Needle Assembly Fluid Flow Sensor for Occlusion Detection

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Solution Overview

Problem

Small gauge needles used in drug delivery devices are prone to clogging due to drug solidification, posing safety and efficacy risks, as they can lead to accidental injection of solidified drug and insufficient dosage.

Innovation Solution

Incorporating a fluid flow sensor within the needle assembly to detect occlusions and ensure proper flow, which generates indications for the user and prevents device malfunction by locking the delivery mechanism until a new needle is replaced.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If small gauge needles are used to reduce injection pain, then patient comfort is improved, but the risk of drug solidification and needle clogging increases

Engineering Contradiction:
Improveinjection painVSAvoidneedle clogging risk
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The sensor detects potential clogging conditions before they lead to complete needle occlusion, allowing the system to take preliminary action by alerting the user to replace the needle before drug solidification causes injection failures or safety issues

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The sensor provides continuous feedback on flow conditions within the needle, enabling real-time monitoring of drug flow and early detection of clogging trends, allowing the system to respond before complete blockage occurs

Inventive Principle:
Principle #23Feedback

2Object-affected harmful factors

If small gauge needles are used for drug delivery, then injection pain is reduced, but drug delivery accuracy deteriorates due to clogging

Engineering Contradiction:
Improveinjection painVSAvoiddosage accuracy
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The sensor system detects flow abnormalities before they result in incomplete dosage delivery, enabling preliminary intervention by alerting the user to replace the needle before dosage accuracy is compromised

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Continuous flow monitoring provides feedback on drug delivery status, ensuring dosage accuracy is maintained by detecting and alerting to conditions that would otherwise lead to insufficient drug delivery

Inventive Principle:
Principle #23Feedback

3Reliability

If a sensor is added to detect needle occlusion, then safety and reliability are improved, but device complexity increases

Engineering Contradiction:
Improveneedle occlusion detectionVSAvoidsensor integration
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The sensor serves multiple functions including detecting needle occlusion, monitoring flow conditions, and providing early warning for needle replacement, making the added complexity justify itself through multi-functional safety and performance monitoring

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The sensor system enables the device to self-monitor its own operational status and automatically detect conditions requiring user intervention, reducing the need for complex external monitoring systems

Inventive Principle:
Principle #25Self-service

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 identifies and mitigates the risk of clogged needles, ensuring safe and reliable drug delivery by preventing accidental injection and ensuring the correct dosage is administered.

Implementation Method 1

A sensor configured to sense a flow condition of a fluid (e.g., a drug) is provided in and/or near a needle assembly of a drug delivery device

Methodology Applied
Scientific EffectFluid flow sensing:

Data Source

PatentEP3442624B1Needle assembly and drug delivery device having such needle assembly
Publication Date: 2023.11.22 SANOFI AVENTIS DEUT GMBH
  • EP3442624B1 patent drawingFigure 1~2
  • EP3442624B1 patent drawingFigure 3~4

AI summary

Described herein are specialized needle assemblies for injection systems. One example injection system includes a needle assembly configured to removably attach to a drug delivery device and a housing configured to receive a drug cartridge. The needle assembly includes a needle configured to extend through an outlet port of the drug delivery device and establish fluid communication with the drug cartridge within the housing of the drug delivery device. The needle assembly may include a fluid flow sensor monitoring the fluid flow and/or occlusions within the needle assembly, and provide indications of an occluded or clogged needle and/or one or more indications of proper flow through the needle, e.g., non-occlusion of the needle. In some examples, the arrangement of the needle assembly includes sensors to detect an occlusion within a portion of a needle.