Occlusion Detection in Infusion Pumps Using Real-Time Pressure Signals

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Solution Overview

Problem

Current methods for detecting occlusions in portable infusion pumps are slow and unreliable, leading to potential life-threatening delays in medicament delivery and overdose risks, especially in continuous subcutaneous insulin infusion treatments.

Innovation Solution

A method and device using real-time evaluation of fluid pressure signals, combined with signal processing algorithms like the Page-Hinkley stopping rule and cumulative sum tests, to quickly detect occlusions, with optional integration into insulin pump firmware and use of pressure sensors like piezoresistive Wheatstone bridges.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If motor current measurement and force sensor threshold comparisons are used for occlusion detection, then the system can detect occlusions, but the detection delay is long and the system is complex

Engineering Contradiction:
Improveocclusion detection accuracyVSAvoiddetection delay
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent replaces mechanical measurement systems (force sensors, motor current measurement) with a pressure-based detection system. A pressure sensor measures fluid pressure directly in the infusion line, and an evaluation unit processes pressure signal changes to detect occlusions. This substitution enables faster detection response because pressure changes occur immediately when occlusion happens, without the slow mechanical response and threshold comparison delays of the previous system.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

2Reliability

If threshold values are set high to avoid incorrect detections, then false alarms are reduced, but detection sensitivity decreases and detection delay increases

Engineering Contradiction:
Improvedetection accuracyVSAvoidocclusion detection sensitivity
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent implements continuous pressure monitoring with real-time signal evaluation that provides feedback about the infusion system state. The evaluation unit continuously compares current pressure values with reference values and detects deviations indicating occlusion. This feedback mechanism allows the system to maintain high detection sensitivity by immediately responding to pressure changes, while maintaining reliability through continuous monitoring and comparison rather than relying on high static thresholds.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system establishes reference pressure values during normal operation before occlusion occurs. These reference values are stored and used as a baseline for detecting occlusion events. By having preliminary reference data available, the system can quickly compare current pressure readings against known normal values, enabling sensitive and rapid occlusion detection without requiring high thresholds that would reduce sensitivity.

Inventive Principle:
Principle #10Preliminary action

3Loss of time

If all influencing variables are controlled in narrow limits to reduce detection delay, then detection speed improves, but device complexity and cost increase

Engineering Contradiction:
Improvedetection delayVSAvoidcontrol system complexity
Core Design Contradiction:
Loss of timeVSDevice complexity

Solution Approach 1:

The patent extracts and isolates pressure measurement as the single key parameter for occlusion detection, removing the need to control multiple influencing variables. By focusing solely on pressure signal changes in the infusion line, the system eliminates the complexity of controlling friction, gear mechanism variations, and other mechanical variables that affected previous force-based systems. This extraction of the essential detection parameter simplifies the control system while maintaining fast detection response.

Inventive Principle:
Principle #2Taking out (Extraction)

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

This approach significantly reduces occlusion detection time, enhancing patient safety by allowing quicker intervention and reducing the risk of overdose, even at higher insulin concentrations, and enabling the use of smaller, more discreet pumps.

Implementation Method 1

use of pressure sensors like piezoresistive Wheatstone bridges

Methodology Applied
Scientific EffectPiezoresistive effect: Piezoresistive Effect

Data Source

PatentUS7881883B2Device and method for the detection of an occlusion
Publication Date: 2011.02.01 ROCHE DIABETES CARE INC
  • US7881883B2 patent drawing
  • US7881883B2 patent drawing
  • US7881883B2 patent drawing

AI summary

A method for detecting occlusions including providing a signal that characterizes a conveying status of a fluid, and determining from a difference between two such signals whether an occlusion has occurred. The invention encompasses a device for detecting an occlusion including a sensor for sensing a fluid flow parameter and/or an operational parameter of the device and an evaluation unit for processing the output of the sensor.