Elastic Cap Body Radial Compression Sealing for Syringe Leakage

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Solution Overview

Problem

Existing syringes face issues with drug solution leakage due to adherence to the inner surface of the female luer section, leading to loose engagement with male luer sections and potential leakage, especially during freeze-drying processes where thermal conductivity and drying efficiency differ between the cylindrical and body portions.

Innovation Solution

A syringe design featuring a cap body made of elastic material with specific sealing sections that compress radially inward to create a liquid-tight seal, preventing drug solution adherence and leakage, and a cap configuration that includes a proximal-end protruding portion to direct internal pressure away from the cap, ensuring secure attachment and easy removal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a cap is inserted into the cylindrical portion without sealing sections, then the device complexity is reduced, but the drug solution adheres to the inner peripheral surface of the female luer section causing leakage

Engineering Contradiction:
Improveprevention of drug solution leakageVSAvoidcap body structure
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The cap body is divided into multiple functional sealing sections: a first sealing section with a first sealing surface that contacts the inner peripheral surface of the cylindrical portion, and a second sealing section with a second sealing surface that contacts the proximal end section of the cylindrical portion. This segmentation allows each section to address specific leakage pathways independently, preventing drug solution from adhering to the female luer section while maintaining a manageable structural complexity.

Inventive Principle:
Principle #1Segmentation

2Reliability

If the cap body is made of rigid material, then the structural strength is improved, but the sealing effectiveness is reduced due to inability to compress radially inward

Engineering Contradiction:
Improvesealing effectivenessVSAvoidcap body strength
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The cap body is constructed from an elastic material that exhibits flexible deformation characteristics. This allows the cap body to compress radially inward when pressed against the cylindrical portion, enabling the sealing surfaces to conform to the inner peripheral surfaces and create liquid-tight seals. The elastic material maintains sufficient structural strength while providing the necessary flexibility for effective sealing during the freeze-drying process.

Inventive Principle:
Principle #30Flexible shells and thin films

3Productivity

If the internal pressure of the body portion increases during freeze-drying, then the drying efficiency is improved, but the cap body may detach from the cylindrical portion

Engineering Contradiction:
Improvefreeze-drying efficiencyVSAvoidcap body attachment
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The cap body is designed with sealing sections that are preliminarily positioned to contact the inner peripheral surfaces of the cylindrical portion before the freeze-drying process begins. The first sealing section contacts the inner peripheral surface of the cylindrical portion, and the second sealing section contacts the proximal end section, creating pre-established sealing pathways that prevent drug solution leakage even when internal pressure increases during freeze-drying, thereby maintaining secure attachment.

Inventive Principle:
Principle #10Preliminary action

4Ease of operation

If the cap body is designed with protruding portions to direct internal pressure, then the cap removal ease is improved, but the device complexity increases

Engineering Contradiction:
Improvecap removal easeVSAvoidcap body structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The cap body incorporates asymmetric protruding portions that extend in the proximal direction from the base. These protruding portions are positioned to interact with the cylindrical portion in a non-symmetric arrangement, creating directional forces that facilitate easy cap removal when internal pressure builds up during freeze-drying. The asymmetric design provides intuitive removal characteristics while adding minimal structural complexity compared to symmetric alternatives.

Inventive Principle:
Principle #4Asymmetry

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 design effectively prevents drug solution leakage and adherence, maintains secure engagement between luer sections, and facilitates effective freeze-drying by ensuring the drug solution remains within the body portion, while allowing easy cap removal and reattachment.

Implementation Method 1

the first sealing section seals a distal end section of the flow path in a liquid-tight manner by being compressed radially inward by an inner peripheral surface constituting the opening of the cylindrical portion

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 2

the second sealing section seals a proximal end section of the flow path in a liquid-tight manner by being compressed radially inward by an inner peripheral surface of the proximal end section of the cylindrical portion

Methodology Applied
Scientific EffectCompression: Compression

Implementation Method 3

a cap body that is attached to the cylindrical portion and that is made of an elastic material

Methodology Applied
Scientific EffectElasticity: Elasticity

Data Source

PatentUS11660402B2Syringe and prefilled syringe
Publication Date: 2023.05.30 TERUMO KK
  • US11660402B2 patent drawing
  • US11660402B2 patent drawing
  • US11660402B2 patent drawing

AI summary

In a syringe, which is a prefilled syringe, when a cap body is attached to a cylindrical portion, a first sealing section is compressed radially inward by an inner peripheral surface constituting an opening of the cylindrical portion, thereby sealing a distal end section of a flow path in a liquid-tight manner, and a second sealing section is compressed radially inward by an inner peripheral surface of a proximal end section of the cylindrical portion, thereby sealing a proximal end section of the flow path in a liquid-tight manner.