Leaf Spring Valve Prevents Insulin Free Flow

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Solution Overview

Problem

Existing insulin delivery devices fail to reliably prevent unintended free flow of liquid insulin from the reservoir to the recipient, especially under varying pressure conditions caused by external factors such as altitude changes, environmental pressures, and component elasticity.

Innovation Solution

A free flow prevention valve system comprising a shutter assembly mounted to the valve body, which prevents fluid flow when pressure is lower than a predefined threshold, ensuring that the pump pressure exceeds any differential pressure and external factors, using a spring valve or membrane valve design to control fluid flow.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a valve system is used to prevent free flow of insulin, then reliability of flow control is improved, but device complexity increases due to additional valve body, shutter assembly, and pressure threshold components

Engineering Contradiction:
Improvereliability of flow controlVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by utilizing pressure as a control parameter to automatically regulate insulin flow. The valve system is designed with a predefined pressure threshold that, when exceeded by pump pressure, automatically opens the shutter to allow flow. This eliminates the need for complex electronic controls while maintaining reliable flow management through physical parameter-based automation.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The valve system implements self-service by using the pump's own pressure output to control the valve opening. When the pump generates sufficient pressure, it automatically opens the shutter without requiring external control signals or additional actuators. The system serves itself by using its operational parameter (pressure) to trigger the flow control mechanism.

Inventive Principle:
Principle #25Self-service

2Adaptability or versatility

If a pressure threshold valve is implemented to prevent free flow under varying pressure conditions, then adaptability to external factors is improved, but manufacturing precision requirements worsen due to tight pressure threshold tolerances

Engineering Contradiction:
Improveadaptability to pressure variationsVSAvoidpressure threshold tolerance
Core Design Contradiction:
Adaptability or versatilityVSManufacturing precision

Solution Approach 1:

The patent applies dynamics by designing a valve system where the shutter can dynamically respond to changing pressure conditions. The shutter assembly is configured to move freely in response to pressure differential, allowing the valve to adapt automatically to varying pump pressures and external pressure changes. This dynamic response mechanism eliminates the need for extremely tight manufacturing tolerances, as the system self-adjusts to pressure variations.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The valve system utilizes pressure parameter changes to control flow state. By designing the shutter assembly with appropriate spring characteristics or pressure threshold settings, the system can accommodate a range of operating pressures while maintaining reliable free-flow prevention. The pressure threshold is set as a parameter that naturally adapts to different operating conditions without requiring precision manufacturing adjustments.

Inventive Principle:
Principle #35Parameter changes

3Productivity

If a shutter assembly is added to the valve body to control flow, then fluid flow control is improved, but device complexity increases due to additional components

Engineering Contradiction:
Improvefluid flow controlVSAvoiddevice complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The patent applies merging by integrating the shutter assembly directly with the valve body as a unified flow control unit. The shutter is positioned within the valve body's flow path and works in conjunction with the inlet and outlet passages. This combined design allows the shutter assembly and valve body to function together as a single flow control mechanism, improving fluid flow control while minimizing the increase in overall device complexity through functional integration.

Inventive Principle:
Principle #5Merging (Combining)

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 solution effectively prevents uncontrolled or reverse free flow of insulin, ensuring reliable and controlled delivery by ensuring the pump pressure always exceeds the maximum differential pressure, thus maintaining consistent fluid administration.

Implementation Method 1

a spring element (3) having a predefined spring force in a closing direction for the shutter assembly (2, 12)

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

a spring element (3) having a predefined spring force in a closing direction for the shutter assembly (2, 12)

Methodology Applied
Scientific EffectSpring force: Spring

Implementation Method 3

a membrane (70) which is stretched over the cone (66)

Methodology Applied
Scientific EffectElastic deformation: Elasticity

Data Source

PatentEP2218476B2Leaf spring valve and cone membrane valve
Publication Date: 2022.03.16 F HOFFMANN LA ROCHE & CO AG
  • EP2218476B2 patent drawingFigure 1
  • EP2218476B2 patent drawingFigure 2~4
  • EP2218476B2 patent drawingFigure 3

AI summary

A delivery device for a fluid, preferably a liquid fluid such as insulin, comprising: a tank (110; 210) for the fluid; a fluid delivery device (100; 200) which delivers the fluid from the tank (110; 210); a valve body (1; 53) comprising an input hole (4; 63) and an output hole (8; 58); an infusion set (120; 220) in order to guide the fluid from the tank (110; 210) to a distal end of the delivery device, wherein the delivery device further comprises a shutter assembly (2, 3; 70) which is or can be mounted to the valve body (1; 53) and prevents the fluid from flowing inside the infusion set (120; 220) when the fluid exhibits a pressure which is lower than a predefined pressure.