Infusion Pump Pressure Sensor for Fill and Occlusion Detection

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Solution Overview

Problem

There is a need for reliable infusion pumps that can accurately monitor and manage the delivery of therapeutic fluids, particularly insulin, to ensure the fluid remains effective and safe for the patient by preventing degradation and occlusions.

Innovation Solution

The infusion delivery device incorporates a pressure sensor to detect fill events, calibrate mechanical compliance, and monitor for occlusions, using a processor to manage operations based on pressure data to prevent device use when therapeutic fluid degradation is likely, ensuring safe and effective delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a pressure sensor is used to detect fill events and monitor operations, then measurement precision and reliability are improved, but device complexity increases

Engineering Contradiction:

Improvefill event detection accuracyVSAvoidinfusion device structure

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The pressure sensor serves multiple functions: detecting fill events, monitoring occlusions, and tracking therapeutic fluid delivery. This multi-functionality improves measurement precision across different operational phases while minimizing the addition of separate sensing components, thereby limiting the increase in device complexity.

Inventive Principle:

Principle #6Universality (Multi-functionality)

Solution Approach 2:

The pressure sensor provides continuous feedback to the processor, which adjusts pump operations based on pressure readings. This feedback mechanism enables precise detection of fill events and occlusions while allowing the system to self-regulate, reducing the need for additional control components and mitigating the complexity increase.

Inventive Principle:

Principle #23Feedback

2Reliability

If pressure monitoring is implemented to detect occlusions and degradation, then reliability is improved, but use of energy increases

Engineering Contradiction:

Improvetherapeutic fluid delivery safetyVSAvoidpressure sensor operation

Core Design Contradiction:

ReliabilityVSUse of energy by moving object

Solution Approach 1:

The pressure sensor operates periodically rather than continuously, taking measurements at key phases such as during filling, during pump operation at intervals, and when occlusion detection is needed. This periodic operation maintains reliable detection of fill events and occlusions while significantly reducing energy consumption compared to continuous monitoring.

Inventive Principle:

Principle #19Periodic action

Solution Approach 2:

The system uses the existing pump operation and fluid flow to generate the pressure conditions needed for sensing. The act of pumping itself creates the pressure variations that the sensor detects, meaning the system's normal operation provides the conditions for self-monitoring without requiring additional energy-intensive active sensing mechanisms.

Inventive Principle:

Principle #25Self-service

3Reliability

If the system prevents operation when fluid degradation is likely, then reliability is improved, but productivity decreases

Engineering Contradiction:

Improvepatient safetyVSAvoidinfusion delivery availability

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The system performs preliminary detection of fill events and monitors for early signs of degradation or occlusion before they compromise patient safety. By detecting issues in advance and preventing operation only when necessary, the system maintains high productivity during normal operation while ensuring reliability when problems are detected.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The system replaces mechanical or manual checking methods with electronic pressure sensing and automated processor-based decision-making. This substitution enables more precise and reliable detection of degradation conditions, allowing the system to maintain productivity by preventing operation only when truly necessary rather than using conservative mechanical safety margins.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

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 system effectively prevents the use of degraded therapeutic fluids and detects occlusions, enhancing patient safety and ensuring accurate delivery of medications.

Implementation Method 1

at least one pressure sensor interfacing at least one of the fluid reservoir or the fluid path

Methodology Applied

Scientific EffectPressure sensing:

Data Source

PatentUS20250213790A1Systems and Methods for Monitoring Operations of an Infusion Delivery Device Using a Pressure Sensor

Publication Date: 2025.07.03 INSULET CORP

AI summary

The present disclosure relates to devices, systems and processes for delivering therapeutic fluids. Embodiments disclosed herein are directed to medical devices for housing a therapeutic fluid, and methods and systems for monitoring in an infusion delivery device, using a pressure sensor of the device, one or more of: (A) fill event detection; (B) fill volume detection; (C) mechanical compliance calibration/air detection of an infusion management system after fill event and priming; (D) occlusion detection after removal of insertion seal assembly; (E) detecting fluid path deployment of an infusion delivery device; (F) monitoring for occlusion detection during pump use; and (G) detecting an empty reservoir.