer of diluent to the drug powder without manual injection. The intermediary device eliminates direct manual manipulation of needles and vials, thereby preventing contamination while simplifying the operation for users.
2Reliability
If manual reconstitution method is used, then reconstitution can be performed, but the needle may be dulled by insertion through the vial stopper
Solution Approach 1:
The transfer device is pre-assembled with the needle positioned to automatically pierce the vial stoppers when the device is engaged. The needle is protected within the transfer device housing until use, and the piercing action is performed as a single integrated motion when the device is activated. This preliminary positioning and integrated action prevents repeated needle insertions that would dull the needle, while maintaining an simple user operation of simply activating the pre-prepared device.
3Reliability
If automated transfer device is used, then contamination is reduced, but the device complexity increases
Solution Approach 1:
The transfer device is segmented into distinct functional components: a transfer syringe for holding and transferring diluent, a needle assembly for piercing vial stoppers, and connection interfaces for attaching to vials. Each component performs a specific function and can be independently manufactured and sterilized. This segmentation allows the device to achieve automated sterile transfer through modular design rather than a single complex integrated system, reducing overall device complexity while maintaining sterility.
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 device simplifies the reconstitution process, reduces contamination risks, prevents needle stick injuries, and allows for efficient mixing and transfer of pharmaceuticals, enabling use in remote settings and for drugs with short shelf life, while being economical and easy to operate.
Implementation Method 1
A device for reconstitution of a solid or semi solid pharmaceutical composition by a negative pressure differential
Data Source
AI summary
A novel device, method and kit for reconstitution of a solid or semi-solid pharmaceutical composition by a negative pressure differential includes (i) a first adapter with a first connector, a first peripheral wall wherein the first adapter is coupled to the first vial by means of a first connector; (ii) a second adapter with a second connector, a second peripheral wall wherein the second adapter is coupled to the second vial by means of a second connector; (iii) a transfer port wherein the transfer port includes a first end ending in first adapter to gain access to first vial and a second end ending in second adapter to gain access to second vial; wherein the first adapters and the second adapter are joined together in vertical direction by means of horizontal wall; wherein the adapter connected to the vials by means of the ends.