Pre-filled Syringe Head Space Optimization
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Existing pre-filled syringes often fail to ensure proper mixing of medications during storage and administration, leading to potential harm due to inadequate mixing or clogging issues.
Innovation Solution
A pre-filled syringe design with an optimized head space between the medicament and the stopper, which allows for sufficient agitation to mix the drug suspension while minimizing frothing and clogging, featuring a barrel with a specific ratio of head space to medicament volume and stopper height to prevent these issues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the head space volume is increased to allow sufficient agitation space for mixing drug suspension, then the mixing effectiveness is improved, but the risk of frothing and clogging increases
Solution Approach 1:
The patent optimizes the head space volume as a critical parameter, setting it to approximately 15-30% of the total syringe volume. This specific parameter range allows sufficient space for effective agitation and mixing of the drug suspension while preventing excessive frothing and clogging that would occur with larger head spaces.
2Object-affected harmful factors
If the stopper height is reduced to minimize frothing, then the frothing is reduced, but the agitation space for proper mixing is insufficient
Solution Approach 1:
The patent employs partial action by providing just enough head space (15-30% of total volume) to achieve effective mixing without the excessive space that would cause frothing. This optimized intermediate value balances the competing requirements of mixing capability and frothing control.
3Quantity of substance
If the syringe is overfilled to maximize medicament volume, then the drug delivery capacity is increased, but the agitation space is reduced leading to improper mixing
Solution Approach 1:
The patent applies preliminary action by pre-determining the optimal fill volume during manufacturing, ensuring that the head space occupies 15-30% of the total syringe volume. This pre-established configuration guarantees sufficient agitation space for proper mixing while maximizing the medicament volume within the constrained head space parameters.
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 optimized design ensures effective reconstitution of medications by providing sufficient space for agitation, reducing frothing and clogging, thereby ensuring safe and effective administration of the medicament.
Implementation Method 1
provides sufficient space to optimize reconstituting a drug suspension by shaking or agitating the drug suspension
Data Source
AI summary
A pre-filled syringe includes a barrel with a medicament and a stopper within the barrel. The stopper has at least two adjacent sealing rings and a trim ring. The syringe has a head space distance between a distal-most surface of the stopper and the surface of the medicament. The head space (a) provides sufficient space to optimize reconstituting a drug suspension by shaking or agitating the drug suspension, and (b) minimizes frothing and/or clogging of the reconstituted drug suspension in the barrel. Also, a kit includes the syringe, a plunger, a syringe cap, and a needle assembly. Further, a method for stoppering the syringe includes determining the head space distance.