Screw-Driven Sleeve for Lyophilized Drug Reconstitution
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Solution Overview
Problem
Existing medicament delivery devices struggle to efficiently reconstitute lyophilized drugs within multi-chamber cartridges, often leading to foaming, incomplete mixing, and difficulty in determining when the mixing process is complete, which can be critical for multiple injections from a single cartridge.
Innovation Solution
A two-piece pen-type injector design that incorporates a screw-driven sleeve with a threaded connection to facilitate slow mixing of the solvent with the lyophilized drug agent within a multi-chambered cartridge, allowing for complete reconstitution and easy visualization of the process through observation windows.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If fast mixing is used to reconstitute lyophilized drugs, then reconstitution time is reduced, but foaming occurs and mixing completeness deteriorates
Solution Approach 1:
The device employs periodic reciprocating motion of the inner cartridge through the threaded connection between the inner cartridge and outer syringe barrel. This back-and-forth movement creates periodic mixing action that gradually reconstitutes the lyophilized drug without excessive agitation, thereby reducing foaming while maintaining reasonable reconstitution time
Solution Approach 2:
The system transitions from static components to dynamic reciprocating motion. The threaded connection enables the inner cartridge to move dynamically back and forth within the outer syringe barrel, creating controlled mixing motion that balances reconstitution speed with foam prevention
2Device complexity
If manual mixing is used to reconstitute lyophilized drugs, then device complexity is reduced, but mixing completeness and dosing accuracy deteriorate
Solution Approach 1:
The device performs self-mixing through the reciprocating motion generated by the threaded connection between the inner cartridge and outer syringe barrel. When the user pushes the plunger, the system automatically creates the mixing action without requiring separate manual mixing steps, ensuring consistent and complete reconstitution
Solution Approach 2:
The mixing function is merged with the injection function. The same threaded connection mechanism that drives the plunger forward also creates the reciprocating mixing motion, combining two functions into one integrated mechanism rather than requiring separate mixing and injection steps
3Duration of action of stationary object
If multi-chamber cartridges are used to store lyophilized drugs and solvents, then shelf life and transport ease are improved, but device complexity and mixing mechanism complexity increase
Solution Approach 1:
The cartridge is segmented into multiple chambers (lyophilized drug chamber and solvent chamber) separated by a stopper. This segmentation allows each component to be stored separately in stable conditions, extending shelf life while enabling controlled mixing when needed through the reciprocating motion mechanism
4Difficulty of detecting and measuring
If observation windows are added to visualize mixing progress, then mixing completeness detection is improved, but device complexity increases
Solution Approach 1:
The observation window allows visual detection of mixing progress by observing changes in the appearance of the reconstituting solution. As the lyophilized drug dissolves in the solvent, the user can see the transition from separate phases to a homogeneous mixture through the transparent or translucent cartridge walls and window
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 complete reconstitution of medicaments within multi-chamber cartridges, reducing the risk of foaming and ensuring accurate dosing, while also simplifying the manufacturing process and user operation.
Implementation Method 1
a screw driven sleeve configured for attachment to the distal part and where rotation of the screw driven sleeve performs a medicament mixing process within the multi-chambered cartridge
Data Source
AI summary
A medicament delivery device is presented for administering a therapeutic substance from a multi-chamber cartridge. The medicament delivery device performs a mixing process to create the therapeutic substance for delivery within the multi-chambered cartridge, where the delivery device includes a distal part comprising a dose setting mechanism having a housing, a dose setting knob, an injection button, a piston rod capable of moving axially along the longitudinal axis of the housing during dose delivery, and a return ring configured to reset the piston rod to a starting position. The delivery device also includes a proximal part comprising a cartridge holder configured to accept a multi-chambered cartridge, where the cartridge holder comprises a screw driven sleeve configured for attachment to the distal part and where rotation of the screw driven sleeve performs a medicament mixing process within the multi-chambered cartridge.