Prefilled Two-Component Mixing Syringe Kit With Sealed Needle Space

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Conventional prefilled syringe kits expose the syringe barrel, plunger, drug container, and connecting portions to the outside, leading to a risk of leakage of drug or liquid components during storage and preparation of the injection solution, especially when the needle is pulled out after mixing.

Innovation Solution

A two-component-mixing prefilled syringe kit design where a syringe barrel and container are held by a holding member, with a needle cap and space-forming body that seals the seal member from the outside, preventing leakage by forming a sealed space around the piercing point, and a lock mechanism to maintain this state.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If the injection needle penetrates the seal member to transfer liquid from container to syringe barrel, then the mixing function is improved, but the risk of liquid leakage to outside increases

Engineering Contradiction:
Improvemixing functionVSAvoidliquid leakage risk
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The needle cap serves as an intermediary component between the injection needle and the external environment. It includes a through-hole that guides the injection needle while maintaining a sealed space between the seal member and the needle cap's front surface, preventing liquid from leaking to the outside during and after the penetration process.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The sealed space formed by the needle cap and seal member creates a preliminary barrier against liquid leakage before the injection needle is fully withdrawn. This pre-established sealed environment prevents the harmful effect of liquid dripping or leaking to the external environment.

Inventive Principle:
Principle #9Preliminary anti-action

2Ease of operation

If the syringe barrel and container are exposed to outside for easy access, then the ease of operation is improved, but the risk of drug or liquid leakage increases

Engineering Contradiction:
ImproveaccessibilityVSAvoiddrug leakage risk
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The needle cap is nested within the holding member structure, creating a hierarchical arrangement where the needle cap's sealed space is contained within the overall device architecture. This nested structure allows the sealed compartment to remain accessible while preventing leakage to the external environment.

Inventive Principle:
Principle #7Nested doll (Nesting)

3Object-affected harmful factors

If the needle cap covers the injection needle tip, then the leakage prevention is improved, but the complexity of the device structure increases

Engineering Contradiction:
Improveleakage preventionVSAvoidstructure complexity
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The needle cap provides localized sealing only at the critical area where the injection needle penetrates the seal member. Rather than enclosing the entire syringe and container, the sealing function is applied locally at the penetration point, reducing overall structural complexity while maintaining effective leakage prevention.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The needle cap appears to be a thin-walled structure that forms a sealed space without requiring heavy or complex materials. This thin-film approach creates an effective barrier against leakage while minimizing the added weight and complexity of the device.

Inventive Principle:
Principle #30Flexible shells and thin films

Data Source

PatentEP3777931B1Prefilled two-component-mixing syringe kit
Publication Date: 2025.07.02 CMC PHARMA CO LTD
  • EP3777931B1 patent drawingFigure 1
  • EP3777931B1 patent drawingFigure 2
  • EP3777931B1 patent drawingFigure 3

AI summary

In a two-component-mixing prefilled syringe kit for preparing an injection solution by mixing a drug component in a syringe barrel and a liquid component in a container, when the injection needle pierced by the seal member of the container outlet is pulled out after preparation of the injection solution, a leaking to the outside of the remaining liquid in the container is effectively prevented. Comprise a syringe barrel in which an injection needle is attached on one end, a plunger is inserted slidably through the opening on the other end, and the solid or liquid component constituting the injection solution is filled, and a container in which an outlet is sealed by a seal member that can be pierced by the injection needle, and the liquid component constituting the injection solution is filled, and a holding member which holds the syringe barrel so that the syringe barrel is movable along the axial direction with the tip of the injection needle facing the outlet of the container, and a space-forming body which forms a space facing the surface of the seal member in a space that is sealed from the outside, and the space-forming body is formed of a material that can be pierced by the injection needle at the portion facing the tip of the injection needle along the barrel axis direction of the syringe barrel.