Insulin Delivery Sensor Assembly for Concentration Verification

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Solution Overview

Problem

Insulin delivery devices that accommodate various insulin concentrations face the risk of user error in setting adjustments, leading to potential over-dosing or under-dosing, which can cause serious health issues like hypoglycemia or hyperglycemia.

Innovation Solution

A sample analyzer with a sample receiving region and analytical reagent that reacts with a fluid sample to modify its color, allowing a detector to determine the insulin concentration, and signal processing components to provide an indication for proper device setting adjustments.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If insulin delivery devices accommodate various insulin concentrations (U100, U200, U500, U1000), then the device versatility is improved, but the risk of user error in setting adjustments increases

Engineering Contradiction:
Improvedevice compatibility with multiple insulin concentrationsVSAvoidaccuracy of pump settings
Core Design Contradiction:
Adaptability or versatilityVSReliability

Solution Approach 1:

The patent implements a feedback mechanism where the sensor assembly continuously monitors the actual insulin concentration in the reservoir and provides real-time feedback to the control system. This allows the device to automatically detect and correct setting errors, ensuring that the pump delivers the correct dosage regardless of which insulin concentration is loaded. The feedback loop compares expected vs. actual concentration and adjusts delivery parameters accordingly.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system performs self-verification by automatically detecting the insulin concentration without requiring user input or manual configuration. The sensor assembly autonomously measures the concentration, and the control system automatically configures the delivery parameters based on the detected value, eliminating the need for users to manually adjust settings and reducing human error.

Inventive Principle:
Principle #25Self-service

2Adaptability or versatility

If users manually adjust pump settings for different insulin concentrations, then the device can accommodate various concentrations, but the complexity of operation increases

Engineering Contradiction:
Improveability to use different insulin concentrationsVSAvoidsimplicity of pump setting adjustment
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The system automatically detects the insulin concentration using the sensor assembly and configures the pump settings without requiring user intervention. The device performs self-configuration by reading the concentration from the reservoir and automatically adjusting delivery parameters, making the device as easy to operate as simply loading the reservoir.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent replaces manual mechanical adjustment of pump settings with an automated sensing and control system. Instead of users physically adjusting dials or buttons, the electronic sensor assembly optically detects concentration and the control system electronically configures the pump, substituting manual mechanical operations with automated electronic control.

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

3Reliability

If a sensor assembly is added to determine analyte concentration, then the reliability of insulin delivery is improved, but the device complexity increases

Engineering Contradiction:
Improveaccuracy of insulin concentration determinationVSAvoidnumber of components in medicament delivery device
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The sensor assembly is designed to perform multiple functions: it detects insulin concentration, verifies the loaded medicament type, and provides data for dosing calculations. This multi-functionality reduces the need for separate verification devices and integrates concentration determination into the existing pump system, minimizing the increase in overall device complexity.

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

Solution Approach 2:

The patent integrates the sensor assembly with the existing pump structure, combining the concentration detection function with the delivery system. The sensor assembly is positioned within the reservoir housing and shares the same control electronics and power supply, merging multiple functions into a single integrated device rather than adding a separate standalone unit.

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

Ensures accurate insulin concentration determination, reducing the risk of over- or under-dosing by enabling non-invasive, miniaturized, and portable insulin delivery devices with improved safety and efficacy.

Implementation Method 1

The analytical reagent is configured to react with the fluid sample to modify a color of the fluid sample

Methodology Applied
Scientific EffectColorimetric reaction:

Implementation Method 2

a sensor assembly with a detector configured to determine the color of the reacted fluid sample

Methodology Applied
Scientific EffectColor detection:

Data Source

PatentEP4667913A1Medicament delivery devices with a sensor assembly for determining analyte concentrations
Publication Date: 2025.12.24 MEDTRONIC MINIMED INC
  • EP4667913A1 patent drawingFigure 1~2
  • EP4667913A1 patent drawingFigure 3
  • EP4667913A1 patent drawingFigure 4

AI summary

Systems and methods for determining medicament concentrations within medicament delivery devices are disclosed. A medicament delivery device can include a fluid path comprising a reservoir in fluid communication with an outlet port, in which the device is actuatable to drive fluid through the fluid path, from the reservoir and out of the outlet port. A sample receiving chamber of the delivery device is configured to receive a fluid sample from the fluid path. The sample receiving chamber includes an analytical reagent configured to react with the fluid sample to modify the color of the fluid sample. A sensor assembly of the delivery device includes a detector configured to determine the color of the reacted fluid sample and one or more signal processing components configured to provide an indication of the analyte concentration in the fluid sample based at least in part on the color determination.